Over half a million bottles of a widely used blood pressure drug, prazosin hydrochloride capsules, have been recalled in the US. The drug, distributed by Teva Pharmaceuticals, contained trace levels of a potentially cancer-causing chemical, according to the FDA
Over half a million bottles of a widely used blood pressure drug have been recalled in the US after testing revealed the presence of a potentially cancer-causing chemical.
The voluntary recall, issued by New Jersey-based Teva Pharmaceuticals, involves its prazosin hydrochloride capsules, a medication commonly prescribed to treat hypertension and related conditions.
The US Food and Drug Administration (FDA) and the company say the move was made out of caution to ensure patient safety while the investigations continue.
Here’s what led to the recall, how serious the risk might be, and what patients who use this medication should do next.
What triggered the nationwide recall?
Teva Pharmaceuticals issued a voluntary recall of its prazosin hydrochloride capsules, a prescription drug widely used to treat high blood pressure.
Prazosin works by relaxing blood vessels, helping blood flow more smoothly and easing the strain on the heart. While the medication is primarily approved by the FDA for treating hypertension, doctors also sometimes prescribe it off-label for managing symptoms of post-traumatic stress disorder (PTSD), according to USA Today.
The recall was triggered after it was discovered that certain batches of the drug might be contaminated with nitrosamine impurities, specifically “N-nitroso Prazosin impurity C.”
Nitrosamines are chemicals that can be found naturally in small amounts in everyday items like water, grilled meats, and dairy, Everyday Health explains. While low exposure through food or water isn’t considered dangerous, higher concentrations, especially in medications, can pose serious long-term health risks, including an increased risk of cancer, according to the FDA.
As a precautionary step, Teva decided to pull back more than 580,000 bottles of the drug from the market. This includes 181,659 bottles of the 1 mg version, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg capsules, each containing up to 1,000 pills.
How big is the risk level?
According to the FDA, a Class II risk is a situation “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Though the risk is considered moderate, the FDA stressed that nitrosamine contamination is a serious concern and must be addressed quickly.
What should people do with recalled medicine?
Neither Teva Pharmaceuticals nor the FDA has issued clear instructions on what to do with the recalled blood pressure medicine.
However, American healthcare company GoodRx advises patients to check their lot number, contact their pharmacist or doctor, and safely dispose of the recalled medication.
So far, Teva has not received any reports of adverse effects or complaints linked to the contaminated product. The company has urged patients who may have purchased the affected medication to reach out to their pharmacy where the prescription was filled, as well as their prescribing doctor.
Teva also warned against stopping the medication abruptly without medical advice, since any sudden change in blood pressure treatment could be dangerous. “Any interruption in a medication regimen can pose serious risks, and switching to a new prescription must be done under proper medical supervision,” the company said.
This isn’t the first such case. Companies like Pfizer, Merck, Sandoz, and Rising Pharmaceuticals have also recalled drugs in the past due to nitrosamine contamination, according to Becker’s Hospital Review.
Wth input from agencies
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