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Cough suppressant hazardous

The FDA has added a warnings and precautions section to the label for the cough suppressant benzonatate to alert healthcare providers about the potential for fatal overdose in children under age 10. A review of the FDA's Adverse Event Reporting System database found that from 1982 to May 2010, five out of seven children age 2 and younger who accidentally ingested benzonatate died. Overdose followed the ingestion of only one or two capsules.

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Signs and symptoms of benzonatate overdose can occur within 15 to 20 minutes of ingestion, and deaths have been reported within hours of ingestion. Parents are urged to keep the drug in a child-resistant container out of the reach of children.


Source: U.S. Food and Drug Administration. FDA says Tessalon liquid cough capsules pose risk for young children.


Drug improves seizure control

The new antiepileptic drug lacosamide has shown promise in controlling seizures in adults with epilepsy. The medication was evaluated in 67 patients ages 18 to 82 with refractory epilepsy. After 1 to 12 months of treatment, 69% of the patients experienced at least a 50% decrease in seizure frequency of all types of seizures. Thirty-three percent experienced no seizure activity in the last month of treatment. The drug was most effective in patients who weren't taking sodium channel-acting drugs.


The most common adverse reactions included dizziness and discoordination, which were experienced by 33%. Fifteen percent of patients had psychiatric adverse reactions, such as mood and anxiety complaints. Three patients (4%) developed a possible allergic rash resembling Stevens-Johnson disease, a potentially fatal adverse reaction. The drug was immediately discontinued for these patients.


Source: Cohn A, Harden C, Lowe M, Serrano E. Initial post-marketing clinical experience with lacosamide in adult patients with epilepsy. Epilepsia. 2010; abstr 2.160.


New treatment works as well as warfarin

A recent comparison of the new direct thrombin inhibitor dabigatran with warfarin has found that dabigatran is just as effective in reducing the risk of both stroke and hemorrhage in patients with atrial fibrillation. Warfarin is a vitamin K antagonist commonly used to prevent and treat venous thromboembolism associated with atrial fibrillation or cardiac valve replacement. Dabigatran is FDA-approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.


The study involved 18,113 patients with atrial fibrillation who had previously experienced a stroke or transient ischemic attack. They were randomly assigned to receive 110 mg of dabigatran twice a day, 150 mg of dabigatran twice a day, or a warfarin dose adjusted to an internationalized ratio of 2 to 3. After a 2-year follow-up, the researchers conclude that the effects of 110 and 150 mg of dabigatran are similar to those of warfarin on stroke or systemic embolism.


Source: Diener HC, Connolly SJ, Ezekowitz MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9(12):1157-1163.


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