FDA Recalls Blood Pressure Medication – Carcinogen Risk
- Food adn Drug Administration (FDA) has announced that Teva Pharmaceuticals USA, Inc.
- The recall impacts prazosin hydrochloride capsules in various strengths (1mg, 2mg, 5mg) and lot numbers.
- A complete list of affected lot numbers can be found on the FDA website.The recall is being conducted to the retail level.
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Teva Pharmaceuticals Recalls Blood Pressure Medication Prazosin Hydrochloride Due to Potential Cancer Risk
Overview
The U.S. Food adn Drug Administration (FDA) has announced that Teva Pharmaceuticals USA, Inc. is voluntarily recalling over 500,000 bottles of prazosin hydrochloride capsules due to the potential presence of a cancer-causing chemical, N-Nitrosodimethylamine (NDMA). The recall affects multiple lot numbers and strengths of the medication.
Details of the Recall
The recall impacts prazosin hydrochloride capsules in various strengths (1mg, 2mg, 5mg) and lot numbers. The FDA states that NDMA is classified as a probable human carcinogen based on laboratory testing.While the agency has established acceptable daily intake limits for NDMA, prolonged exposure above these limits could perhaps increase cancer risk.
| Strength | Lot Numbers Affected (Example – check FDA website for complete list) | NDC Code (Example) |
|---|---|---|
| 1mg | 1473053A, 1473054A | 0172-9301-01 |
| 2mg | 1473055A, 1473056A | 0172-9302-01 |
| 5mg | 1473057A, 1473058A | 0172-9305-01 |
A complete list of affected lot numbers can be found on the FDA website.The recall is being conducted to the retail level.
What is Prazosin Hydrochloride?
Prazosin hydrochloride is a medication used to treat high blood pressure (hypertension) and symptoms of benign prostatic hyperplasia (BPH), an enlarged prostate. It works by relaxing blood vessels, which lowers blood pressure and improves urine flow.
What Should Patients Do?
The FDA advises patients to continue taking their medication until thay can consult with their healthcare provider or pharmacist.Discontinuing medication without medical advice can be dangerous. Patients should contact their doctor or pharmacist to discuss alternative treatment options or whether they need a new prescription.
Individuals who experience adverse reactions related to taking prazosin hydrochloride should report them to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online at https://www.fda.gov/safety/medwatch.
The Issue of NDMA in Medications
The presence of NDMA in medications has been a growing concern in recent years. NDMA can form during the manufacturing process of certain drugs, particularly those containing dimethylamine. Several recalls of medications, including angiotensin II receptor blockers (arbs) like valsartan, losartan, and irbesartan, have occurred due to NDMA contamination. The FDA is actively working with manufacturers to identify and address the sources of NDMA contamination.