Over-the-counter drugs have widespread safety problems, too

• · Over-the-counter drugs must have little potential for abuse or addiction.
• · The FDA must weigh whether people will be able to self-diagnose the problem, figure out the appropriate treatment and how to use it.
• A government finding that Aleve, the widely used pain reliever, appears to increase the risk for heart problems underscores how little is known about possible side effects of some common older medicines.
• Although much attention has been paid recently to drug-safety problems that have emerged in newer prescription drugs, such as Vioxx, the same scrutiny hasn't been applied to older over-the-counter medicines and prescription drugs that long ago went generic.
• Those three are so-called Cox-2 inhibitors, a new category in the broader class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDs, including Aleve.
• For years, Aleve was thought to be protective of the heart, like aspirin.
• Indeed, Merck has cited that to explain why patients taking Vioxx had more heart problems than patients taking naproxen in a clinical trial.
• Aleve's maker, Bayer AG, said the findings contradict nearly 30 years' experience of safe use of the drug.
• "People are misunderstanding that a drug is safe because it's over-the-counter," says Brian L. Strom, chair of the Department of Epidemiology & Biostatistics at the University of Pennsylvania School of Medicine.
• Besides being perceived as safe, these drugs are old and unlikely to generate blockbuster sales growth.
• Therefore the companies have little incentive to run clinical trials that would look for side effects.
• NSAIDs have long been known to raise the risk of gastrointestinal bleeding with long-term use.
• In fact, that shortcoming is what fueled the development of drugs such as Vioxx and Celebrex to relieve pain and inflammation while reducing the risk of bleeding.