The U.S. Food and Drug Administration (FDA) is responsible for making sure medications that are approved for use in patients have been rigorously tested for both safety and effectiveness. Even so, sometimes a medication slips through the cracks or a problem with a drug is not discovered until after it is out on the market. When this happens the FDA is responsible for issuing a recall if the drug company does not issue one voluntarily. Consumers need to understand what recalls are and what to do when one is issued.
Reasons for Recalls
There are several possible reasons that a drug company or the FDA might recall a medication. The most urgent reason is that it presents a health hazard. In spite of rigorous testing, some hazards of side effects of a medication may not be obvious until the drug has been on the market and the FDA has collected reports of adverse events. Some examples include a medication that increases the risk of heart attack or stroke in those who use it.
A drug may also be recalled because it has been packaged or labeled incorrectly. The instructions or warnings may be incorrect, confusing, or incomplete, for instance. A contamination that occurs in specific lots of a drug may also be a reason for a recall. This occurred in 2012 when lots of injectable steroids were recalled after having been found to be contaminated with a fungus that caused deadly meningitis infections in some patients. Defects in purity, concentration, or quality of a drug are also reasons for a recall.
When Your Drug is Recalled
When medications are recalled the FDA issues an announcement, as do the drug companies responsible for the drug being recalled. If you hear that a medication you are using has been recalled, you should take a few steps:
- Learn more about the recall. The urge to panic when you hear of a recall may be strong, but instead, read up on the recall statement and find out if it really impacts you. It may be for a lot that does not include your medication.
- Discard the drug. If you do find that your medication has been recalled, do not take any more of it and dispose of it immediately so that no one else accidentally takes something that is harmful. You can safely dispose of a drug by mixing it into cat litter or coffee grounds and sealing it in a plastic bag. Do not flush your medication down the toilet. You can also dispose of a recalled drug by taking it back to your pharmacist.
- Contact your doctor. It is also important to call your doctor right away, especially if you used any of the recalled medication. You need to find out if you are at risk of being harmed by it, what to do next, and to get a new prescription.
Drug recalls should be taken seriously, but if you follow these steps you are not likely to be harmed or become sick from a recalled medication. It is always better to be safe than sorry, so if you are unsure if your drug is included in a recall, contact your pharmacist or doctor to find out.