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Diet drugs (Fen-Phen, Pondimin, Redux)
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Diet Drug Information
Baycol (cerivastatin) Bayer Pharmaceutical Division (website)
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. 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." Cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream.
Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.
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.
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.
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.
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.
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.
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