Contaminated Blood Pressure Drug Recalls Likely to Continue, FDA Warns

Published on February 25, 2019 by Sandy Liebhard

With the U.S. Food & Drug Administration’s (FDA) investigation far from over, regulators are warning that recalls for valsartan and other contaminated blood pressure medications will continue well into the future.

Blood Pressure Drug Recalls Affected Some of the Most Frequently Prescribed Medications

Generic drug makers around the world began recalling certain angiotensin II receptor blockers (ARB) last summer, after tests detected N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) – both considered probable human carcinogens — in Active Pharmaceutical Ingredient (API) supplied by China-based Zhejiang Huahai Pharmaceutical and Hetero Labs of India.

The blood pressure drug recalls have since grown to include generic versions of:

• Valsartan
• Amlodipine/Valsartan
• Valsartan/Hydrochlorothiazide (Valsartan HCT)
• Valsartan/Amlodipine/HCT
• Losartan
• Irbesartan

Losartan, irbesartan, and valsartan rank among the most frequently prescribed drugs in the United States. For example, 49 million patients filled a losartan prescription at a community pharmacy in 2016. An additional 8 million people received valsartan, while another 3 million filled a script for irbesartan.

The true number, however, is likely much higher, as the figures do not account for prescriptions dispensed by the VA health system or in-patient hospital pharmacies.

FDA Import Alert after Blood Pressure Drug Recalls

In an interview with CNN that aired last Friday, Dr. Janet Woodcock confirmed that the FDA’s investigation had not yet concluded.

The contamination problems began sometime after 2010, and likely resulted from a chemical reaction that occurred during  the manufacturing process. Zhejiang Huahai and Hetero may have reused solvents or other materials that led to the contamination.  However, it’s also possible “some of the source material may have had some of this in it,” Woodcock said.

In September, the FDA placed Zhejiang Huahai on an import alert, which banned imports of the company’s drug products and API. The company also received and FDA Warning letter in September, after an agency inspection turned up numerous quality control issues at its factory in China.

Valsartan Lawsuits Consolidated in New Jersey Federal Court

At least 40 valsartan lawsuits have been filed in federal courts around the country since the first blood pressure drug recalls were announced last June.

The filings include 17 personal injury claims that allege ingestion of tainted valsartan medications caused cancer, while the rest are consumer class actions that seek reimbursement for the purchase of allegedly worthless drugs.

The cases name numerous pharmaceutical defendants, including Zhejiang Huahai Pharmaceutical Co., Ltd., Prinston Pharmaceutical Inc., and Solco Healthcare U.S., LLC, among others.

On February 14^th, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all currently pending-valsartan lawsuits before a single judge in the U.S. District Court, District of New Jersey for coordinated discovery and other pretrial proceedings. Any valsartan lawsuits filed in federal courts in the future could also be transferred to the centralized proceeding.