Weight Loss Pill Qsymia gains FDA Approval

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(Best Syndication News) - A new weight loss pill, Qsymia (phentermine and topiramate), was approved by the US Food and Drug Administration (FDA) today. Taking phentermine and topiramate weight-loss medication along with a diet and exercise program could help a person lose weight.

The drug was approved for adults that have a body mass index (BMI) of 30 or more. Additionally, adults with a BMI of 27 or more who have either high blood pressure, type 2 diabetes, or high cholesterol are also approved to take the medication.

Qsymia is made up of two other FDA approved medications – phentermine and topiramate. Qsymia is an extended release formulation. The short-term weight loss is associated with taking phentermine. Topiramate was initially given to people with epilepsy for seizures, and to prevent migraine headaches.

The recommended daily dose of Qsymia contain 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. There is also a higher dose of 15 mg phentermine and 92 mg of topirmate extended-release for certain patients.

Two randomized, placebo-controlled trials were conducted for the safety and effectiveness of Qsymia on around 3,700 obese and overweight participants. The studies lasted for one year. All participants were instructed on lifestyle modification, which involved eating a reduced calorie diet and exercising regularly.

The Qsymia group of participants taking the highest daily dose lost an average of 8.9 percent of their body weight, while those taking the recommended amount of Qsymia lost an average of 6.7 percent.

Sixty-nine percent of the participants that were taking the high dose of Qsymia lost at least five percent of their body weight. The recommended dose of Qsymia allowed 62 percent of these participants to lose a minimum of five percent of their body weight. Only 20 percent of the placebo group participants lost more than five percent of their body weight.

During the first 12 weeks, some taking the standard recommended dose did not lose the expected three percent of their body weight. If the patient has not achieved at least 3 percent of body weight loss, doctors are instructed to consider moving them to the higher dose of Qsymia. Then the patient should follow up again after 12 weeks and if the patient does not lose at least five percent of their body weight, they should discontinue the medication. Doctors are also instructed to continually monitor patients taking Qsymia.

Qsymia could cause birth defects in the first trimester of pregnancy and therefore should not be taken when pregnant. The birth defects include oral clefts, such as cleft lip with or without a cleft palate. Women that could become pregnant should not take the medication. Women should have a negative pregnancy test before starting the medication and should take one every month thereafter. It is also recommended that women should take an effective contraception while taking Qsymia.

Qsymia can increase heart rate. People with glaucoma or hyperthyroidism are excluded from this medication. It is not known if the medications effect on heart rate would increase a person's risk for heart attack or stroke. Because the heart safety is unknown, it is not recommended for patients that have had unstable heart disease or stroke in the last six months.

The marketers of Qsymia, Vivus Inc., are required to complete ten long-term cardiovascular outcome trials to determine if there are any major unfavorable results on the heart from taking this medication.

Common side effects reported included tingling in hands and feet, dizziness, changes in taste sensation, insomnia, constipation, and a dry mouth.

By: Marsha Quinn
Health Reporter

ref: FDA



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