Valsartan is a drug used to treat high blood pressure and heart failure. In June 2018, the FDA announced a voluntary recall of Valsartan due to the discovery of carcinogenic chemicals in the drug. Anyone who has taken Valsartan needs to know what this recall entails and what to do if they currently take this medication.
FDA Guidance on Valsartan
Valsartan’s main intended uses include the treatment of high blood pressure and heart failure conditions. However, the manufacturer issued a voluntary recall after identifying an impurity detected in this medication. The impurity is the presence of N-nitrosodimethylamine (NDMA), a substance classified as a potential human carcinogen. The manufacturer identified recent changes in the production process as the probable cause of this impurity.
The FDA recommends that despite this recall, patients currently taking Valsartan do so for very serious health conditions, and interruptions in their medication dosage schedule can be disastrous for some individuals. The FDA advises continuing to take Valsartan until replacement doses become available. The manufacturers affected by the recall are taking appropriate steps to remove this impurity from their Valsartan products.
Patients can identify recalled drug products by checking their prescription labels and manufacturer information. Patients taking Valsartan made by Major Pharmaceuticals, Solco Healthcare, or Teva Pharmaceuticals, Ltd. should note these products have been recalled. The recall also applies to Valsartan/Hydrochlorothiazide (HCTZ) produced by Solco Healthcare and Teva Pharmaceuticals, Ltd.
What to Do if You Currently Take or Have Taken Valsartan
Any person who confirms that he or she has taken or is taking any Valsartan medications affected by the recall should confirm the manufacturer of their medication and check the company’s recall information. Every company handles recalls differently, but most will encourage patients to continue taking their medications as prescribed until a safe replacement becomes available.
If you have concerns about your exposure to potentially harmful NDMA, speak with your primary care physician as soon as possible to learn more. A doctor may be able to prescribe a replacement or substitute product so the patient experiences minimal interruption in his or her medication schedule.
NDMA is a possible carcinogen, so it is unclear if there is any possibility of short-term cancer risk after taking Valsartan. The long-term health implications also remain unclear. Despite the possible risk of carcinogenic exposure, patients who take Valsartan do so for serious medical conditions that require consistent doses of these medications, and interruptions may cause serious health problems. Ultimately, patients taking recalled Valsartan medications should consult with their physicians and refer to manufacturers’ recall information in the meantime.