The Food and Drug Administration, reacting to statistics showing that pregnant women who use Topamax during their pregnancies run a high risk of having children with birth defects, has issued a safety alert informing consumers about these dangers. The FDA specifically said that such women are at a far higher risk of giving birth to children suffering cleft palates, cleft lips and other defects than women who do not use the anti-seizure medication while pregnant.
Dr. Russell Katz, who is director of the FDA Division of Neurology Products, said that the data has prompted the agency to warn doctors to reconsider whether to prescribe the medicine to women of childbearing age and to ensure that they have frank discussions with these women about these dangers and the serious withdrawal symptoms that may occur. Katz told doctors that “alternative medications that have a lower risk of birth defects should be considered.”
In response Johnson & Johnson, the drug’s manufacturer, issued a statement in which the company said it had changed its labeling procedures to warn women about this link to dangerous side effects such as birth defects and “recommended cautious use in pregnant patients.” Johnson & Johnson also said it would cooperate with the FDA in monitoring further developments with the drug.
Consumer advocates and lawyers representing women who gave birth to children who suffered Topamax birth defects before these changes were made have been filing lawsuits against Johnson & Johnson in which they are seeking millions of dollars in damages. Among the allegations against Johnson & Johnson are that the company was aware of these dangers and did not warn women or inform the government regulatory agencies of them.