JFDA pulls Reductil off market for heart attack risks


12-02-2010 10:24 AM

Ammon News - AMMONNEWS - The Jordan Food and Drug Administration (JFDA) has suspended the registration of 'Reductil Tablet Sibutramine,' a medicine prescribed to treat obesity and overweight patients and is pulling the product off the market after it was found to increase the risk of heart complications.

The decision comes after the European Medicines Agency (EMA) banned the product, manufactured by Abbot GmbH & CokG of Germany in 10 and 15 mg concentrations, across Europe and ordered doctors across Europe to stop prescribing sibutramine and told pharmacists not to dispense the drug.

A clinical study on the drug found that the risks associated with taking the drug outweighed its benefits especially for patients with heart problems.

Reductil is prescribed for patients suffering from obesity and overweight people who also have conditions such as type 2 diabetes or abnormal levels of fat in their blood.

There is only one pharmaceutical product registered in Jordan (Reductil) and the manufacturing company is cooperating with JFDA to pull the product off the market until further reviews are conducted.

JFDA calls on all doctors to stop prescribing the medicine for weight treatment and all pharmacies are to stop dispensing the drug and return remaining quantities to the distributor.

Patients are urged to stop taking the product and discuss with their physicians alternative weight management solutions.

JFDA also urges those who are taking similar products not legally registered in Jordan, such as 'Reduct,' to also stop taking the products for their own safety.




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