In late July, the U.S. Food and Drug Administration warned consumers that several pharmaceutical companies have initiated recalls of the popular blood pressure drug valsartan after discovering that the medication is contaminated with a potentially carcinogenic chemical.
Valsartan is the generic name for Diovan, a drug used to treat hypertension (high blood pressure) and to lower the risk of complications like stroke after a heart attack. The drug is widely used-in 2010, global Diovan sales topped $6 billion. It was discovered that valsartan products manufactured by the Chinese firm Zhejiang Huahai Pharmaceuticals contained an impurity known as NDMA (N-nitrosodimethylamine), a chemical suspected to cause cancer in the U.S. (in Europe, it is accepted that NDMA is carcinogenic). NDMA is also toxic to the liver, and there have been several incidents in which it has been used intentionally to poison someone. Once the contamination was discovered, the distributors Major Pharmaceuticals, Solco Healthcare LLC, and Actavis LLC all began voluntary recalls of impacted valsartan products. The recalls include products distributed to individual consumers as well as others that are only administered by healthcare professionals in a healthcare facility.
The FDA noted that not all valsartan-containing products are contaminated, warning consumers not to stop taking their medication until they consult with their physicians and are advised to switch to a similar medication or different valsartan product. However, because the impurity may have been present in some of the valsartan products for as long as four years by the time of the FDA’s warning, it may be too little, too late, for some.
Although a nationwide Danish study published last week in the British Medical Journal found “no evidence of a markedly increased short-term overall risk of cancer,” the authors cautioned that this study only looks at short-term risk and gives limited insight into possible increases in the risk of individual types of cancer. The researchers urged that long-term studies are needed to be sure of the risks.
If you or someone you know has been harmed by a prescription medication, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling 713-231-9360 or 1-888-229-5094.