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Dallas class action lawyers fight for the rights of individuals suffering personal injury. Find a Dallas class action lawyer or class action law firm at Dallas Texas Lawyers, and have a Dallas class action attorney fight for you. You need a Dallas lawyer experienced in class action lawsuits. Note that not all Dallas class action attorneys listed are Board Certified by the Texas Board of Legal Specialization. For more information on class actions, click here. This web site is not intended as a source for legal advice. If you need legal assistance, please consult with an attorney.

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Class action lawsuits

Christian Hill And Associates - Houston Personal Injury Lawyer. At Christian Hill & Associates we care about you and your well being. Here, you are not just a case number.
Street & Ragsdale - Dallas Personal Injury Lawyers. Dallas law firm Street & Ragsdale has more than 37 years experience handling personal injury and wrongful death cases. 
Law Offices of Jeff Rasansky - Dallas personal injury lawyer Jeff Rasansky goes to work each morning with one mission in mind: to fight for the rights of personal injury victims.
Polewski & Associates - Dallas Personal Injury Law Firm. At Polewski & Associates, we represent clients in all types of personal injury, malpractice and wrongful death lawsuits.
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Class Action Information:

Baxter Dialyzers

November 7, 2001 - U.S. Food and Drug Administration (FDA) (website)

The FDA is investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by certain dialyzers made by Baxter Healthcare Corporation (website) , Deerfield, Ill.

Baxter voluntarily recalled the dialyzers (Baxter recall notice) in mid-October after reports of deaths associated with its product in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the U.S. The U.S. deaths occurred at dialysis facilities in Austin, Tex., and Kearney, Neb. Most of the dialysis patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed.

Preliminary tests have led Baxter to conclude that a perfluorohydrocarbon-based performance fluid used in a manufacturing step may have played a role in the deaths of these patients (Baxter news release). Confirmatory tests are underway. Baxter reports that it has permanently ceased manufacturing these dialyzers. No dialyzer shortage is anticipated as a result of Baxter's decision.

The following dialyzers--labeled either Althane or Baxter--were recalled:

* Series A11, A15, A18 and A22
* Series AF150, AF180 and AF220
* Series AX1500 and AX2200

The products were distributed from January 1998 to October 15, 2001, to dialysis facilities in more than 50 countries. The first reported deaths occurred in Spain in mid-August.

If you would like to contact Baxter you can either call the Center For One Baxter at 1-800-422-9837 or 847-948-4770 (Monday through Friday, 8:00 a.m. to 5:00 p.m. CST)


FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney ...

USATODAY.com - Baxter recalls kidney filters after deaths

CNN.com - Dialysis product may be behind patient deaths ...

NY Times Article: Baxter Dialyzer Recall


From National Institute on Safety and Health - NIOSH (website)
Asbestos is defined in Federal regulations as the minerals chrysotile, crocidolite, amosite, tremolite asbestos, actinolite asbestos, and anthophyllite asbestos. These six minerals are regulated by the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA) and the Environmental Protection Agency (EPA).

Serious Risk and Ongoing Exposure

Workplace exposure to asbestos remains a serious occupational health problem in the United States, with both vast numbers of workers at risk due to past occupational exposures and many other workers experiencing ongoing occupational exposures. As many as eight million workers have been exposed to asbestos. In 1991, NIOSH estimated that nearly 700,000 workers in general industry remained potentially exposed to asbestos, but that estimate did not include mining, railroad work, agriculture, and several other industry sectors.

The U.S. Geological Survey reports that asbestos continues to be imported for use in friction products (e.g., brakes and clutches), roofing products, gaskets, and thermal insulation. Construction workers involved in the renovation or demolition of buildings that contain asbestos are at particular risk of asbestos exposure. Many workers in the relatively new asbestos removal industry are potentially exposed. Industrial maintenance personnel are also at risk when they repair equipment, sometimes in enclosed spaces, that is insulated with asbestos-containing material, as are automotive service personnel involved in brake and clutch repair work.

In addition, "take-home" exposures – involving family members of workers who bring asbestos home on their hair, clothing, or shoes – is also a well-recognized hazard and was addressed in a 1995 NIOSH report to Congress (Report).

Substantial Deaths

Deaths associated with asbestosis increased from fewer than 100 annually in 1968 to more than 1200 per year in 1998.

Asbestos-Related Diseases

asbestosis – a disease characterized by scarring of the alveolar regions of the lungs

lung cancer – for which asbestos is one of the leading causes among nonsmokers, and which occurs at dramatically high rates among asbestos-exposed smokers

malignant mesothelioma – a cancer of the tissue lining the chest or abdomen for which asbestos and similar fibers are the only known cause

nonmalignant pleural disease – which can appear as a painful accumulation of bloody fluid surrounding the lungs, but which more commonly is seen as thick and sometimes constricting scarring of the tissue surrounding the lungs.

