Baptist Cardiologist Answers Questions About Blood Pressure Medication Recall

On Jan. 2, 2019, pharmaceutical company Aurobindo Pharma USA announced a recall of its Valsartan-containing blood pressure medications. According to the Centers for Disease Control and Prevention, high blood pressure affects nearly 75 million Americans. While many people manage high blood pressure with medication, patients should pay close attention to medication recalls for long-term health and safety.

To help answer your questions about the blood pressure medication recall, we sat down with Dr. Arie Szatkowski, board-certified cardiologist with the Stern Cardiovascular Foundation and director of the cardiovascular service line at Baptist Memorial Hospital-DeSoto.

1. Why is this medication being recalled?

“The recall from Aurobindo Pharma USA cautions health care professionals and patients about a possible cancer-causing impurity—a chemical called N-nitrosodiethylamine (NDEA)—in their Valsartan-containing drugs,” said Szatkowski.

The recall includes Amlodipine Valsartan, Valsartan HCTZ and Valsartan tablets. Aurobindo Pharma USA has instructed health care professionals to remove these medications from store shelves.

“Some people might wonder how this happened,” said Szatkowski. “And it’s not entirely clear. What we do know is that since the 1990s, many generic drug companies began manufacturing drugs outside of the United States. It was less costly to manufacture medications in other countries where laws and regulations might not be as stringent as they are in the United States. The Food and Drug Administration is in the process of looking into exactly how this happened.”

2. Is this the same blood pressure medication recall as last year?

“In July 2018, the FDA discovered potentially cancer-causing agents in blood pressure medications containing Valsartan, Losartan and Irbesartan,” said Szatkowski. “Over the past several months, investigators have recalled dozens of blood pressure medications from multiple manufacturers of these generic drugs.”

The recalled drugs are manufactured by companies in China and India. Patients who want to find out if their blood pressure medication is affected by the recall can view the FDA’s list of Valsartan products under recall or the list of Valsartan products not under recall.

“The FDA’s list shows all recalled medication batches,” said Szatkowski. “It’s a helpful resource for patients who want to check if a recalled medication matches what’s on their medication bottle.”

3. Are there any long-term side effects?

There is a small cancer risk associated with the impurities found in these medications.

“The risk of developing cancer is extremely low,” said Szatkowski. “The FDA reviewed the impurities and estimated that if 8,000 people took the highest dose of Valsartan every day for four years, there might be one additional case of cancer in those 8,000 people. The likelihood that this causes a clinical problem is very unlikely and very low.”

4. What should patients do if they’re taking this medication?

If you discover your medication is on a recall list, Szatkowski recommends switching to an alternate medication.

“Contact your physician. He or she will determine an alternate medication for you,” said Szatkowski. “However, do not stop taking your recalled medication until you have a new medication. If you stop, you may do yourself much more harm by causing a sudden rise in blood pressure. Similarly, some of these drugs treat congestive heart failure—so you don’t want to stop the drug immediately.”

Patients can also go to their pharmacy where pharmacists have up-to-date knowledge of all medication recalls.

“Your pharmacist is already in the process of getting batches of replacement drugs from manufacturers that don’t have products with impurities,” said Szatkowski. “It’s important to not only stop taking your recalled medication but get a safe replacement.”

Learn about heart and vascular care at Baptist, including high blood pressure, heart and vascular conditions and early symptoms of a heart attack. Find a doctor by visiting our Find a Physician page.