Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the USA, as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk. Officials say the recall comes after a trace amount an unexpected impurity, N-nitrosodimethylamine (NDMA) was detected.
Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA.
In these cases, the FDA has told patients to continue taking the drug until their health care provider is able to provide them with a substitute. If the medication's label does not explicitly name the manufacturer, or if there is any confusion whatsoever, the agency is advising patients to call their pharmacy and make sure their drug is not part of the recall.
Not all medications containing valsartan were included in FDA's recall.
"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", Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. These recalls were made after a review from the European Medicines Agency or EMA had found that valsartan supplied by China-based company Zhejiang Huahai Pharmaceuticals contained NDMA.
The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", Commissioner Dr. Scott Gottlieb said Friday.
Patients should contact their healthcare professional (the pharmacist who dispensed the medication or the doctor who prescribed the medication) if their medicine is included in the recall to discuss treatment.
Patients who are taking one of the recalled medicines listed above should follow the recall instructions that are provided by the FDA's website. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.