Ministry of Health (MoH).Ministry of Health (MoH).

The ministry said that three slightly contaminated batches of a drug belonging to the Heparin group were detected in the country. Heparin drugs, which are produced by various pharmaceutical companies, are a group of blood thinners used to treat certain heart conditions such as heart attacks and to prevent abnormal blood clotting.

After consultations with the company that produces the widely-used heparin drug called Clexane, the MoH has decided against pulling the contaminated batches of the drug out of the market opting instead to limit its usage.

The ministry issued a circular to all healthcare institutions in the country asking them to stop injecting the drug intravenously, and administer it exclusively through under the skin injections (subcutaneously).

According to Dr Amin Al Amiri, CEO of Medical Practice and Licensing at the MoH, the ministry's decision came after the assessment of the position of local health authorities in various European countries, including the UK and France, who also opted not to pull the drug out of the market.

The United States controversy was regarding another Heparin drug manufactured by the pharmaceutical company Baxter International, which caused the death of around 81 people.

The United States Food and Drug Administration (FDA) reported that since the end of 2007, it received about 350 reports of health problems associated with Baxter's multiple dose injectable heparin. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure.

Investigations by the FDA and Baxter revealed that the source of the contamination was most likely a Chinese manufacturer of the active pharmaceutical ingredient found in the drug.

Since most of the raw material for making all Heparin drugs comes from China, companies producing Heparin drugs with ingredients imported from China remain succeptible to receiving contaminated batches.

According to Dr Hisham Mahmoud, the Head of Medical Affairs at the Gulf branch of the company that produces Clexane, there have been no reported adverse reactions to Clexane in the country, and no indications that the low levels of impurities detected constitute a public health concern.

"The ministry decided to go an extra mile by limiting the drug's administration to under the skin injections, as over 95 per cent of adverse reactions to other Heparin drugs were reported after administration of the drug through the vein," he said.

Dr Mahmoud explained that the decision of some European countries to keep the drug in the market was made because these authorities decided no other drug would compensate for Clexane's medical usage.

"Clexane is showing a clinical advantage, and cannot be substituted by other heparin brands. Although some European countries decided to recall the drug, this was not due to any reported side-effects", he said.

Physicians in the country are urged to report all unexpected side-effects of all drugs to health authorities, such as the Abu Dhabi and Dubai health authorities and the MoH.

asma@khaleejtimes.com

By Asma Hamid

© Khaleej Times 2008

 

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