The valsartan recall list continues to grow as manufacturers and the FDA find more lots contaminated with potential human carcinogens.

What Is Valsartan?

Valsartan is a high blood pressure medication which is part of the angiotensin II receptor blockers (ARBs) drug class. These medications reportedly treat high blood pressure by blocking the action of substances in the body which tighten blood vessels. As a result, blood can flow more freely and blood pressure isn’t increased.

When Was Valsartan Recalled?

In 2018, the U.S. Food and Drug Administration (FDA) announced that manufacturers had voluntarily recalled several lots of medications containing valsartan due to the presence of a probable human carcinogen.

The medications were reportedly found to contain N-nitrosodimethylamine (NDMA). According to Chemical & Engineering News, NDMA can be found in tobacco, cured meats, fermented foods, and other household products. However, the impurities may also be generated during pharmaceutical manufacturing processes – leading to several recall announcements in recent years due to NDMA contamination.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” then-FDA Commissioner Scott Gottlieb said in a 2018 press release. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”

Since the initial announcement, the FDA has continued to update consumers about ongoing recalls and action the agency has taken. For example, the FDA sent out several warnings in 2019 to manufacturers who reportedly violated Current Good Manufacturing Practice regulations.

It has been speculated that the NDMA valsartan impurities originate from the manufacturing process issues. In fact, many of the recalled medications used active pharmaceutical ingredients supplied by Zhejiang Huahai Pharmaceuticals.

Which Valsartan Has Been Recalled?

As of September 2019, there are over 1,000 lots included in the Valsartan recall list. Countless manufacturers such as Aurobindo Pharma, Camber Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals, and more have multiple lots of valsartan and other ARBs included on the list.

Is Valsartan Safe?

Although over 1,000 medication lots are included on the valsartan recall list, not all lots of valsartan from all manufacturers are affected. This means that while some lots of valsartan may cause concerns others may be completely safe.

When in doubt, consumers can search the FDA site or contact their pharmacist to see if their lot of valsartan is affected by the recall. If on the list, the pharmacist will likely be able to provide a different lot of the same medication which doesn’t carry the same contamination risks.

In 2019, a new valsartan generic was introduced to help provide more options to prescribers and, hopefully, fight the ongoing shortage of ARBs due to recalls. The approved generic alternative comes from Alkem Laboratories, a pharmaceutical company based out of Mumbai, India. The FDA has reportedly fast-tracked reviews for ARB generics, though the agency has also made sure that Alkem’s manufacturing and testing processes were clear to help avoid future impurity issues.

“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” then-FDA Commissioner Scott Gottlieb told USA Today following the drug’s approval.

Like all medications, valsartan does carry the risks for side effects. According to the Mayo Clinic, side effects of valsartan may include headaches, diarrhea, coughing, hair loss, and more concerning issues like numbness, swelling, vomiting, and confusion. Contamination issues have also been tied to the risk of stomach cancer.

Should I Stop Taking Valsartan?

Taking a medication contaminated with a known carcinogen can be frightening. Consumers worried about their prescribed blood pressure medication may want to stop taking the pills, but the FDA has warned against this.

According to the agency, all patients who are worried about valsartan contamination should consult with their doctor before stopping medication. Untreated blood pressure issues or other health problems could be life threatening.

The FDA also encourages patients who have experienced unexpected valsartan side effects to report their experiences to the agency’s MedWatch program. This database allows the FDA to collect feedback on medications and monitor for serious health issues that need to be addressed.

Consumers taking Valsartan may also be speak to a qualified attorney who can evaluate their legal claims. Although valsartan manufacturers have not been declared guilty of unlawful behavior, attorneys are interested in speaking to impacted consumers about this issue.