FDA issued a recall of popular blood pressure drugs. Here’s what you need to know.
After learning that some generic versions of the drug valsartan were contaminated with a potentially cancer-causing chemical called N-nitrosodimethylamine (NDMA), FDA has issued a recall to 13 manufacturers and some repacking companies. Valsartan is an angiotensin II receptor blocker that treats high blood pressure and heart failure.
In late August, FDA said it may need to recall more drugs in the angiotensin II receptor blocker class depending on its lab test results. “The active ingredient is made at a factory in China or India; it is then repackaged and sold under other manufacturer’s names,” says Guy L. Mintz, MD, FACP, FACC, FNLA, director of cardiovascular health and lipidology at Sandra Atlas Bass Heart Hospital and North Shore University Hospital, and associate professor of medicine at Zucker School of Medicine, all in Manhasset, New York.
In addition to valsartan, recalled products include valsartan and hydrochlorothiazide, a valsartan-amlodipine combination, and a valsartan-amlodipine-hydrochlorothiazide combination. Twenty-two countries have recalled more than 2,400 batches of valsartan product.
Here are six other things MCOs should know about the recall.
1. The severity of risk is unknown. The Environmental Protection Agency classifies NDMA as a chemical that can increase cancer risk in humans. “The increased risk of cancer was found in animal studies, however the level of NDMA was much higher than the levels of NDMA found in the affected valsartan products,” says Michael Ganio, PharmD, MS, BCPS, FASHP, director of Pharmacy Practice and Quality at American Society of Health-System Pharmacists in Bethesda, Maryland.
Acceptable levels of NDMA are found in some food products and some water supplies. “The levels of NDMA in the affected valsartan products were above acceptable levels, and FDA determined that they posed an unnecessary risk to patients,” Ganio says.
2. Not all valsartan products have been recalled. Only products made with the active ingredient that contained NDMA are affected. Products from some manufacturers are not affected by the recall, Ganio says. Patients may be able to switch to the same strength drug from a manufacturer that is unaffected by the recall. FDA keeps a comprehensive and up-to-date list of recalled drugs on its website.
3. Patients shouldn’t stop taking their medication immediately. Abruptly stopping valsartan could result in a dangerous rise in blood pressure, which may place patients at risk for stroke or other types of organ damage, says Brent Reed, PharmD, an associate professor at University of Maryland School of Pharmacy in Baltimore. The FDA has advised patients to continue taking their medication and to call their pharmacist to switch to a version made by an unaffected manufacturer or to contact their prescriber to receive an alternative medication.
4. Good alternatives exist. There are seven other drugs in the angiotensin II receptor blocker class that patients might be able to take, Mintz says. Patients might also be able to use other families of drugs to treat high blood pressure such as diuretics, calcium channel blockers, beta blockers, and angiotensin converting enzyme (ACE) inhibitors. These families of medications have been used for decades to treat high blood pressure.
Managed care pharmacists can identify which products are available based on each drug’s unique 10-digit National Drug Code and work with a health insurer’s network prescribers and dispensing pharmacists to steer patients toward those drugs, says Susan A. Cantrell, RPh, CAE, chief executive officer of Academy of Managed Care Pharmacy in Alexandria, Virginia., a national organization representing pharmacists and other healthcare professionals who design and oversee pharmacy benefits.
5. Recalls are costly. The cost of a drug recall can vary widely, and is impacted by many factors such as potential FDA fines, the amount of product in the marketplace, the operational details of the recall (notification, collection, etc.), and product liability. Some well-known recalls and their estimated costs include Vioxx in 2004, which incurred nearly $6 billion in litigation expenses alone, and Baycol in 2001, with litigation expenses exceeding $1 billion. “Given that the harm suffered by Baycol and Vioxx patients was relatively easily tied to product use, these are likely extreme examples,” says Todd Edgar, MS, PharmD, senior vice president of Payer Access Solutions, Precision for Value, a pharmaceutical consulting firm.
6. Health insurers can spread the word. Health insurers may wish to develop a process to rapidly notify members of recalls if they don’t already have such a system in place. “While this will likely occur at the pharmacy level, an alternate notification method may catch members more quickly,” Edgar says. Insurers with their own pharmacy distribution should have contracts with wholesalers and manufacturers to address how recalls are handled.
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.