Approval for epilepsy treatment and indication for the prevention of migraine headaches has been given to Topamax, the brand name of Topiramate. 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. 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.
Topamax’ efficacy in treating PTSD is supported by growing evidence that it could either be used as an add-on strategy or as a monotherapy with particular value for re-experiencing symptoms such as nightmares. However, the fact that this evidence is based on only a limited controlled data with only three smaller scale placebo-controlled trials should not be disregarded. 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. 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. For not publicizing the warnings early, 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.
Infants being at high risk for cleft lip and cleft palate and the genital birth defect known as hypospadias are among the Topamax side effects suggested in the studies. These side effects should caution against the off-label prescription of Topamax such as for PTSD treatment.
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