The FDA issued on September 13th, 2018 the second recall on the popular hypertension medication “Valsartan”. Yet another cancer-causing agent was found in the drug
The U.S. Food and Drug Administration has found a second cancer-causing impurity in three lots of the popular blood pressure medicine valsartan. The lots were all sold through Torrent Pharmaceuticals. The discovery could lead to additional recalls or warnings to patients taking valsartan.
The latest FDA tests found three lots of Torrent Pharmaceutical’s valsartan contained NDEA (N-Nitrosodiethylamine). NDEA is a known cancer-causing agent in animals and a suspected of causing cancer in humans. The Torrent lots were already under recall for NDMA contamination when the FDA tests discovered the second impurity. NDMA is also a probable cause of cancer in humans.
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Cancer is not a typical valsartan side effect. But the contamination could raise cancer risks for people taking the medicine.
Valsartan is a widely-used generic drug. The recalls over the summer raised questions about NDMA and cancer risks for people taking the drug. An estimated 3 million Americans take valsartan for high blood pressure or related heart conditions. The European Medicines Agency estimates the risk of cancer from the maximum dose of NDMA-tainted valsartan at one in 5,000. That could still mean hundreds of additional cancer cases in the U.S. The first valsartan lawsuits over NDMA contamination were filed in late August.
FDA Recall Alert
The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (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’s review is ongoing and has included investigating 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.
Information for Patients and Health Care Professionals
Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines 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 below, they should follow the recall instructions provided by the specific company. This information will be posted on the FDA’s website.
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Patients should also contact their healthcare professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
Products Being Recalled
Medicine Being Recalled
Valsartan- Manufactured by Major Pharmaceuticals
Valsartan- Manufactured by Solco Healthcare
Valsartan- Manufactured by Teva Pharmaceuticals
Valsartan/Hydrochlorothiazide (HCTZ)- Manufactured by Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)- Manufactured by Teva Pharmaceuticals
The agency advised patients taking the drug to look at the manufacturer’s name on the label of their prescription bottle to determine if it is part of the recall. If the information is not there, patients should contact the pharmacy where they got it, the F.D.A. said.
The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute. Their healthcare provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero, according to Fore Pharma.
“The recall is huge, based on the volume and the large number of patients it could have impacted,” said Mr. Brito, “but we believe this could get offset by other players stocking up in short term. Switch options are available for a hypertension patient.”
Even the EMA “European Medicines Agency” has also started a massive recall.
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
Rekindling an Old Fear
Due to the recent recall, many are once again concerned about medications that are manufactured overseas. Specifically in India and China.
Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said he was concerned about quality control of generic medicines, like valsartan, made in China and India. He believes that manufacturers should be more transparent about where their active ingredients are made.
“It’s not just valsartan,” Dr. Lever said. “It’s becoming very difficult for me to write prescriptions at all. 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.”
The FDA Protecting the Public
The Food and Drug Administration is caught between two hard rocks. On the one hand, the agency has been criticized for inadequate oversight of foreign drug manufacturing facilities, especially in China and India. On the other hand, the FDA has been hammered for allowing drug shortages to persist, especially when many of the drugs are essential for the public health.
But the path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident.
Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug–from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
The fact that the FDA has put out this recall should give us a sense of well-being and protection. In every industry from time to time, there are recalls. The fact is the safety check system that is in place allowed the FDA to find this problem and initiate the recall.