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. The approval, however, does not stop the off-label prescription by medical practitioners especially with Topamax effective at treating PTSD (post-traumatic stress disorder) with studies suggesting its efficacy. 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. Approved by the Food and Drug Administration (FDA) for the treatment of PTSD are some selective serotonin reuptake inhibitor (SSRI) drugs like Zoloft and Paxil, however, their effects are often limited and introduce problematic side effects like sexual dysfunction and weight gain.
There is, however, growing evidence that Topamax may 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. That this evidence is based on only a limited controlled data with only three smaller scale placebo-controlled trials should be given importance. This fact and recent studies linking Topamax to serious birth defects years after it was approved by FDA as a treatment for epilepsy should make both prescribers and patients take notice.
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. And since then, this fact has been studied in the U.S., however, Topamax manufacturer Johnson and Johnson failed to change the medication’s pregnancy warnings until this year when the FDA released information about it. Families who have been affected or suffered the side effects of the antiepileptic drug Topamax could file a lawsuit against Johnson and Johnson for failing to reveal warnings early.
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. Off-label prescription of Topamax such as for PTSD treatment should take into consideration the discovery of these side effects.
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