AARP Hearing Center
Susan Haskell Maxson had just purchased a three-month refill of the blood-pressure-lowering drug valsartan in the summer of 2018 when she got a scary warning letter. The U.S. Food and Drug Administration (FDA) was recalling the generic medication due to contamination with N-nitrosodimethylamine (NDMA), a chemical that may pose a cancer risk.
After her doctor switched her meds, says Maxson, 73, of Laguna Woods, California, “it took two months to stabilize my blood pressure. Now I've developed breathing problems and lung nodules. No one knows if valsartan was involved. I even called the FDA about it. I never used to think about the safety of medications before. Now I do."
Tainted blood pressure and heart failure drugs have been in the headlines in recent months. More than a thousand lots of these generic ARBs (angiotensin II receptor blockers) from roughly two dozen drugmakers were recalled between July 2018 and mid-October 2019 after unsafe levels of NDMA — as well as another probable carcinogen and a third potential carcinogen — were discovered in FDA tests. In June 2019 an independent testing lab warned of another impurity in valsartan: the probable human carcinogen dimethylformamide (DMF). To treat high blood pressure and congestive heart failure and to help prevent strokes, doctors wrote more than 79 million prescriptions for ARBs in 2016, according to government statistics.
Meanwhile, prescription and over-the-counter (OTC) versions of Zantac and generic ranitidine, digestive medicines known as H2 blockers, have been recalled by some drugmakers and pulled from drugstore shelves after tests found low levels of NDMA in many of these products. In late October five more makers of ranitidine announced voluntary recalls. So how worried should you be? Are your drugs impure?
Recent recalls
Drugs removed from pharmacy shelves as of mid-October:
Valsartan
Prescribed for: high blood pressure
Recalled for: NDMA contamination
ARBs
Prescribed for: high blood pressure and congestive heart failure; also lower risk of stroke
Recalled for: potential carcinogen
Zantac and generic ranitidine
Used for: over-the-counter relief of heartburn associated with indigestion
Recalled for: low levels of NDMA
The FDA is still investigating, but the sources of the various problems seem to be very different. In the case of ARBs, there appear to be serious issues in the manufacturing of active ingredients in the drug. Compounds in the other drug, ranitidine, seem to form NDMA as the drug is broken down in the body — a process not previously suspected.
Experts differ about what it all means for the safety of America's drugs, many of which are produced outside the U.S.
"This is a very serious problem. I think it raises a lot of potentially serious questions about the supply chain and where drugs come from,” says Mark Benson, a cardiologist at Beth Israel Deaconess Medical Center in Boston. “Physicians and patients are end users in a very complicated worldwide chain, but neither group completely understands it."
But Caleb Alexander, M.D., codirector of the Johns Hopkins Center for Drug Safety and Effectiveness, counters: “Of course you can still trust generics. The recalls are highly visible and very disconcerting, but the generic supply chain is safe. These are isolated events.”
Leigh Purvis, director of health services research at the AARP Public Policy Institute, notes that “there is no real evidence that generics are less safe than brand-name drugs. The U.S. Food and Drug Administration is trying to harmonize inspections with other countries. We've always been very clear at AARP that the FDA should have the resources to do its job.”
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