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    — 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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NEWS

 

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. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html

 

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).

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

 

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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01787.html

 

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The Lancet: Articulos de interes

Safety of drug-eluting stents: demystifying network meta-analysis

Given concerns about the safety of drug-eluting stents, Christoph Stettler and colleagues (Sept 15, p 937) provide the most extensive meta-analysis to date comparing sirolimus-eluting stents, paclitaxel-eluting stents, and bare-metal stents: 38 trials in 18 023 patients.

Asthma guidelines on house dust mites are not evidence-basedIn your Sept 8 Editorial (p 802), you describe the new US guidelines for asthma control as being rigorous and evidence-based. This is not correct for the recommendations on house dust mites.

Lamotrigine and the risk of fulminant hepatic failureI refer to a letter by Debbie Shawcross and colleagues (July 28, p 314), written in response to the SANAD study, in which a case of fatal hepatic failure is attributed to lamotrigine. As the consultant neurologist involved in the care of this patient, I would like to add some relevant information that seems to have been either omitted or neglected: continuous exposure to valproate before the liver failed, and a concomitant acute cytomegalovirus infection.