What medications approved by the FDA have been recalled or given consumer safety warnings ... and why!

BY ASSIA MORTENSEN

A hundred thousand Americans die every year of adverse reactions to prescription drugs, according to a Journal of the American Medical Association (JAMA) report, and adverse drug reactions are the fourth-leading cause of death in the U.S. Yet approximately 20% of newly approved drugs will be issued drug recalls or will be required to include additional safety warnings over a 25-year period, JAMA estimates.

The FDA, a 102-year-old agency, is expected to regulate $1.5 trillion worth of food, drugs, vaccines, medical devices, vitamins, and much more. Critics of the agency say that it is critically understaffed and underfunded.

Worse yet, since drug company dollars pay for more than half the FDA’s drug review budget, accusations are flying about whether or not the FDA has literally “sold-out” to drug companies. The funds paid to the FDA, called “user fees,” amounting to $400 million annually—are meant to speed decisions on new drugs—and it’s certainly working in that respect. However, some say the FDA is now rushing through the approval process too fast, using data cherry-picked by drug companies, and therefore, leaving the American public at greater risk.

Here are some of the drugs that have made recent headlines due to severe health warnings or because of an FDA recall:

AVANDIA: Last year, the FDA announced that GlaxoSmithKline agreed to add a "black-box" label to Avandia warning that the drug may cause or worsen heart failure, and that patients should be closely monitored. Avandia (rosiglitazone) is approved to treat Type 2 diabetes. A "black box" label is the most severe warning a prescription drug can carry. The announcement followed a July 30 FDA advisory meeting which concluded that the data shows that Avandia increases heart risks and recommended a black-box warning.

BAYCOL: In November 2004, the FDA launched a review of its records of the August 2001 recall of Baycol, in light of recent allegations that the pharmaceutical company was aware of the risks associated with the drug, but failed to promptly inform the FDA of its findings. By the time Bayer removed the anti-cholesterol drug Baycol from the market, the estimated number of cases of the muscle destroying disease rhabdomyolysis had reached into the thousands.

HEPARIN: Heparin, the anti-blood-clotting drug used extensively throughout hospitals across the United States, has been in the news most recently because of the huge recall of the drug, supplied by the company Baxter International, in February 2008. The recalled heparin, which may be contaminated, may have caused dangerous side effects in hundreds of patients who were administered this anti-coagulant drug during their medical treatment.

KETEK: An antibiotic used to treat minor respiratory infections, like earaches, may cause liver failure in as little as five days. Ketek, made by Sanofi-Aventis, was given a black box warning after 134 cases of liver damage were reported, as well as 18 deaths. Dr. David Ross, an FDA medical reviewer said in a 2006 advisory board hearing that he was pressured by his superiors to soften his report about the drug’s link to liver toxicity so that it would be approved.

OXYCONTIN: Oxycontin, produced by Purdue Pharma, is commonly prescribed to treat arthritis, back pain, cancer, and other serious painful conditions. Oxycontin has been linked to over a hundred deaths and its addictive properties have been compared to that of heroin. At the request of the FDA the manufacturer agreed to add a black box warning calling Oxycontin as potentially addictive as morphine, and sent out letters to doctors asking them to only prescribe Oxycontin for severe pain.

VIOXX, CELEBREX, and BEXTRA: A group of painkillers called Cox 2 inhibitors have become among the best selling prescription painkillers in recent years. Popular Cox 2 inhibitor drugs include Vioxx, Celebrex, and Bextra which have been used by millions of Americans. Vioxx was recalled after analysis of various studies and company documents showed that the drug more than doubled (or even tripled) the risk of heart attacks, stroke, and other cardiovascular problems among users. The recall of Vioxx in September 2004, raised serious questions about the safety of similar medications. Later that year, the FDA recommended that doctors limit prescriptions for Celebrex and Bextra because recent studies have suggested that they may increase the risk of heart attack and stroke. The National Institutes of Health announced that it was ending a study using Celebrex because high doses of it more than tripled the risk of heart attacks and stroke among patients; moderate doses more than doubled those risks.

ZELNORM: Zelnorm (tegaserod) is a prescription drug for the short-term treatment of women with irritable bowel syndrome. The maker of the drug, Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm due to a new safety analysis, which found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack. The FDA recommended that patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.

Please consult with your doctor before making any healthcare related decisions.