Pharmaceutical companies recall 87 batches of blood pressure drugs over cancer concerns

Blood Pressure Med Recall 87 lots

Camber Pharmaceuticals is voluntarily recalling 87 lots of the blood pressure drug Losartan due to traces of a potential carcinogen.

The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. The impurity is a known animal and potential human carcinogen.

Recent federal research has found NDMA and NDEA's "risk to individual patients is very low", a U.S. Food and Drug Administration statement said.

The factory at the center of the latest recall, Hetero Labs of India, has received warnings from the FDA, and reportedly shredded documents before inspection.

USA health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

A man has his blood pressure checked at the Remote Area Medical Clinic in Wise, Virginia, U.S., July 22, 2017.

A series of drugs have been identified as potentially unsafe since an initial recall began seven months ago.

"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA". NMBA had not been found in previously recalled ARB products, but the FDA continues its investigations.

Gottlieb said the agency is "deeply concerned about the presence of a third nitrosamine impurity" in hypertension drugs and is working on "novel and sophisticated testing methods" to detect these impurities. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future". If patients take an ARB drug product, they should check the list periodically, as information may change.

From a community pharmacy perspective, this recall has been hard because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively".

Related:

Comments


Other news