Breastfeeding While Taking Seizure Drugs May Not Harm Childs IQ, Study Suggests

"While more research is needed with larger numbers of women and their babies, these results are reassuring to women who want to give their babies all the benefits of breastfeeding but also need to remain on their epilepsy medications to avoid devastating seizures," said study author Kimford Meador, MD, of Emory University in Atlanta and a Fellow of the American Academy of Neurology (AAN).

The study followed 194 pregnant women who were taking one epilepsy drug. Of their 199 babies, 42 percent were breastfed. When they were three years old, the children were given IQ tests.

The study found that there was no difference in IQ scores between the children who were breastfed and those who were not. Those who were breastfed scored 99 on the test, while those who were not scored 98, which is not a significant difference.

The women were taking the drugs carbamazepine, lamotrigine, phenytoin, or valproate. Meador noted that more research is needed on the effects of other, newer drugs for epilepsy. The children whose mothers were taking valproate had lower IQ scores, whether or not they were breastfed. American Academy of Neurology guidelines recommend that valproate be avoided during pregnancy due to risks of birth defects and effects on cognitive skills. AAN guidelines also recommend that women avoid taking more than one epilepsy drug at a time during pregnancy since taking more than one drug has been found to increase the risk of birth defects compared to taking only one medication.

Editorial author Autumn Klein, MD, PhD, of Brigham and Women's Hospital and the Harvard Medical School in Boston said that this is one of the first large studies on breastfeeding while taking an epilepsy drug.

"Many women are counseled not to breastfeed due to the lack of information on the effects of these drugs, but breastfeeding has many positive emotional effects for the mother and the baby along with the decreased risks for heart disease, diabetes, and obesity in the child and breast and ovarian cancer in the mother," Klein said. "This study highlights the pressing need for more data on epilepsy drugs in breast milk and the long-term effects."

The study was supported by the National Institutes of Health and the UK Epilepsy Research Foundation.

read more» Read more...

Sepracor announces new drug submission to Health Canada for seizure drug

Sepracor has announced that its Canadian subsidiary, Sepracor Pharmaceuticals, has submitted an application to the Therapeutic Products Directorate of Health Canada for eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate in both the US and Canada is Stedesa.

Stedesa, a new chemical entity, is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures. Under Health Canada's Food and Drugs Act and Regulations, the Therapeutic Products Directorate has 45 days in which to screen the submission to determine whether it is complete and of suitable quality to be reviewed.

Sepracor submitted its new drug application (NDA) for Stedesa to the FDA in March 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, and the FDA accepted the filing for formal review in June 2009. The Prescription Drug User Fee Act (PDUFA) action date for Stedesa in the US is January 30, 2010. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.

Sepracor is seeking approval of Stedesa in the US and Canada for adjunctive therapy with once-daily maintenance doses of 800mg and 1200mg in the treatment of partial-onset seizures in adults with epilepsy.

Douglas Reynolds, president of Sepracor Pharmaceuticals, said: "The Stedesa submission represents Sepracor Pharmaceuticals's continuing commitment to providing Canadians with important new therapies in the treatment of central nervous system disorders, which is a therapeutic area in which we already have commercial experience. If approved by Health Canada, Stedesa has the near-term potential to be an important new treatment option for patients suffering with epilepsy."

Source : www.tradingmarkets.com

read more» Read more...