Blood Pressure Drug Recalls

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If you are a health care professional, or a person who takes blood pressure medicine, or even just a person who watches the news, you have probably heard about a lot of recent drug recalls involving blood pressure medicines. The drugs involved belong to a class of antihypertensives called ARBs, or angiotensin 2 receptor blockers, and include the drugs valsartan, losartan and irbesartan.

The drugs are being recalled due to contaminants found in the tablets, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). These substances are believed to be carcinogens. It’s important to note that the drugs themselves are not carcinogenic, only the NDMA and NDEA.  These cancer-causing substances are also found in fish, dairy products, beer, and other foods, especially smoked or cured meats. They can form during cooking of foods that contain nitrites. They are also present in the environment as industrial pollutants.

The reason that products from so many different manufacturers are involved is that often the bulk drug powder comes from a single source and is distributed to different manufacturers who produce the finished drug products, i.e. tablets or capsules.

The amount of contaminant in the affected products is not likely to be sufficient to cause harm. However, drug products sold in the United States have to meet stringent standards for purity and safety, and this sort of contamination is not acceptable. The FDA has identified Zhejiang Huahai Pharmaceutical Co. Ltd in China as the source of contaminated drug product, and ceased imports of its bulk drugs and any finished products that were made with their bulk drug.

A drug recall of this scope is unusual and is having additional effects outside of the concerns raised by the contamination. Many patients were switched to another drug when the one they were taking was recalled, only to find out later that their new medication was also being recalled. Frequent medication changes create confusion at the pharmacy as well as at the medicine cabinet.

Some manufacturers who still have unrecalled product have raised their prices in response to the recalls. Some patients switched to brand name drugs and are paying a much higher cost because generics are unavailable. Other patients no doubt have just stopped taking their blood pressure medications out of safety concerns, leaving them at risk of a heart attack or stroke.

With plenty of options available to treat hypertension, patients who are concerned about the recalls should work with their healthcare providers to come up with a safe alternative. Ask your pharmacist about similar medications that are not involved in the recall.

For a list of recalled products click here

Read the FDA statement on the recalls here

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