Avandia (Rosiglitazone Maleate), the anti-diabetes drug produced by GlaxoSmithKline (GSK), has been withdrawn from the Omani market.
The registration of the drug has also been “suspended” in the Sultanate and the doctors and pharmacies have been asked to stop prescribing rosiglitazone-containing anti-diabetes medicines. In a similar action, Avandaryl and Avandamet, both GSK’s anti-diabetes medicines, have also been withdrawn from the Omani market.
Avandia contains a component called rosiglitazone, which will reduce blood sugar levels in a type-2 diabetic patient.
It has been withdrawn in most parts of the world because it poses potential heart attack risks for a diabetic patient.
Confirming the decision, a Ministry of Health official said that the drug information centre under the directorate general for pharmaceutical affairs and drug control (DGPA&DC) has issued a circular to all the pharmacies, hospitals and other concerned authorities to withdraw the drug.
The DGPA&DC is a member of World Health Organisation (WHO) collaborating centre for adverse drug reactions (ADR). The ADR reports are received and analysed through drug information centre in the drug control department.
“The drug was registered a long time ago in the Sultanate. But, before we took this decision to withdraw the medicine completely, you must remember that it has always been kept under close review. In 2007, we issued a circular to concerned departments that some adverse reactions have been reported and that the drug was under observation.
“Similarly, in May 2010, we issued a circular stating that some heart-related problems had also been reported,” said a Ministry of Health official.
The European Medicines Agency on September 23 recommended the suspension of the marketing authorisation for the rosiglitazone-containing anti-diabetes medicines citing “risk of heart failure”, as a reason.
The US Food and Drug Administration too agreed that the drug carries risks, but has decided to allow Avandia to remain on the market as a drug of last resort for patients that they have notified of the risks of heart failure associated with the drug.
While confirming that they had received a circular dated September 26 from the health authorities in Muscat, officials at the head office of a pharmacy, said: “We recommend that patients who are currently taking these medicines should meet their doctor to discuss appropriate alternative treatments.”
According to many reports since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review.
Media reports said data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of heart disease associated with the use of rosiglitazone.
Avandia, once the best selling diabetes drug and the second best-seller in GSK’s product line, has seen sales drop dramatically since the controversy over its safety erupted.
In 2009, sales plummeted to $1.2 billion, down from $3.2 billion in 2006.
Times of Oman