FDA Now Says Potential Carcinogen May Have Been in Recalled Valsartan Medicines for Years

Megan Brooks

July 13, 2018

UPDATED JULY 20, 2018 // A potentially cancer-causing impurity leading to the recall of several medications containing the heart drug valsartan may have been in the products for years, according to updated information from the US Food and Drug Administration (FDA).

Earlier this month, the FDA announced a voluntary recall of some valsartan-containing drugs after N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredients (API) manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China. NDMA is classified as a probable human carcinogen based on results from laboratory tests.

"The presence of the potentially cancer-causing NDMA was unexpected and the agency believes the NDMA is related to changes in the way the active substance was manufactured," the FDA said in the updated statement, posted July 19, 2018. "Some levels of the impurity may have been in the valsartan-containing products for as long as four years."

Valsartan is used to treat hypertension and heart failure. The following valsartan products are currently under US recall:

  • Teva Pharmaceuticals, labeled as Major Pharmaceuticals — Recall is at the retail level because these products are used only in facilities where they are directly administered to patients by health care professionals: valsartan 80 mg and 160 mg.

  • Prinston Pharmaceutical Inc, labeled as Solco Healthcare — Recall is at the consumer/user level: valsartan 40 mg, 80 mg, 160 mg, and 320 mg; valsartan/hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg products.

  • Teva Pharmaceuticals, labeled as Actavis — Recall is at the consumer/user level: valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg.

These companies are recalling all lots of nonexpired products that contain valsartan supplied by a third party, according to the FDA. They note that the investigation is ongoing and the list may change but that not all valsartan-containing drugs distributed in the United States have the API supplied by Zhejiang Huahai Pharmaceuticals.

The supplier has stopped distributing its valsartan API, and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

"The FDA has determined the recalled valsartan products pose an unnecessary risk to patients," the updated statement says. "Therefore, FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient's medical condition."

It also advises physicians who have samples from the US companies to quarantine the products and not provide them to patients.

The FDA recall follows a July 5 decision by European authorities' decision to recall medications containing valsartan supplied by the Chinese drug maker because of concerns they may contain NDMA, as reported by Medscape Medical News.

Health Canada moved to voluntarily recall the affected drugs July 9, and media outlets are now reporting that documents have been filed requesting a national class-action suit against five pharmaceutical companies that supplied the contaminated valsartan across Canada.

The FDA is currently investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

"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," FDA Commissioner Scott Gottlieb, MD, said in the July 13 statement first announcing the recall.  "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," he added.

Because valsartan is used to treat serious medical conditions, patients taking the recalled valsartan products should continue taking their medicine until they have a replacement product, the FDA advises.

The FDA encourages patients to contact their doctor or pharmacist if their medication is included in the recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

Patients who are taking one of the recalled medicines should follow the recall instructions provided by the specific company. This information will be posted to the FDA's website.

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