Glaxo defends handling of Avandia heart risks

Feb 24, 2010 By MATTHEW PERRONE , AP Business Writer

(AP) -- GlaxoSmithKline said Wednesday a Senate report criticizing its handling of heart risks with its diabetes drug Avandia "mischaracterizes and distorts" the company's record.

In a memo posted online, the British drugmaker takes aim at the highly critical Senate Finance Committee report that has reignited debate around its troubled diabetes treatment.

The added a warning about potential heart attacks to Avandia in 2007, but the scope of that risk is still not fully understood.

The Senate report, issued over the weekend, charged that Glaxo downplayed the drug's safety risks and withheld important data from the FDA.

"That suggestion is fundamentally flawed and contradicted by the record of extensive, ongoing interactions between GSK and the FDA," states the company.

According to the 30-page Glaxo document, the company voluntarily submitted data on Avandia's heart effects in 2005, and has steadily updated the government since then.

The company also blasts Senate investigators for excluding results of several recent studies that appear to support Avandia's safety.

One trial, called RECORD, followed patients for five years and found no difference in heart-related hospitalization or death between those taking Avandia versus other treatments.

"The absence in the staff report of any reference to the final results of these studies ... leaves the record incomplete," Glaxo states.

Avandia was Glaxo's third best-selling drug in 2006 with revenue of $2.2 billion. But the safety concerns disclosed the following year slashed revenue to $1.2 billion by 2008.

The debate over Avandia was sparked by a May 2007 analysis that showed a 43 percent higher risk of for patients taking Avandia compared to other diabetes drugs or no diabetes medication.

Because the analysis involved results from dozens of different studies, experts have continued to debate its accuracy.

In 2007, the FDA's panel of outside experts voted 22-1 to keep Avandia on the market.

The FDA has scheduled another meeting for July to have the panel re-examine the issue.

Explore further: Clinical trial of Auxilium's Xiaflex shows it to be effective in smoothing cellulite

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Senate report: Avandia maker knew of cardiac risks

Feb 22, 2010

(AP) -- A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

FDA: Bristol-Myers diabetes drug appears safe

Mar 30, 2009

(AP) -- A potential blockbuster diabetes medication from Bristol-Myers Squibb appears free from heart-related side effects that have plagued similar treatments, federal health officials said Monday.

FDA questions safety of Glaxo kidney cancer drug

Oct 01, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

Recommended for you

Using computers to design drugs

Aug 22, 2014

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

Aug 22, 2014

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

Aug 21, 2014

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments : 0