Topamax a Double-Edged Sword for Women

Durham, NCTopamax side effects encompass more than the potential for birth defects in children. In fact, anyone who takes Topamax for either of the approved uses as determined by the US Food and Drug Administration (FDA) could be at risk for adverse reactions.

That said, Topamax topiramate has been prescribed off-label for various uses beyond that for which it carries formal FDA approval: control of seizures associated with epilepsy and Lennox-Gastaut Syndrome, and the prevention of migraine headaches.

In fact, according to the June 27 issue of India Pharma News, Topamax has been studied and used for conditions ranging from bipolar disorder to bulimia and weight gain stemming from antidepressant use. While doctors have always possessed the legal, moral and medical authority to prescribe drugs off-label, such uses are not sanctioned by the FDA.

There is little doubt that Topamax has been effective for weight loss when combined with phentermine, according to a recent study undertaken by the Obesity Clinic Trials Program at Duke University Medical Center. Study participants lost an average of 18 pounds after one year on low-dose topiramate/phentermine or 22 pounds at the higher dose as compared with an average of three pounds lost by participants taking a placebo, and observing a diet and exercise regimen.

However, various topiramate side effects were observed. And not lost on any observer to the issue are the concerns over Topamax and pregnancy—especially after the FDA in March of this year issued a Drug Safety Communication revealing that babies born to mothers taking Topamax are 20 times more likely to deliver babies born with a deformity such as Topamax cleft palate or Topamax cleft lip. The latter can have a significant emotional impact on the child and place the family into financial hardship.

And there is yet another Topamax concern beyond Topamax birth defects. India Pharma News noted evidence that suggests the use of Topamax could also decrease the effectiveness of oral contraceptives, which results in a corresponding increase in the risk of pregnancy.

Thus, Topamax for the woman can be a double-edged sword.

In a related issue, the FDA announced late last month that it has approved an NDA for a Topamax oral tablet at various strengths: 25mg, 50mg, 100mg, 200mg, 300mg and 400mg. While there are various generic equivalents in doses up to 200mg, there are none currently available at 300mg and 400mg doses. Thus, the Ortho McNeil Janssen unit of Johnson & Johnson continues to have market exclusivity at the upper doses for Topamax.