She had just purchased a refill of valsartan, a blood-pressure-lowering drug when she got a disturbing letter in the mail. Due to the medication being contaminated with N-nitrosodimethylamine (NDMA), a chemical that may pose a cancer risk, the U.S. Food and Drug Administration was recalling the generic medication.
This news brought great concern to Sarah as it took 2 months for her blood pressure to stabilize when her doctor put her on valsartan and since then she has developed breathing problems and lung nodules. She contacted the FDA about her condition and says no one knows for sure if valsartan is responsible. Sarah says before this, she would never even think to question whether or not her medications were safe, but now she does.
In the recent months, contaminated blood pressure and heart failure drugs have been in the media. From July 2018 to October 2019 more than a thousand lots of these drugs from approximately two dozen drug makers were recalled after unsafe levels of NDMA as well as two other potential carcinogens were discovered in FDA tests.
Meanwhile, prescription and over-the-counter versions of Zantac and generic ranitidine (drugs that are prescribed to treat stomach or intestinal ulcers) have been recalled by some drug makers after low levels of NDMA were found in many of these products. So, are your drugs tainted? How worried should you be? The FDA is still investigating. And experts all have differing opinions on what this means for the safety of America’s drugs, many of which are produced outside the U.S.
Here’s what you should know and do if a drug you take has been recalled or pulled from the drugstore shelves.
HOW CAN I CHECK FOR A DRUG RECALL?
If a prescription drug you are taking has been recalled, you may get a letter, email, or call from your pharmacy or doctor’s office. You can also call the pharmacy that fills your prescriptions or go to the FDA’s online list of recalled drugs at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls. You may also call the FDA Consumer Hotline at (888) 463-6332. To sign up for alerts for future recalls, you can go to https://updates.fda.gov/subscriptionmanagement.
WHAT INFORMATION DO I NEED TO CHECK FOR A RECALL?
You will need the drug’s generic (if it has one) and name brand, dose, manufacturer’s name, and lot number. Most of this information will be found on the label. The lot number is usually printed next to the expiration date near the label’s bar code or near the directions for use. For a drug blister pack, check the foil backing. The lot number for creams and gels may be found on the back of the tube. It is possible, though, that the lot number may be entirely missing and in this case your pharmacy can provide the information.
WHAT SHOULD I DO IF MY DRUG HAS BEEN RECALLED?
Contact your doctor or pharmacist. It is possible that your pharmacist may be able to refill your prescription with a lot that has not been recalled or with a comparable medication. They may also be able to recommend something that works in the same way if it is an over-the-counter medication.
SHOULD I STOP TAKING A RECALLED DRUG?
No. The risk of quitting a drug, even temporarily, may outweigh the risk of continuing to take it. It is best to contact your doctor or pharmacist for a replacement medication.
CAN I FLUSH A RECALLED DRUG?
No. In some cases, that could taint the ground water. Ask your pharmacist or check the FDA recall information. Often times, drugstore chains will take back the medication and give a refund.