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

Published On: 24th September 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.

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

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

Published On: 2nd September 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)

Improper Transfer in Nursing Home leads to Death of Priest

Published On: 27th August 2009

Minnesotan’s have seen in the news the loss of a local priest and victim of war injuries from Iraq, Father Tim Vakroc. Father Vakroc was critically wounded in a roadside bomb attack near Mosul in May 2004. Even though he survive the bomb blast he could not survive the poor care and treatment he received in a Minnesota Nursing Home, St. Therese whe he was injured in an improper transfer from his wheel chair to bed. Father Vakroc fell during the transfer and sustained an injury to his head, causing his death.
Unfortunately as an attorney that handles nursing home abuse and neglect cases in Minnesota I see this scenario too often. Most of the cases I see involved a fall from either transfer using less than the required number of people or from old and poorly maintained lift equipment. Both of these causes could be prevented. Nursing Homes need to invest in hiring the necessary numbers of well trained fully vetted staff. Nursing Homes also need to spend the necessary capital to maintain and purchase safe and modern transfer lifts for their residents.
The Father Vakroc case is so tragic and newsworthy due to his personal story and the completely avoidable nature of his accident.
For more information about the death of Father Vakroc at St. Therese see: August 25, 2009, WCCO: Nursing Assistants ‘Devastated’ in Vakroc Death and Star and Tribune: 2 Nursing Assistants Blamed for Priest’s Fall.This website is not to provide 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.
If you or a loved one has suffered an injury or abuse in a nursing home or other care facility that serves the elderly in Minnesota , please contact our firm for a free consultation and information regarding the obligations of the facility and your rights as a resident or concerned family member. To contact attorney Kenneth LaBore, directly please send an email to klabore@prslegal.com, or call Ken at 612-767-7503.

National Arbitration Forum Pulling Out of Consumer Debt Collection, for Now

Published On: 20th August 2009

     Recently, the Wall Street Journal reported that arbitration groups, such as the National Arbitration Forum, are pulling out of agreements with credit card and cell-phone companies to resolve disputes. The arbitration companies are waiting until new guidelines are established in the wake of controversial handling of consumer debt collection disputes. The pull-out happened quickly after the Minnesota Attorney General’s Office filed suit against the National Arbitration Forum in Mid-July for, among other things, not disclosing its financial ties to debt-collection companies. The National Arbitration Forum reports that companies prevail in over 94% of such consumer cases and that it processed over 214,000 consumer-debt collection claims in 2006. For the entire Wall Street Journal article, entitled Credit Care Disputes Tossed Into Disarray, click here.

     Arbitration is considered as a less expensive, less formal, and quicker alternative to the traditional court process of resolving disputes. A neutral arbitrator is the cornerstone of the arbitration process. Many consumers choose to arbitrate, while others are forced to arbitrate by terms of their business contracts. The recent examples show the need to protect the process. Consumers are most vulnerable in both being forced to arbitrate and then losing their case before a potentially biased arbitrator. This is not the way arbitration was envisioned. At least for now, credit card and cell-phone companies will reflect on that process, which will hopefully translate to increased fairness for consumers.
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     This website is not to provide 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.

     If you or a loved one have experienced adverse consequences as a result of consumer arbitration, please contact our firm for a free consultation and information. To contact attorney Suzy Scheller, directly please send an email to sscheller@prslegal.com, or call Suzy at 612.767.7500.

WILL NATIONAL ARBITRATION FORUM’S TAINT EXTENDS TO ARBITRATORS?

Published On: 12th August 2009

 

On July 20, 2009, the office of Attorney General Lori Swanson of the State of Minnesota announced a settlement with the National Arbitration Forum (NAF). The State of Minnesota brought suit against the NAF because the NAF had financial and ownership interests aligned with the corporate consumer credit interests bringing matters before arbitrators of the NAF. As a result of the Attorney General’s lawsuit, the NAF agreed to “get out of the business of arbitrating credit card and other consumer collection disputes.” (See Press release from the Office of the Attorney General Lori Swanson dated July 20, 2009; http://www.ag.state.mn.us/Consumer/PressRelease/090720NationalArbitrationAgremnt.asp.)
It is obvious that this settlement will have a huge affect on the results of countless arbitration decisions. Even those arbitration decisions appropriately awarding money to the credit card companies are now not to be believed. The NAF has been exposed as a biased organization that was holding itself out to the public as “A forum Dispute Management Organization” that in fact was an organization with a financial interest in the outcome of the many disputes it was managing.
As people who were wronged by the NAF find legal counsel and bring lawsuits against the NAF and the creditors who benefited from the NAF conduct, some of the wrongs will be righted. But what is going to become of the individual arbitrators who must have done the bidding of the NAF in order to bring about these unfair arbitration decisions? So far I have not seen any arbitrators publically identified who performed arbitrations on behalf of the NAF. But, inevitably, individual reputations of arbitrators will be affected by the fall out of the NAF’s conduct.
This website information is not intended to provide 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.
If you or someone you know has lost such an arbitration and wish to fight back against a party that wronged you unfairly, please contact our firm for a free consultation and information regarding your rights as a consumer. To contact the author, Attorney Steve Randall directly, please send an email to srandall@prslegal.com, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500.

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