Copaxone shows no increased risk in pregnancy.

2003 MAY 1 - (NewsRx.com & NewsRx.net) -- Women who took Copaxone (glatiramer acetate injection) during part of their pregnancies demonstrated no more risk than the general population of pregnancy outcomes, according to an abstract presented this week at the American Academy of Neurology (AAN).

The study reviewed the pregnancy outcomes in women treated with Copaxone through 21 global clinical trials and postmarketing surveillance data. The relapsing-remitting multiple sclerosis (MS) patient population is comprised of a high percentage of women of childbearing age. Despite warnings that women should use adequate birth control and not take immunomodulating drugs during pregnancy, many women become pregnant while taking these drugs.

Of the disease-modifying drugs approved by the FDA, the interferons are assigned FDA Category C because of the risk of spontaneous abortion shown in animal studies. Copaxone is FDA Category B because studies have not shown adverse effects on fetal development, delivery, or infant growth in animal models.

"It is important to understand the risks of a drug therapy for women who may become pregnant," said Pat Coyle, MD, department of Neurology, SUNY at Stony Brook. "Copaxone had not shown adverse outcomes in animal studies and this review of safety data indicates that in women with relapsing-remitting MS the risk of congenital anomalies or spontaneous abortion is within the expected range for the general population."

During clinical trials, 3,400 patients received Copaxone (glatiramer acetate injection). Of these, 40 pregnancies were reported, and the average duration of therapy before discontinuing therapy was within the first trimester of pregnancy. Of those, 18 chose elective abortions, 5 spontaneous abortions occurred, and there were 7 live births; the rest were lost to follow up.

In postmarketing ...