Doctors Issue Warning Against Heartburn Drug

Days after drugmakers and global public health regulators claim to have taken steps to remove supplies of a popular heartburn medication currently under invesigation by US-Food and Drug Administration (FDA) for the presence of human carcinogen called NDMA, or N-Nitrosodimethylamine in Zantac and its generic forms, doctors in India too have cautioned the general public about this popular drug and asked for an urgent advisory by the Indian drug regulator.

Novartis AG’s Sandoz unit said earlier this week that it was halting worldwide distribution of generic versions of the stomach drug Zantac after regulators in the U.S. and Europe began investigating the drug.

“In India Ranitidine (some versions of Zantac is is also known by the generic name ranitidine) is used for treating gastrointestinal disorders and discomfort. The news regarding the presence of NDMA in Ranitidine is disturbing. Ranitidine remains the most commonly prescribed medicine for acid peptic disorders and has generally been considered safer than many other medicines,’’ said Dr. Shanti Swaroop Dhar, principal consultant, Gastroentorology, Max Super Speciality Centre, Panchsheel Park.

He added that doctors need to know whether NDMA is present as an additive and if it is possible to make Ranitidine which is NDMA-free.

“Further we also need more information as to whether the amount of NDMA present is above the threshold and a genuine risk as small amounts of NDMA is present in many common foods. Short of above clarifications it is prudent to exercise caution in prescribing this drug pending the directives from competent authorities. We also need to educate the community as the drug is easily available over the counter and a large number of people are using this on a regular basis,’’ he said.

Ranitidine, in India is manufactured by Cadila Pharmaceuticals and GlaxoSmithKline Pharmaceuticals. Zantac is manufactured by French pharma major, Sanofi. A senior official at the Central Drugs Standard Control Organisation (CDSCO), maintained that while they are aware of the alert issued by the FDA there is no emergency. “We will wait for more information on this,’’ he noted.

Dr. S.L. Broor, senior consultant, Dept. of Gastroenterology, Indraprastha Apollo noted that FDA’s report on NDMA presence does not issue any warning so far to withdraw the drug from the market. “Also it has not said that patients should not take this drug. The level of NDMA found is very small. NDMA is present as a contaminant in food, water, vegetables and meat also in very small amounts. The drug has been used very commonly for treatment of acid peptic disorders all over the world and has a very good safety profile. We have not seen any case of cancer due to its usage so far.’’

Dr. Lalit Verma, Paediatric Gastroenterologist, Surya Hospitals said: “NDMA may cause harm in large amounts and FDA’s prelim findings suggest that levels of NDMA in ranitidine do not exceed the levels found in common NDMA containing food. We suggest that patients taking over-the-counter drug and medical professionals prescribing should switch to other approved medications until final FDA results are published.’’ – The Hindu