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ARB 6 articles

Third cancer-causing impurity found in certain ARB blood pressure drugs

A third type of cancer-causing impurity has been found in a type of high blood pressure and heart failure medication from a class of drugs known as ARBs (angiotensin receptor blocker), the Food and Drug Administration (FDA) announced in a news release. The impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), was detected in losartan potassium tablets made by Hetero Labs Ltd., and distributed by Camber Pharmaceuticals. As a result, Hetero Labs recalled 87 lots of the pills in 25mg, 50mg, and 100mg dosages. Since last summer, the FDA has issued numerous recalls of the ARBs losartan, valsartan and irbesartan mainly due to the ... Read More

Recalls cause shortage of high blood pressure drugs

Sweeping recalls of a class of high blood pressure drugs known as ARBs, or angiotensin II receptor blockers, has resulted in a shortage, Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and FDA director of drug evaluation and research Dr. Janet Woodcock said in a joint statement. And the problem will probably get worse. The shortage is among ARBs that contain the active drug ingredient valsartan, and may soon also affect other ARBs that contain losartan and irbesartan. The shortage is due to recalls of the drug over an unexpected impurity, which was identified as a chemical called NDMA ... Read More

Blood pressure drugs associated with severe, chronic diarrhea with substantial weight loss

The blood pressure drug olmesartan medoxomil, known by the brand names Benicar, Benicar HCT, Azor, and Tribenzor, and in generic forms, can cause intestinal problems known as sprue-like enteropathy, a condition that can cause severe, chronic diarrhea with substantial weight loss, the Food and Drug Administration (FDA) warned. The FDA says it will continue to evaluate the safety of olmesartan-containing drugs and will issue another safety communication if additional information comes available. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) used to treat high blood pressure either alone or with other antihypertensive agents. It is one of eight marketed ... Read More

FDA researcher wants lung cancer warning added to class of blood pressure drugs

Thomas Marciniak, a scientist for the Food and Drug Administration (FDA), wants the agency to warn consumers that a class of high blood pressure drugs may cause lung cancer. Marciniak’s concern arises from a 2010 study that concluded that angiotensin receptor blockers, or ARBs, taken by millions of people to treat high blood pressure, could increase the risk for cancer, in particular lung cancer. The study found people who used ARBs, which include the brand-name drugs Diovan and Cozaar, had a 25 percent greater risk of developing lung cancer. The study prompted the FDA to conduct its own safety review, ... Read More

Blood pressure drug labels now warn of fetal toxicity

The Food and Drug Administration (FDA) has announced changes to the safety labels of some medications used to treat high blood pressure to include a black box warning that using the drugs while pregnant may cause serious injury or death to the developing fetus. A boxed warning is the strongest warning that the FDA requires, and signifies that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. Hypertension drugs whose labels will carry the new warnings include Atacand HCT (candesartan cilextetil/hydrochlorothiazide) tablets, Benicar (olmesatan medoxomil) tablets, Twynsta (telmisartan/amlodipine) tablets, Zestoretic (lisinopril/hydrochlorothiazide) tablets, and ... Read More

FDA investigates link between blood pressure drugs and cancer

The Food and Drug Administration (FDA) is investigating a recently published study that suggests medications used to treat high blood pressure and other conditions, known as angiotensin receptor blockers (ARBs), may increase cancer risk. Brand name ARBs include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. The published meta-analysis combined data from more than 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs during which adverse events related to cancer were captured. New cancer occurrence was 7.2 for patients receiving ARBs compared to 6.0 for patients not receiving ARBs. No statistically significant difference in cancer deaths were reported. ... Read More