As we reported last month, the FDA is recalling a common heart medication because it is contaminated with a carcinogen. The FDA widened the recall as part of their ongoing investigation.
The U.S. Food and Drug Administration is recalling drugs used to treat high blood pressure and heart failure that contain the active ingredient Valsartan. The U.S. FDA joins at least 22 other countries that are recalling drugs that include this drug.
Tests showed that there was N-nitrosodimethylamine (NDMA) in the recalled products. The FDA reported that NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
NDMA is a chemical that is in a family of potent carcinogens. It has been used to make liquid rocket fuel, softeners, and lubricants. It can also be unintentionally produced through certain chemical reactions, and it is a byproduct of some pesticide manufacturing, the making of rubber tires, and fish processing.
"However, not all products containing valsartan are being recalled. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," added the FDA.
The contaminated drugs were made at a lab in China. They were then repackaged by pharmaceutical companies worldwide.
The recall initially started on July 13. On July 27, the FDA released a new press release because they had discovered additional companies that had repackaged the contaminated drugs.
However, on Friday, July 27, the FDA revealed that consumers may have been taking the contaminated drug for four years—since the Chinese company changed their manufacturing process. Other reports say the drug may have been contaminated since 2012. The drug has been widely prescribed across the world for 15 years.
In a clarifying statement, the FDA said that "some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people."
However, they judged that rate high enough for the recall.
The US recall includes the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. They are also recalling valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
Testing done on animals has shown that NDMA can cause tumors in the liver, kidney and respiratory tract. It can also potentially cause liver damage and probable cancer in humans at high levels.
The investigation into the drugs is ongoing. They are also in the process of investigating the impact of patients who have been taking the contaminated drug. They are also working with the companies to prevent future batches of the drug from being contaminated.
“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."
But no worries for people who rely on these drugs. They are working to find substitutes.
"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," added Gottlieb.
Because valsartan is used in medicines that treat serious medical conditions, patients are advised to continue taking their valsartan-containing medicines until they have a replacement product.
To determine whether a specific product has been recalled, patients are told to look at the drug name and company name on the label of their prescription bottle. If that information isn't on the bottle, they should contact the pharmacy that dispensed the medicine.
If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. They should also contact their prescribing doctor to discuss further treatment. Going off the medication without consulting a doctor could be dangerous.
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party.
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.
On July 27, they added three more repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals: labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack.
The following companies have been removed from a list of companies not effected by the recall. They are expected to recall their products as well.
-Bryant Ranch Prepack Inc.
-H. J. Harkins Company Inc. (this company was not originally included on either list)
-Lake Erie Medical, doing business as Quality Care Products LLC
-NuCare Pharmaceuticals Inc.
“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.
Please pray for everyone who had been taking these drugs long-term. It's a very scary recall for anyone who has had heart problems given the scope of the recall. Please share this with anyone you think might be impacted.