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July 16, 2018

DRAP orders immediate recall of heart drug over cancer fears


July 16, 2018

Islamabad: The drug regulator has ordered the immediate recall of some heart medicines for containing a potentially cancer-causing chemical.

The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications. The substance is a potential carcinogen suggesting its long-term exposure could cause cancer.

However, the DRAP orders won't affect the medicines containing valsartan produced by other companies. Pakistan is among 23 countries, which have separately announced a recall of several drugs with valsartan as a precautionary measure to protect patient health.

The announcements were prompted by the review of some medicines by European Union’s London-based drug watchdog, EMA, over the detection of NDMA in the Zhejiang Huahai-made valsartan. According to the EMA, it is investigating the levels of NDMA in these valsartan medications, its possible impact on users, and steps to reduce or eliminate the impurity from future batches produced by the Chinese company.

The review will also see if other valsartan medicines are affected. The doctors prescribe valsartan drugs for patients with high blood pressure to reduce complications like heart attack and stroke. They’re also used by the people with heart failures or attacks in recent times.

According to a relevant official, the DRAP asked pharmaceutical companies to call in all such products made from valsartan supplied by Zhejiang Huahai Pharmaceuticals, while the authority’s federal and provincial additional directors were told to enforce the recall.

He said directions had also been issued to the federal drug inspectors to prepare an inventory of the active pharmaceutical substance of valsartan manufactured by Zhejiang Huahai and not to ‘dispose of that on prescribed form in the public interest until the final decision by the authority’.

The official said the recall orders would apply to both locally-manufactured and imported medicines. He said the importers of the Zhejiang Huahai-supplied valsartan included Karachi’s Amarant Pharmaceuticals, Efroze Chemical Industries, High-Q Pharmaceuticals, Pharm-Evo, Safe Pharmaceuticals, Sami Pharmaceuticals and Tabros Pharma, and Lahore’s Searle Pharmaceuticals and Genetics Pharmaceuticals.

Revealing that the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the official asked doctors to take necessary measures to protect the users of those drugs from NDMA complications and report side-effects or adverse events to the DRAP.

He advised patients not to stop taking valsartan drugs without the doctor’s permission, warning that going off medication without supervision could be dangerous. When contacted, DRAP deputy director (quality control) Abdul Sattar Sohrani confirmed the recall orders and said the pharmaceutical firms concerned had been given one week to remove from the market the medicines made from Zhejiang Huahai’s valsartan. He said the DRAP would strictly enforce its recall orders.

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