Posts Tagged ‘Avandamet’

FDA makes a decision on the fate of Avandia, restricting access to the drug

Friday, September 24th, 2010

The United States FDA (the federal Food and Drug Administration) has announced that it will significantly restrict access to the diabetes drug Avandia for new patients. [1]

The pharmaceutical manufacturer of the drug, GlaxoSmithKline (GSK), is now required by the FDA to develop a “risk evaluation and mitigation strategy,” or “REMS” for to restrict access to Avandia. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications. Current users of Avandia can continue using the medication if they choose to do so, but should be aware of the significant risks involved.

The drug known as rosiglitazone, or by its brand name Avandia, or the combinations with Avandia of Avandamet or Avandaryl, used in managing and treating Type 2 diabetes mellitus has been the subject of personal injury lawsuits and continuing medical criticism across the United States. The use of this drug, Avandia (rosiglitazone), has been associated with an increased risk of serious cardiovascular events, such as heart attacks, congestive heart failure, stroke and resulting deaths.

The FDA has been continuing to investigate these adverse effects and evaluate the use of this medication. In July 2010, a joint advisory committee met with the FDA to further advise them about the effects of Avandia/Avandamet/Avandaryl (rosiglitazone) use, with the majority of the committee suggesting that federal action be taken to restrict or eliminate use of the drug due to the significant cardiovascular risks and death.

Now the FDA has made a decision to restrict access to that drug for only new patients and requires that these new patients be informed about the cardiovascular safety concerns associated with this drug. Physicians will also have to attest to and document their new patients’ eligibility for the medication and new patients will have to acknowledge they understand the risks and potential serious side effects.

If you or someone you know has taken this drug and suffered an injury or death as a result, please contact our firm for a free consultation and information regarding a potential claim. Pearson Randall, Schumacher & LaBore, P.A. is a law firm that practices in the areas of personal injury, consumer protection and national pharmaceutical litigation, and is working on issues relevant to this case. To contact the author, Attorney Nicole L. Kreklau directly, please send an email to nkreklau@prslegal.com, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500 or toll-free at 800-774-0757.

This website information is not intended to provide medical or legal advice, as each situation is different and specific factual information must be obtained before an attorney is able to assess the legal questions relevant to your situation. In addition to providing related information, this blog may also be considered an advertisement for legal services.

Footnotes/Links: [1] For the FDA press release announcing this decision, see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226975.htm  

Pearson, Randall, Gempeler, Schumacher & LaBore, P.A.

AGGRESSIVE AND COMPASSIONATE ATTORNEYS HELPING FAMILIES RECOVER

FROM BAD ACCIDENTS, BAD DRUGS AND BAD PRODUCTS.

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Serious cardiovascular events and resulting deaths from Avandia (rosiglitazone), Avandamet or Avandaryl use continue as FDA considers removal of the drug from the pharmaceutical market

Thursday, September 2nd, 2010

A drug known as rosiglitazone, or by its brand name Avandia, or the combinations with Avandia of Avandamet or Avandaryl, used in managing and treating Type 2 diabetes mellitus has been the subject of personal injury lawsuits and medical criticism across the United States.

The way Avandia (rosiglitazone) works is to help sensitize the body to insulin. At the time of its introduction to the market in 1999, Avandia (rosiglitazone) was considered a breakthrough medication for blood sugar/glucose level controls. Avandia (rosiglitazone) can also be combined with metformin, an anti-hyperglycemic agent that increases the effect of insulin. When metformin was combined with Avandia (rosiglitazone), it was sold as Avandamet. Another combination was Avandaryl, which contains the secretagogue, glimepiride, a substance that triggers insulin release.

The use of this drug, Avandia (rosiglitazone), has been associated with an increased risk of serious cardiovascular events, such as heart attacks, congestive heart failure, stroke and resulting deaths. These conclusions were based on concordant evidence from 3 independent metaanalyses performed.

Despite the known potential cardiovascular risks, Avandia (rosiglitazone) was kept on the market. In 2007, a study published in the New England Journal of Medicine, authored by Dr. Steven Nissen and Kathy Wolski [1], shows that patients on Avandia (rosiglitazone) had a 43% higher risk of a heart attack than those who took other drugs. The findings are based on the analysis of 42 clinical trials.

In November 2007, the FDA (the federal Food and Drug Administration) added a “black box” warning to the drug labels for Avandia, as well as Avandaryl and Avandamet, about potential cardiovascular risks, specifically the myocardial ischemia. Although the addition of a “black box” warning sounds impressive, the impact was relatively minimal. Avandia/Avandamet/Avandaryl (rosiglitazone) remained on many formulary drug lists and its use remained relatively stable.

Now in July 2010, a joint advisory committee met with the FDA to further advise them about Avandia/Avandamet/Avandaryl (rosiglitazone). The majority of the committee still agreed that the drug posed significant cardiovascular risk after analysis of 3 additional lines of evidence emerged through continued studies since 2007 and suggested that further federal action be taken by the FDA. [2] The ultimate decision about the fate of Avandia/Avandamet/Avandaryl (rosiglitazone) lies with the FDA in determining if the drug should be taken off the market. Any action by the FDA is expected to occur before the end of this year.

If you or someone you know has taken this drug and suffered an injury or death as a result, please contact our firm for a free consultation and information regarding a potential claim. Pearson Randall, Schumacher & LaBore, P.A. is a law firm that practices in the areas of personal injury, consumer protection and national pharmaceutical litigation, and is working on issues relevant to this case. To contact the author, Attorney Nicole L. Kreklau directly, please send an email to nkreklau@prslegal.com, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500 or toll-free at 800-774-0757.

This website information is not intended to provide medical or legal advice, as each situation is different and specific factual information must be obtained before an attorney is able to assess the legal questions relevant to your situation. In addition to providing related information, this blog may also be considered an advertisement for legal services.

Footnotes/Links:

[1] Nissen, Steven E., M.D., and Kathy Wolski, M.P.H. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med. 2007;356:2457-2471. Click for link to June 14, 2007 volume: http://www.nejm.org/toc/nejm/356/24/

[2] Graham, David J., MD, MPH; Ouellet-Hellstrom, Rita, PhD; MaCurdy, Thomas E., PhD; et al. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone. JAMA. 2010;304(4):411-418. Click for link to abstract of study: http://jama.ama-assn.org/cgi/content/abstract/304/4/411

Pearson, Randall, Gempeler, Schumacher & LaBore, P.A.

AGGRESSIVE AND COMPASSIONATE ATTORNEYS HELPING FAMILIES RECOVER

FROM BAD ACCIDENTS, BAD DRUGS AND BAD PRODUCTS.

612-767-7500 or 800-774-0757 (toll free)