Healthcare professionals and patients are being advised of a voluntary recall of products containing the active pharmaceutical ingredient (API) valsartan.

Valsartan is a medicine that is used to treat high blood pressure and heart failure. The recall has been issued in the United States by the Food and Drug Administration (FDA), in Europe the European Medicines Agency (EMA) and in Asia.

Chief of Drugs and Pharmaceutical Services, Mrs. Gracia Wheatley-Smith explained that the recall is due to an impurity, N-nitrosodimethylamine (NDMA) which has been found in the recalled pharmaceuticals.

NDMA is classified as a probable carcinogen by the World Health Organization’s International Agency for Research on cancer. However, there is limited evidence of the carcinogens affecting humans.

Mrs. Wheatley-Smith further stated that not all pharmaceuticals containing valsartan are being recalled.

“The Ministry of Health and Social Development has checked with the pharmacies in the BVI and none of the affected lots are in stock, but we acknowledged the fact that we have patients who access healthcare abroad and may have filled their prescriptions overseas as well and so we need to share this information for the benefit of those patients,” Mrs. Wheatley-Smith said.

Patients who are taking valsartan tablets are being advised to discontinue their medication and consult with their physicians or their pharmacists on their treatment options.

The Ministry of Health and Social Development is urging healthcare professionals and patients to report any adverse medicine reaction to any medication to Chief of Drugs and Pharmaceuticals Services Gracia Wheatley-Smith at 468 4526 or 468 9850 or grwheatley-smith@gov.vg.

The reporting of adverse medicines reactions falls under the Ministry’s pharmacovigilance programme.

Recalled Products

The FDA has found that the valsartan-containing medications sold by these companies do not meet safety standards and are being withdrawn from the market.

Photo Caption: Photo provided from google.