Regulatory body orders medicine recall over cancer fears – Newspaper

ISLAMABAD: The Pakistan Drug Regulatory Authority (Drap) on Monday ordered dozens of companies across the country to stop manufacturing drugs made with the raw material "Ranitidine", including Zantac, and withdraw all those products that are already in the market.

The substance is used for the treatment of heartburn and related discomfort. The directive was issued after an alert generated by the United States Food and Drug Administration (US FDA) that the drug can cause cancer.

The Drap document, available with Dawn, says that a nitrosamine impurity called N-nitrosodimethylamine (NDMA) [a probable carcinogenic impurity] It has been found in some products that contain ranitidine.

"[The] The FDA and the European Medicines Agency (EMA) are evaluating the risk associated with low levels of NDMA in Ranitidine. NDMA is a known environmental pollutant and is found in water and food, including meats, dairy products and vegetables. Drap is working closely with international regulatory agencies to monitor the outcome of the investigations. However, for the sake of greater public interest and to protect patients from the probable risk associated with the detection of low levels of NDMA in Ranitidine. […] it is recommended to suspend the production of all dosage forms of medicines containing ranitidine until further orders; interruption of the release / distribution of all dosage forms of drugs containing ranitidine until further orders; and interruption of the sale / supply / use of all dosage forms of medicines containing ranitidine until further orders. In addition, you are asked to initiate the withdrawal of the available medicine at the points of sale / distributors / hospitals / health centers, ”he says.

A Drap official, who is not authorized to speak on the record, said Ranitidine was discovered in 1976 and entered into commercial use in 1981.

"It is primarily used for heartburn and is on the Model List of Essential Medicines of the World Health Organization. It was the 50th most prescribed medication in the United States, with more than 15 million prescriptions. However, the FDA has advised to patients who do not use it. In addition, Canada has also ordered companies to stop manufacturing the drug and withdraw it. The EMA has taken similar measures, "he said.

"As it is also sold without a prescription in different countries, which means that a prescription is not required for it, the sale stopped immediately instead of advising doctors not to prescribe it," he explained.

In response to a question, he said that it should be investigated if any impurity had been mixed with the raw material or at any other stage. "However, sometimes it happens without mixing impurities, as an apple turns brown after being cut, but you can't blame the fruit or the knife," he explained.

The Executive Director of Drap, Dr. Asim Rauf, confirmed that letters were written to all concerned to withdraw medications from the market and stop manufacturing.

"However, it is a fact that the company that has been manufacturing Zantac (Ranitidine), has already informed us that it has been withdrawing medications since the company is taking a similar step in Europe," he said.

Posted on Dawn, September 24, 2019