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Posted 25 Sep 2013 by Drugs.com
WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, 18 months and 36 months. The women also provided information on breast-feeding during the first year for the study, which was published online Sept. 23 in the journal JAMA Neurology. Of the children in the study, 223 were exposed to one or more epilepsy drugs in the womb. At age 6 months, 11.5 percent of infants whose mothers took epilepsy drugs during pregnancy had impaired fine motor skills (which involve small muscle movements) compared with less than 5 percent of those who were not exposed ... Read more
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FDA Medwatch Alert: Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)
Posted 24 Nov 2008 by Drugs.com
[Posted 11/24/2008] FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed ... Read more