It has been a scary month for people taking medication for high blood pressure and heart failure. On July 13, a worldwide recall of the common medication valsartan began.
The recall started with a few companies, but then European and U.S. health officials began to expand their recall of valsartan. They began the recall because they discovered the potentially cancer-causing substance N-nitrosodimethylamine (NDMA) in the medication.
Now, a month later, they've made yet another expansion of the recall. They found that valsartan made by a second Chinese drugmaker and by a drugmaker in India also contain the contaminate, reported WebMD.
More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent weeks after NDMA was discovered in the drugs’ ingredients manufactured by Zhejiang Huahai Pharmaceuticals of Linhai, China. The second Chinese drugmaker is Zhejiang Tianyu Pharmaceuticals of Taizhou, China.
The FDA has also recalled some valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals. They were also found to contain NDMA at even higher levels that those from the Chinese labs.
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.
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.
Visit the FDA for a full list of all the drugs being recalled. The list is being constantly updated, so we will not reprint it here so that you can have the most update health information.
In other news, a common thyroid medication as also been impacted by the low standards in China. Find out if you need to swap out your medication.