In addition, asbestos exposure is associated with excess mortality due to cancer of the larynx and cancer of the gastrointestinal tract. The malignant diseases – the cancers including mesothelioma – are often fatal within a year or a few years of initial diagnosis. In contrast, asbestosis deaths typically occur only after many years of suffering from impaired breathing.

Symptoms: Asbestosis (chronic exposure): dyspnea (breathing difficulty), interstitial fibrosis, restricted pulmonary function, finger clubbing; irritation eyes; [potential occupational carcinogen]

Occupations at Risk:

insulation workers; plumbers; sheet metal workers; plasterers; heating/air-conditioning/refrigeration mechanics; electricians; welders; chemical technicians; mechanics and repairers; stevedores; masons; furnace and kiln operators; painters; construction workers; and janitors and cleaners.

Industry sectors at Risk:

ship and boat building and repairing, nonmetallic mineral products; construction materials and industrial chemicals; petroleum refining; tires and other rubber products; aluminum production, hardware, plumbing, and heating supplies; construction; electric power generation; railroads; glass products; building material retailing; paper manufacturing; and steelmaking.

Asbestos Links

State-wide asbestos check urged

Asbestos scare forces school evacuation

Is there asbestos in your house?

ACE Boosts Asbestos Reserves by $2 Billion

Insurers accused of shirking liability to asbestos victims

WR Grace documented asbestos dust

Former foundry workers earn settlement in asbestos lawsuit

Austin American Statesman ABA Confronts Asbestos Lawsuit Limits

Battle Builds in Texas Legislature over Asbestos Litigation

Is there asbestos in your house?

Lawsuits may not be over in asbestos-related case

(More Asbestos Information) (Return to top)

Baycol (cerivastatin) Bayer Pharmaceutical Division (website)

On August 8, 2001 , the FDA (website) (Baycol info. page) today announced that Bayer Pharmaceutical Division (website) is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.

Baycol, which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.

Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund.

Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.

Baycol Links

MDL 1431 - Baycol Product Liability Litigation

Federal Court Orders Expedited Case Management Schedule in Baycol Products Litigation, MDL 1431

CNN.com - Bayer: Baycol anti-cholesterol drug linked to 52 deaths

Bayer Facing 7400 Baycol Suits

Cholesterol drug damaged woman, she says

FDA Safety-Based Drug Withdrawals, 1997-2001

Bayer Facing 7400 Baycol Suits

Cholesterol drug damaged woman, she says

Bayer faces more suits

Germany's Bayer Faces Drug Lawsuits

Celebrex (celocoxib capsules) (website) Pfizer (website)

FDA (website) Special Warnings with Celebrex:

Celebrex (website) and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get: 

* a burning stomach pain 
* black bowel movements that look like tar 
* vomit that looks like blood or coffee grounds 

Celebrex and other NSAID medicines can cause serious allergic reactions that include swelling of the face, lips, tongue or throat. These allergic reactions may cause problems with breathing, swallowing, and wheezing. Serious allergic skin reactions have also happened. 

General Precautions with Celebrex:

Celebrex and other NSAID medicines can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If these happen, stop taking Celebrex and call your health care provider right away. 

Celebrex and other NSAID medicines can cause serious kidney problems that include sudden kidney failure or worsening of kidney problems that you already have. 

Celebrex and other NSAID medicines can cause fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure. 

What are some possible side effects of Celebrex? (This is NOT a complete list of side effects reported with Celebrex. Your health care provider can discuss with you a more complete list of side effects.)  

In addition to the serious side effects listed above, some common, but less serious side effects with Celebrex include: 

* headache 
* indigestion 
* upper respiratory tract infection (a "cold") 
* diarrhea 
* sinus inflammation 
* stomach pain 
* nausea 

Who should not take Celebrex?

Do not take Celebrex if you: 

* have had an allergic-type reaction to sulfa medicines 
* have had asthma, hives or allergic-type reactions after taking aspirin or other NSAID medicines 
* are allergic to Celebrex or to any of the ingredients in Celebrex 

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAID medicines have happened in aspirin-sensitive patients, aspirin-sensitive patients should not take Celebrex. 

Celebrex Links

Celebrex shows 5 pct risk of ulcer bleeding-study

Celebrex Study Fuels Debate Over Painkiller Side Effects

Celebrex effectiveness called into question

Study Casts Doubt on Celebrex's Anti-Ulcer Properties

Study questions effectiveness of Celebrex at blocking bleeding ...

Costrini: Greater caution advised with popular arthritis ...

JAMA concludes Celebrex potentially causes acute pancreatitis ...

