The U.S. Food and Drug Administration (FDA) has announced the recall of popular blood pressure medication Irbesartan, after finding an impurity that could cause cancer, months after it recalled Valsartan over similar reasons.
The agency discovered the pills contain N-nitrosodiethylamine (NDEA), classified as a potential human carcinogen. NDEA is used to make rocket fuel and is a byproduct of fish processing and the making of certain pesticides.
The lot of Irbesartan, used to treat high blood pressure and hypertension, is being recalled by the FDA on behalf of Sciegen Pharmaceuticals. Aurobindo Pharma Limited is voluntarily recalling the drugs and has notified Sciegen Pharmaceuticals.
“Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is arranging for the return of all available Irbesartan drug substance. Aurobindo Pharma Limited has further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that has been identified by Aurobindo Pharma Limited,” said the FDA in the release.
If you have one of the affected bottles, you should contact your doctor before you stop taking the medicine or throw it out, said the FDA announcement, which noted: “The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”
“Patients who are on Irbesartan should continue taking their medication,” the agency said. Meanwhile, “Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan,” it said.
Valsartan Update
This month, prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a massive recall of much of the drug’s supply (as seen in the top video), reported Reuters.According to the National Average Drug Acquisition Cost (NADAC) survey for last month, prices for 160-milligram and 80-milligram tablets of the drug more than doubled last month from August rates.
The U.S. Food and Drug Administration in late September halted imports of drug ingredients made by Zhejiang Huahai Pharmaceuticals after a massive recall of one of its drugs over cancer-causing ingredients.