Avandia® (Rosiglitazone) « ssem.com

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® (rosiglitazone). The study, nicknamed RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes), was designed to evaluate how safe rosiglitazone (Avandia®) is for patients with Type II Diabetes Mellitus.

The RECORD report, released last weekend by the Committee on Finance Chair, Senator Max Baucus and ranking member Senator Chuck Grassley, concludes that there are “serious health risks associated with Avandia.”  It states that GlaxoSmithKline failed to disclose the cardiovascular risks to clinicians and patients.  The report includes more than 250,000 pages of documents provided by the company, the FDA, and several research institutes, as well as interviews with numerous people at GlasxoSmithKline, the FDA and “anonymous whistleblowers.” In response to the RECORD study, the FDA Avandia Safety Announcement on February 22, 2010 regarding possible cardiovascular risks with the use of Avandia® (rosiglitazone).  The FDA warned that patients who take Avandia® should be monitored for signs and symptoms of heart failure, including excessive and rapid weight gain, difficulty breathing and/or swelling.

If you or a family member were prescribed Avandia® (rosiglitazone) to treat Type II Diabetes and suffered serious cardiovascular problems, including myocardial infarction (heart attack); heart failure or death, you should contact us immediately to begin a free evaluation to determine if the event was caused by Avandia®.

Source: Avandia® (Rosiglitazone) « ssem.com

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Avandia

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Avandia - News


Glaxo leads drug stocks lower on Avandia worries
MarketWatch - Feb 22, 2010
A Senate report released over the weekend once again questioned the safety of Avandia and criticized Glaxo's handling of certain safety information.

Looking For Bad Guys
DTC Perspectives Magazine - Mar 12, 2010
The search for drug company evil continues as Glaxo's Avandia is the latest drug in the crosshairs of regulators, the media and lawyers.

What's Your Guidance for People Taking Avandia?
U.S. News & World Report (blog) - Feb 26, 2010
What's Your Guidance for People Taking Avandia? The Food and Drug Administration is scrutinizing the safety of diabetes drug Avandia, as concerns about its heart risks are swirling

FDA reviewers probe health risks associated with diabetes drug Avandia
Justice News Flash - Mar 11, 2010
The debate into whether or not GlaxoSmithKline's (GSK) highly scrutinized diabetes drug Avandia does in fact cause a greater number of heart attacks and

Avandia Lawsuits Could Cost Glaxo as Much as $6 Billion
Newsinferno.com - Mar 09, 2010
Avandia Lawsuits Could Cost Glaxo as Much as $6 Billion Liability for Avandia lawsuits could total as much as $6 billion, according to a UBS analyst. GlaxoSmithKline, the maker of Avandia, faces more than 13000

UBS weighs Glaxo's Avandia liability
BusinessWeek - Mar 05, 2010
GlaxoSmithKline PLC could be facing liabilities up to $6 billion over personal injury lawsuits relating to its diabetes drug Avandia, UBS analysts said in a

Abbott's High-Stakes Weekend
Forbes (blog) - Mar 10, 2010
Abbott's High-Stakes Weekend Is Abbott Laboratories about to get caught up in the same wave of controversy that damaged Merck's Zetia and GlaxoSmithKline's Avandia?

Antidiabetic Directory

Avandia (Rosiglitazone Maleate)
From GlaxoSmithKline. Providing treatment for type 2 diabetes mellitus, controlling insulin resistance.

Avandia (Rosiglitazone Maleate) Drug Information: Uses, Side ...
Learn about the prescription medication Avandia (Rosiglitazone Maleate), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling.

Avandia Information from Drugs.com
Avandia (rosiglitazone) is used to treat people with type 2 (non-insulin-dependent) diabetes. Includes Avandia side effects, interactions and indications.

Diabetic Medication Side Effects and safety information.
Taking AVANDIA with insulin or nitrates is not recommended. ... Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. ...

Avandia Official FDA information, side effects and uses.
Accurate, FDA approved Avandia information for healthcare professionals and patients - brought to you by Drugs.com.

What's Your Guidance for People Taking Avandia?

26.02.10

Suggesting that the drug increased the risk of heart attack.

The drug Avandia remains controversial. Many physicians have stopped prescribing Avandia, but others remain unconvinced about the risk. A recent study suggested that Avandia might be safe, but the study had many flaws and did not completely rule out the possibility that Avandia may increase the risk of heart attack. In July, the FDA will convene an advisory panel to consider what action to take, including the possibility of removing the drug from the market. Currently, American Diabetes Association guidelines do not recommend taking Avandia. Fortunately, there is a safe alternative, pioglitazone (Actos), which appears not to have the same heart attack risk as Avandia. Both Avandia and Actos carry warnings about fluid retention and heart failure, so don't use either drug if you carry the diagnosis of heart failure. Both drugs can also increase the risk of fracture, particularly in women.

Nissen's research

Source: U.S. News & World Report (blog)

Avandia Lawsuits Could Cost Glaxo as Much as $6 Billion

09.03.10

Last month, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said. The Senate report also claimed that Glaxo tried to undermine criticism of the drug. The report drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials, as well as interviews with Glaxo and FDA officials and anonymous whistleblowers.

Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market. The FDA is conducting another safety review of Avandia, the results of which will be discussed at a public meeting in July.

In a UBS note made public last Friday, the brokerage said Glaxo’s Avandia lawsuit liability was in the range of $1 billion to $6 billion. “We expect liability below the midpoint of this range and note GlaxoSmithKline has underperformed by around $2.5bn already,” the note said.

Source: Newsinferno.com

UBS weighs Glaxo's Avandia liability

05.03.10

GlaxoSmithKline PLC could be facing liabilities up to $6 billion over personal injury lawsuits relating to its diabetes drug Avandia, UBS analysts said in a note made public on Friday.

The UBS note, which comes a week after a highly critical report on the drug by the U.S. Senate Finance Committee, said the risk came from more than 13,000 personal injury lawsuits outstanding in the United States.

"As U.S. Avandia contributes 1 percent to sales, our concerns are solely on personal injury lawsuits," analysts said in a note headed by analyst Gbola Amusa.

UBS said the poll of experts suggested Glaxo's liability was in the range of $1 billion to $6 billion.

"We expect liability below the midpoint of this range and note GlaxoSmithKline has underperformed by around $2.5bn already," the note said.

The first of two U.S. federal bellwether trials, which will likely provide an indicator of court decisions on the other cases, is due to start on June 1 in Pennsylvania.

Source: BusinessWeek