Treatment for epilepsy has been approved for Topamax, the brand name of Topiramate, which has also been given an indication for the prevention of migraine headaches. Despite that, medical practitioners still prescribed Topamax off-label especially with studies suggesting
Topamax effective at treating PTSD (post-traumatic stress disorder). However, with lawsuits expected to crop up as studies continue to associate Topamax with an increasing number of birth defects, off-label prescription should be done with caution.
Significant psychiatric comorbidity and the persistence and intensity of symptoms like nightmares and hyper-arousal makes chronic PTSD a notoriously difficult illness to treat. The Food and Drug Administration (FDA) had approved some selective serotonin reuptake inhibitor (SSRI) drugs like Zoloft and Paxil to treat PTSD but their effects are often limited and introduce problematic side effects like sexual dysfunction and weight gain.
Topamax could be effective in treating PTSD either as an add-on strategy or as a monotherapy with particular value for re-experiencing symptoms such as nightmares based on growing evidence. That this evidence is based on only a limited controlled data with only three smaller scale placebo-controlled trials should be given importance. Caution should be taken by both prescribers and patients knowing this fact and with recent studies linking Topamax to serious birth defects years after it was approved by FDA as a treatment for epilepsy.
In 2008, studies were released, suggesting that women taking Topamax during pregnancy are putting their infants at high risk for birth defects, in the United Kingdom. Topamax manufacturer Johnson and Johnson failed to change the medications pregnancy warnings until this year when the FDA released information about it despite studies done in the U.S. Johnson and Johnson could be facing lawsuits which could be filed by families who have been affected or suffered the side effects of the antiepileptic drug Topamax for not releasing the warnings earlier.
Studies showed that infants being at high risk for developing cleft lip and cleft palate and the genital birth defect known as hypospadias are among the Topamax side effects. These side effects should caution against the off-label prescription of Topamax such as for PTSD treatment.