Celebrex Study Fuels Debate Over Painkiller Side Effects

Celebrex effectiveness called into question

Concerns About Popular Arthritis Drugs


The Food and Drug Administration (website) is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstacy," because these products pose significant health risks to consumers. These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart.

Consumers who have been injured or suffered an adverse effect after taking a dietary supplement or any product containing an ephedrine alkaloid should call 1-800-FDA-4010. Health professionals who have treated patients suffering from an adverse event to these products are urged to report the event to the FDA's MedWatch adverse event and product problem hot line at 1-800-MEDWATCH.

The FDA is also warning of the increasing promotion of various dietary supplement-type products as "natural" herbal alternatives to the prescription drug combination commonly known as "fen-phen." So-called "herbal fen-phen" products are being marketed over the internet and through weight loss clinics, print ads and retail outlets as natural alternatives to the prescription drugs phentermine and fenfluramine (commonly referred to as "fen-phen"). FDA considers these products to be unapproved drugs because their names reflect that they are intended for the same use as the anti-obesity drugs, fenfluramine and phentermine.

The agency is warning consumers that these unapproved drugs have not been shown to be safe or effective and may contain ingredients that have been associated with injuries. Two anti-obesity drugs, fenfluramine (brand name Pondimin) and dexfenfluramine (brand name Redux), have been withdrawn from the marketplace because of safety concerns. FDA believes the use of unapproved alternative products may increase as a result of the withdrawal. Herbal fen-phen products contain none of these prescription drugs.

The main ingredient of most herbal fen-phen products is ephedra, commonly known as Ma Huang. Ephedra is an amphetamine -like compound with potentially powerful stimulant effects on the nervous system and heart. FDA has received and investigated more than 800 reports of adverse events associated with the use of ephedrine alkaloid-containing products since 1994. These events ranged from episodes of high blood pressure, heart rate irregularities, insomnia, nervousness, tremors and headaches to seizures, heart attacks, strokes and death.

"We will move as aggressively as the law and the science allow us to protect the public from the potential dangers of ephedra and other products, including taking actions to stop unlawfully marketed drug products." Today's actions do not preclude further measures that may be taken in response to the findings of a review of ephedra that is currently being conducted by the Rand Corporation.

Also, in a letter to the FDA, Thomas N. Tiedt, Ph.D., of the Med-Tox group, concludes "IRB's are primed for a collision, and inevitably will sued by plaintiffs damaged by the IRB approvals based on falsified information" (read more - pdf)

Ephedra Links

The Public Citizen Health Research Group, representing 135,000 members, petitions the Food and Drug Administration (FDA) to ban the production and sale of dietary supplements containing ephedrine alkaloids (here)

Public Citizen’s Health Research Group Concerning HHS Failure to Ban Ephedra or Issue Adequate Warnings (here)

AF Surgeon General: Risks of ephedra outweigh benefits...

FDA/CFSAN Dietary Supplements: Ephedrine Alkaloids

Adverse Event Reports Associated with the Use of Dietary Supplements Containing Ephedrine Alkaloids (here)

FDA Proposes Safety Measures for Ephedrine Dietary Supplements

Adverse Events with Ephedra and Other Botanical Dietary Supplements

Ephedra `food supplement' manufacturer, marketer and distributor records revealed in litigation... The intentional adding of dangerous drugs and controlled substances to food supplements typically made from poorly-defined materials from unknown and unregistered suppliers for sale to misled consumers appears to be exemplify an insidious form of bioterrorism. (more)

Ephedra caused many poison calls

Herbal stimulant 'should be banned'

To report Ephedra side effects go here


FDA (website) The U.S. Department of Health and Human Services today (1997) issued preliminary recommendations for the medical management of people who took the diet drugs fenfluramine or dexfenfluramine. The recommendations, published in the November 14 issue of Morbidity and Mortality Weekly Report, were developed jointly by the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health. "Since these drugs were withdrawn from the U.S. market last September, many people who took them have been asking what they should do, "said FDA's lead deputy commissioner Michael Friedman, M.D. "We in the government, together with the medical community,have developed these recommendations to provide guidance based on the best information we have at this time." The recommendations are based on current knowledge about the association of these drugs with the development of heart valvular disease. The valvular damage can cause regurgitation--a backflow of blood into a heart chamber--that may in some cases lead to heart and lung disease. Of immediate concern for patients with valvular disease is the possible increased risk of bacterial endocarditis--an often serious and potentially fatal infection of the heart's lining--following certain invasive medical and dental procedures. Until more complete information is available, HHS recommends the following measures for people who have taken fenfluramine ordexfenfluramine.

* Anyone who has taken fenfluramine or dexfenfluramine for any period of time, either alone or with another drug or drugs, should see their doctor for a medical history and physical
examination to determine whether there are signs or symptoms of heart or lung disease.

