Aurobindo Pharma USA is voluntarily recalling a blood pressure tablet because of a potential cancer risk, according to the U.S. Food and Drug Administration (FDA).
The company is recalling two lots of its quinapril and hydrochlorothiazide tablets, which are prescribed to lower blood pressure in people with hypertension, over concerns that the pills may be contaminated with nitrosamine, the FDA said in a statement.
Nitrosamines are found naturally in many foods including a variety of vegetables, dairy products, and cured or grilled meats. Exposure to high levels of nitrosamines over a long period of time can increase the risk of cancer, the FDA said.
Both lots of recalled blood pressure medicine have an expiration date in January 2023, the FDA said. The tablets are “pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on the scored side and ‘19’ on the other side.”
There have not been any reports of adverse events related to the tablets covered by the recall, the FDA said.
“Patients should contact their doctor or healthcare provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication,” the FDA said.
The recalled tablets contain a combination of two medicines: quinapril hydrochloride, in a family of medicines known as angiotensin-converting enzyme (ACE) inhibitors that lower blood pressure by relaxing blood vessels; and hydrochlorothiazide, in a family of medicines known as diuretics that manage blood pressure by reducing fluid retention.
Some patients may be able to switch to a treatment regimen of two separate tablets — one for each of the medicines contained in the recalled pills.
Consumers with medical questions about the recall can contact Aurobindo Pharma at 866-850-2876 or email the company at email@example.com.
Nitrosamines have previously been found in drugs to treat high blood pressure, heartburn, acid reflux, and diabetes, according to the FDA. Some of these drugs from certain manufacturers — including angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin — have been recalled because of nitrosamine impurities.
Chemical reactions during the drug manufacturing process can cause nitrosamines to form in medicines.
Some previous research has linked exposure to high levels of nitrosamines to several different types of cancer, including pancreatic and gastrointestinal tumors, but because many cancers can form slowly over decades it’s hard to quantify the exact risk. The World Health Organization classifies nitrosamines as probable human carcinogens, but also notes that the cancer risk may be low for nitrosamine impurities found in prescription medicines.
Read the full article here