FDA Has Recalled A Common Drug Used By Blood Pressure Patients Due To Possible Contamination By Carcinogens
The US FDA has put doctors and patients on a high alert after various drugs, manufactured in China were found to include a possible human carcinogen. The drugs are still being reviewed but three US based companies have agreed to stop the sale of these medications containing valsartan. This ingredient is very commonly used in the treatment of high blood pressure and heart failure.
In a press release, Janet Woodcock, director of the FDA’s center for Drug Evaluation and Research said,
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. That is why we’ve asked these companies to take immediate action to protect patients.”
Not all products containing valsartan are being recalled. Only the ones that have N-nitrosodimethylamine (NDMA) are being recalled. This particular ingredient has been classified by the EPA (Environmental Protection Agency) as a possible human carcinogen. The surprising thing is that each of these drugs has been made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd.
Concern among valsartan using patients
Patients and doctors are being warned to ensure that the valsartan that they are taking is not being manufactured by this particular company. Patients who rely heavily on valsartan should ask their health care provider to provide them with a substitute.
According to Scott Gottlieb, the FDA commissioner “The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured. When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”
Doctors are claiming that this isn’t just the problem of one drug. Apparently there are other medications that have similar issues. This is raising concerns among the people about what medications can be used without causing further deterioration to the patients. According to Harry Lever, a cardiologist at the Cleveland Clinic, “It’s not just valsartan. It’s becoming very difficult for me to write prescriptions at all. There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don’t know what’s what.”