* Anyone who has taken these drugs for any period of time, either alone or with another drug or drugs, who has signs or symptoms of heart or lung disease, such as a new heart murmur or shortness of breath, should have an echocardiogram performed.

* An echocardiogram should be strongly considered for any patient who has taken these drugs, either alone or with another drug or drugs -- regardless of whether they have signs and symptoms of the heart or lung diseases -- BEFORE having any invasive procedure for which the American Heart Association recommends antibiotic prophylactic treatment to prevent the development of bacterial endocarditis. This will provide an accurate determination of whether or not the person needs the antibiotic treatment.

These interim recommendations may be updated as new information becomes available.

On September 15, at the request of the Food and Drug Administration, Wyeth-Ayerst Laboratories and Interneuron Pharmaceuticals, which manufactured and marketed fenfluramine under the brand name Pondimin and dexfenfluramine under the brand name Redux, voluntarily withdrew these products from the market. The withdrawal was based on initial echocardiographic findings in five surveys indicating that approximately 30 percent of patients in these surveys who took these drugs had valvular abnormalities, even though most had no symptoms. This is apparently much higher than would be expected in the general population, where additional preliminary reports suggest that significant valvular regurgitation occurs in less than five percent of the general population of young and middle-aged adults in the United States.

Studies are underway and others planned to learn more about the clinical significance of these findings, the natural course of the valvular lesions (that is, whether they generally disappear, become worse, or stay the same once the drugs are stopped), and what factors, if any, may increase an individual's susceptibility to their development. More information is available on FDA's (website) and on CDC's (website)

Fen-Phen Links

FDA Announces Withdrawal Fenfluramine and Dexfenfluramine

Cardiac Valvulopathy Associated with Exposure to Fenfluramine or Dexfenfluramine

Fen-Phen Information

Fen-Phen Questions and Answers

Fen-Phen Data "FDA Analysis of Cardiac Valvular Dysfunction in Patients Treated with Appetite Suppressants"

Questions and Answers Concerning Interim Recommendations for Patients

FDA - Safety-Based Drug Withdrawals, 1997-2001

State's First Diet-Drug Case Begins

Plaintiff Testifies In Diet-Drug Court Case

New Mexico Woman Goes to Court Over Diet Drug

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The Food and Drug Administration (FDA) (website) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to the islands in the South Pacific where it is commonly used to prepare a traditional beverage. Supplements containing the herbal ingredient kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. FDA has not made a determination about the ability of kava dietary supplements to provide such benefits.

Liver-related risks associated with the use of kava have prompted regulatory agencies in other countries, including those in Germany, Switzerland, France, Canada, and the United Kingdom, to take action ranging from warning consumers about the potential risks of kava use to removing kava-containing products from the marketplace. Although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk.

Kava-containing products have been associated with liver-related injuries – including hepatitis, cirrhosis, and liver failure -- in over 25 reports of adverse events in other countries. Four patients required liver transplants. In the U.S., FDA has received a report of a previously healthy young female who required liver transplantation, as well as several reports of liver-related injuries.

Given these reports, persons who have liver disease or liver problems, or persons who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements.

Consumers who use a kava-containing dietary supplement and who experience signs of illness associated with liver disease should also consult their physician. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.

FDA urges consumers and their health care professionals to report any cases of liver and other injuries that may be related to the use of kava-containing dietary supplements. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet (here).

The presence of kava in a supplement should be identified on the product label in the "Supplement Facts" box. The following are commonly used names for kava:

* ava
* ava pepper
* awa
* intoxicating pepper
* kava
* kava kava
* kava pepper
* kava root
* kava-kava
* kawa
* kawa kawa
* kawa-kawa
* kew
* Piper methysticum
* Piper methysticum Forst.f.
* Piper methysticum G. Forst.
* rauschpfeffer
* sakau
* tonga
* wurzelstock
* yangona

FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury. The agency's investigation includes attempting to determine a biological explanation for the relationship and to identify the different sources of kava in the U.S. and Europe. The agency will alert consumers, and if warranted, take additional action as more information becomes available.

Also, FDA informs healthcare professionals that products containing herbal extracts of kava have been implicated in Europe in at least 25 cases of serious liver toxicity including hepatitis, cirrhosis, and liver failure. Products containing herbal extracts of kava have been implicated in cases of serious liver toxicity in Germany and Switzerland. Approximately 25 reports of hepatic toxicity associated with the use of products containing kava extracts have been reported in these countries. Serious hepatic adverse effects include hepatitis, cirrhosis, and liver failure. At least one patient required a liver transplant. Based on their assessment of the adverse events reported to them, the regulatory authority in Switzerland has prohibited the sale of products containing the kava extract associated with the adverse effects. Last month, the German authorities issued a proposal to remove all kava extract-containing products from the market.

