Last year the FDA changed the way it classifies the popular migraine prevention drug Topamax® because of evidence that Topamax causes cleft lip and cleft palate in children whose mothers took Topamax very early in their pregnancy.
Topamax was originally approved by the FDA as a medicine to treat people with epilepsy, a very serious neurological disorder that causes seizures. After several years on the market, Janssen Pharmaceuticals, Inc., the company that makes Topamax, applied to the FDA for permission to sell Topamax as a medicine to treat conditions other than just epilepsy. In 2004, the FDA approved Janssen’s application to allow it to sell Topamax to people who suffer from migraines.
As you can imagine, there are far more people who suffer from migraine headaches than from epilepsy. The market for Topamax went from 3 million potential daily users to almost 40 million. That meant billions of additional dollars for Janssen and its parent company, Johnson & Johnson.
When the FDA approved Topamax to treat epilepsy, it was initially classified the same as other epilepsy drugs – a Category C. When the FDA classifies a drug as Category C, it means that animals given the drug during pregnancy had babies that suffered birth defects or other injuries, but that there was not enough data from human clinical trials to say if there were risks to human babies.
Once Janssen started selling Topamax to prevent migraines, a lot more babies whose mothers took Topamax early in their pregnancy developed cleft lip or cleft palate. Cleft lip and cleft palate can range from just a small notch in the lip to a much deeper groove that runs into the roof of the mouth and nose. This possibly can lead to problems with eating, talking and ear infections. Most babies born with a cleft lip of cleft palate have to go through one or more very painful surgeries to close the gaps.
Because of this, the FDA has forced Janssen to label Topamax a Category D drug. That means doctors have to carefully weigh the benefits versus the risks of prescribing Topamax to a woman of child-bearing age, especially for prevention of migraines – a condition that is not usually associated with permanent injury or death. In doing this, the FDA sent a clear message: Topamax is dangerous when taken during pregnancy.
Babies whose mothers took Topamax may have been born with cleft lip, cleft palate or other serious injuries involving heart defects, skeletal defects and defects of the baby’s urinary system. Many of those mothers and fathers never understood what went wrong in the pregnancy. Now some of them have the answer: Topamax caused their baby’s birth defects.
The drug company that made billions of dollars selling Topamax is now having to answer to mothers and fathers in court about why a prescription drug caused them and their baby so much pain. There are several lawsuits already filed against Janssen and Johnson & Johnson in federal and state courts. Some of the cases already filed are set for trial less than a year from now.
Slack Davis Sanger represents families injured by Topamax. If you suspect that your child’s birth defects were caused by Topamax, feel free to contact us for a free consultation about your claim.