DRAP Orders Recall of Medicine That Can Cause Cancer - Android

The Drug Regulatory Authority of Pakistan (DRAP) has ordered all the pharmaceutical companies to stop manufacturing medicines using ‘Ranitidine’ and… Read More

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The Drug Regulatory Authority of Pakistan (DRAP) has ordered all the pharmaceutical companies to stop manufacturing medicines using ‘Ranitidine’ and to recall all such products in the market. The substance is used to treat acidity and other stomach related issues.

The notification has come days after a Swiss pharma group Novartis recalled its popular product Zantac using this raw material.

Last week, the United States’ Food and Drug Administration (US FDA) had issued a directive to ban the use of Ranitidine in drugs, fearing it could cause cancer.

It said that a nitrosamine impurity, medically called N-Nitrosodimethyla­mine (NDMA), had been found in some products containing Ranitidine. This is a probable carcinogenic impurity which helps the formation of cancer.

DRAP said that they are working closely with international agencies to monitor the outcome of the investigation.

However, to protect patients from the 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 authority further directed the companies to recall all such products from markets.

“Furthermore, it is requested to initiate the recall of the medicine available in sale outlets, distributors, hospitals, healthcare facilities,” it states.

About Ranitidine

The substance was discovered in 1976 and was introduced for commercial use in 1981. It is mostly used to cure stomach acidity and is on the World Health Organisation’s Model List of Essential Medicines.

Since then, it has been among the 50 most prescribed medications in the US, with more than 15 million prescriptions.

Ranitidine has been banned in the US, Canada, and Pakistan. DA has advised patients not to use it. Other countries and health agencies are also following suit.

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