FDA is investigating whether the use of kava-containing dietary supplements in the United States poses similar public health concerns. The agency has received several reports of serious injury allegedly associated with the use of kava-containing dietary supplements, with at least one report of hepatic failure requiring liver transplantation in a previously healthy young female.

Dietary supplements containing kava are promoted for a variety of uses, including relaxation (e.g., to relieve stress, anxiety, and tension), insomnia, and postmenstrual syndrome (PMS). The products are marketed to all segments of the population, including children, women, men, and the elderly.

Due to the potentially serious nature of these concerns, we urge you to report any cases of hepatic toxicity that you think may be related to the use of kava-containing dietary supplements. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by telephone (1-800-332-1088) or through the Internet (here). (more)

Kava Links

FDA/CFSAN Consumer Advisory: Kava (more)

It is now official in the United States. The U.S. Food and Drug Administration has issued a warning about the potential for serious liver damage and toxicity, in some cases requiring liver transplant, if you use kava (more)

FDA investigating kava kava (more)

FDA information on dietary supplements (more)

Kava May Cause Liver Damage (more)

'Emotional aspirin' herb may damage the liver - Kava, an herb that's supposed to make you feel relaxed, has been banned in two European countries because of possible liver toxicity. (more)

Drugs that pose a risk to the liver Fort Worth Star-Telegram (here)

The case against kava

Feel-good kava has a down side

Herbal Remedies: Natural Does Not Mean Safe

To report Kava side effects go here

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Meridia (sibutramine hydrochloride monohydrate) Abbott Laboratories (website)

MERIDIA (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity. Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. Sibutramine produces its therapeutic effects by norepinephrine, serotonin and dopamine reuptake inhibition.

Although Meridia has been implicated in the deaths of 29 users in 3 years from apparent cardiac complications, Abbott Laboratories has not voluntarily withdrawn Meridia from the market.  Abbott Labs refutes these death claims.

Voluntary reports of adverse events temporally associated with the use of Meridia are listed below. It is important to emphasize that although these events occurred during treatment with Meridia, they may have no causal relationship with the drug. Obesity itself, concurrent disease states/risk factors, or weight reduction may be associated with increased risk for some of these events.

Body as a Whole: anaphylactic shock, anaphylactoid reaction, facial edema, fluid retention, lack of drug effect.

Cardiovascular: angina pectoris, abnormal ECG, arrhythmia, atrial fibrillation, cerebrovascular accident, chest pressure, chest tightness, congestive heart failure, heart arrest, heart rate decreased, hemorrhage, myocardial infarction, sudden unexplained death, supraventricular tachycardia, syncope, torsade de pointes, transient ischemic attack, ventricular extrasystoles, ventricular fibrillation, ventricular tachycardia.

Digestive: abnormal stools, cholecystitis, cholelithiasis, duodenal ulcer, eructation, gastrointestinal hemorrhage, increased salivation, intestinal obstruction, mouth ulcer, stomach ulcer, tongue edema.

Endocrine: goiter, hyperthyroidism, hypothyroidism.

Hemic and Lymphatic: anemia, leukopenia, lymphadenopathy, petechiae, thrombocytopenia.

Metabolic and Nutritional: hyperglycemia, hypoglycemia. Musculoskeletal: arthrosis, bursitis.

Nervous: abnormal dreams, abnormal gait, amnesia, anger, concentration impaired, confusion, depression aggravated, Gilles de la Tourette's syndrome, hypesthesia, libido decreased, libido increased, manic reaction, mood changes, nightmares, serotonin syndrome, short term memory loss, speech disorder, tremor, twitch, vascular headache, vertigo. Respiratory: epistaxis, nasal congestion, respiratory disorder, yawn.

Skin and Appendages: alopecia, dermatitis, limb pain, photosensitivity, urticaria. Special Senses: abnormal vision, blurred vision, dry eye, eye pain, increased intraocular pressure, otitis externa, otitis media, photosensitivity, tinnitus.

Urogenital: abnormal ejaculation, hematuria, impotence, increased urinary frequency, micturition difficulty.

