Qsymia (phentermine and topiramate) approved by US FDA on July 17, 2012

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Wednesday, July 18, 2012 4:00 pm Email this article

Qsymia (phentermine and topiramate extended-release) was approved as a diet pill by the U.S. Food and Drug Administration on July 17, 2012 to be used in addition to a reduced-calorie diet and exercise for chronic weight management.

Info about Qseymia

Info about Qseymia from the FDA

The following information is from the FDA’s press release.

“The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

“BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories.

“According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

“Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation.

“Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet.

“Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.”

Reference

FDA. FDA approves weight-management drug Qsymia. July 17, 2012.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm

More Info

More info about Qsymia here

Drug companies website:

• Qsymia’s home page
• Information about Qsymia for patients
• About Qsymia
• Is This Qsymia Right for Me?
• FAQs about Qsymia
• report
• Qsymia full prescribing information
• Qsymia medication guide
• Qsymia home page for Health Care Providers
• Qsymia Indication and Usage for Health Care Providers
• Risk Evaluation and Mitigation Strategy about Qsymia
• Important Safety Information about Qsymia
• Qsymia (phentermine and topiramate extended-release) Healthcare Provider Training Program
• Risk of Birth Defects with Qsymia
• FDA-Required Risk Evaluation and Mitigation Strategy (REMS) required for Qsymia
• Qsymia Prescriber Dosing and Management Checklist
• Healthcare Provider Counseling Tool for Females of Reproductive Potential with the use of Qsymia

Other Articles

Other articles about Qsymia (formerly Qnexa)

• Qsymia side effects: Paresthesia (tingling in hands, feet, or face,) in 14% to 20% of patients
• Qsymia side effects: Dry Mouth in 14% to 19% of patients
• Qsymia side effects: Constipation in 15% to 16% of patients
• Qsymia side effects: Dizziness in 7% to 9% of patients
• Qsymia side effects: Altered taste or bad taste (dysgeusia) in 7% to 9% of patients
• Qsymia side effects: Cognitive disorders (problems with concentration, memory) in 7.6% of patients
• Qsymia side effects: Anxiety in 4% of patients
• Qsymia side effects: Depression in 4% of patients
• Qsymia side effects: Reduced sense of touch (hypoesthesia) in 4% of patients
• Qsymia side effects: Irritability in 3% to 4% of patients
• Qsymia side effects: Hair loss (alopecia) in 3% to 4% of patients
• Qsymia side effects: Disturbance in attention in 2% to 4% of patients
• Qsymia side effects: Low potassium levels (hypokalemia) in 2% to 3% of patients
• Qsymia (phentermine / topiramate) dosage and administration
• Qsymia (phentermine / topiramate) contraindications
• Qsymia (phentermine / topiramate) warnings and precautions
• Qsymia (phentermine / topiramate) drug interactions
• Qsymia (phentermine / topiramate), possibility of Suicidal Behavior and Ideation
• Qsymia (phentermine / topiramate), possibility of Myopia (nearsightedness) and Glaucoma
• Qsymia (phentermine / topiramate) can cause anxiety, depression and insomnia
• Qsymia (phentermine / topiramate) can cause Cognitive Impairment
• Qsymia (phentermine and topiramate) approved by US FDA on July 17, 2012
• Qsymia (phentermine and topiramate) should NOT be used during pregnancy
• Qsymia (7.5 mg phentermine plus 46 mg topiramate) lost 6.7% more than with placebo
• Qsymia (15 mg phentermine plus 92 mg topiramate) lost 8.9% more than with placebo
• Those who don’t lose at least 3% in 3 months with Qsymia (phentermine plus topiramate)
• Qsymia (phentermine plus topiramate) must not be used in patients with glaucoma
• Qsymia (phentermine plus topiramate) must not be used in patients with hyperthyroidism
• Qsymia (phentermine / topiramate) can increase heart rate; risk of heart attack and stroke not known
• Qsymia (phentermine/topiramate) most common side effects: tingling of hands and feet, dizziness, etc
• 3.75 mg of phentermine plus 23 mg of topiramate caused weight loss of 5.1% vs 1.6% with placebo
• 15 mg of phentermine plus 92 mg of topiramate caused weight loss of 10.9% vs 1.6% with placebo
• Most common side effects with phentermine plus topiramate: paresthesia, dry mouth, constipation
• Depression-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.3% vs 3.8%
• Anxiety-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.7% vs 2.8%
• Attention problems more common in those given 15 mg phentermine + 92 mg Topamax: 3.5% vs 0.7%
• Kidney stones 5 times more common in those given 15 mg of phentermine plus 92 mg of Topamax
• 7.5 mg of phentermine plus 46 mg of Topamax caused weight loss of 17.8 lbs vs 3.1 lbs with placebo
• 15 mg of phentermine plus 92 mg of Topamax caused weight loss of 22.4 lbs vs 3.1 lbs with placebo
• Most common side effects of phentermine plus Topamax were paraesthesia, dry mouth, constipation
• Qnexa (phentermine plus Topamax) causes woman to lose 55 lbs, man 73 lbs
• 2.1% to 2.6% of patients given Qnexa (phentermine + Topamax) dropped out due to cognitive effects
• High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 10.4% vs 1.8% w/placebo
• Mid-dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes weight loss of 8.4% vs 1.8% w/placebo
• High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 11% vs 1.6% w/placebo
• Low-dose Qnexa: 3.75 mg Phentermine plus 23 mg Topamax causes weight loss of 5.1% vs 1.6% w/placebo
• Qnexa (Phentermine/Topamax) side effects dry mouth, tingling, constipation, altered taste, insomnia
• Qnexa side effects (phentermine plus Topamax): 20% paresthesia, 18% dry mouth, 15% altered taste
• Low dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes weight loss of 8.5% vs 1.7% w/ placebo
• Full dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 9.2% vs 1.7% w/ placebo
• Low dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes 5% weight loss in 62% of people vs 15%
• Full dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes 5% weight loss in 66% of people vs 15%
• 43-year-old man loses 50 lbs in 4 months on phentermine plus Topamax (topiramate) - update
• 43-year-old man loses 44 lbs in 3 months on phentermine plus Topamax (topiramate)
• Qnexa: Phentermine-Topriamate drug combo causes half of patients to lose an average of 25 pounds

Articles on the same subject can be found here:

• Qsymia (phentermine and topiramate) (formerly Qnexa)