There are some people who refuse to take a drug unless it's been approved by the FDA.
But sometimes the FDA is just blatantly wrong.
The FDA’s Hall of Shame
Vioxx
What it is: Vioxx is a COX-2 selective nonsteroidal anti-inflammatory (NSAID) painkiller related to drugs such as ibuprofen and naproxen.
Why it was taken off the market: The result of a clinical study showed an increased risk of serious cardiovascular events such as heart attacks and strokes.
Expiration date: Merck withdrew Vioxx from the worldwide markets in 2004.
Bextra
What it is: Like Vioxx, Bextra is an NSAID painkiller.
Why it was taken off the market: Two short-term studies indicated potential increases in cardiovascular events such as heart attacks and strokes and increased risk of serious skin reactions. The FDA also concluded that Bextra had no unique advantages over other NSAIDs. FDA scientists decided that the known cardiovascular risks of other NSAIDs demonstrated in long-term trials justified a request for withdrawal.
Expiration date: Pfizer withdrew Bextra from the U.S. market in 2005.
Zelnorm
What it is: Zelnorm is a drug to treat irritable bowel syndrome (IBS).
Why it was taken off the market: 29 studies showed that 13 of 11,614 patients taking the drug had heart problems. One of 7,031 patients on placebo experienced the problem. About 500,000 people were taking the drug at the time of its withdrawal. Novartis continues to market the drug in Europe, citing its belief that the trial results were a fluke.
Expiration date: Novartis withdrew Zelnorm from U.S. markets in March 2007. IBS patient groups objected to the withdrawal, arguing that the benefits outweighed the risks. The FDA responded to complaints from patients and physicians by creating a restricted-access program for patients that have no therapeutic alternatives or who had satisfactory outcomes on previous treatment with Zelnorm.
Tysabri
What it is: Tysabri is a drug that treats multiple sclerosis.
Why it was taken off the market: After three patients in a clinical study developed progressive multifocal leukoencephalopathy (PML, a serious brain infection), the FDA halted trials of the multiple sclerosis drug until the company could prove that no additional cases of PML had occurred.
Expiration date: Biogen-Idec withdrew Tysabri from the worldwide market in 2005. In 2006 it was allowed back on the market with a risk-minimization program with mandatory patient registration and follow-up.
NeutroSpec
What it is: NeutroSpec is an antibody labeled with a radioactive marker that was used to diagnose appendicitis in patients that show some but not all of the clinical signs of appendicitis.
Why it was taken off the market: While the agent was on the market, 17 patients who received NeutroSpec experienced life-threatening side effects soon after it was injected, including shortness of breath, low blood pressure, and cardiac and pulmonary arrest. Two patients died. About 11,000 patients received NeutroSpec while it was on the market.
Expiration date: Palatin Technologies withdrew NeutroSpec from the U.S. market in 2005.
Cylert
What it is: Cylert is a drug used to treat Attention Deficit Hyperactivity Disorder (ADHD).
Why it was taken off the market: The FDA learned of 13 reports of liver failure leading to liver transplant or death. The number of cases reported was small, but patients taking the drug had a liver failure rate of 10-25 times the rate of liver failure in the general population.
Expiration date: Abbott withdrew Cylert from the U.S. market in 2005.
Permax
What it is: Permax is a drug used to treat Parkinson’s disease.
Why it was taken off the market: Two studies confirmed previous findings that Permax is associated with increased chance of blood backflow to aortic valves of the heart. Symptoms include shortness of breath, fatigue and heart palpitations. In 2006, about 12,000 patients received prescriptions in the US.
Expiration date: In 2007, Valeant Pharmaceuticals voluntarily withdrew Permax from the U.S. market. Two other companies, Par and Teva, withdrew generic versions.
Baycol
What it is: Baycol is a cholesterol-lowering drug.
Why it was taken off the market: Reports of sometimes fatal rhabdomyolysis—a severe muscle condition. All statins cause rare cases of rhabdomyolysis, but Baycol patients experienced it at a significantly higher rate than patients on other statins. The FDA received reports of 31 deaths related to Baycol.
Expiration date: Bayer withdrew Baycol from the U.S. market in 2001.
Palladone
What it is: Palladone is a narcotic painkiller in a slow-release capsule.
Why it was taken off the market: Severe side effects were reported when Palladone was taken with alcohol. Alcohol use caused high levels of the drug in the body, with potentially fatal effects such as the depression or halting of breathing and coma.
Expiration date: Purdue Pharma withdrew Palladone from the U.S. market in 2005.
See a list of all recalled drugs since 1980