Drug Topics - February 18, 2008 - (Page 8)

8 DRUG TOPICS FEBRUARY 18, 2008 www.drugtopics.com > > > NEWS Roundup Rx Care FDA: Antiepileptics are linked to increased risk of suicide The FDA has issued a warning to healthcare professionals of an increased risk of suicidal behavior or ideation in patients taking antiepileptic drugs (AEDs). After completing an analysis of data from 27,863 patients receiving at least one of 11 different AEDs and 16,029 taking placebo, the agency said there was approximately twice the risk in the group treated with an AED. Four suicides were reported in the AED group, while none was found in the placebo-takers. Also there were 105 reports of suicidal ideation in the AED group versus 35 in the group receiving placebo. In addition, the review of data showed the higher risk was observed as early as one week after initiating therapy with an AED and continued for at least 24 weeks. There was no difference in risk between the 11 different products and the effect was observed across all demographic groups and age groups. The affected drugs include carbamazepine, felbamate (Felbatol, Medpointe), gabapentin, lamotrigine, levetiracetam (Keppra, UCB Inc.), oxcarbazepine, pregabalin (Lyrica, CP Pharms), tiagabine (Gabitril, Cephalon), topiramate (Topamax, Ortho-McNeil), valproate, and zonisamide. The FDA reminds healthcare professionals to carefully monitor patients currently taking AEDs or beginning therapy for changes in behavior. clot buster from the Tucson, Ariz., firm’s most recent lot will have a prolonged shelf life. The thombolytic is indicated for the treatment of acute massive pulmonary embolism. New IV iron and phosphate binder products poised for launch A new report by BioTrends Research Group predicts that some new products may be launched in the IV iron and hyperphosphatemia markets this year. The Exton, Pa., firm said that a new form of intravenous iron, ferumoxytol, from AMAG Pharmaceuticals could be available in the second half of this year. In a survey of 305 clinical nephrologists that BioTrends did last December, it found that 68% are not familiar with this product. BioTrends added that in the phosphate binder market, respondents feel that there is a strong need for new products, but knowledge of new binders, such as Genzyme’s recently approved Renvela (sevelamer carbonate), is low. Renvela is expected to launch in the first quarter. Drug delivery called critical to asthma market Schering-Plough/Novartis’ formoterol/mometasone could become the clinical gold standard for asthma by 2011 if the companies pursue both a metered dose inhaler (MDI) and dry powder inhaler (DPI) formulations of the drug. By doing so, they could beat out AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate). That’s the conclusion of a new report from market research firm Decision Resources. The Waltham, Mass., firm added that the current asthma market leader, GlaxoSmithKline’s Advair, comes in both an MDI and DPI. The research company explained that pulmonologists value having a delivery device and formulation that can influence patient compliance. Merck gets approval for intravenous antiemetic Merck & Co.’s antiemetic Emend (aprepitant) has now been approved as an injection. Emend (fosaprepitant dimeglumine) for Injection is designed to be used in combination with other antimetics to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy, including high-dose cisplatin. Emend for Injection (115 mg) may replace 125 mg oral capsule of Emend on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. This dosage is followed by Emend (80 mg orally) on Days 2 and 3 in a three-day antiemetic regimen, in addition to a corticosteroid and a 5-HT3 antagonist. Many schizophrenic patients stop taking drugs due to side effects A survey of 250 patients with schizophrenia found that almost seven out of 10 respondents have discontinued use of second-generation atypical antipsychotics due to side effects such as weight gain. The survey also found that almost 40% of respondents said the longest they have remained on medication was less than a year. These findings were reported by Mental Health America (MHA), a nonprofit group dedicated to helping people live mentally healthier lives. MHA had commissioned International Communications Research, a market research firm, to conduct the study. Clot-dissolving agent gains additional shelf life ImaRx Therapeutics’ urokinase has received an additional 20 months of expiration dating. This means the http://www.drugtopics.com http://www.drugtopics.com

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Drug Topics - February 18, 2008

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