Following is a brief summary of drugs that were either withdrawn from the market or given new warnings in recent years. Although not an exhaustive list, it demonstrates the point that FDA-approved drugs can be dangerous.
• Erectile dysfunction drugs, including: Sildenafil (Viagra) Vardenafil (Levitra) Tadalafil (Cialis) Use: Treatment of erectile dysfunction (ED). In 2007, the FDA informed doctors of reports of sudden decreases or loss of hearing following the use of these drugs.
• Thiazolidinedione class of antidiabetic drugs, including: Rosiglitazone maleate (Avandia) Pioglitazone hydrochloride (Actos) Rosiglitazone maleate and glimepiride (Avandaryl) Rosiglitazone maleate and metformin hydrochloride (Avandamet) Pioglitazone hydrochloride and glimepride (Duetact) Use: Type 2 diabetes. In 2007, the FDA requested an updated label with a boxed warning on the risks of heart failure.
• Tegaserod maleate (Zelnorm) Use: Irritable bowel syndrome and constipation. In 2007, this drug was removed from the market due to serious cardiovascular problems, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke.
• Antidepressant medications Use: Treatment of depression.
In 2007, the FDA notified the makers of all antidepressant medications to update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years during the first one to two months of treatment.
• Amphetamine with dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta) Use: Pediatric and adult attention deficit/hyperactivity disorder treatment. In 2006, a black box warning was given for cardiovascular risk.
• Pimecrolimus (Elidel) and tacrolimus (Protopic) Use: Topical eczema treatments. In 2006, these were given a black box warning after researchers found a link between these drugs and increased risk of lymphoma and skin cancer.
• Celecoxib (Celebrex) Use: Anti-inflammatory. In 2005, a boxed warning was required regarding potentially serious adverse cardiovascular events and possibly life-threatening gastrointestinal events.
• Valdecoxib (Bextra) Use: Anti-inflammatory. In 2005, this was withdrawn due to lack of data on the cardiovascular safety of long-term use of Bextra, along with increased risk of adverse cardiovascular events, possibly associated with chronic Bextra use. There also were reports of rare, but serious, potentially life-threatening skin reactions.
• Rofecoxib (Vioxx) Use: Nonsteroidal anti-inflammatory. In 2004, this drug was withdrawn due to increased risk of serious cardiovascular events, including heart attacks and strokes.
• Cerivastatin (Baycol) Use: Cholesterol-lowering. In 2001, it was withdrawn due to reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction.
• Phenylpropanolamine (PPA) and phenylpropanolamine hydrochloride (the active ingredient in PPA) Use: Ingredients in cold and cough medicines, nasal decongestants, and over-the-counter appetite suppressants and weight-loss products. In 2000, they were withdrawn due to risk of hemorrhagic stroke.
• Troglitazone (Rezulin) Use: Treatment of type 2 diabetes. In 2000, it was withdrawn due to severe liver toxicity.
• Cisapride (Propulsid) Use: Treatment of acid reflux. Serious cardiac arrhythmias (irregular heart rhythms) and cardiac arrest. In 2000, it was withdrawn from the market.