Your blood pressure medication may be contaminated

The US Food and Drug Administration (FDA) has published a list of blood pressure medications that can be safely used, which means they do not contain nitrosamine.

On April 5, the agency released a list of about 40 drugs for the treatment of hypertension and heart where nitrosamine, related to cancer, is "absent".

The problem appeared in July 2018 when the FDA announced that it had recalled several drugs containing valsartan after the discovery of impurities. These drugs were manufactured by a drug manufacturer in China.

Since then, the FDA "has been working hard to understand how this problem has arisen, how we could treat and mitigate exposure to this unnecessary risk to patients and what we could do to prevent these types of impurities from occurring. reproduce in future drugs, "according to the newspaper. to a press release of April 4th.

The statement from the health agency adds that the presence of nitrosamines is "not acceptable" in drugs.

"We also continue to work with manufacturers to quickly remove drugs from the market if they contain a nitrosamine impurity at levels above the acceptable intake limits. The removal of the relevant drugs from the market has resulted in shortages, and since then, we have been working to mitigate and prevent shortages as often as possible, "the agency said.

Common nitrosamines include N, N-dimethylnitrosamine (NDMA), N, N-diethylnitrosamine (NDEA), 4- (methylnitrosamino) -1- (3-pyridyl) -1-butanone (NNK).

Updated list

A list of 40 "safe" drugs can be found on the FDA website.

For drugs marked "not present", this means that the FDA "has completed the complete badessment noted above".

At the same time, "to be determined" means that "one or more parts of our badessment remain incomplete and the product remains acceptable for distribution and for use by the patient," according to the release.

For batches with "to be determined", "the product had dockage levels in excess of the acceptable interim limits, but they have already been removed from the market," adding that the agency "prioritizes badessments based on needs and in response to credible information on nitrosamine contamination. "

For a list of losartan recalls, the FDA website contains details.

For a list of valsartan recalls until March 1, the FDA website contains details.

For a list of irbesartan recalls until March 1st, the FDA website contains details.

FDA warning about scarcity

The FDA issued a warning in January about a blood pressure medication shortage caused by frequent recalls.

"Valsartan products are in short supply and we know that other types of products may be in the near future," said FDA Commissioner Scott Gottlieb and FDA's director of badessment and research. drugs, Janet Woodbad.

In July, the FDA conducted laboratory tests on drugs containing valsartan made by a Chinese company and discovered the presence of NDMA and NDEA. According to the Environmental Protection Agency, NDMA is found in rocket fuels, lubricants and other additives.

"Both of these substances are known environmental contaminants and are found in water and food, including meats, dairy products and vegetables. But their presence in pharmaceuticals is not acceptable, "said the FDA at the time.

The problem appeared in the summer of 2018 after the FDA had learned that an active ingredient manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, contained NDMA.

"We also sent them a warning letter describing several manufacturing violations, including impurity control, change control, and cross-contamination from one production line to another," the statement said. the FDA last month.

After an investigation into Zhejiang's manufacturing process, the FDA discovered a change that could lead to the introduction of carcinogenic chemicals. The impurity was also not detected by global health agencies, including the FDA, until the last time.