Topamax Side Effects Recall and Birth Injuries

Topamax, manufactured by Johnson & Johnson, is being recalled for an “uncharacteristic odor”. The recall involves100 milligram tablets in 57,000 bottles of the epilepsy and migraine drug. Johnson & Johnson spokesman Mark Wolfe has stated that the odor is caused by TBA, a compound used to treat wooden pallets.
The company says in a statement that the two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012.
This is not the first issues concerning Topamax safety. Women who’ve taken Topamax during pregnancy have experienced an increased risk in giving birth to a child with a cleft palate or cleft lip.
On March 4, 2011, the FDA warned healthcare professionals of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. The FDA requested a label change for Topamax and its generic equivalent which has been on the market since 2006.
According to the FDA, “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.”