Avandia
If you have taken Avandia and you have developed heart problems you may be entitled to compensation.
In November 2007, the Food and Drug Administration (FDA) announced the
addition of a black box warning for Avandia’s increased risk of heart
attacks. Avandia (rosiglitazone maleate), the best-selling oral diabetes
treatment in the world, is taken by more than 1 million people in the U.S.
and generating billions of dollars in sales for drug maker GlaxoSmithKline.
However, U.S. sales of the drug dropped 48 percent after the Cleveland
Clinic published a study linking Avandia to increased risk of heart attacks.
The Cleveland Clinic analysis of 42 clinical trails showed that patients taking Avandia had a 43% higher risk of having a heart attack. Based on those published results, the FDA in May 2007 issued a safety alert on the drug. The FDA stated in its alert that it doesn’t yet have enough information to determine what level of “potential” risk the drug poses to patients:
"Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia."
Glaxo executives said more rigorous research showed no increase in danger. The FDA advises that patients taking Avandia, especially those with heart disease or who are at high risk of heart attack, talk to their doctor about the published study.
Because of that study, the American Diabetes Association in November 2007 called on doctors to use more caution when prescribing oral medications to treat people with type 2 diabetes. This follows an announcement the month before by the United States Department of Veterans Affairs (VA) stating that it was dropping Avandia from its prescription drug formulary. In a statement announcing the move, the VA said that it had conducted its own review and concluded that, for some patients, Avandia did not afford the same margin of safety as other diabetes medications.
Avandia lowers blood sugar levels, which can cause complications including kidney and eye damage, by increasing the body's sensitivity to insulin. The FDA approved Avandia in 1999 for the treatment of type 2 diabetes, the most common form of diabetes, and one that affects more than 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. According to the American Diabetes Association, in type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use sugar. Sugar is the basic fuel for the cells in the body, and insulin takes the sugar from the blood into the cells. When glucose builds up in the blood instead of going into cells, it can cause two problems:
Right away, your cells may be starved for energy.
Over time, high blood glucose levels may hurt your eyes, kidneys, nerves
or heart.
Other side effects of Avandia include fluid retention, edema and congestive heart failure. In 2006, the FDA ordered that warning labels state that there is a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.
The consumer group Public Citizen has said that it had repeatedly warned the Glaxo and the FDA about the dangers of Avandia, stating that the drug should only be a “last-choice” option for the treatment of type 2 diabetes because studies have shown it to cause serious cardiac problems.
The Cleveland Clinic analysis of 42 clinical trails showed that patients taking Avandia had a 43% higher risk of having a heart attack. Based on those published results, the FDA in May 2007 issued a safety alert on the drug. The FDA stated in its alert that it doesn’t yet have enough information to determine what level of “potential” risk the drug poses to patients:
"Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia."
Glaxo executives said more rigorous research showed no increase in danger. The FDA advises that patients taking Avandia, especially those with heart disease or who are at high risk of heart attack, talk to their doctor about the published study.
Because of that study, the American Diabetes Association in November 2007 called on doctors to use more caution when prescribing oral medications to treat people with type 2 diabetes. This follows an announcement the month before by the United States Department of Veterans Affairs (VA) stating that it was dropping Avandia from its prescription drug formulary. In a statement announcing the move, the VA said that it had conducted its own review and concluded that, for some patients, Avandia did not afford the same margin of safety as other diabetes medications.
Avandia lowers blood sugar levels, which can cause complications including kidney and eye damage, by increasing the body's sensitivity to insulin. The FDA approved Avandia in 1999 for the treatment of type 2 diabetes, the most common form of diabetes, and one that affects more than 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. According to the American Diabetes Association, in type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use sugar. Sugar is the basic fuel for the cells in the body, and insulin takes the sugar from the blood into the cells. When glucose builds up in the blood instead of going into cells, it can cause two problems:
Other side effects of Avandia include fluid retention, edema and congestive heart failure. In 2006, the FDA ordered that warning labels state that there is a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.
