FDA: Recalled Blood Pressure Meds Due To Link Cancer
FDA: Recalled Blood Pressure Meds Due To Link Cancer.
The U.S. Food and Drug Administration (FDA) has issued a series of recalls of blood pressure medication over the last 10 months, all linked to concerns that the drugs may be linked to an increased risk of cancer. A worldwide recall earlier this year removed several common drugs for high blood pressure containing valsartan from the market due to a potential cancer risk.
Now, a new fast-tracked study suggests that there’s no “markedly increased short-term overall risk of cancer” among people who had taken valsartan contaminated with N-nitrosodimethylamine, or NDMA.
But what makes these drugs a cancer risk? All of the medications were found to contain a set of impurities in the drugs’ active ingredients.
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In July last year, the FDA and other agencies around the world issued a voluntary recall of certain products containing valsartan due to the presence of an “impurity.”
The impurity, NDMA, is classified as a probable human carcinogen based on laboratory tests. The long-term risks posed by valsartan-containing drugs contaminated with NDMA is unclear, and depends in part upon the amount of the impurity consumed.
The impurities are organic chemicals, apparently formed as byproducts during drug production, that are known to cause cancer in lab animals. Still, users of the affected medications shouldn’t panic: According to the FDA, the likelihood of low levels of exposure causing cancer in humans is small. However, people who use the drugs are urged to talk to their doctors about switching medications.
“Even if it’s a very relatively small risk, that’s still risk we don’t want,” said Craig Beavers, a cardiovascular clinical pharmacist at the University of Kentucky Medical Center at UK Healthcare.
Impurities Found In Valsartan Products
The affected drugs are called angiotensin II receptor blockers, or ARBs, and go by generic names including valsartan, losartan and irbesartan. A full list of the recalled medications is available on the FDA website.
ARBs work by blocking molecules in the muscles around blood vessels that tend to contract those muscles and narrow the vessels. As the muscles relax, the blood vessels open, reducing blood pressure. The impurities, discovered in July 2018, don’t affect the drugs’ efficacy, said Beavers, who is a member of the American College of Cardiology Cardiovascular Team Leadership Council.
Both NDMA and NDEA have long been known to cause cancer in laboratory animals, and researchers assume the same is true for humans. The compounds particularly affect the liver, kidneys and lungs, according to The National Institute for Occupational Safety and Health.
NDMA and NDEA are both the byproducts of various industrial processes, including wastewater treatment. The compounds also appear naturally in some foods, such as cured meats and beer. In the case of the ARB drugs, the problem seems to originate with some of the solvents used to manufacture the active pharmaceutical ingredients, according to the FDA.
The overall risk of developing cancer from taking ARB medications is low, according to the FDA. The agency estimated that if 8,000 people took the highest valsartan dose of the contaminated medication for four years, there would be one additional cancer case above the average rate. Most people taking valsartan would not have reached that maximum contaminated dose, the agency noted.
The FDA said that patients taking one of the affected medications should keep taking it until they can work with their health care provider to find an alternative medication (uncontrolled blood pressure, of course, is dangerous in its own right. ARBs are rarely the only medically effective option for someone, Beavers said.
“If you have to switch to another class of agents, most people could,” he said.
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