New, Controversial Qsymia Diet Pill May Cause Birth Defects

Patient Expert

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 Qsymi

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 Qsymi

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 Qsymi

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.

If a woman has a positive pregnancy test, has missed a period, or thinks she may be pregnant, she must not start treatment with Qsymia. If she is already taking Qsymia, she must stop treatment immediately and tell her healthcare provider.

While on treatment with Qsymia, women who can become pregnant must use an effective means of birth control. Sometimes a second birth control method is necessary to prevent pregnancy while taking Qsymia.

Controvery Over  Qsymisymia Approved in the US

Some American physicians have expressed enthusiasm about Qsymia, stating that it will be a useful medicine for people who are compromising their health, a welcome new tool that is cause for excitement, and a viable medical therapy to accompany diet and exercise.

Qsymia Not Approved in Europe

The European Union is resistant to the new drug, and Vivus Inc., the manufacturer of Qsymia, states that do not anticipate approval for distribution in Europe. If they are denied approval, either a new application or an appeal will be filed.

Is Qsymia Right for You?

If you are an average height woman with a BMI of 30 (obese), your expected weight loss with Qsymia is 12.5-16.6 lbs. If you are healthy, without cardiovascular disease, and cannot become pregnant or will follow a strict birth control plan if you can become pregnant, then you may wish to  talk to your doctor to see if a weight loss program that includes Qsymia in combination with diet and exercise is right for you.

If you do not meet the above criteria, then it is my opinion that you would do best to consider other weight loss options.

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