Pregnancy Category X means the risks involved in using Qsymia in pregnant women clearly outweigh the potential benefits. Studies in animals or humans have demonstrated fetal abnormalities. What are the fetal abnormalities? To be more specific – oral cleft birth defects such has cleft palate and/or cleft lip.
The FDA just approved a new diet drug called Qsymia. For obese post-menopausal women and for men of all ages, Qsymia has some concerns and contraindications such as increased heart rate, hyperthryroidism and glaucoma but the real danger lies with women of child bearing age who could and/o are trying to get pregnant.
Qsymia is comprised of two active ingredients – topiramate and phentermine. Topiramate (Topamax) is prescribed as an anticonvulsant and/or to prevent migraine headaches. Many women who took this drug also lost weight. Topamax previously was a Pregnancy Category C upgraded to a Pregnancy Category D in 2011. Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet.
There is something terribly wrong about a diet drug like Qsymia when doctors and pharmacists are mandated to counsel women about birth control before prescribing and dispensing Qsymia.
Do you think the risks of having a baby born with a cleft palate and/or cleft lip far exceed the benefits weight loss? Results from the two trials demonstrate that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, vs. treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo. Are those numbers worth the risk of a baby born with cleft birth defects?
Obesity is an epidemic of astounding proportions in today’s society. Is it prudent for doctors to prescribe Qsymia to a large segment of the diet pills market – women of child bearing age? Is it prudent to public health for the FDA to even approve Qsymia?