The Food and Drug Administration (FDA) is the government agency tasked with regulating the safety of all the drugs, food, makeup, medical devices, dietary supplements, biological products, vaccines and supplements available in the United States. The FDA works to ensure that products are safe, wholesome, sanitary and carry the proper labels. Even though the department has been responsible for these issues since the 1906 Pure Food and Drug Act, there are occasional oversights that result in FDA recalls, including some in recent history.
1. Zelnorm (tegaserod maleate): This drug was approved for the market in 2004 to treat irritable bowel syndrome (IBS). However, when studies showed that the medication might cause heart problems, the drug was recalled by pharmaceutical company Novartis in 2007. This medication is still available for patients who had success using it before the FDA recall or those who have no other medicinal options.
2. Rezulin (troglitazone): This drug was prescribed for patients with diabetes mellitus type 2 but was recalled by the FDA after reports that the drug had damaged the livers of 35 patients by causing elevated liver enzymes. It was pulled from the market in 2000.
3. Palladone (hydromorphone): Originally created as a narcotic painkiller in a slow-release capsule, Palladone became an FDA recall in 2005. Purdue Pharma was forced to pull the drug from the market after it was shown that when mixed with alcohol the drug caused depression, halting of breath or coma.
4. Rofecoxib: This nonsteroidal anti-inflammatory drug was marketed by Merck & Co to treat osteoarthritis, acute pain conditions and dysmenorrhoea. Though originally approved by the FDA in 1999, Rofecoxib (also known as Vloxx, Ceoxx and Ceeoxx) was recalled in 2004 after concerns about long-term effects arose. The drug was withdrawn after being associated with increased risk of heart attack and stroke, and it was eventually blamed for between 88,000 and 140,000 cases of heart disease. Merck eventually disclosed that the company knew of the effects, resulting in large lawsuits.
5. Permax: Permax was voluntarily withdrawn from the market by Valeant Pharmaceuticals in 2007 after it was associated with an increased risk of blood backflow to the aortic valves. The FDA approved the drug as a way to treat Parkinson’s disease, and more than 12,000 prescriptions were written.
6. NeutroSpec (technetium fanolesomab): After the FDA issued a public health advisory on NeutroSpec in 2005, the drug was taken off the market as a diagnostic imaging agent that was used to diagnose patients with appendicitis. Patients using the drug reported shortness of breath, drops in blood pressure leading to death, and other serious complications within minutes of taking the drug. The drug was approved in 2004 after a study showed no serious health issues.
7. Bextra (Valdecoxib): After being introduced as a NSAID painkiller,
Pfizer was asked to voluntarily withdraw Bextra in 2005 from the U.S. market after the drug was found to increase the risk of serious cardiovascular problems. Other patients reported serious skin reactions. The FDA decided the benefit did not outweigh the risk and Bextra offered no real advantages over other NSAID options.
8. Tysabri (natalizumab): This drug was introduced in order to treat multiple sclerosis. However, Biogen-Idec withdrew the drug in 2005 when three patients in a clinical study developed serious brain infections. However, in 2006, Tysabri reemerged with strict guidelines for usage.
9. Baycol: Bayer marketed Baycol as a cholesterol-lowering drug starting in 1997. However, after it was found that the medication caused rhabdomyolysis — a condition that causes damaged skeletal muscle to break down — at a higher rate than similar drugs, it was recalled from the market in 2001. It was eventually blamed for 31 deaths.
10. Meridia: Weight-loss drugs seem to have a particularly bad record with FDA recalls. Meridia, approved as a weight-loss drug in 1997, was found to increase stroke, heart attack, cardiac arrest or death by 16 percent. It was pulled from the market in 2010.
Recent drug recalls demonstrate an important fail-safe in the pharmaceutical approval process. Occasionally, serious health issues caused by drugs do not appear in pre-approval trials, so it is important to have a system in place to remove drugs from the marketplace even after they have been approved.