Impurities detected in ranitidine medicines


Recently, the European Commission (EC) has been informed that ranitidine medicines may contain low levels of a nitrosamine impurity, termed N-nitrosodimethylamine (NDMA). Based on laboratory tests results, NDMA is classified as a probable human carcinogen.

Since last year, the European Medicine Agency (EMA) has been investigating the presence of NDMA and other carcinogens in angiotensin-II-receptor blockers, known as sartans. These agents are prescribed to reduce arterial hypertension and heart failure symptoms. In the sartan context, the EMA has commended numerous sartan recalls from the market, in an effort to protect patients against any risk to their health.

Ranitidine, a histamine-2 blocker, is both an over-the-counter and prescription drug, which is widely used to decrease acid secretion by the stomach. Presently, the EMA is closely working with international regulators and industrial partners to assess the source of this impurity, find out the NDMA levels in ranitidine medicines, and reveal any possible risks to patients. At present, the EMA is not calling for patients to stop taking ranitidine. Nonetheless, patients who wish to discontinue ranitidine intake should discuss this issue with their healthcare professional, as a number of other treatment options are available on the market.