FDA Recalls Medications for Carcinogen Contamination

Earlier this week, the Food and Drug Administration (FDA) issued a voluntary recall of several medications that contain the generic valsartan, a medication that is used by  doctors  to treat high blood pressure and prevent heart failure.

Which Medications Are Being Recalled?

According to the recall statement released by the FDA, the recall was issued because investigators found an impurity in seveeral of the samples of products containing valsartan-containing they had examined. More specifically, they found N-nitrosodimethylamine (NDMA), which has been identified as a known carcinogen. They pointed out, however, that their findings were limited to a specific manufacturing location and method, so there are no plans to recall all products containing valsartan at this time, although the investigation continues.

As noted, according to the CDC and the FDA, NDMA has been classified as a probable human carcinogen, which means it is more likely than not to be a cause of cancer. They noted that the findings in this case were based on results from relatively recent laboratory tests. As to how the NDMA made its way into the product, the FDA said they suspect the presence of the carcinogen is “related to changes in the way the active substance was manufactured.” That said, the agency continues to investigate the situation.

According to a separate statement from the FDA’s Center for Drug Evaluation and Research, “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards.”

The specific medicines subject to the recall include the following, along with the three manufacturers who produced it:

  • Valsartan, manufactured by Major Pharmaceuticals.
  • Valsartan, manufactured by Solco Healthcare.
  • Valsartan/Hydrochlorothiazide (HCTZ), also manufactured by Solco Healthcare
  • Valsartan, manufactured by Teva Pharmaceuticals Industries Ltd.
  • Valsartan/Hydrochlorothiazide (HCTZ), also manufactured by Teva Pharmaceuticals Industries Ltd.

The FDA has asked all three of the above manufacturers to “take immediate action to protect patients.” All agreed to the recall after the FDA made its case. Impacted medication includes the 40 mg, 80mg, 160mg, and 320mg strengths of Valsartan, while the strengths of Valsartan-HCTZ Tablets being recalled include 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg. The products have expiration dates from July 2018 to Jan. 2020. Pharmacies have been asked to “immediately return the product.”

What You Should Do With Recalled Medications

The valsartan that is subject to recall was manufactured in China by Zhejiang Huahai Pharmaceutical and distributed by the Actavis label. The medications were being distributed by the three separate pharmaceutical companies in the United States named above.

The FDA warns those patients who may be taking the recalled medications to immediately contact their doctor or pharmacist. In order to determine if the specific product they were prescribed is being recalled. Patients can possibly examine the drug name and company name on the prescription bottle label and, if the information is not on the bottle, they should contact the dispensing pharmacy to get that information, which will be on the bottle they store in their pharmacy.

The agency recommend that patients taking valsartan or one of the medications using it as an ingredient, should continue to take it until they can be prescribed a substitute. However, their health care provider should be able to offer them an alternate treatment, such as another product containing valsartan that is not being recalled. There are actually quite a few alternatives available.

The FDA and other agencies have been debating the safety of imported drugs, including generic medications, for quite some time. The FDA contends that it simply lacks the resources to inspect overseas facilities on a continuous basis. Despite that, the agency plans to continue to investigate NDMA levels in the recalled products, as well as examine the effects on patients and look into ways to prevent future batches of the drug from contamination with the NDMA impurity.

Meanwhile, health departments throughout the country are demonstrating concern over the quality control in the manufacture of generic medications, and recommending greater transparency on the part of pharmaceutical companies with regard to where their active ingredients are made.

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