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: FDA approves hard-to-abuse narcotic painkiller

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

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

User comments : 0