FDA Recalls Blood Pressure Medications for Possible Carcinogenic Contamination
It has been more than six months since the U.S. Food and Drug Administration (FDA) ordered several prescription blood pressure medications to be removed from pharmacy shelves due to the threat of contamination with an impurity known as N-nitrosodimethylamine (NDMA). The medications are a type of pharmacological product known as angiotensin II receptor blockers or “ARBs.” Blood pressure medications valsartan, losartan, and irbesartan are ARBs and have been recalled by the FDA’s order.
One of the recalled drugs, losartan, is a major medication dispensed by U.S. pharmacies. In 2016, 49 million patients were dispensed losartan, while 8 million patients received valsartan and 3 million irbesartan. The exposure could be even greater as these figures do not account for medication dispensed by hospitals and the VA system. The chance of developing cancer from contaminated medication is about 1 in 8,000.
As a result of the recall, patients have to have their medications changed out to medication lots that have not been affected. However, pharmacies typically don’t track the lot numbers of medications after they’re dispensed.
The Suspected Source of the Contamination
NDMA is a chemical byproduct found after manufacturing pesticides and used to make rocket fuel. However, NDMA can be accidentally synthesized through specific chemical reactions. Nitrosamines – the chemical group to which NDMA belongs – are genotoxic. Genotoxicity refers to the ability of a substance to negatively impact DNA replication and cause cancer.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that the contamination likely occurred when Chinese manufacturers modified its synthesizing processes in 2010, reusing materials such as solvents. However, source materials may have also contained NDMA in it.
Despite FDA safeguards to prevent drug contamination, this particular chemical was able to circumvent such safeguards because no one knew that this type of impurity was a risk. According to Professor Maisha Kelly Freeman from Samford University’s Center for Healthcare Innovation and Patient Outcomes Research, “Before they found this particular compound, [the FDA] didn’t even know there could be a chemical reaction that could produce the compound.”
Consult an Experienced Indianapolis Defective Drug Attorney for Advice
If you are among the millions of Americans who have been prescribed an ARB such as losartan, valsartan, and irbesartan, and are concerned about the potential effect of NDMA contamination, you should consult your doctor for an assessment. If you have been diagnosed with cancer and had been using an ARB medication after 2010, you might be entitled to a legal remedy. To determine the full extent of your legal rights and option, you should discuss your case with an experienced Indianapolis defective drug attorney. At Wagner Reese, we have years of litigation experience handling dangerously defective drugs and medications. Our firm is currently representing over 1,000 patient victims who developed cancer after using medication contaminated with NDMA.
Call Wagner Reese at (888) 204-8440 or contact us online to schedule a free consultation with one of our dedicated attorneys about your case today.