AVANDIA LITIGATION
What is Avandia?
Avandia is an oral diabetes medicine that helps control blood sugar levels. Avandia is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.
What are the dangers and risks of Avandia?
ADVANDIA USERS FIGHT BACK
Franzblau Dratch, PC, a law firm dedicated to fighting for victims of pharmaceutical companies that sell defective drugs, announced that it will be representing victims of Avandia use in lawsuits to be commenced in Federal Courts in both New York and New Jersey . These lawsuits will be filed against GlaxoSmithKline, the British manufacturer of the diabetes drug Avandia. The lawsuits will seek compensation on behalf of the many seriously and devastatingly injured individuals who were prescribed this diabetes drug.
A recent study conducted at the Cleveland Clinic and published in the New England Journal of Medicine established that Avandia INCREASES THE RISK OF HEART ATTACK BY 43% AND DEATH BY 64%. In addition to heart attacks and death, there exist a number of other serious potential risks associated with this diabetes drug including heart failure, heart valve disease, primary pulmonary hypertension, liver damage, edema, and blood artery disease.If you or a loved one is an AVANDIA victim, call Franzblau Dratch for a free consultation to discuss whether you are eligible to make a claim. You may also fill out our claim evaluation form.
Despite very convincing testimony and clear findings of increased risks of heart attacks that Glaxo failed to disclose, it still does not seem likely that the FDA will pull Avandia from the market. We are dissapointed by this decision which will expose thousands of people to risks that could otherwise be avoided. As we have seen in the past, with Vioxx and many other drugs, the FDA appears willing to wait until there are thousands of more deaths and an overwhelming amount of evidence before protecting the consumer from dangerous drugs. Furthermore, the company itself should not want to continue to expose consumers to these risks but once again puts its profits over people's lives. Our Firm will continue to represent victims of Avandia to bring justice and obtain fair compensation for their injuries.
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Glaxo Shares Surge After Panel Says Avandia Can Stay
By Justin Blum and Michelle Fay Cortez
July 31 (Bloomberg) -- Shares of GlaxoSmithKline Plc, Europe's largest drugmaker, rose the most in two years after a U.S. panel voted to keep the diabetes pill Avandia on the market.
The shares rose 40 pence, or 3.3 percent, to 1,255 pence in London . They have dropped about 14 percent since a May 21 report in the New England Journal of Medicine linked Avandia to heart attack risks. The advisory panel yesterday voted 22-1 to support the pill.
Avandia is the London-based drugmaker's second-best selling medicine and part of Chief Executive Officer Jean-Pierre Garnier's plan to keep profit growing while experimental products move closer to the market. The drug's sales slumped last quarter as doctors warned patients about the heart risk. The experts at the Food and Drug Administration advisory meeting said new warnings in the prescribing information should be enough to protect users.
``At 22-1, this was a clear endorsement of the product,'' said Peter Cartwright, an analyst at Evolution Securities in London . "They've strengthened the label. Now Glaxo can get back on the road.''
Avandia sales fell 22 percent in the second quarter as doctors turned to a similar drug, Takeda Pharmaceutical Co.'s Actos, and newer medications from Merck & Co. and Eli Lilly & Co. The stock closed at a two-year low yesterday before the decision.
'Negative Impact'
Glaxo will still struggle to win back patients, said Jon Fisher, who helps oversee $22 billion at Fifth Third Asset Management in Minneapolis.
"We've already seen a negative impact on the sales'' of Avandia, he said. "I imagine that the momentum will continue to feed on itself.'' A strict warning on the drug will ``make the slowdown of Avandia more aggressive,'' Fisher said.
Glaxo said in a statement that it welcomed the panel's recommendation.
"A lot of physicians have been waiting for this day and I think it will be a major news event for them to see that the committee has voted to maintain the availability of Avandia,'' Chris Viehbacher, president of U.S. pharmaceuticals at Glaxo, said in an interview after the meeting.
"It's absolutely essential to maintain a full range of treatment options in this very important disease and Avandia has got to be a part of that range,'' he said.
The company reaffirmed its February forecast for profit growth of 8 percent to 10 percent for 2007, spokesman Philip Thomson said today in a telephone interview.
Doctors Informed
Panel members, who met in Gaithersburg , Maryland , suggested the new warnings should advise doctors not to use Avandia for patients who take insulin or have heart disease. The drug generated $3.3 billion last year, trailing only the asthma treatment Advair for the U.K. company.
"I am very satisfied the committee voted to put a strong warning on the drug,'' said Steven Nissen, the head of cardiology at the Cleveland Clinic and author of the May study linking Avandia to a 43 percent increased risk of heart attacks. "This will allow patients and physicians to make decisions based on more information than we had,'' he said.
The FDA usually follows the advice of its advisory panels, although the agency isn't required to do so. Officials gave no timetable for making a final decision.
"It's probably beneficial to some people,'' FDA panel Chairman Clifford Rosen, a senior staff scientist at the Maine Center for Osteoporosis, said in an interview after the meeting. "You can keep the highest-risk patients from taking the drug.''
A separate study from Takeda found patients taking Actos had 22 percent fewer heart attacks than those taking Avandia. Researchers used a database from UnitedHealth Group Inc., the largest U.S. health insurer, to compare the medical histories of nearly 30,000 diabetics treated from 2003 to 2006.
Takeda executives said the panel's debate on Avandia underscored the favorable safety profile of Actos in terms of cardiovascular risks. Sales of the drug rose 27 percent in the second quarter, the Osaka-based company said today.
