If the FDA identifies a violation of the law it is entrusted to enforce, the agency may take action in the interest of public safety. One way the agency protects consumers from unsafe drugs and medical devices post-approval is through an FDA recall.
Drug companies and device manufacturers often go along with FDA recalls voluntarily. In some cases, however, they submit to the recall to avoid an FDA-initiated court proceeding.
Recalls are classified according to the degree of health hazard presented by the product. A Class I recall is the most serious, involving a product that is reasonably probable to cause serious adverse health consequences or death. At the other end of the spectrum, a Class III recall involves a product that is in some way not legally compliant but is not likely to cause adverse health consequences.
Notice of an FDA Recall
Typically, the FDA will issue a public warning of the danger associated with the drug or medical device. If the recalling firm plans to issue its own public warning, the FDA requests that the company submit the proposed warning and distribution plan to the agency in advance.
The recalling company is responsible for notifying its direct customers of the recall in writing, and such communications should be prominently marked as such. In the case of a Class I or Class II recall, “urgent” must be marked on the outside of the envelope.
Medical Device Recalls
You may be aware of some of these recent medical device recalls and safety advisories:
- Hip replacement devices: Various hip replacement devices have been the subject of several FDA actions, including the issuance of three separate Class II recall notices for problems ranging from mislabeling to distorted curvature to metal toxicity. In addition, concerns over complications related to metal-on-metal hip replacement kits led the FDA to require pre-market approval for two types of hip replacement mechanisms.
- Power morcellators: Power morcellators were marketed as a less invasive means of removing uterine fibroids, reducing recovery time and possibly saving the uterus of a patient who would otherwise have required a hysterectomy. However, it was discovered that the spinning action of a power morcellator could spread cancerous tissue, seeding new tumors and reducing chances of survival. Although the FDA issued a safety advisory and one company voluntarily recalled its morcellators, these devices remain in use.
- Transvaginal mesh: Some of the problems associated with transvaginal mesh include excessive bleeding, infection, cutting through the vaginal walls, and eroding into other organs. Despite a significant push by consumer health advocates and tens of thousands of lawsuits, there has been no widespread recall of transvaginal mesh. The FDA has reclassified the product and strengthened clinical requirements.
- Vioxx: Vioxx was approved by the FDA in 1999. By the time the drug was withdrawn from the market in 2004, at least 38,000 deaths were tied to its use. The drug and related lawsuits drew significant media attention, as evidence suggested that the manufacturer had been aware of the associated risk of heart failure and concealed adverse data even as patients were dying.
- Actos: Popular diabetes drug Actos has been linked to bladder cancer, heart failure, and blindness. The FDA hasn’t issued a recall, though the agency is monitoring ongoing post-market studies. The drug was recalled in France and Germany in 2011.
- Accutane: The acne drug Accutane has been linked to severe bowel problems, but it has never been recalled in the United States. Original manufacturer Roche voluntarily ceased production in 2009 amid a growing number of lawsuits, but generics remain available today.
- Xarelto: In 2011, the FDA approved the blood thinner Xarelto for marketing despite concerns about data integrity. The agency issued three post-market requirements, but the following year expanded approved uses. In 2013, Johnson & Johnson was found to have violated advertising regulations by downplaying the side effects of the drug, and additional warnings were ordered in 2014. The drug remains on the market.
- Risperdal: The antipsychotic drug Risperdal has been tied to side effects ranging from weight gain and abdominal pain to movement disorders and male breast enlargement. Despite thousands of lawsuits and several multi-million dollar verdicts, Risperdal has not been recalled.
Some recent key drug actions include:
Drug Safety and the FDA
Unfortunately for consumers, FDA approval doesn’t automatically mean that a drug or medical device is safe, and evidence of significant risks isn’t always sufficient to trigger an FDA recall.