Researchers Reach Conclusion Based on 21 Global Clinical Trials
1st April, 2003
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, M.D., 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, five spontaneous abortions occurred, and there were seven live births; the rest were lost to follow up.
In postmarketing surveillance, 345 pregnancies have been reported. More than 90 percent of these women discontinued use of COPAXONE® when they discovered they were pregnant, so they were mostly exposed in the first trimester. There are 130 cases that either have not reached their due date or that were lost to follow up.
Of the 215 pregnancies with known outcomes, there were 155 healthy live births. Of the remainder, there were 43 spontaneous abortions, nine elective abortions, six cases of congenital anomalies, one stillbirth, and one ectopic pregnancy.
These results are consistent with the risk in the general population. The risk of congenital anomalies is estimated at three percent, and the incidence of spontaneous abortion is 15 to 20 percent in recognized pregnancies, according to data from the March of Dimes Perinatal Center.
COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 42 countries worldwide, including the U.S., Canada, Australia, Israel and all the European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and Aventis Pharma. In North America, COPAXONE® is marketed by Teva Neuroscience. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies in the world. Close to 90 percent of Teva’s sales are in North America and Europe. The company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva’s innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE® (glatiramer acetate injection).
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