Study shows no increased heart risk for newborns with mothers on Paxil
TORONTO According to a new study published in the American Journal of Psychiatry, infants whose mothers took the GlaxoSmithKline antidepressant drug Paxil during early pregnancy do not have an increased risk of heart defects.
The study was performed by the Motherisk program at the Hospital for Sick Children and University of Toronto. Almost 1,200 infants were studied and the results showed that infants who had been exposed to the medication had the same risk for the defects as infants not exposed, 0.7 percent.
GSK had originally published a report stating that risk of cardiovascular defects was 2 percent. Adrienne Einarson, the lead author of the new report called GSK’s initial report, “preliminary information.” GSK later adjusted its figure to 1.5 percent.
In general, the incidence of heart defects in the general population is about 1 percent.
Rite Aid posts sales increase for March
CAMP HILL, Pa. Rite Aid on Thursday reported a same-store sales increase of 2.6 percent (which does not yet include the Brooks/Eckerd acquired stores) for the four weeks ended March 29.
Pharmacy same-store sales increased 1 percent, which included an approximate 493 basis points negative impact from new generic introductions. Front-end same-store sales were up 5.7 percent. March same store sales were positively affected by a shift to a March Easter this year from an April Easter last year (March 23 this year as compared to April 8 last year).
Total drug store sales for the four-week period increased 50.7 percent to $2 billion. Prescription revenue accounted for 67.6 percent of drugstore sales, and third party prescription revenue represented 96.2 percent of pharmacy sales.
FDA grants orphan designation for MELAS syndrome drug
WASHINGTON Sirtris Pharmaceuticals has been granted orphan drug designation for resveratrol by the Food and Drug Administration, according to published reports.
Resveratrol is a drug used to treat MELAS syndrome, a progressive fatal aging disease that produces symptoms of muscle weakness, fatigue, recurrent headaches and seizures. The government’s grant is usually offered in cases in which companies are discovering treatments for rare drugs, and the grant would allow the company to speed up their testing period.
Sitris has decided to focus on the SIRT1 gene, which is a gene tied to the aging process. SIRT1 is being studied as a possible source in treating MELAS or type 2 diabetes. According to published reports, the grant has resulted in Sitris being offered seven years of marketing exclusivity for its formulation of resveratrol.