Epilepsy -
Epilepsy 2008
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Monday, 22 December 2008 00:30 |
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By Nicole Chiu - Contributing Health Journalist
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On Tuesday, the Food and Drug Administration announced that drugs used for epileptic seizure control must carry warnings about heightened risks of suicide. The administration had evidence that the drugs were posing higher risks of suicide since at least one year ago. The current literature shows that about 1 in 500 patients will face an increased risk of suicidal tendencies whilst taking anti-epileptic drugs, which includes all anti-seizure drugs. The advice released by the FDA is for patients to consult their physicians about treatment and any necessary changes. A new requirement is also being released that manufacturers distribute pamphlets with information on these risks for patients. "All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression," stated the FDA. These warnings apply to at least 21 different medications, including GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topaax, and Pfizer’s Lyrica. Concerns over the warnings were debated about how much information and presented in which way. If the warnings were “black boxed” then there were fears that patients would cease taking necessary medications altogether. Anti-seizure drugs have been used for other disorders besides epilepsy, such as migraines, some nerve-pain disorders, as well as psychiatric diseases such as bipolar disease. Glaxo, the brand behind Lamictal, one of the medications identified to be a part of the risk, issued a statement saying that they remained “confident in the overall safety and efficacy profile of Lamictal based on our extensive clinical trial experience and the experience of more than 5 million people worldwide." The FDA’s current warnings includes evidence from an analysis of nearly 200 studies which included 11 different epilepsy drugs that revealed suicidal thoughts and behavior risks in patients under treatment. According to research by IMS Health, seizure drugs were the fifth-best selling drug in the US last year, with sales of over $10 billion. Glaxo’s Lamictal had total sales of $2.2 billion in 2007, and Pfizer’s Lyrica had sales of $1.8 billion. Thus the reality of the amount of these drugs being consumed by Americans, with the knowledge now of their risks for suicidal behavior or thoughts, is concerning. Pfizer stated that it would work with the FDA to label its products Lyrica and Neurontin, a drug that has been previously approved to treat epilepsy and nerve pain. "Pfizer hopes that the labelling change will further facilitate important dialogue that should always occur between patients and their doctors." Physician groups, however, are warning that the FDA should not go overboard in their warnings as to completely repel patients from the idea of taking any medication at all, as need for treatment remains in many cases.
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