More than half a million bottles of the widely used blood pressure drug, prazine hydrochloride capsules, have been recalled in the US. A drug distributed by Teva Pharmaceuticals contained traces of a chemical that may cause cancer, according to the FDA.
More than half a million bottles of a widely used blood pressure drug have been recalled in the US after testing revealed the presence of a cancer-causing chemical.
The voluntary recall issued by New Jersey-based Teva Pharmaceuticals concerns its prazazine hydrochloride capsules, a drug commonly prescribed to treat hypertension and related conditions.
The US Food and Drug Administration (FDA) and the company say the move was taken out of an abundance of caution to ensure patient safety while investigations continue.
Here’s what led to the recall, how serious the risk might be, and what patients using the drug should do next.
What caused the nationwide recall?
Teva Pharmaceuticals has voluntarily recalled its capsules of prazine hydrochloride, a prescription drug widely used to treat high blood pressure.
Prazine works by relaxing the blood vessels, helping the blood flow more smoothly and easing the strain on the heart. Although the drug is primarily FDA-approved to treat hypertension, doctors also sometimes prescribe it off-label to treat symptoms of post-traumatic stress disorder (PTSD). USA Today.
The recall was prompted after it was discovered that some batches of the drug may be contaminated with nitrosamine impurities, specifically “N-nitrosase prazazine impurity C.”
Nitrosamines are chemicals that occur naturally in small amounts in everyday foods such as water, grilled meats, and dairy products. Everyday health explains. While low-level exposure through food or water is not considered dangerous, higher concentrations, especially in medications, can pose serious long-term health risks, including an increased risk of cancer, according to FDA.
As a precaution, Teva decided to recall more than 580,000 bottles of the drug. This includes 181,659 bottles of 1 mg, 291,512 bottles of 2 mg and 107,673 bottles of 5 mg capsules, each containing up to 1,000 tablets.
How big is the level of risk?
According to the FDA, a Class II risk is a situation “in which use or exposure to the offending product may cause temporary or reversible adverse health effects or where the likelihood of serious adverse health effects is low.”
Although the risk is considered moderate, the FDA stressed that contamination with nitrosamines is a serious concern and should be addressed quickly.
What should people do with recalled drugs?
Neither Teva Pharmaceuticals nor the FDA have provided clear instructions on what to do with the recalled blood pressure medications.
However, the American health care company GoodRx advises patients to check the batch number, contact their pharmacist or doctor and safely dispose of the recalled medication.
To date, Teva has received no reports of adverse effects or complaints related to the contaminated product. The company urged patients who may have purchased the damaged medication to contact their pharmacy where the prescription was filled and the doctor who wrote the prescription.
Teva also warned against suddenly stopping the medication without medical advice, as any sudden change in blood pressure treatment could be dangerous. “Any break in the medication regimen can cause serious risks, and switching to a new prescription should be done under proper medical supervision,” the company said.
This is not the first such case. Companies such as Pfizer, Merck, Sandoz and Rising Pharmaceuticals have also recalled drugs in the past due to nitrosamine contamination. Becker Hospital Review.
With the help of agencies
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