A Public Service Announcement from Beebe Healthcare- By Jeffrey E. Hawtof, MD, FAAFP, VP of Medical Operations and Informatics
Lewes, DE (July 18, 2018) The FDA recently announced a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.
The FDA said that the recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The FDA recommends that patients take the following action:
• Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
• To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
• If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website: https://www.fda.gov/Drugs/DrugSafety/DrugRecalls
• Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
The US recall includes the versions of valsartan that are made by
1. Major Pharmaceuticals
2. Solco Healthcare
3. Teva Pharmaceuticals Industries Ltd.
As well as valsartan/hydrochlorothiazide (HCTZ) sold by
1. Solco Healthcare
2. Teva Pharmaceuticals Industries Ltd. *Patients should check the FDA website and their pharmacy for the most up-to-date list. If you have questions about your medication, please call your pharmacist or your healthcare provider.
*Patients should check the FDA website and their pharmacy for the most up-to-date list.
If you have questions about your medication, please call your pharmacist or your healthcare provider.