Meridia Links

Meridia Product Information (Abbott Laboratories)

Letter to FDA Requesting ban of Meridia written by Public Citizen: Public Citizen, a nationwide consumer organization petitions the FDA to immediately ban the unacceptably dangerous prescription diet drug Meridia (sibutramine, Knoll Pharmaceuticals/Abbott). According to the FDA data base, since its launch in early 1998 sibutramine has now been associated with 29 deaths including 19 from cardiovascular adverse effects in people using this minimally effective drug. Two weeks ago, its use was suspended in Italy because of two cardiovascular deaths and its safety is currently under review in other European countries where, in the UK and France alone, there have been a total of 103 serious adverse reaction reports in people using the drug including two deaths in Britain. Prior to its approval in 1997, a FDA advisory committee voted five to four...(letter here)

A letter to Department of Health and Human Services urging them to bring criminal charges against Abbott Laboratories for illegally withholding from the FDA important information concerning eight deaths and other adverse effects of their big-selling obesity drug, sibutramine (Meridia) (letter here)

Interesting letter from Abbot Labs to FDA responding "furthermore, Abbott is confident that all confirmed fatalities reported to the company coincident with Meridia use (more)

Testimony: Yesterday, we asked for criminal prosecution of Abbott, based on an FDA inspection of the company in the last few weeks in which there was some manipulation of information on eight deaths that occurred with Meridia. There must be a major effort to prevent risk management from becoming a device to rescue and salvage drugs that should be withdrawn.  Recent examples include Lotronex, Meridia, Posicor, Rezulin, Duract and so forth (more)

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PPA (phenylpropanolamine)

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA.  In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.  

Scientists at Yale University School of Medicine recently issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project."   This study reports that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women.  Men may also be at risk.  Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA.

FDA’s Nonprescription Drugs Advisory Committee recently discussed this Yale study along with additional information on phenylpropanolamine. The Advisory Committee determined that there is an association between PPA and hemorrhagic stroke.  It recommended that PPA be considered not safe for over-the-counter use.

PPA Links

Questions and Answers about Phenylpropanolamine (PPA)

Phenylpropanolamine & Risk of Hemorrhagic Stroke: ? Final Report of the Hemorrhagic Stroke Project

Questions and Answers about Phenylpropanolamine (PPA)

Science Background Statement on Safety of Phenylpropanolamine (PPA)

FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000

Nonprescription Drugs Advisory Committee Meeting: Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products, (10/19/00)

FDA Safety-Based Drug Withdrawals, 1997-2001

PPA Being Replaced In All Drugs KXAN-TV, TX

Why is BFAD coddling big drug firms?

Woman who took Robitussin sues over brain hemorrhage

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Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) Wyeth (website)

Prempro is a medicine that contains two kinds of hormones: estrogens and a progestin. Adding progestin reduces the risk of endometrial cancer in a woman with a uterus. Because Premphase contains the same combination of hormones as Prempro, this document will only refer to Prempro.

Prempro is given to postmenopausal women with a uterus to:

* reduce hot flashes
* treat vaginal dryness, itching, and burning
* help reduce chances of getting osteoporosis (thin weak bones)

Wyeth estimates that approximately 5 million U.S. women are taking Premarin and 1.5 million are taking Prempro. Approximately 10 million postmenopausal women are taking some form of estrogen, either alone or in combination with a progestin.

The major points arising from the WHI study are:

* Postmenopausal women should not take estrogen and progestin to protect the heart.
* Estrogens and progestins may increase the risk of heart attack, stroke, blood clots and breast cancer.
* Although other doses of Prempro and other estrogens and progestins were not studied, postmenopausal women who take estrogens and progestins should also be warned about potential risks, which must be presumed to be the same.
* When these drugs are being prescribed only to prevent osteoporosis, other treatments should be considered before prescribing estrogen or estrogen with progestin.
* Estrogens and estrogens with progestins should be used at the lowest dose for the shortest duration.

The study results show that of every 10,000 women per year taking Prempro, there would be:

* 8 more cases of breast cancer
* 7 more cases of heart attacks
* 8 more cases of stroke
* 18 more cases of blood clots in the lungs and leg

Some side effects of estrogens and progestins:

Less common but serious side effects include:

* Breast cancer
* Uterine cancer
* Stroke
* Heart attack
* Blood clots
* Gallbladder disease
* Ovarian cancer

Common side effects include:

* Headache
* Breast pain
* Irregular vaginal bleeding or spotting
* Stomach cramps
* Nausea and vomiting
* Hair loss

Specific study findings for the estrogen plus progestin group compared to placebo include:
* A 41 percent increase in strokes
* A 29 percent increase in heart attacks
* A doubling of rates of venous thromboembolism (blood clots)
* A 22 percent increase in total cardiovascular disease
* A 26 percent increase in breast cancer
* A 37 percent reduction in cases of colorectal cancer
* A one-third reduction in hip fracture rates
* A 24 percent reduction in total fractures
* No difference in total mortality (of all causes)

These are not all the possible side effects of Premarin or Prempro. For more information, a health care provider or pharmacist should be consulted.

