Avandia Concerns Widen Woes For GlaxoSmithKline

FDA is reviewing data from a long-term study concerning possible cardiovascular risks with the drug Avandia, following a recent report from the U.S. Senate Finance Committee that showed a link between the type 2 diabetes drug and thousands of heart attacks. Avandia is manufactured by GlaxoSmithKline, which is also undergoing scrutiny related to the safety of its asthma drug Advair.

FDA says its review of the Avandia clinical trial, as well as several observational studies of Avandia, are ongoing. The agency states that "no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time."

FDA plans to present all new and existing cardiovascular safety data on the drug during a July public meeting, as well as an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes. Healthcare professionals are being advised to follow the recommendations in the drug label when prescribing rosiglitazone, which includes a Boxed Warning.

 GlaxoSmithKline responded to the The Staff Report of the Senate Committee on Finance at its Web site on Saturday.

 "As our statement says, the science shows us that Avandia is safe and effective when used appropriately, in accordance with labeling," a GlaxoSmithKline spokesperson told Pharmaceutical and Medical Packaging News. "Consistent with the FDA-approved labeling the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events."

In the years since FDA convened the joint Advisory Committee Meeting to address questions about the cardiovascular safety of Avandia, seven large, prospective, randomized, clinical trials have reported results. None of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, shows a statistically significant association between Avandia and myocardial infarction or other ischemic cardiovascular events.

With regard to patient questions and concerns, the marketer's spokesperson states that there is no special contact line set up for Avandia or for Advair. Current hotlines include the GSK Response Center at 888-825-5249 and the Over-the-Counter Products Hotline at 800-245-1040.

"Patients should continue to use the standard methods of communication with GSK," the spokesperson adds.

According to The News And Observer, a Raleigh, N.C.-based newspaper, the mounting safety concerns of GlaxoSmithKline’s diabetes drug Avandia could hurt profit at one of the Triangle’s largest employers, weigh on its stock, and provide new ammunition for lawsuits. The committee report released over the weekend contends that GlaxoSmithKline knew about heart attack risks linked to Avandia years before the evidence became public — a controversy that raises the possibility that the drug could be pulled from the U.S. market.

GlaxoSmithKline asserts that Avandia is safe. The marketer alleges that the Senate committee report ignores scientific evidence and mischaracterizes the company’s efforts to communicate results to regulators, doctors, and patients.

The new questions about Avandia are the latest hard hit for the drug marketer, which employs about 5,000 people in the North Carolina Research Triangle, home to the marketer's North American headquarters. Federal regulators also are worried about the safety of another key drug, the asthma treatment Advair.

GSK has been slashing costs and thousands of jobs worldwide in recent years to offset slowing sales, and could make additional reductions if it must pull Avandia off the market or pay high legal damages. Avandia and Advair are packaged at GlaxoSmithKline’s Zebulon factory.

Worldwide sales of Avandia reached $1.2 billion last year.

Congresswoman Rosa DeLauro (CT-3) released the following statement in response to the reports by  FDA showing hundreds of people suffered heart problems while taking the diabetes drug Avandia and recommending that it be removed from the market:

"I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug. It is reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists.

"The safety and efficacy of a prescription drug should be based on independent, science-based evidence, and not a drug company's interpretation of what constitutes science-based evidence. The Avandia case provides further evidence that patients should not trust drug companies with their health."

Advair Safety Concerns Linger

The news about Avandia could not come at a worse time for the drug marketer, which this month announced more layoffs. In addition, last week U.S. regulators warned that long-term use of Advair, which is GlaxoSmithKline’s best-selling drug, and competing asthma medications has been linked with serious health risks.

According to a spokesperson at GlaxoSmithKline, patients should be aware that for Advair there is no evidence in more than 10 years of clinical studies, observational studies, and worldwide clinical experience exceeding 30 million patient years use of Advair that the medicine is associated with an increased risk of asthma related death, hospitalization, or other serious respiratory-related outcomes for any age group. 

Asthma is an inflammatory disease and must be treated with an anti-inflammatory.

"There are no asthma-related deaths in clinical trials involving nearly 18,000 patients taking Advair," a GlaxoSmithKline spokesperson told Pharmaceutical and Medical Packaging News. "We agree with FDA that use of a LABA alone does not treat the inflammation of asthma, therefore is inappropriate," the spokesperson continues. "When the regular use of an inhaled corticosteroid is assured, there is no evidence that a LABA increases severe asthma-related outcomes. This information is reflected on the label."