The U.S. Food and Drug Administration (FDA) said Friday that drugmakers have recalled a staggering number of the blood pressure drug prazosin hydrochloride over concerns it may contain a cancer-causing impurity.
Earlier this month, the FDA said New Jersey-based Teva Pharmaceuticals USA and drug distributor Amerisource Health Services voluntarily recalled more than 580,000 bottles of various strengths of prazosin capsules nationwide, the AP reported.
What are prazosin hydrochloride capsules?
Prazosin hydrochloride is a popular blood pressure medication and belongs to the alpha-1 adrenergic blocker drug class. It helps to relax the blood vessels.
Doctors prescribe prazosin to help lower blood pressure. It is also sometimes prescribed for nightmares and other sleep disturbances caused by PTSD.
What happened in the US?
The US company Teva Pharmaceuticals has voluntarily recalled over 580,000 bottles of various strengths of prazosin capsules.
“Voluntary recall” means that the recall was not ordered by the FDA – but prazosin capsules were voluntarily withdrawn from the market and stores by the drug companies and distributors.
Teva issued a voluntary recall on October 7.
Why withdraw blood pressure medication?
Blood pressure drugs have been recalled over fears they may contain a cancer-causing compound.
According to the FDA report, the recalled drug contained a nitrosamine impurity — identified as “N-nitroso Prazosin impurity C.”
Nitrosamines are classified as possible human carcinogens, and long-term exposure could increase the risk of cancer in patients taking this drug.
The FDA also said in enforcement orders posted online that it assigned the affected batches of the drug a Class II hazard classification. Drugs classified as II. class mean that if ingested they could cause “temporary or medically reversible health problems”, although serious harm is unlikely.
Which are the affected lots?
According to the FDA recall notice, prazosin hydrochloride products affected by blood pressure medications are as follows:
- 181,659 bottles of 1 mg capsules
- 291,512 bottles of 2 mg capsules
- 107,673 bottles of 5 mg capsules
Each bottle can contain 100 to 1000 capsules depending on the packaging.
What to do if the drug is withdrawn?
Teva advised those taking the medication to contact their pharmacy to determine what to do with the remaining amount, and Teva also said it had sent recall letters to its customers with instructions for returning the recalled product.
“In addition, consumers with questions or concerns should also contact the health care provider who prescribed the medication,” the drug distributor said in a statement.
