Women are often deeply concerned about the risk of birth defects in their babies if they take certain drugs during pregnancy. And although this can result in catastrophic lawsuits for damages once the damage is done no matter how large the financial compensation is this can not make up for the lifetimes of pain and suffering for the babies and their families afflicted with such birth defects.
A recent FDA news release dealing with information about birth defects associated with Topamax has been released, http://1.usa.gov/dLCprd. The FDA has reported new data suggests that the drug Topamax (topiramate) and its generic versions are associated with increased risks for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.
The FDA has gone on to report that before prescribing topiramate, which has been approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug. Topiramate has also been approved to prevent migraine headaches, but not to relieve the pain of migraines.
Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, has said “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered.” Based on this report topiramate will now have a stronger warning in its prescribing information.
And the pregnancy category will be changed to Pregnancy Category D which means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA had previously designated the drug as Pregnancy Category C because of the lack of human data. Also, the patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
Therefore, before starting topiramate, pregnant women and women of childbearing age should discuss other treatment options with their health care professionals. And women taking topiramate should tell their health care professionals immediately if they are planning to or if they become pregnant.
Photographer: Louisa Stokes
Mandel News Service: