by Dr. Fernando Boccalandro
As seen in the Odessa American’s Medical Matters at:
The U.S. Food and Drug Administration (FDA) protects the public health by assuring the safety, effectiveness and security of human drugs, vaccines and other biological products for human use, as well as medical devices. Recently, the FDA announced a voluntary recall for various drug products containing the active ingredient valsartan. Valsartan is an effective and commonly used medication prescribed to treat high blood pressure and heart failure. It is commonly prescribed combined with a diuretic called Hydrochlorothiazide. The recall is due to the presence of an unexpected impurity in the products manufactured by only three companies that produce valsartan including Major Pharmaceuticals, Solco Healthcare LLC (which owns Prinston Pharmaceutical Inc.) and Teva Pharmaceuticals Industries Ltd. Not all products containing valsartan are recalled. The FDA found N-nitrosodimethylamine in the recalled products, which is classified as a substance that could cause cancer based on results from laboratory tests. The FDA review is ongoing regarding the levels of this substance in the products, possible effects on patients and measures to eliminate this issue in the future.
If you are taking valsartan, please continue taking your medication until you have a replacement product since it is used to treat serious medical conditions. To determine if your medication needs to be changed, look at the drug name and company name on the label of the prescription bottle. If the company manufacturing your medication is not any of the three companies mentioned above, there is no need to change your prescription. If the information is not on the prescription bottle, you should contact the pharmacy that dispensed your medication to determine the manufacturer of the drug.
If you are taking one of the recalled medicines you should contact your pharmacist or your health care professional that prescribed the medication to discuss your treatment, which may include an alternative treatment option or another valsartan based-product.
Dr. Fernando Boccalandro, MD, FACC, board certified in both Cardiovascular Services and Interventional Cardiology, is with ProCare Odessa Heart Institute.