Avandia: August 2007 Archives

GlaxoSmithKline: Avandia Unlikely to Recover

The U.S. Food and Drug Administration recently voted to keep Avandia on the market. Avandia is a drug manufactured by GlaxoSmithKline and it is used to treat type 2 diabetes. However, though the news would seem positive for GlaxoSmithKline, the FDA's treatment of the situation has called into question the FDA's ability to manage situations such as these and the review likely will damage Avandia sales.

The FDA's panel meeting was prompted by a meta analysis conducted by Dr. Steven Nissen. Nissen's report was published in the New England Journal of medicine in May. Many medical specialists have stopped prescribing Avandia to patients as a result of the study.

Posted by Patricia Bowling at 11:03 PM | Permalink

Warning Label Urged for Avandia

A U.S. Food and Drug Administration panel has concluded that diabetes patients taking the drug Avandia to treat their condition have a greater risk of heart attack than those taking other drugs to treat their conditions. While the panel did not advise removing the drug from the market, they did say that Avandia needs a stricter warning on its label.

Warning Label Urged for Avandia

The panel's recommendation likely will only cause more problems for GlaxoSmithKline, the manufacturer of Avandia. Increasing information suggests that GlaxoSmithKline was aware of the dangers of Avandia more than a year before a report linked Avandia to increased heart and kidney risks. More than 20 million Americans and about 170 million people around the world have diabetes.

Posted by Patricia Bowling at 10:16 PM | Permalink

Reports of Avandia-Related Heart Attacks Jumps

The side effects noted by patients taking diabetes drug Avandia tripled in the months after a study linked the drug to increased rates of heart attacks. A report from the U.S. Food and Drug Administration says: "In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped... Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."

Reports of Avandia-Related Heart Attacks Jump, Highlight Flawed FDA Monitoring

The reports may indicate that doctors who were previously unfamiliar with the side effects of Avandia began to report side effects that they had believed to be unrelated to Avandia. However, it is not possible to determine much more than that from the report, though the report is suggestive of the fact that the FDA needs to change its post-approval drug monitoring process.

Posted by Patricia Bowling at 08:52 PM | Permalink

Class Action Filed Against Avandia

A class action lawsuit has been filed against GlaxoSmithKline, saying that the drug company did not do enough to alert those taking the drug of the drug's risk. The lawsuit was filed at the Court of Queen's Bench in Regina on the behalf of a 75-year-old woman who died in May after having taken Avandia.

Class Action Suit Launched Over Avandia

Avandia was approved for the treatment of Type 2 diabetes in March 2000. Tony Merchant, the lawyer representing the plaintiff's estate, says of the lawsuit: "People have to have informed consent. They have to know what the risks are ... And that affords people the opportunity to really decide. That's where we think Avandia fell down." A spokesperson for GlaxoSmithKline in Toronto says that the company has not yet heard of any Canadian class action lawsuit.

Posted by Patricia Bowling at 09:07 PM | Permalink

FDA Gave Glaxo Extra Year to Profit from Avandia

A memorandum acquired by the Senate Finance Committee shows that Food and Drug Administration knew that there were dangerous side effects associated with GlaxoSmithKline drug Avandia. The memo shows that Dr. David Ross, a FDA reviewer, recommended that there be a highlighted boxed warning on Avandia packaging about an increased risk of CHF. CHF is a life-threatening condition that occurs when fluid builds in the lungs and causes a shortness of breath.

FDA Gave Glaxo Extra Year to Profit Off Avandia

The memo also recommended that a warning about an increased risk for macular edema be added to Avandia's packaging. Even though the recommendations were approved by Dr. Rosemary Johann-Liang, they never were added to Avandia's label. Congestive heart failure "is a very, very clear adverse reaction syndrome" with Avandia, said Johann-Lang. Johann-Lang has since left the FDA.

Posted by Patricia Bowling at 09:45 PM | Permalink

Avandia- FDA Controversy Causes Questions of Comeback

The U.S. Food and Drug Administration decided this week that GlaxoSmithKline's diabetes drug Avandia shall remain on the market, but will carry more warnings on its label. Avandia recently was linked to increased heart and kidney problems in those who take the drug to manage their diabetes. Shares of GlaxoSmithKline had their biggest gain in two years after the FDA advisory panel decided not to withdraw Avandia from the market.

Glaxo Avandia FDA Adversity Fuels Doubts of Comeback

The news causes questions for GlaxoSmithKline: will the drug company's stock market value ever recover to its value prior to the Avandia scandal? Pascale Boyer Barresi, an analyst at Bordier & Cie, says "Glaxo probably will receive a black-box warning and the sales will probably not recover to the previous level. [Avandia sales] will probably recover 10 to 15 percent, but the decline was so far that I think once doctors have changed their patients, they will not switch back."

Posted by Patricia Bowling at 08:18 PM | Permalink

Diabetes Drug May Cause Heart Problems

A month after a study found a possible link between heart attacks and GlaxoSmithKline's diabetes drug Avandia, the number of reported side effects tripled. Dr. Ronald Goldberg from the University of Miami Diabetes Research Institute says that diabetes patients are excited to switch medications. Goldberg says that when he explains the risks possibly associated with Avandia to patients, they "tend to feel more comfortable going off to a different medicine, a different oral medicine."

At Baptist Medical Arts pharmacy, the pharmacists say that they have seen about a 50 percent decline in the number of Avandia prescriptions. Goldberg, however, says that he only is insistent that patients switch drugs in a few cases: "The only situation where I'm a little bit more insistent that they change is if they have cardiovascular disease," he said. "That might be the group where it's most prudent to insist on a change until we know more."

Posted by Patricia Bowling at 10:18 PM | Permalink

Is Avandia Safe? Depends Who You Ask.

A majority of the recent federal drug panel has voted to keep Avandia on the market. Data from recent studies have linked Avandia to increased risk of heart and kidney problems. The panel advises that Avandia remain on the market, but with more warnings on its labeling.

Is Avandia Safe? Depends Who You Talk To?

Dr. David Graham testified at the federal drug panel on July 30. He said of Avandia: "It's well established that rosiglitazone increases congestive heart failure." GlaxoSmithKline, the manufacturer of Avandia, reiterates its position that Avandia is safe. Since Steven Nissen's report in the New England Journal of Medicine implicated Avandia for increasing heart and kidney problems, further studies have indicated similar results. Sales of Avandia have fallen drastically since Nissen's report was made public.

Posted by Patricia Bowling at 07:43 PM | Permalink

August 10, 2007

GlaxoSmithKline: Avandia Unlikely to Recover

August 09, 2007

Warning Label Urged for Avandia

Reports of Avandia-Related Heart Attacks Jumps

August 08, 2007

Class Action Filed Against Avandia

August 07, 2007

FDA Gave Glaxo Extra Year to Profit from Avandia

Avandia- FDA Controversy Causes Questions of Comeback

August 06, 2007

Diabetes Drug May Cause Heart Problems

Is Avandia Safe? Depends Who You Ask.