Health professionals generally treat high blood pressure and heart conditions with drugs that contain the active ingredient ‘Valsartan.’
While a number of companies sell these Valsartan-based drugs that go by different names, some of them are marketing products whose Valsartan content doesn’t meet the US Food and Drug Administration’s safety requirements.
The sub-standard Valsartan has been found to contain a dangerous impurity, referred to as NDMA, short for N-nitrosodimethylamine – a substance believed to be “a probable human carcinogen (a substance that could cause cancer).”
In light of that, the US Food and Drug Administration (FDA) is issuing an alert to healthcare professionals and patients of a voluntary recall of several brands of these drugs that were found to contain NDMA-contaminated Valsartan, the agency said in a July 13 press release.
FDA says that the discovery of NDMA in the active ingredient was unexpected and is believed to be the result of changes in the standard manufacturing practice for Valsartan.
The FDA endeavour is continuing and it’s now in the process of testing the recalled drugs to determine the NDMA levels in them; to understand how it could have possibly affected patients who have been using them; and what can be done to ensure reduction, if not total elimination, of the impurity in the future.
“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,” the press release quoted FDA Commissioner Scott Gottlieb.
“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,” Gottlieb said, justifying the recall.
“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,” the FDA commissioner added.
Companies that are recalling all their non-expired products that contain third-party supplied active ingredient Valsartan include:
- Major Pharmaceutical – recalling Valsartan
- Solco Healthcare – recalling Valsartan and Valsartan/Hydrochlorothiazide (HCTZ)
- Teva Pharmaceuticals Industries Ltd. – recalling Valsartan and Valsartan/Hydrochlorothiazide (HCTZ)
Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., said that after careful investigation of Valsartan-based medicines sold in the U.S., the aforementioned companies were found to be in violation of the agency’s safety standards and, hence, asked to take prompt measures to safeguard patients.
“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,” said Woodcock.
“This is why we’ve asked these companies to take immediate action to protect patients,” she added.
The FDA alert comes in the wake of a multi-nation recall that saw 22 countries recalling some 2,300 batches of Valsartan-containing drugs, just a week prior to the FDA press release.
These countries include (in alphabetical order) Austria, Bahrain, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Spain, Sweden, and The Netherlands.
According to Novartis, the original developers of the Valsartan, only Sandoz Valsartan and Sandoz Valsartan/HCT film-coated tablets were recalled in these countries as they did not meet the company’s “high-quality standards.”
UK pharmacies were advised to recall batches containing Valsartan-based medicines manufactured by Accord Healthcare and Dexcel Pharma Ltd.
Novartis spokesman Eric Althoff had said at the time of the recall that the move wouldn’t have any bearing on the products sold in the U.S., while FDA spokeswoman Sandy Walsh had said that the agency was aware of the developments but she had “no comment at this time.”
She, however, did add that the US Food and Drug Administration was “committed to informing the public in a timely manner when the agency identifies safety issues.”
She added: “Generally, the agency does not comment on third-party announcements, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The FDA has advised patients to continue taking the recalled drugs until they get an NDMA-free Valsartan product.
The agency also urged patients to “look at the drug name and company name on the label of their prescription bottle” to confirm whether, or not, a specific product has been recalled.
“If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine,” says FDA.
The release went on to say that any patient taking a recalled drug “should follow the recall instructions provided by the specific company,” which can be found on the FDA website.
Additionally, the FDA has advised patients using recalled drugs to get in touch with the pharmacist who dispensed the medication or the prescribing doctor to discuss alternative treatment options like, for example, NDMA-free Valsartan products or an altogether different line of treatment.
The influx of sub-standard medicine in the United States is becoming a serious cause for worry for health professionals.
Speaking to the New York Times, Cleveland Clinic cardiologist Harry Lever said that the problem was not just limited to Valsartan.
“It’s becoming very difficult for me to write prescriptions at all,” Lever told NYT.
“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,” added the concerned cardiologist.