Teva Issues Amlodipine/Valsartan Combo Drug Recall Over NDEA Contamination

Amid a growing number of hypertension drug recalls issued in recent months, another group of Teva Pharmaceutical drugs are being pulled from the market doe to concerns that the active pharmaceutical ingredients contained in certain generic products may be tainted with cancer-causing impurities. 

On Tuesday, the FDA announced a Teva Pharmaceuticals amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination tablet recall, indicating that they may contain the chemical N-nitroso-diethylamine (NDEA), which is classified as a probable carcinogen.

The action is the latest in a string of recalls affecting valsartan and other generic hypertension drugs, due to manufacturing problems that may cause the chemical byproduct to contaminate the active pharmaceutical ingredients.

NDEA occurs naturally in certain foods and drinking water, as well as from industrial processes, which is what the FDA believes occurred in this instance and with other recent 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).

This latest recall affects all lots of Teva Pharmaceuticals Amlopidine and Valsartan Tablets and all lots of Amlodipine, Valsartan and Hydrochlorothiazide Tables which have not yet expired. The recall notice contains a full list of lot numbers and NDC numbers.

Teva is recommending patients with recalled tablets continue taking them until they talk to their doctor and arrange an alternative treatment, as the danger is not believed to be an immediate health risk. Instead, there are concerns that constant exposure to the contaminant over time could increase the risk of cancer.

Valsartan Cancer Concerns

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.

In late September, 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.

As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring. For those diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, individual cases are being reviewed by valsartan lawyers.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

Consumers with questions about this specific recall may contact Teva Medical Information at 888-838-2872 or by emailing druginfo@tevapharm.com

Consumers are urged to contact their doctor if they have experienced any problems that may be related to the recalled valsartan. Healthcare professionals and patients are urged to report adverse events to FDA’s MedWatch adverse event reporting program.