Epilepsia
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Review
Don't test, do sell: legal implications of inclusion and exclusion of women in clinical drug trials.
This article explores the historic underpinnings of the exclusion of women from clinical drug trials, identifies recent developments, and examines legal implications for women with epilepsy and for others. Distinguishing stakeholders and their interests may lead to policies that better serve all. Past and present statutory, regulatory, and judicial frameworks were reviewed, as well as legal, medical, and historical commentary. ⋯ At this time the most effective shields will involve procurement of informed consent as well as testing of both women and men. In the long run, tort, health care, and regulatory reform will best serve all interested persons. Inclusion of women in clinical drug trials has become a how question, not an if one.
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Standard antiepileptic drugs (AEDs) are associated with a wide variety of acute and chronic adverse events and with many interactions with each other and with non-AEDs that complicate patient management. The safety and interaction profiles of the newer AEDs have also been intensively studied. Safety data are available for six of the newer AEDs, lamotrigine (LTG), vigabatrin (VGB), gabapentin (GBP), tiagabine (TGB), felbamate (FBM), and topiramate (TPM). The potential for the most recently developed AEDs for producing rare idiosyncratic reactions cannot be ascertained until additional patient exposures have been reported from careful postmarketing surveillance.
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To understand the prognosis of newly diagnosed epilepsy to provide rational therapy and advice for patients and their physicians. ⋯ Overall, most patients with epilepsy will enter remission; however, there is a higher than expected risk of death, especially in those with symptomatic epilepsy.