ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) on Monday directed tens of companies across the country to stop manufacturing medicines made with the raw material ‘Ranitidine’ — including Zantac — and recall all such products already on the market.
The substance is used for the treatment of stomach acidity and related discomforts. The directive has been given out after an alert generated by the United States’ Food and Drug Administration (US FDA) that the medicine can cause cancer.
The Drap document, available with Dawn, says that a nitrosamine impurity called N-Nitrosodimethylamine (NDMA) [a probable carcinogenic impurity] has been found in some products containing Ranitidine.
“[The] FDA and European Medicines Agency (EMA) are evaluating the risk associated with low levels of NDMA in Ranitidine. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Drap is closely working with international regulatory agencies to monitor the outcome of the investigations. However, in the greater public interest and in order to protect patients from probable risk associated with the detection of low levels of NDMA in Ranitidine […] it is advised to suspend production for all dosage forms of Ranitidine-containing drugs till further orders; the stoppage of the release/distribution of all dosage forms of Ranitidine-containing drugs till further orders; and the stoppage of the sale/supply/utilisation of all dosage-forms of Ranitidine-containing drugs till further orders. Furthermore, it is requested to initiate the recall of the medicine available in sale outlets/distributors/hospitals/healthcare facilities,” it states.
An official of Drap, who is not authorised to speak on record, said that Ranitidine was discovered in 1976 and came into commercial use in 1981.
“It is mostly used for acidity and is on the World Health Organisation’s Model List of Essential Medicines. It was the 50th most prescribed medication in the United States, with more than 15 million prescriptions. However, the FDA has advised patients not to use it. Moreover, Canada has also directed companies to stop manufacturing the medicine and recall it. Similar action has been taken by the EMA,” he said.
“As it is also sold over the counter in different countries, which means a prescription is not required for it, sale has immediately been stopped rather than advising medical practitioners not to prescribe it,” he explained.
Replying to a question, he said that it was to be investigated whether some impurity had been mixed into the raw material, or at any other stage. “However, sometimes it happens without the mixing of any impurity, like an apple goes brown after being cut, but neither the fruit or the knife can be blamed,” he explained.
Drap Chief Executive Officer Dr Asim Rauf confirmed that letters were written to all the stakeholders to recall the medicines from the market and stop manufacturing.
“However it is a fact that company which has been manufacturing Zantac (Ranitidine), has already informed us that it has been recalling medicine as a similar step is being taken by the company in Europe,” he said.
Published in Dawn, September 24th, 2019