Qsymia (phentermine / topiramate) can increase heart rate; risk of heart attack and stroke not known

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Wednesday, July 18, 2012 2:50 pm Email this article

Qsymia (phentermine plus topiramate) "can increase heart rate; this drug’s effect on heart rate in patients at high risk for heart attack or stroke" is not known notes the FDA press release.

“Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended.

“Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose.”

“Qsymia will only be dispensed through specially certified pharmacies. 

Drug Company to assess long-term risk of cardiac problems

Vivus to conduct long-term evaluation of the risk of heart attack and stroke

“Vivus Inc. will be required to conduct 10 postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.”

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)