Qsymia Side Effects

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Qsymia®, previously known as Qnexa®, is a prescription medication used to treat obesity. Qsymia® was initially rejected by the FDA on October 28, 2010, due to the risk of side effects such as depression, suicidal thoughts, pregnancy complications, and memory lapses. The medication was approved in July of 2012, but the FDA does not recommend the medication for pregnant women (due to complications with the fetus), patients suffering from hyperthryoidism or glaucoma, or patients who have recently had a stroke or suffered from heart disease.[1] [2]

The most common side effects of Qsymia® in clinical trials were changes in taste, tingling, dryness in the mouth, respiratory infection, and constipation.[2]

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WeightLoss.jpg
Flickr: klf_blf
Brand name for Phentermine and topiramate combination pill[2]
Manufacturer Vivus, Inc.[2]
Uses Weight loss drug used to treat obesity[2]
Common Qsymia® side effects Dry mouth, sleep disturbances, tingling, sinus and other respiratory infections, constipation[2]
Who should not take Qsymia®? Pregnant women, those suffering from hyperthryoidism or glaucoma, and those suffering from a recent stroke or heart disease[1]
Disclaimer The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Allison Hughes
 
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Contents

Common Qsymia Side Effects

Results from the clinical trials addressed during the FDA's safety review of Qsymia® returned several side effects of note. The FDA saw increases in heart rate among patients taking the drug, but the clinical significance was not conclusive. Other side effects included:[3]

  • Increased anxiety
  • Sleep disturbances
  • Dry mouth
  • Tingling
  • Constipation
  • Altered taste
  • Depression
  • Infections in the sinus and respiratory tracts

Drug Side Effects

Side effects of prescription drugs like Qnexa
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Qsymia Clinical Trials and Research

On Thursday, July 15, 2010, the FDA’s advisory committee on endocrinologic and metabolic drugs took a closer look at Qsymia® after initial clinical studies showed the drug to significantly increase weight loss in clinical trials. However, the drug was rejected by this panel. Then, on October 18, 2010, the FDA rejected Qsymia® due to potentially serious side effects. This included concerns about cardiovascular issues and the effects on the fetus in pregnant women.[4]

When Qsymia® was studied over a period of a year, users were reported to lose an average of 10 to 14 percent of their total body weight. Qsymia® also reportedly reduced risk of some cardiovascular illnesses like high cholesterol, as well as the risk of diabetes.[5]

In comparison, the three prescription diet drugs on the market at that time showed the following effectiveness:[5]

  • Users of subitrimine, sold as Meridia, averaged 3 to 4 percent body weight loss in six months to a year of use.
  • Phentermine users showed an average of 4 to 5 percent weight loss in three months of use, the longest time frame it is approved for.
  • Prescription orlistat Xenical users lost an average of 3 to 4 percent in a year.

Qsymia Allergic Reactions

Since Qsymia® is a combination of two medications, phentermine/Adipex® and topiramate/Topamax®, allergies to either of these could cause a reaction. Patients who are allergic to similar drugs are likely to have reactions to Qsymia® as well. These include stimulants such as amphetamines, decongestants like pseudoephedrine, appetite suppressants like diethylpropion, or any other sympathomimetic amines.

Qsymia Precautions and Warnings

The FDA found that Qsymia® was connected to low but increased risks of cardiovascular issues such as high blood pressure, heart rhythm disorders, and heart disease, as well as psychiatric issues such as possible memory impairment, depression, mood swings, suicidal ideation, and attention deficits. Qsymia® has also been linked to cleft palate, when taken by pregnant women. Topiramate has been previously linked to this birth defect.[5]

Qsymia (Qnexa) Background

The obesity drug combines low doses of the appetite suppressant phentermine and the epilepsy drug topiramate, which increases a person's sense of being full. Phentermine is also sold under the brand name Adipex® and topiramate is also sold as Topamax®.

Qsymia® is prescribed alongside exercise and a lower calorie diet to help patients who suffer from weight-related health problems like high cholesterol, high blood pressure, and Type 2 diabetes. Manufactured by the biopharmaceutical company Vivus, Inc., Qsymia® was approved by the Food and Drug Administration on July 16, 2012. The medication's name was changed to eliminate confusion with other medications sounding similar to Qnexa®.[1]


Also See: Qnexa Approval, Lorcaserin Approval, Contrave Approval, Green Tea Diet Pills, Diet Pill Side Effects, Acai Diet Pills, Alli, Contrave Side Effects, Botox Side Effects, Phentermine Free Samples

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References

  1. 1.0 1.1 1.2 http://www.cbsnews.com/8301-504763_162-57474619-10391704/obesity-pill-qsymia-gains-fda-approval/
  2. 2.0 2.1 2.2 2.3 2.4 2.5 http://www.vivus.com/pipeline/qnexa-obesity
  3. http://ir.vivus.com/releasedetail.cfm?ReleaseID=407933
  4. http://www.msnbc.msn.com/id/39905030/ns/health-diet_and_nutrition/
  5. 5.0 5.1 5.2 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdf