If you are one of the millions of Americans living with high blood pressure and one of the thousands taking a generic valsartan medication to control your hypertension, you might have experienced a health scare this summer. On July 13th, 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several generic high blood pressure medications containing the ingredient valsartan due to a likely carcinogenic or cancer-causing contamination. Following this announcement, many consumers were left confused, angry, and scared by the potential impact that this contamination could have on their health. Let’s take a look at the facts surrounding the Valsartan recall, and what consumers need to know in order to respond safely.
The initial recall targeted the drug companies that used valsartan supplied by the Chinese manufacturer Zhejiang Huahai Pharmaceuticals. This was where the initial contamination was identified. Since the FDA’s announcement on July 13th, there have been several updates to the investigation of this consumer drug recall.
During the months of July and August, the FDA continued to update its list of recalled medications as their investigations uncovered more contaminated drugs. During the investigations, the FDA also found two other manufacturing sources of the contaminated ingredient. These are the Chinese manufacturer Zhejiang Tianyu Pharmaceutical and the Indian manufacturer Hetero Labs Limited.
On September 13th, 2018, the FDA released another shocking announcement. A second carcinogenic impurity was found within several of the previously recalled medications. In an effort to further ensure the health and safety of American consumers, the FDA placed an import alert on all “drug ingredients or drugs made with ingredients produced at China’s Zhejiang Huahai Pharmaceuticals’ Chuannan factory” at the end of September.
Before we look at the carcinogenic impurities, we need to talk about valsartan itself. Valsartan is what is known as an active pharmaceutical ingredient (API). It is most commonly associated with the brand-name medication Diovan. When Diovan’s patent expired in 2012, valsartan was used in a number of generic medications to treat high blood pressure, heart failure, and other similar conditions. It is crucial that consumers recognize that the ingredient valsartan was not the root of the issue. It was the contamination of some valsartan produced by certain manufacturers which led to the recall in July. Valsartan remains a safe ingredient.
The first impurity found is known as N-nitrosodimethylamine (NDMA). According to information from the U.S. Environmental Protection Agency, NDMA was previously used “ in the production of rocket fuel, antioxidants and softeners for copolymers.” Studies of the impurity have found that it may cause liver damage in humans and encouraged tumor growth in different animal test subjects.
The second impurity found in September is called N-nitrosodiethylamine (NDEA). From similar testing using animal subjects, NDEA is also classified as a probable human carcinogen. While the full extent of the health impact that these impurities may have on humans is still unknown, the evidence against the impurities was enough to incite an FDA recall.
In the wake of this recall, here are the next steps consumers should take:
- Determine if your medication was affected by the recall. Because not all valsartan medications were included in the recall, compare your medication with the FDA’s published list detailing the specific medications affected by the contaminated ingredient. Use the company name, lot number, and National Drug Code (NDC) on your prescription bottle to determine if you are taking a recalled medication. Call your pharmacist if you have trouble locating this information.
- If your medication is included on the recall list, call your doctor immediately. For many people, their valsartan medication treats a serious health condition like high blood pressure or heart failure. While the recalled medication may pose health risks, discontinuing the medication could cause greater complications. Talk to your doctor about an alternative medication. Unless otherwise instructed by your doctor, continue taking your recalled medication until you have the replacement in hand.
- Report any ill side effects of the recalled medication to your doctor and the FDA. Many consumer drug recalls come about because consumers report adverse side effects and issues that they find with consumer drugs. If you experienced any harm from the recalled medication or notice side effects from the replacement medication, do not hesitate to report your symptoms to the FDA’s MedWatch Voluntary Reporting System.
- Finally, if you do experience harm from a medication and accrue medical costs, you have the legal right to seek compensation for your pains. You have the right to seek legal counsel and guidance should you choose to do so. As of October 16th, 2018, no settlements have occurred for a consumer valsartan lawsuit.
Medication recalls can be scary and often confusing. But with a little research and the expertise of your doctor and pharmacist, you can safely and smartly respond. Know your rights and become an informed consumer to better protect yourself and your family.