Tuesday, September 28, 2010

Diabetes drug Avandia recalled in UAE

The Gulf Today, 27 Sept 2010 

The UAE Ministry of Health (MoH) has recalled a widely-used medicine for diabetes mellitus Type 2 Avandia from the pharmacies and hospitals across the country.
The MoH issued a circular on Sunday recalling the drug, following guidelines from international competent bodies to ban the use of the medicine made with the component Rosiglitazone as it caused dangerous consequences like stroke and cardiac disorders.
The MoH sources said that the circular had been sent to private and public sector pharmaceutical establishments and hospitals in the country enforcing them to temporarily suspend the drug use.
All quantities of the drugs circulated in the country should be pulled off the shelves within four weeks from the date of the circular, according to a senior official.
Dr Amin Al Amiri, CEO for Medical Practices and Licensing at the MoH, indicated that the drug has been suspended as per recommendations of the European and American drug control bodies.
“The Food and Drugs Authority (FDA) on Saturday recommended limiting the use of medication after emergence of new information that the drug caused high risk of heart attacks and serious damage to blood vessels,” he added.
According to him, the pharmaceutical vigilance committee under the ministry would follow up the decision monitoring circulation of the medicine across the seven emirates, even during holidays.
“The MoH also temporarily suspended local production of Avandia using Rosiglitazone component. The registration or import of new batches of the drugs and their promotion or marketing have been cancelled,” pointed out Dr Amiri.
“The ministry is working on providing the diabetes patients with suitable alternative medications. The drugs control and registration department will monitor incidents of complications from the use of the replaced medication. The decision comes in order to preserve public health,” he added.
“There were warnings earlier on the impacts of the drugs on the cardiovascular system. The recommendations were issued by the global bodies after reviewing the studies on this matter,” he said.
“The suspended medicines included Avandia (2, 4 and 8mg tablets), Avandamet (1mg/500mg, 2mg/500mg, 4mg/500mg, 2mg/100mg, 4mg/100mg), and Avandaryl (4mg/1mg, 4mg/2mg, 4mg/4mg),” detailed health ministry.
According to Dr Amiri,  the FDA had asked to implement a special programme to monitor and control the risks arising from the use of the drugs.
“The MoH drug control department met on Sunday the  manufacturers and distributors of Avandia at the Cabinet Office in Abu Dhabi to immediately implement the new regulatory decision on the supply of the drug,” he said.
“Several steps are being undertaken, including stopping their supply immediately at the state level from the date of issuance of the circular on Sunday.”

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