KUALA LUMPUR: Medical practitioners in the country have been advised to use Avandia only with approved indications in treating diabetes, while patients receiving treatment must adhere to medical advice.
Health director-general Datuk Seri Dr Hasan Abdul Rahman said this when commenting on a report that GlaxoSmithKline (GSK) was penalised USD$3 billion (RM9 billion) after pleading guilty to unlawful promotion of two anti-depressant drugs, Paxil (paroxetin) and Wellbutrin (bupropion) with unapproved indications.
The penalty was also due to the company’s failure to report the safety data of diabetes drug, Avandia (rosiglitazone), to the United States Food and Drug Administration, he said in a statement here yesterday.
Hasan said the Drug Control Authority, where Avandia had been registered since July 2000, had closely and continuously monitored the drug following information on excess water retention effect in the body and risk of heart failure and adverse cardiovascular effects connected to the consumption of the drug.
In fact, in July last year, the ministry had issued a guideline to monitor rosiglitazone users in a bid to control the use of Avandia and the risks of adverse cardiovascular effects, he said.
“The use of the drugs among private medical practitioner has also been controlled by ensuring that only suitable patients are treated with Avandia. Counseling on the safety issues of the drug are also given to the patients,” he said.
He said, as a result of the control measures, the use of Avandia at the ministry’s facilities and also the private sector had also dropped fourfold last year compared to 2010.
“On matters concerning the adverse effects of rosiglitazone, only one report was received last year,” he said.
Dr Hasan said the Drug Control Authority would continue to monitor the use of Avandia and study any new safety information. — Bernama