With Topiramate in More Medications, Will Topiramate Side Effects Increase?

Washington, DCThe active ingredient in Topamax, which is considered a contributor to sometimes serious Topamax side effects, has appeared in recently-approved weight-loss medications known as Qsymia and Qnexa in the US. Topamax has also been indicated for treatment of migraine headaches, as recently evidenced in a medical column that ran in Florida Today (9/5/12).

While Topamax topiramate was originally approved as an anti-seizure medication and for the treatment of migraines, the evolution of topiramate as an ingredient to foster weight loss begs the question: will we be seeing more incidents of Topamax birth defects and other grievous adverse reactions with topiramate now available to a larger cross section of the population?

There is little doubt that Topamax is effective in mitigating the onset of seizures--and for that constituency the medication proves welcome and effective. Ditto for migraines. However, the association between Topamax and pregnancy remains a concern, given the link to birth defects such as cleft palate and cleft lip.

With seizures affecting a minority of the population, health advocates note that doctors treating patients with such a serious, and specific condition might be more apt to be proactive in discussing the drug's potential for topiramate side effects--especially for women who are pregnant, intend to become pregnant or are likely to become pregnant.

With Topamax birth defects, the concern with oral cleft defects is derived from the development of the oral area during the first trimester of a pregnancy, a time when some women may not even be aware they are pregnant. By then, for topiramate patients, it may be too late to avoid Topamax side effects in children.

Now, with the introduction of new medications to the market containing topiramate, there is renewed concern for side effects such as Topamax cleft lip.

That's because topiramate--which tends to have weight loss as a side effect--has been combined with phentemine in two drugs which recently received approval by the US Food and Drug Administration (FDA): Qsymia, and Qnexa.

If phentermine sounds familiar, it should: phentermine was one-half of the notorious Fen-phen diet drug that was pulled from the market years ago due to severe side effects and adverse health reactions. The combination of phentermine and topiramate is thought to carry less risk, but in spite of that reduced risk has nonetheless been approved as a weight-loss aid. The intended market is the morbidly obese who have been unable to lose weight through normal protocols of diet and exercise. According to advocates of the new drugs, a ten percent weight reduction is possible through use of the drug alone.

However Dr. Richard Besser, Senior Health and Medical Editor for ABC News, told Elizabeth Vargas on Good Morning America (2/23/12) that side effects remain a concern and doctors will have to be especially careful when treating women of childbearing age, due to the potential for topiramate side effects in children.

According to the Chicago Daily Herald (12/3/12) Qnexa received FDA approval in July. As for Qsymia, its European counterpart Qsiva has come under fire by the European Medicines Agency (EMA) due to the potential for depression and anxiety, an adverse reaction that was seen in clinical trials for the new diet drug containing topiramate.

As for migraine headache sufferers, Topamax has long been indicated as an effective treatment for migraines. But its use for that indication may increase, thanks in part to reports like that appearing in Florida Today that suggested migraine antidotes such as Topamax are under-utilized for migraine prevention.

"Migraine prevention guidelines released earlier this year by the American Academy of Neurology and the American Headache Society note that about 38 percent of people who have migraines could benefit from preventive medications," wrote Dr. Stephanie Haridopolos. "But less than a third of those people actually utilize these treatments."

Topamax is listed under these new guidelines as a worthy treatment, albeit with the caveat of potential Topamax side effects.

One has to wonder; therefore, if adverse reactions associated with Topamax topiramate will increase if topiramate use increases through the utilization of not only Topamax, but also new medications containing the anti-seizure drug intended for other indications.

And will Topamax and topiramate patients harmed by the drug file a Topamax lawsuit?