Patients should work with doctors to update medications in wake of recall

Patients affected by the recall of a common blood pressure medication should work with their doctors and pharmacists to find a substitute, an MUSC doctor says. 

Jan Basile, M.D., professor of medicine with a focus on hypertension and vice chair of clinical programs at the Council on Hypertension of the American Heart Association, said a good number of patients have been affected by the recall. 

The FDA first announced in July that certain brands and dosages of blood pressure medications with the active ingredient valsartan were contaminated with N-nitrosodimethylamine (NDMA). NDMA is a probable human carcinogen, meaning it could cause cancer.  

The first announcement covered pills made in China, but a subsequent announcement this month added brands and dosages made in a different company’s plant in India. The two companies used a similar manufacturing process, according to the FDA. The FDA is now working with other valsartan manufacturers to ensure their manufacturing processes are safe, according to a press release. 

Basile said patients shouldn’t abruptly stop taking their medications. The quantity of NDMA in the valsartan is very small, and the cancer risk is small, he said. Nonetheless, it is something that needs to be addressed, he added. 

Valsartan is a common medication now available generically, he said. It is prescribed for people with congestive heart failure and high blood pressure and for patients after a heart attack. Valsartan is often used instead of an angiotensin-converting enzyme (ACE) inhibitor. Once the manufacturing process is fixed, doctors might switch patients back to valsartan, Basile said. That is something for the patient to discuss with his or her clinician. 

The FDA’s investigation is ongoing. The agency said NDMA may have been in the valsartan manufactured in China for as long as four years. It has published a list of all recalled valsartan products, as well as a list of valsartan products not recalled. In the future, when the problem is resolved, patients may be placed back on valsartan. For now, patients should inquire if their valsartan has been recalled.