Monday, February 18, 2019

Valsartan, larsartan, irbesartan risks cited

Finding cancer-causing contaminants causes FDA to recall blood-pressure drugs 

Millions of bottles of generic blood-pressure meds have been recalled after a contaminant that causes cancer was found.

According to a recent story on the website, the Federal Drug Administration (FDA) ordered the recall after determining that folks who've taken certain hypertension meds over the past four years may have been exposed to small amounts of impurities following a change in the way companies manufacture the active ingredient.

The carcinogens, the article continues, "are a chemical byproduct of the process used to synthesize the active ingredients in medicines, which includes valsartan, losartan and irbesartan."

Agency leaders, the story says, have estimated that "between 1 and 2 million people may have taken the drugs with the impurities."

The recalled products, a USA Today story says, "are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which relax blood vessels. Many of these commonly prescribed drugs are not part of the recall."

But, overall, "the risk to individual patients remains very small, although this doesn't diminish the significance of this episode or our concerns," read a joint statement from FDA Commissioner Scott Gottlieb and FDA Director Janet Woodcock.

David Light
David Light, founder and chief exec officer of Valisure, an online pharmacy that chemically validates the drugs before shipping them to consumers, said "companies may not be cleaning the active ingredients as a cost-saving measure," noting, too, that "it would not have been unexpected that the synthesis process would cause pollutants."

Details on risks of drugs that might worsen medical conditions can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book that I, Woody Weingarten, aimed at male caregivers.

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