The latter was brought to the fore through a Topamax lawsuit filed February 28, 2013, at the Philadelphia Court of Common Pleas. In the filing, the plaintiff alleges her child was born with cleft lip and cleft palate due to Topamax use during pregnancy.
The Topamax and pregnancy lawsuit, according to PRWeb Newswire (3/14/13), is case #130203056. The plaintiff, from Indiana, alleged her child was born with cleft lip and Topamax cleft palate from her use of topiramate in 2004.
Such Topamax side effects in children are rarely something that can simply be outgrown. Surgical intervention is usually necessary in order to correct the defects. In many cases, several procedures are required. The physical scarring that often results can affect a child for a lifetime.
The US Food and Drug Administration (FDA) has previously warned that use of Topamax topiramate during pregnancy increases the risk for Topamax birth defects such as Topamax cleft lip and cleft palate, according to various studies. The federal drug regulator has gone so far as to advocate that doctors reconsider prescribing Topamax to any woman of child-bearing age.
Such an over-the-top position has grown from the tendency, according to research, that most of the potential risk for Topamax and pregnancy occurs in the first trimester, the point in a pregnancy when many women are not even aware they are with child.
By then, it may be too late.
Given that Topamax is prescribed for migraine prevention as well as mitigation and management of epileptic seizures, levels for concern have been rising given the prevalence of migraine headaches in a stress-laden world, and a doctor’s willingness to prescribe topiramate.
And then there is the concern over Qsymia, the new weight loss combo put out by Vivus and approved by the FDA in July of last year.
The teaming of topiramate with phentermine grew from a study by researchers at Duke University Medical Center with a focus on weight loss. Phentermine, once part of the banned Fen-Phen combination, but was not the reason for the combo’s removal, has proven credentials to treat obesity as a short-term response dating back to 1959.
Teamed with topiramate, the potential for successful weight loss is even more significant, according to the study. The combination of phentermine and topiramate in doses up to 400 mg achieved a weight loss of nearly 11 percent in study participants taking the highest allowable doses. The 56-week, phase 3 studies were conducted in 93 US centers with 2,487 patients who had a Body Mass Index (BMI) of 27-45kg/m2, and two or more co-morbidities such as diabetes or heart disease.
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But what of topiramate birth defects? The FDA initially rejected Qsymia in 2010 for that very reason. Approval was eventually secured in tandem with the development of a risk management template that involves a pregnancy test prior to starting Qsymia, and monthly pregnancy tests thereafter.
But, according to The Huffington Post, it’s a recommendation. A doctor, whose patient is morbidly obese, may feel a patient’s health risk from severe obesity is greater than any birth defect risk to a fetus posed by the presence of topiramate in Qsymia.
Will there be increased incidents of Topamax side effects? Time will tell…