75th Hypertension Medication Recall Issued For Cancer Causing Agent
Written by Eli Ben-YehudaOn November 26, 2019
Discussing The Problem
Dozens of medications used to treat high blood pressure have been recalled over the past several months as federal investigators discover potentially cancer-causing impurities in them. When American Health Packaging recalled one lot of valsartan pills on March 7, the Public Interest Research Group said it was the 75th recall of blood pressure medications since the problem first appeared.
These common prescription drugs include valsartan, losartan, and irbesartan in different combinations and from different manufacturers.
The problems have become so widespread that on March 12 the FDA prioritized approval of a new generic of valsartan to help relieve shortages of the drug. In April, the agency released a list of 40 blood pressure medications it says are free from contamination. You can find the list here.
“Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients,” the agency said in a statement.
The FDA is also working to determine what exactly has caused the impurities and what changes need to be made in the manufacturing process to prevent it. The Public Interest Research Group said in March that the FDA needs to step up the pace.
“After 75 recalls it is clear more aggressive action is needed,” PIRG consumer watchdog Adam Garber said in a release. “Americans expect their blood pressure medication to treat their conditions, not cause cancer. The FDA needs to finish its investigation and develop a plan to prevent further contamination.”
Almost 60 million prescriptions were written for losartan drugs in 2016 and 14 million for valsartan or a drug that includes it. An additional 3.6 million prescriptions were written for irbesartan that year. Here’s what you need to know.
The drug manufacturer Torrent Pharmaceuticals broadened its voluntary nationwide recall of its blood pressure medication losartan this week when trace amounts of a potential cancer-causing ingredient were detected in batches of the product.
The recall now includes three lots of losartan potassium tablets and two lots of losartan potassium-hydrochlorothiazide tablets, according to the U.S. Food and Drug Administration (FDA), which lists the specific batch numbers on its website.
Losartan products are used to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in patients with type 2 diabetes.
The medication is a type of angiotensin II receptor blocker (ARB), which helps control blood pressure by blocking the action of a chemical in the body that narrows blood vessels. Two other popular ARBs — valsartan and irbesartan — have been under an ongoing recall for months.
Discontinuing Therapy Can Be Deadly
The American Heart Association advises patients to keep taking their blood pressure medication because abrupt discontinuation can have serious health consequences.
“Stopping any blood pressure medication suddenly, without a substitute product, will increase your risk for stroke or heart attack,” says Sarah Samaan, MD, a cardiologist with Baylor Scott & White Legacy Heart Center in Plano, Texas.
Michael Ganio, PharmD, director of pharmacy practice and quality at the American Society of Health-System Pharmacists in Bethesda, Maryland, urges anyone on these therapies to consult with their healthcare provider or pharmacist.
“They can find an alternative medication for you or offer some peace of mind if the medication you have already is not affected,” he says.
The FDA reminds consumers that not all valsartan-, losartan-, or irbesartan-containing medicines are affected and being recalled.
Dr. Ganio notes that some drugs may be in short supply, so patients may want to talk to their prescriber about other options, such as candesartan and telmisartan, which are in the same class but not affected by the recall at this time.
What’s Behind the Problem?
The culprits behind the latest recalls are N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA), substances that occur naturally in certain foods, drinking water, air pollution, and industrial processes. The chemicals have been classified as probable human carcinogens by the International Agency for Research on Cancer (IARC).
These are organic compounds that can be found in food products such as bacon and other cured meats, fish, cheese, and malt beverages, including beer, according to a policy summary report by the Technology Centre Mongstad in Kaland, Norway.
In the worst-case scenario, the FDA estimates that if 8,000 people took the highest dose of valsartan (320 mg) containing NDMA daily for four years, it might cause one additional case of cancer over the lifetimes of those 8,000 people. The agency underscores that, in reality, the risk is probably much less because patients are likely to receive a much smaller dose of the impurity.
Efforts to Improve Drug Quality
Dr. Samaan underscores that the drugs themselves are not the problem, but poor manufacturing processes that allow contaminants to be introduced.
“If you have a ‘clean’ version of the drug, there is no reason to worry about this particular issue,” she says.
Many of these products, however, are manufactured as inexpensive generics outside of the United States, which makes it more difficult to assure quality control.
“A lot of the products are sourced overseas, and we don’t have transparency in knowing where these products are coming from,” says Ganio.
The FDA maintains that it is taking regulatory and advisory steps to prevent the presence of unacceptable levels of these impurities, including actions to improve quality control abroad.
The agency points to a warning letter dated August 8, 2019, which it recently sent to a company in India that was not meeting good standards for drug production.
“We rely on the FDA to ensure the safety of our drug supply. But when drugs are manufactured overseas, it is becoming increasingly clear that the oversight is not as careful or consistent as we have come to believe,” says Samaan.
Heartburn Medication Has Also Been Recalled
Compounding consumer worries about drug safety even further this month, the drug company Novartis halted the distribution of all products containing ranitidine, including its popular heartburn medication Zantac.
Again, the detection of cancer-causing impurities triggered the recall, but the cause of the contamination is still under investigation.
“Until we know a little more information, it seems prudent to just switch to another heartburn medication that’s over-the-counter,” says Ganio. “For prescription-strength ranitidine, consult with the prescriber to see if there’s another medication that he or she would recommend.”
To help you stay on top of all the latest information regarding drug recalls, the FDA maintains a dedicated webpage that is updated regularly.Tags:
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