— Food, Medical Product Safety Among Key FY ‘O9 FDA Budget Requests
— Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use
— FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries
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Food, Medical Product Safety Among Key FY ‘O9 FDA Budget Requests
FDA is requesting nearly $2.4 billion as part of the president’s fiscal year (FY) 2009 budget—a 5.7 percent increase over the current fiscal year budget. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices.
Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use
FDA has alerted health care professionals about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent).
FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries
FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The device
is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to a narrowed section of a coronary artery through a long, thin catheter. When the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.
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