Long-term risks of Prempro in postmenopausal women include increased risks of breast cancer and thromboembolic disease associated with estrogen and combination estrogen/progestin therapy, as well as increased risk of cardiovascular disease, including myocardial infarction and stroke, in healthy women. (more)

Prempro Links

Prempro Product Information (website)

Wyeth - Prempro manufacturer (website)

NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit (here) or (here)

Systematic Evidence Reviews from the U.S. Preventive Services Task Force

JAMA article on Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women (concerns Prempro Hormone Replacement Therapy, Wyeth Ayerst, Philadelphia, Pa) (here)

Profile of the Estrogen Plus Progestin Component of the Women's Health Initiative chart (click here)

frequently asked questions about the Women's Health Initiative Estrogen Plus Progestin Study (here)

Questions and Answers for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women

Facts About Postmenopausal Hormone Therapy

NIH Postmenopausal Hormone Therapy

The Office on Women's Health, U.S. Department of Health and Human Services Office: The National Women's Health Center

FDA Office of Women's Health

FDA Fact Sheet: New Advice to Postmenopausal Women

FDA Orders Warning on All Estrogen Labels

Results of WHI Prempro Study

Menopausal Hormone Therapy

Suit filed against maker of hormone replacement drug

Mary Tyler Moore’s public service announcement about the dangers of Premarin and Prempro (requires Real Player, click here for video)

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Propulsid (cisapride) Janssen Pharmaceutica (website)

FDA, March 23, 2000:
Cisapride is a prescription drug treatment approved only for severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.

As of December 31, 1999, use of cisapride has been associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths. Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride. (more here)

FDA, May-June 2000:
The manufacturer of the prescription drug Propulsid (cisapride), Janssen Pharmaceutica Inc., Titusville, N.J., announced in March that it was voluntarily withdrawing the drug from the U.S. market. Propulsid is a prescription drug treatment for severe nighttime heartburn experienced by patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.

Propulsid has been associated with a significant number of reports of heart rhythm abnormalities and several deaths. Most adverse events have occurred while patients were taking other medications or suffering from underlying conditions known to increase risk.

Since the drug's approval in 1993, its label has been revised several times to inform health care professionals and patients about the risks. But despite these risk management efforts and additional steps that have been under consideration, the firm decided in consultation with FDA that continued prescription access to the drug poses unacceptable risks. The company will, however, continue to make the drug available to patients with severely debilitating conditions for whom the benefits may outweigh its risks, and who meet specific clinical eligibility criteria for limited access.

Patients currently taking Propulsid are urged to promptly contact their health care providers to discuss alternative treatments. Physicians who are treating patients with severely debilitating conditions are encouraged to contact Janssen at 1-800-JANSSEN.

Propulsid Links

Janssen Pharmaceutica (website)

A letter from Janssen Pharmacuetica to Doctors warning of dangers 1998 (here)

Propulsid Product Liability Litigation (MDL-1355) (Website) United States District Court Eastern District of Louisiana

Infant Death Tied to Lax Review of Propulsid (WebMD article here)

Popular Heartburn Drug Continues to Cause Deaths (WebMD article here)

Heartburn Drug Withdrawn (WebMD article here)

FDA Safety-Based Drug Withdrawals, 1997-2001

FDA Why Drugs Get Pulled Off the Market

Rezulin (troglitazone) Pfizer (Website)

The FDA asked the manufacturer of Rezulin (troglitazone), a drug used to treat type 2 diabetes mellitus, to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.

FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.

"When considered as a whole, the pre-marketing clinical data and post-marketing safety data from Rezulin as compared to similar, alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients," said Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research. "We are now confident that patients have safer alternatives in this important class of diabetes drugs," she added.

Severe liver toxicity has been known to occur with Rezulin since 1997. In consultation with FDA, Parke-Davis has strengthened the drugís labeling several times and has recommended close monitoring of liver function in patients taking Rezulin.

Rezulin Links

(Pfizer) ... Pfizer will reimburse patients for their out-of-pocket expenses for unused supplies of Rezulin® (more)

(Pfizer) ..."more than 2,000 suits involving Rezulin have been filed in federal and state courts involving approximately 5,100 Rezulin users." (more)

"Rezulin to Be Withdrawn from the Market."

Serious Liver Injury: Leading Reason for Drug Removals, ...

(American Diabetes Association) What You Should Know About the Market Withdrawal of Rezulin (Troglitazone), a Drug for Type 2 Diabetes (more)

FDA Safety-Based Drug Withdrawals, 1997-2001

Caps prompt lawsuit blitz

Drugs that pose a risk to the liver Fort Worth Star-Telegram (here)

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Serzone (nefazodone hydrochloride) (website) Bristol-Myers Squibb Company (website)

(FDA) SERZONE is a medicine used to treat depression. SERZONE is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain.

Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE.

The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 – 300,000 patient-years of SERZONE treatment. This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this.