The consumer group Public Citizen has said that it had repeatedly warned the Glaxo and the FDA about the dangers of Avandia, stating that the drug should only be a “last-choice” option for the treatment of type 2 diabetes because studies have shown it to cause serious cardiac problems.
If you or someone you care about is currently taking Avandia for type 2
diabetes, contact your doctor immediately. Because Avandia is in the same
class of drugs as Rezulin, users may suffer similar symptoms.
If you are in need of legal assistance, contact Brown & Crouppen today
for a free and confidential case evaluation. We’ll find answers, hold
negligent companies responsible and get you the compensation you deserve.
Brown & Crouppen can help you make informed decisions about your legal rights, so please call Brown & Crouppen at Toll-Free: 866-991-4700 for your free legal consultation or save time with our online Contact Form.
Recent Avandia Headlines
 Javno.hr |
Avandia woes may drown Glaxo's good news on cancer Reuters.uk, UK - But industry analysts believe it will struggle to gain traction with news from ASCO as investor attention stays fixed on Avandia, sales of which are in ... UPDATE 1-Glaxo letter affirms Avandia safe, shares pick up Glaxo Letter Affirms Avandia Drug Is Safe, Shares Move Higher Glaxo shares slide again as Avandia worries grow |
 Dog Flu Diet and Diseases |
Recent Study Offers Further Evidence Indicting Avandia Evening Bulletin, PA - This column has already pointed out that when Avandia, a widely-used drug to treat type 2 diabetes, first hit the market, it should have been avoided by ... Diabetics Worry About Avandia Risks Diabetics are worried about Avandia's effects Popular drug worries diabetics |
 E Canada Now |
GSK hit as Avandia market share slides after health scare Independent, UK - Doctors have virtually stopped prescribing the GlaxoSmithKline diabetes pill Avandia in the wake of a health scare, and frightened patients are abandoning a ... Prescriptions for Avandia take a plunge ImpactRx Reports Premature Conclusions in Analyst Report on Avandia Making Sense of the Avandia Mess |
 SpiritIndia |
Data affirms Avandia cardiovascular safety profile SpiritIndia, India - GlaxoSmithKline (GSK) confirms that a letter to the editor summarising additional Avandia cardiovascular safety data from several large-scale clinical ... |
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Glaxo shares slide again as Avandia worries grow Times Online, UK - Avandia is Glaxo's No 2 best selling medicine after the asthma drug Advair, but Glaxo has now lost more than £13 billion in value in the past nine days ... Glaxo comment: More pain Broker tips: GlaxoSmithKline, Standard Life, Misys |
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Vodafone spurs FTSE, Avandia pulls Glaxo lower Reuters - L: Quote, Profile, Research fell on further fears for its diabetes drug Avandia. The FTSE 100 (.FTSE: Quote, Profile, Research closed up 36 points, ... Vodafone spurs FTSE, Avandia pulls Glaxo lower European Shares Gain FTSE down after China tax hike; Glaxo weighs |
 Javno.hr |
Vodafone Spurs FTSE, Avandia Pulls Glaxo Lower Javno.hr, Croatia - But on the downside, GlaxoSmithKline dipped 2.1 percent, also taking Shire into the red, as the fallout from its diabetes drug Avandia deepened. ... |
 Canada.com |
London shares firmer; Vodafone up on FY results; Glaxo slips on
... Forbes, NY - On the downside, GlaxoSmithKline (nyse: GSK - news - people ) was 25 lower at 1309 on news its oral anti-diabetic Avandia drug market share had slumped to ... London shares firmer; Vodafone up on FY results; Glaxo slips on ... |
 Servihoo |
London shares fall as investors eye China losses MarketWatch - The broker told clients that, while it agrees safety concerns over diabetes drug Avandia in the wake of an article recently published in the New England ... NZ market down |
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GlaxoSmithKline Says Data Wall Street Journal - LONDON -- GlaxoSmithKline PLC Wednesday said additional data from several large clinical trials support the safety profile of diabetes drug Avandia, ... |
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