In the report, the CHMP articulated concerns with regard to topiramate side effects as they related to the potential for birth defects, as well as long-term psychiatric effects, long-term memory and attention issues. The CHMP concerns were founded upon the depression and anxiety that emerged as the result of clinical trials for topiramate.
But here’s the thing - the EMA was not concerned about Topamax side effects per se, but rather the impact that topiramate might have as part of a new blockbuster diet pill that made its debut in the US this past July…
Qsymia, a combination of topiramate and phentermine, was given the blessing of the US Food and Drug Administration (FDA) in the summer of 2012, after being firmly rejected by an expert panel two years before.
And while phentermine - one-half of the vilified Fen-Phen combination pulled from the market in the 1990s - remains an approved drug in the US, it does not carry EMA approval in that part of the world. Coupled with concern over the potential for phentermine to elevate the heart rate, Drug Injury Watch (10/22/12) notes the EMA is giving the manufacturer of the new diet combo, Vivus, a rough ride.
That drug, which contains topiramate as an active ingredient and therefore draws concern over potential topiramate side effects, is known as Qsymia in the US and Qsiva in Europe.
The concern over the potential for topiramate birth defects is such that the FDA directed, as a condition of approval, manufacturer Vivus to conduct long-term, post-market studies on the effects of Qsymia to gauge long-term cardiovascular effects related to the presence of phentermine. As for topiramate, various media pundits were making the point that Qsymia, due to the presence of topiramate and the potential for topiramate birth defects, is not to be used by women while pregnant, and that women will have to present a negative pregnancy test before they will be allowed to start Qsymia for weight loss, regardless of their degree of obesity and need. As well, it was suggested by a medical consultant appearing on ABC News (9/18/12) that women actively taking Qsymia will be required to undergo a monthly pregnancy test in order to remain on the medication.
Such is the concern for topiramate side effects related to birth defects and potential harm to an unborn child.
What does that say about Topamax? When there is this much concern with regard to a medication that carries topiramate as a component of the overall formulation, what risk is there with Topamax when it carries topiramate as its primary component?
We are coming up to the second-year anniversary of an FDA-issued warning about Topamax birth defects and, specifically, concern with regard to an increased risk of oral cleft birth defects in children whose mothers used Topamax to help manage epileptic seizures.
Topiramate is also used to help manage migraine headaches. Migraine sufferers are far more prevalent in society than those suffering from various forms of epilepsy. And morbidly obese Americans are even more prevalent.
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And how many women taking topiramate and thus at risk for a Topamax pregnancy welcome a child into the world with a Topamax Cleft Lip or Topamax Cleft Palate? Such defects can be surgically repaired, but at significant medical cost and they carry potential for scarring.
While the EMA continues to struggle with topiramate side effects as it relates to the Qsiva diet drug, sister drug Qsymia is already on the market in the US and predicted to reach a peak sales level of $1.6 billion in the US within six years. But at what cost to our unborn children?