Avandia Side Effects Cause Two Healthcare Providers to Drop the Drug

LONDON (Reuters) - Two U.S. pharmacy benefit managers said on Thursday they had dropped GlaxoSmithKline Plc's diabetes drug Avandia from their national formularies due to safety concerns.

The moves by Prime Therapeutics and HealthTrans mark the latest example of U.S. healthcare providers deciding to limit access to the drug, following an earlier decision by the U.S. Department of Veterans Affairs to severely restrict use.

Such actions, particularly if followed by others, may further undermine sales of the once-popular medicine, which have been hit hard recently by a report linking it to heart attacks.

Prime and HealthTrans said in separate statements they had made their decisions after a thorough analysis of the clinical literature examining the safety and efficacy of Avandia.

"Prime takes drug safety warnings very seriously and our primary concern is the safety of our members," said Craig Mattson, senior director of drug technology assessment and formulary development.

Britain-based Glaxo, Europe's biggest drugmaker, said it was surprised and disappointed.

"It limits options for treatment and could be detrimental for patients. The FDA (Food and Drug Administration) has said the data remains inconclusive and therefore to limit patients' options in this is disappointing," a spokeswoman said.

Concerns about the safety of Avandia were triggered in May by a U.S. analysis linking it to a 43 percent higher risk of heart attack.

Avandia was Glaxo's second-biggest drug in 2006, with worldwide revenue of 1.6 billion pounds ($3.2 billion), but sales have plunged since May, with revenue in the United States down 48 percent in the third quarter from the year-ago period.

(Reporting by Ben Hirschler; Editing by David Holmes)

UPDATE from11/19/2007
Information for Healthcare Professionals Sheet
highlights changes to the prescribing information for rosiglitazone,
including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS,
and INDICATIONS sections of the product's prescribing information about
the potential increased risk of myocardial ischemia.
 
FDA ALERT: November 14, 2007.

Avandia (rosiglitazone maleate) Tablets

The FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks.

The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.

At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options.

Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.