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Product Liability — Celebrex (celocoxib capsules)

Celebrex (website), manufactured by Pfizer (website), may 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 sometimes happen suddenly in patients taking Celebrex.

Product Liability — Ephedra

Ephedra, commonly known as Ma Huang, is an amphetamine -like compound with potentially powerful stimulant effects on the nervous system and heart. The Food and Drug Administration (FDA - website) 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.

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Product Liability — Kava

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, sleeplessness, menopausal symptoms and other uses. Possible 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

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Product Liability — Meridia (sibutramine hydrochloride monohydrate) Abbott Laboratories (website)

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in the deaths of 29 users in 3 years from apparent cardiac complications, Abbott Laboratories has not voluntarily withdrawn Meridia from the market.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 death claims related to Meridia.

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Product Liability — PPA (phenylpropanolamine)

The Food and Drug Administration (FDA) removed phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. Phenylpropanolamine is an ingredient used in many over-the-counter and prescription cough and cold medications, and in weight loss products.  

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Product Liability — Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) Wyeth (website)

Prempro contains two kinds of hormones: estrogens and a progestin. 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.

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Product Liability — Propulsid

Janssen Pharmaceutica (website), the manufacturer of the prescription drug Propulsid (cisapride), announced 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. Propulsid has been associated with a significant number of reports of heart rhythm abnormalities and several deaths.

Product Liability — Rezulin (troglitazone)

The FDA asked the manufacturer, Pfizer (Website), 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 remove it. The 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.

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Product Liability — Serzone

Cases of life-threatening hepatic failure have been reported in patients treated with Serzone (nefazodone hydrochloride) (website), manufactured by Bristol-Myers Squibb Company (website). The reported death 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.

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Product Liability — Sulzer Hip and Knee Products

The Sulzer Settlement Trust issued payments totaling over $285,000,000 to approximately 5,500 claimants who 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”) (website).

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Product Liability — Vioxx

Bleeding and other serious problems from stomach ulcers are known complications in people treated with NSAIDs. Similar problems have arisen in people treated with Vioxx (rofecoxib), manufactured by Merck & Co., Inc. (website), 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. Symptoms include gnawing or burning stomach pain, black or tarry stools or vomiting. If symptoms occur, stop taking Vioxx and call your health care provider.

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