Every year, the U.S. Food & Drug Administration (FDA) issues recalls and alerts for various drugs and medical devices. Unfortunately, the clinical trials that are supposed to ensure the safety of prescription medications and medical implants often fail to undercover their serious risks before they come to market. For this reason, the FDA has issued safety alerts warning of dangerous side effects associated with Byetta, Lipitor, Risperdal and other medications. Medical devices like transvaginal mesh have also been the subject of FDA warnings, while metal-on-metal hip implants and other products have been named in recalls after they had already been implanted in tens of thousands of patients.
Drug recalls can be announced by the FDA for any number of reasons. In some cases, the agency determines that the risks associated with a particular medication outweigh its benefits. Recalls have also been issued for particular lots of drugs because of manufacturing issues that result in product contamination or other problems. In 2010, for example, Johnson & Johnson’s McNeil Consumer Healthcare Unit issued a recall for Tylenol and other over-the-counter drugs because of possible contamination.
In addition to drug recalls, the FDA may announce an alert for a medication when unknown side effects become apparent. Some important FDA drug recalls and alerts issued in recent years include:
A surprisingly high number of medical devices were not subjected to human testing before they were approved for sale by the FDA. That’s because the agency allows for a streamlined process known as 510(k) clearance when a manufacturer can show that a product’s design is substantially equivalent to a device that has already received FDA approval. Unfortunately, this program has allowed some faulty medical devices onto the market, resulting in recalls and warnings years later, including: