European Drug Agency Rejects Abbott’s Diet Pill
Following a study of 10,000 patients, European regulatory authorities said Thursday, Abbott Laboratories (ABT) sibutramine weight-loss products should be suspended from the market, as study findings suggest they put them at greater risk of suffering a stroke or heart attack.
Sold under the brand-names Reductil, Reduxade, Zelium, Sibutral, Raductil and Ectiva in Europe and Meridia in the USA, the risk for heart disease is higher from taking these medicines than any benefits they offer.
The news caused Abbott shares close at $55.56 Thursday, down 68 cents or 1.2%.
The European Commission will now review the agency’s recommendation to suspend the medicine, with Kurt Ebenhock, spokesman for Abbott says, though the company disagrees with, it will comply with the request.
The product, which can still be purchased outside of the European Union sold $300 million of the product in 2009 globally, with most of the sales outside the USA. However, if Abbott resolves the Europen agency’s concerns, the suspension could be lifted.
The agency’s decision comes just as the U. S. Food and Drug Administration (FDA) announced Thursday, heart disease patients were not to use Meridia, as studies had suggested high risks of heart attacks, strokes or death from taking the diet pill.
Operating independently of each other, European and U. S. regulatory bodies often arrive at different conclusion regarding safety of medicines.
Complying with FDA, Abbott has agreed to update Meridia labels, which will now carry the warning that the drug is not to be used by heart disease patients, including those suffering from heart attacks, uncontrolled hypertension and heart-rhythm problems.
Specifically, the warning is for patients with a history of:
* Coronary artery disease, heart attack, angina.
* Stroke or transient ischemic attack.
* Arrhythmia.
* Congestive heart failure.
* Peripheral arterial disease.
* Uncontrolled hypertension more than 145/90 mmHg.
According to the study’s findings, 11.4% of the 10,000 patients, all with a history of heart disease or diabetes, as well as, a cardiovascular risk factor, and who were taking Meridia had a cardiovascular event like a heart attack, compared with 10% of those given fake pills.
An FDA advisory committee meeting will be held for discussing the risks and safety of Meridia after Abbott presents FDA with the study report sometime in March.
In the meanwhile, healthcare professionals have been asked to monitor blood pressure and heart rates of patients taking the drug, which is to be stopped immediately if any increase is observed.
Meridia was approved in 1997 in USA for helping patients lose weight.
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