(NaturalHealth365)  The U.S. Food and Drug Administration (FDA) just announced that a drug manufacturer was issuing a voluntary recall of a drug used to treat and prevent stroke, one of the most common chronic health conditions in the nation.

The reason?  Contamination with a substance known to increase the risk of cancer in some individuals.

RECALL ALERT: FDA warns pharmacies, warehouses with contaminated batches of popular stroke drug to “stop use and distribution and quarantine the product immediately”

According to the FDA’s March 22, 2023 news release, the company Ascend Laboratories LLC has initiated a recall of a drug known as Dabigatran Etcxilate Capsules (USP 75 mg and 150 mg).

Specific batches of this drug – which is “used as an oral anticoagulant to lower the risk of stroke and blood clots,” according to the FDA – were found to be contaminated with concerning levels of a compound called N-nitroso-dabigatran, which is a type of nitrosamine.

Sadly, this is not the first drug recall of its kind.

On a webpage called “Information about Nitrosamine Impurities in Medications,” the FDA explains that nitrosamines “are common in water and foods, including cured and grilled meats, dairy products and vegetables” and that “everyone is exposed to some level of nitrosamines.”  The concern over this specific drug from Ascend Laboratories LLC, however, is because the presence of the impurity was found to be above the established Acceptable Daily Intake (ADI) level.

There are a number of possible ways that nitrosamine impurities can get into drugs, notes the FDA, including manufacturing and storage processes.  The agency adds that Ascend Laboratories LLC has, to date, “not received any reports of adverse events related to this recall.”

Recalls and market withdrawals are common – these resources can help you stay informed

You might be surprised to learn just how common drug recalls are (let alone recalls, safety alerts, and market withdrawals for other products – from organic foods to motorized vehicles).  One recent 2021 paper published in Innovations in Pharmacy cited data suggesting that, worldwide, 462 medications were withdrawn from the market between 1953 and 2013 – on average, that’s about 7 to 8 drug withdrawals per year for sixty years!  The majority of these medications, the article continues, “were found to be withdrawn due to severe drug reactions and [liver damage].”

It’s important to note that plenty of these drugs were withdrawn after years or even decades of use in the market, which underscores a worrisome but perhaps unavoidable risk of Big Pharma in general.  “In some cases,” writes the U.S. Government Accountability Office (GAO), “[the] FDA or drug manufacturers have removed from the market drugs that have been shown to have unacceptable health risks once they were in widespread use” (emphasis ours).

No wonder people feel concerned when new drugs are pushed out onto the market at warp speed and given to as many millions of people as possible!

And while there’s no need to become overly vigilant, “It is important that consumers be aware of recalls because recalled foods may cause injury or illness,” explains FoodSafety.gov, “especially for people who are pregnant or have weakened immune systems because of age, chronic illness, or medical treatment.”

If you’re curious about whether products and items you use are subject to recalls or safety alerts, be sure to check out these websites for up-to-date information:

• Recalls, Market Withdrawals, & Safety Alerts from the U.S. Food and Drug Administration (FDA)
• Recalls & Public Health Alerts from the U.S. Department of Agriculture (USDA)

And as always, stay tuned with our team here at NaturalHealth365 for even more updates that can help you and your family stay well.

Sources for this article include:

FDA.gov
FDA.gov
NIH.gov
GAO.gov
Foodsafety.gov