The FDA has recently issued a statement regarding the valsartan product recall, which was initiated due to certain stocks of the blood pressure medication reportedly being tainted with nitrosodimethylamine (NDMA).

In the statement, the FDA describes the different events that led to the valsartan product recall, which was expanded to include Torrent Pharmaceuticals Limited unexpired lots of the blood pressure medication.

The FDA statement notes that the agency also updated its list of recalled valsartan products and clarified which medications are not apart of the valsartan product recall.

In its recent announcement, the FDA explains that Prinston Pharmaceuticals Inc. had contacted the agency’s Center for Drug Evaluation and Research in June 2018. The company informed the FDA that it had stopped manufacturing its valsartan medications due to NDMA being detected in the supply manufactured by Zhejiang Huahai Pharmaceutical Co.

While the traces of NDMA were small, the FDA says that it considered the reported contamination to be unreasonably dangerous to patients because the substances are known to be a potential carcinogen.

“We estimated that if 8,000 people took the highest valsartan dose [320 mg] from NDMA-affected medicines daily for 4 years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer over the lifetimes of these 8,000 people beyond the average cancer rate among Americans. [T]his estimate represented the highest possible level of NDMA exposure. It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario,” the FDA stated.

Overview of Valsartan Complications

Valsartan is the generic version of Diovan, which is often prescribed to patients with high blood pressure and for hypertension in adult patients and children over the age of six. It can also be used to treat heart failure in adults, as well as reduce the risk of death in patients who recently suffered a heart attack.

Valsartan is manufactured by a number of different generic manufacturers including Teva Pharmaceuticals and Major Pharmaceuticals, which makes it readily available for patients at economic prices. However, the medical community became very concerned when the alleged NDMA contamination was discovered earlier this year and was announced by the European Medicines Agency.

The first valsartan product recall started in Europe when health officials recalled potentially contaminated valsartan products, with the FDA following in July 2018. The agency announced that it asked three generic drug manufacturers to conduct a voluntary valsartan product recall, and asked pharmacists to return all potentially contaminated inventory to their manufacturers.

The FDA also stated that the valsartan product recall does not affect every stock of the medication, and that patients should check their medication label to confirm whether or not the manufacturer was apart of the recall. The FDA says it is also working with different health organizations around the world, exchanging information regarding the inspections and laboratory tests regarding the valsartan product recall.

For now, the agency recommends that patients should not stop taking their medication without talking to their physician and discussing potential side effects from the NDMA contamination.

In addition to the valsartan product recall, the FDA reports that it is now investigating other medications that may have been contaminated by NDMA. The medications are other angiotensin II receptor blockers (ARBs), because they are synthesized in a similar process as valsartan.