In a bid to reduce the exponentially increasing obesity rates, the Food and Drug Administration on Tuesday approved Qsymia, the second weight loss drug this year after Belviq. However, some are concerned over potential side effects of the weight loss drug, manufactured by Vivus Inc.
Qsymia, which is a combination of two older weight loss drugs: phentermine and topirimate, is found to have common side effects like dizziness, change in taste, tingling in the hands and feet, trouble sleeping, constipation, and dry mouth.
The FDA-approved anti-obesity pill is also found to have side-effects like increased heart rate, increased risk of suicidal thoughts or behavior. Development of eye problems, such as glaucoma or an increased pressure in the eye due to fluid blockage, difficulty with attention and concentration, memory and word-finding have been found to be some of the other side-effects faced by people taking Qsymia.
In the clinical trials Qsymia produced dramatic weight loss, but some patients suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia.
Topiramate, one of the ingredients in Qsymia, is an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women, who have taken it for migraines or seizures.
Expressing concern over the possible side-effects of the new weight loss drug, Cindy Pearson, executive director of the National Women’s Health Network, said, ”Our belief is that women will be invited to compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks.”
The FDA and Vivus both have agreed that the three clinical trials conducted to measure Qsymia’s safety and effectiveness were not designed to completely assess the cardiovascular risk of the drug. A study on Qsymia’s cardiovascular effects was ordered by the FDA. Vivus said it would be done after the drug’s approval.