FDA Recalls Potentially Toxic Medications
SILVER SPRING, MARYLAND – 16 July, 2018
The U.S. Food and Drug Administration (FDA) alerted patients and health care professionals that they were issuing a recall of several medications containing the active ingredient valsartan, used to treat high blood pressure and heart failure. According to an FDA statement the recall was issues after N-nitrosodimethylamine (NDMA) was detected in certain products.
“Not all products containing valsartan are being recalled. NDMA is classified as a substance that could cause cancer based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA said.
The FDA’s review is ongoing and has included an investigation regarding the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
“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,” said FDA Commissioner Scott Gottlieb, M.D. “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. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
Here is the list of recalled products:
- Valsartan produced by Pharmaceuticals Major
- Valsartan produced by Solco Healthcare
- Valsartan produced by Teva Pharmaceuticals Industries Ltd.
- Valsartan/Hydrochlorothiazide (HCTZ) produced by Solco Healthcare
- Valsartan/Hydrochlorothiazide (HCTZ) produced by Teva Pharmaceuticals Industries Ltd.
“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. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
For Patients and Health Care Professionals
The FDA informed patients and health care professionals using valsartan in medicines to treat serious medical conditions that patients should continue taking their medicine until they have a replacement product.
To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
If a patient is taking one of the recalled medicines listed above, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed it) if their medicine is included in the recall to discuss their treatment, which may include another valsartan product not affected by the recall, or an alternative treatment option.
The FDA will continue to investigate this issue and provide additional information as it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 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.