Saturday, May 18, 2013

New, Controversial Qsymia Diet Pill May Cause Birth Defects

By My Bariatric Life, Health Guide Thursday, October 11, 2012

 

Qsymia Prescription Weight Loss Supplement Now Available

 

Qsymia, the first prescription weight loss drug to reach the marker in thirteen years, is now being sold at certified pharmacies.

The prescription diet pill was approved by the U.S. Food and Drug Administration in July of this year as a supplement to a reduced-calorie diet and program of exercise for chronic weight problems.

 

Qsymia has been approved for obese adults with a body mass index of 30 or more, and overweight adults with a body mass of 27 or more who also have a weight-related health condition such as high blood pressure, type 2 diabetes, or high cholesterol.

What is Qsymia?

 

Qsymia is a combination of two drugs that have received approval from the Food and Drug Administration (FDA): phentermine and topiramate. Phentermine is for short-term weight reduction in obese or overweight people who are dieting and exercising. Topiramate is meant to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.

Recommended Dosage of Qsymia

The recommended daily dose of Qsymia has 7.5 milligrams of phentermine and 46 milligrams of topiramate. Higher doses are available for specific patients.

 

Average Weight Loss with Qsymia

 

Trial patients had an average weight loss of 6.7 percent of body weight at the lower dosage of Qsymia and 8.9 percent at a higher dosage over treatment with a placebo. If a patient does not lose at least 3 percent of her body weight in a twelve week period, she should be evaluated to determine whether treatment with Qsymia should be discontinued or whether a higher dose should be administered. If a higher dose is administered and the patient does not lose five percent of her body weight in a twelve week period, treatment with Qsymia should be stopped.

Side Effects of Qsymia

While the weight loss experienced in clinical trials was positive, concerns about Qsymia side effects have been raised.

The most common side effects Of Qsymia reported were tingling in the hands and feet, dizziness, change in taste, difficulty sleeping, constipation, and dry mouth.  Also reported but much less likely side effects are increased risk of suicidal thoughts or behavior and eye problems.

Some of the patients in the clinical trials experienced increased heart rates and metabolic acidosis, a condition that can lead to hyperventilation, fatigue and anorexia. Other concerns about Qsymia involve potential birth defects. Topriamate has been linked to cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures.



Risk of Birth Defects with Qsymia

 

Qsymia can cause fetal harm. Qsymia can increase the risk of a birth defect called cleft lip or cleft palette early in pregnancy, sometimes even before a woman knows she is pregnant. 

 

Qsymia Treatment in Women Who Can Become Pregnant

 

Women who can become pregnant need to take a pregnancy test before beginning treament with Qsymia, as well as every month thereafter while on treatment with Qsymia.

By My Bariatric Life, Health Guide— Last Modified: 01/31/13, First Published: 10/11/12