News Feature | January 29, 2014

Janssen Pharmaceuticals On Trial For Topamax

Source: Pharmaceutical Online

By Cyndi Root

Janssen Pharmaceuticals faces trials on its epilepsy and migraine drug Topamax early this year. The trials come on the heels of two judgments for plaintiffs that asserted Topamax caused birth defects and the company failed to warn them of the risk. The company intends to appeal both verdicts. The upcoming trials and the adjudicated court actions are part of over 100 legal actions on Topamax filed in the Philadelphia Courts, First Judicial District of Pennsylvania, Court of Common Pleas.

First Topamax Trial

On October 30, 2013, a Philadelphia jury found in favor of the plaintiff April Czimmer. She asserted that she took the anti-seizure medication for six months during her pregnancy with her son, Blake. When the child was born, he had a cleft lip and had to undergo four surgeries to repair it. The jury found that Topamax did cause the damage and awarded Czimmer a verdict of $4.02 million.

Second Topamax Trial 

The jury ordered Janssen, a subsidiary of Johnson & Johnson (J&J), to pay $11 million to plaintiffs. The petitioners stated that the epilepsy drug caused birth defects in their children. On November 18, 2013, the jury found that Topamax caused a cleft lip due to the South Carolina’s mother use of the drug during pregnancy. Michael Gurley and Haley Powell expect their son to have five corrective surgeries.

FDA Action

The Food and Drug Administration (FDA) issued a drug safety communication in March 2011, informing consumers that data showed that taking Topamax increased risks for cleft lip and palate in infants. Prior to the alert, animal studies showed  potential fetal risks, but human studies were unavailable. The drug was classified as a Pregnancy Category C medication. When human studies confirmed possible fetal  risks, the FDA changed the drug to Pregnancy Category D classification. The FDA used data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry and the U.K. Epilepsy and Pregnancy Register.  

Janssen’s Position

Charles Morrow, an attorney for the company said, “Janssen acted appropriately when it was required to act. Topamax has been extensively studied and approved by the FDA multiple times as safe and effective.”  The company states that it did warn health care providers of the risks of the drug, including plaintiffs’ physicians. Janssen believes that the lawsuits are without merit.