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Asbestos	PPA
Baxter Dialyzers	Prempro
Baycol	Propulsid
Celebrex	Rezulin
Ephedra	Serzone
Fen-Phen	Sulzer Hip and Knee Products
Kava	Vioxx
Meridia

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

Ephedra

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Kava

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.

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
*Nausea
*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)
*Fainting
*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)

FDA:
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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