Doctors Raise Questions-Concerns About FDA Suicide Warning
Epilepsy experts urge patients and caregivers to continue drug therapy
SEATTLE, December 8, 2008-Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.
It is well known that non-adherence to antiepileptic drug therapy can lead to a dramatic increase in accidents and deaths. For these reasons, epileptic experts believe it is imperative that patients continue their antiepileptic therapy to prevent the occurrence of serious accidents and death.
During the American Epilepsy Society's annual meeting, epidemiologists, epileptologists and psychiatrists offered a critical review of the FDA's methodology and analyses, describe the suicide alert's potential impact on patient compliance and seizure management, and its likely effect on the selection of patients for AED regulatory studies. Among the doctors' concerns is that news reports of the FDA's analyses have confused patients and, perhaps, some physicians on the risks associated with epilepsy drugs. They cite data showing that the risk of suicide possibly associated with AEDs is extremely small compared to the potential danger of leaving patients untreated. Also of concern is that epilepsy patients prone to suicidal ideation or behavior will be excluded from clinical trials of new AEDs.
The panel is seriously concerned about methodological flaws in the FDA's data collection and analysis, including biased measurement of suicidality and exclusion of a large proportion of the data. The FDA performed similarly flawed analysis of the SSRIs. After the black box warning appeared, there was a decrease in use of the SSRIs with a corresponding increase in suicide, contrary to what the FDA's conclusions would predict.
The discussion by leading experts was headed by Andres M. Kanner, M.D., professor of neurological sciences at Rush Medical Center and associate director of the Rush Epilepsy Center. The other panelist for the session, titled Suicidality and Epilepsy: A Complex Problem, are Dr. Hesdorffer (Columbia University), Anne T. Berg, Ph.D. (Northern Illinois University), John J. Barry, M.D. (Stanford University), Rochelle Caplan, M.D. (UCLA), and Jacqueline A. French, M.D. (New York University).
EDITOR'S NOTE: In addition to the panel presentation, the American Epilepsy Society submitted a letter to the FDA expressing its concern for potential misinterpretation by patients, families and physicians of package insert warnings.
About The American Epilepsy Society
The American Epilepsy Society (AES), based in West Hartford, CT, is among the oldest neurological professional organizations in the nation, with roots dating to 1898. The AES annual meeting is the world's preeminent professional meeting on epilepsy and attracts some 4,000 participants from around the globe. The Society promotes research and education for professionals (epileptologists) dedicated to the prevention, treatment and cure of epilepsy. Membership includes epilepsy clinicians, basic science and clinical investigators, and other health-care professionals interested in seizure disorders.
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LegalView Updates Avandia Information Portal with News That Avandia May be More Dangerous Than Similar Drugs
LegalView recently relaunched is Avandia information portal with updated news that the type 2 diabetes drug has more safety risks than drugs of a similar nature. A study from U.S. researchers was published evaluating the dangers of the diabetes drugs and found Avandia as riskier for patients than Actos.
Denver, CO, December 02, 2008 -- LegalView.com, the number one resource for everything and anything legal on the Web, recently announced an update to its Avandia information portal with news that the type 2 diabetes drug poses more safety risks to patients than similar drugs including Actos. According to a Reuters article published in November, the Avandia study as well as analysis has been conducted of the drugs and has found that of both Avandia and Actos, Avandia poses greater risks, especially among older-aged diabetic patients and that the risks include an increased chance of developing heart disease.
Individuals who consume Avandia and who are concerned about the Avandia side effects, which may potentially include early on-set osteoporosis as well as heart failure, according to the New England Journal of Medicine, may need to discuss discontinuing use of the drug with a medical professional. Additionally, contacting an experienced pharmaceutical and Avandia attorney who may be able to provide a free legal consultation as to the development of a potential Avandia class action lawsuit.
Avandia was first introduced from GlaxoSmithKline in May 1999 and was prescribed to nearly 3 million type 2 diabetes sufferers. In 2007 a U.S. Food and Drug Administration (FDA) health advisory alert was issued regarding the discovery of the alleged link that Avandia patients may be at a greater risk for developing heart disease and heart failure, while also being more susceptible to broken bones and fractures due to a potential osteoporosis risk. Patients consuming the drug should speak with their physician as well as consider the development of litigation for the potential of earning monetary compensation.
LegalView has also made available information portals on several other topics ranging from information on traumatic brain injuries to other controversial pharmaceutical drugs such as Byetta and Ketek.
According to the Brain Injury Association of America, approximately 1.4 million Americans suffer from a traumatic brain injury each year. The condition has also been deemed the signature injury of the war in Iraq by news organizations and medical professionals. Additionally, thousands of individuals are not treated for their TBI condition, which could cause a worsening of the TBI side effects among patients. It is imperative that an individual who may have suffered from a TBI accident contact a medical professional regarding their potential condition.
Byetta (exenatide) from Amilyn Pharmaceuticals and Eli Lilly was released in 2005, however, the type 2 diabetes drug was allegedly under investigation by the FDA for the potential link to pancreatic inflammation among Byetta patients. In August 2008, approximately six individuals consuming the drug had developed acute pancreatitis and of the six, two had died. Patients of Byetta who are concerned about the potential dangers allegedly associated with the drug are advised to contact a Byetta law firm for more information.
Ketek, which has been available since 2004 from Sanofi-Aventis, has been allegedly linked to the development of liver damage among patients who have consumed the antibiotic that treats upper respiratory infections such as bronchitis and community acquired pneumonia. The FDA is also currently investigating the drug, but those who have been affected by the Ketek side effects are encouraged to contact a medical professional as well as a pharmaceutical attorney.
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