If you get any of the following symptoms while taking SERZONE, call your doctor right away because you may be developing a liver problem:

*Yellowing of the skin or whites of eyes (jaundice)
*Unusually dark urine
*Loss of appetite that lasts several days or longer
*Abdominal (lower stomach) pain

People who currently have liver problems should not take SERZONE

The most common side effects of SERZONE are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion. Call your doctor right away if you have any of the following side effects:

*Yellowing of the skin or whites of eyes (jaundice)
*Unusually dark urine
*Loss of appetite that lasts several days or longer
*Severe nausea
*Abdominal (lower stomach) pain
*Rash or hives
*Seizure (convulsion)
*Erection that lasts too long

Serzone Links

Serzone Safety Information (Bristol-Myers Squibb)

JAMA Warning on Serzone (here)

FDA Safety Related Drug Labeling Changes (Serzone) (here) and (here)

Bristol-Myers to withdraw antidepressant in Europe

Company to Pull Antidepressant from Dutch Market

Drugs that pose a risk to the liver Fort Worth Star-Telegram (here)

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Sulzer Hip and Knee Products

Switzerland based Sulzer Medica (website) and Austin, TX based Sulzer Orthopedics (website), are now known as Centerpulse and Centerpulse Orthopedics, respectively.

CLEVELAND, OHIO.-- December 19, 2002 -- James J. McMonagle, Claims Administrator to the Sulzer Settlement Trust, announced today that the Trust is issuing payments totaling over $285,000,000 to approximately 5,500 claimants who have filed Claims arising from the implantation of certain hip and knee replacement joints manufactured by United States subsidiaries of Swiss medical device manufacturer, Sulzer (now “Centerpulse”). The Trust was created pursuant to the Class Action Settlement Agreement, which was approved by the Honorable Kathleen M. O’Malley, United States District Judge of the Northern District of Ohio in May of this year. The $1 billion Settlement, which became final after no appeals were filed, provides compensation to Class Members who qualify for benefits.

To qualify for benefits, Class Members must prove that they were implanted with one of the hip or knee replacements involved in the Settlement. These products include specific hip replacements known as an Inter-Op™ Acetabular Shell and specific knee replacements known as a Natural Knee II® Tibial Baseplate. Class Members must submit Claim Forms and medical records proving that they were implanted with the specific products, known as “Affected Products” and that they otherwise meet the criteria spelled out in the Settlement Agreement necessary to receive a payment. The range of benefits depends on whether the Class Member can prove implantation of an Affected Product, whether the Affected Product has been removed and replaced in a subsequent surgery, and whether there have been further medical complications arising from the surgery or condition.

“Today’s payment is a tribute to Judge O’Malley’s hard work in approving a Settlement that provided compensation quickly and fairly to deserving claimants,” said Eric Kennedy, lead Class Counsel with Weisman, Goldberg & Weisman Co., in Cleveland. “Claimants getting paid today have worked hard to complete their claim forms and send in all of the necessary paperwork to allow the Claims Administrator to issue a determination that they are qualified for benefits.”

The Settlement Agreement contains specific deadlines by which Claimants must act to file their Claims. For further information, contact the office of the Claims Administrator at (800) 683-1861.

Sulzer Hip and Knee Products Links

Sulzer Implant Settlement

Sulzer Implant Settlement - Important Dates

Sulzer Implant Settlement - Claim Forms

Sulzer Implant Settlement - Class Action Settlement Agreement

(Centerpulse) ... Centerpulse transfers USD 725 million to Settlement Trust; Financing of U.S. litigation successfully concluded (here)

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Vioxx (rofecoxib) Merck & Co., Inc. (website)

Vioxx is a NSAID with selective cyclooxygenase 2 (COX-2) inhibitory properties. It was approved on May 20, 1999, for the treatment of primary dysmenorrhea, for the management of acute pain in adults, and for relief of the signs and symptoms of osteoarthritis.

Vioxx is used to relieve:

* Signs and symptoms of osteoarthritis
* Acute pain in adults
* Painful menstrual cycles.

Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away

Check with your health care provider. Vioxx may not be right for you, if you:

* have had ulcers or stomach bleeding
* have had asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs
* have severe kidney problems
* have severe liver problems
* are pregnant

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.

Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you:

* retain fluids
* have high blood pressure
* have heart failure

Side effects can include:

* Upper respiratory tract infection
* Diarrhea
* Nausea
* Heartburn
* Swelling of the lower legs or feet
* High blood pressure

Rarely, serious ulcers have occurred in patients taking Vioxx.

Vioxx Links

VIOXX (website)

(Vioxx) ... Patient Product Information

Vioxx Consumer Information

JAMA Risk of Cardiovascular Events

Concerns About Popular Arthritis Drugs

Warning letter from Dept. of Health & Human Services to Merck & Co., Inc. about misleading promotional campaign and misreprentation of potential health risks associated with Vioxx. (here)

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