Medication Safety

Understanding drug recalls and what you should do

Adrug recall is the most effective way to protect the public from a defective or potentially harmful product. It’s a voluntary action taken by a company at any time to remove a defective drug from the market. It applies to prescription as well as over-the-counter medications. Medicine is rigorously tested for safety and effectiveness before becoming available to the consumer. In the United States, the Food and Drug Administration (FDA) makes sure this happens. Once on the market, the FDA, along with the maker of the drug, continues to monitor the medicine for any unforeseen problems. Should an issue develop, or the safety of a medication come into question, a recall may be initiated.

Over the past several months, dozens of medications used to treat high blood pressure have been recalled as federal investigators discover potentially cancer-causing impurities in them. The FDA is also working to determine what exactly has caused the impurities and what changes need to be made in the manufacturing process to prevent it.

WHY DRUGS ARE RECALLED

A number of factors can cause a drug to be recalled. A recall may be issued if a medicine is:

• A health hazard—unfortunately, some health risks associated with certain medications are not realized until after they become widely used, causing severe side effects in a large group of people using them.

• Mislabeled or poorly packaged, with confusing dosing instructions.

• Potentially contaminated with a harmful or nonharmful substance.

• Not what it says.

• Poorly manufactured, with defects related to a product’s quality, purity and potency.

WHAT YOU SHOULD DO

If you are taking a recalled drug, you should continue to do so, but contact your doctor immediately. The threat from the contamination may be less than the threat from not taking the drug. Your doctor can help you find an alternative. Then consider taking the following actions:

• Get educated. To find out more about drug recalls, visit the FDA website.

• Play it safe. If you notice anything unusual with a medication or medicine bottle or wrapper, such as signs of tampering, an odd smell, or suspected contamination, notify your pharmacist before taking it, regardless of whether the drug has been recalled.

• Safely discard recalled drugs. See instructions for disposal on the medicine’s label or the package’s patient information.

• Call your doctor. If you have taken a drug that has been recalled or you have any unusual symptoms that you suspect may be linked to the medicine, call your doctor immediately.

• Above all, don’t panic. Most drug recalls are for minor issues.