Generic Avapro (Irbesartan) Recall Issued Over Cancer Risks From Manufacturing Impurities

Following a number of recent valsartan recalls issued due to generic drug manufacturing problems that resulted in cancer-causing impurities, federal regulators now warn about a risk of similar problems with generic Avapro (irbesartan), which is another type of hypertension drug that may pose a cancer risk from manufacturing impurities. 

The FDA announced irbesartan recalls this week, which impact drugs sold by Aurobindo Pharma Limited and Sciegen Pharmaceuticals, after trace amounts of N-nitrosodiethylamine (NDEA) were found in products from both companies. In both cases, the contaminated active ingredients were manufactured by Aurobindo Pharma.

While there have been no adverse events or cases of cancer reported in connection with the recalled irbesartan tablets to date, the impurity is a known human carcinogen.

NDEA occurs naturally in certain foods and drinking water, but can be created as a byproduct of industrial processes, which is what the FDA believes occurred in this instance and with valsartan recalls linked to the presence of a similar impurity, N-nitrosodimethylamine (NDMA). Both are considered probably cancer-causing agents by the International Agency for Research on Cancer (IARC).

The recall affects 22 batches of irbesartan manufactured by Aurobindo Pharma, which were then used to make 27 lots of Sciegen Pharmaceuticals irbesartan. However, Sciegen then sold the drugs under the Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS) labels in 75mg, 150mg and 300mg strength tablets with expiration dates of September 2019 and February 2020. The details on the affected batches and recalled lots are available on the recall notices, linked above.

The new warning represents a significant expansion of the ongoing valsartan recalls, which began this summer.

The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals tested positive for NDMA.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

Late last month, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals, after an inspection report outlined a number of serious manufacturing problems at the company’s facility in late August.

The recalls have led to a valsartan shortage and a spike in prices, with the cost of 160 milligram and 80 milligram tablets of generic valsartan more than doubling in September 2018.

In late September, the FDA indicated that NDEA also appeared to be an impurity in some drugs, and warned that the recalls may expand to other hypertension medications.

Consumers with recalled Westminster Irbesartan tablets who have questions can call Westminister’s Regulatory Affairs department at 888-354-9939 or contact them via e-mail at recalls@wprx.com. Those with recalled GSMS tablets with questions can call 800-284-8633, extension 215, or e-mail recalls@gsms.us.

Patients who have suffered adverse reactions when taking these drugs are encouraged to report the incidents to the FDA MedWatch Adverse Event Reporting Program.