Qnexa Side Effects
From Pharmacy Drug Guide
Potential Qnexa side effects have slowed its approval by the FDA for use in the United States. Qnexa is an investigational prescription diet pill and weight maintenance drug. 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 asTopamax.
The most common side effects of Qnexa in clinical trials were changes in taste, tingling, dryness in the mouth, respiratory infection, and constipation.[1]
Qnexa is manufactured by the biopharmaceutical company Vivus, Inc. Qnexa was 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. Therefore, Qnexa is not currently available for use in the United States. However, the FDA is re-evaluating the drug based on a revised safety plan submitted by Vivus and has extended the final review date from April 17 to July 17, 2012.[2]
Flickr: klf_blf | |
| Brand name for | Phentermine and topiramate combination pill[1] |
|---|---|
| Manufacturer | Vivus, Inc.[1] |
| Uses | Weight loss drug used to treat obesity[1] |
| Common side effects | Dry mouth, sleep disturbances, tingling, sinus and other respiratory infections, constipation[1] |
| Who should not take Qnexa | Pregnant women[1] |
| Disclaimer | The information provided by PharmacyDrugGuide.com 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. |
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Qnexa Side Effects
Results from the clinical trials addressed during the FDA's safety review of Qnexa 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
Qnexa Clinical Trials and Research
On Thursday, July 15, 2010 the FDA’s advisory committee on endocrinologic and metabolic drugs took a closer look at Qnexa after initial clinical studies showed the drug to significantly increase weight loss in clinical trials. However, the drug was rejected by this panel, and then on October 18, 2010 the FDA rejected Qnexa due to potentially serious side effects.[4]
When Qnexa was studied over a period of a year, users were reported to lose an average of 14% of their total body weight. In a two-year study of Qnexa users, patients lost just 10% of their total body weight. Qnexa also reportedly reduced risk of some cardiovascular illnesses like high cholesterol, as well as risk of diabetes.[5]
In comparison, the three prescription diet drugs currently on the market show the following effectiveness:[5]
- Users of subitrimine, sold as Meridia, average 3 to 4% body weight loss in six months to a year of use.
- Phentermine users show an average of 4 to 5% weight loss in three months of use, the longest time frame it is approved for.
- Prescription orlistat--Xenical--users lose an average of 3 to 4% in a year.
Qnexa Allergic Reactions
Since Qnexa 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 Qnexa as well. These include stimulants such as amphetamines, decongestants like pseudoephedrine, appetite suppressants like diethylpropion, or any other sympathomimetic amines.[6]
Qnexa Precautions and Warnings
The FDA found that Qnexa was connected to low but increased risks of cardiovascular issues such as high blood pressure, heart rhythm disorders, and heart disease; and psychiatric issues such as possible memory impairment, depression, mood swings, suicidal ideation, and attention deficits. Qnexa has also been linked to cleft palate, when taken by pregnant women. Topiramate has beeen previously linked to this birth defect.[5]
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, Adipex Side Effects, Alli Side Effects, Adipex Coupons, Phentermine
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References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 http://www.vivus.com/pipeline/qnexa-obesity
- ↑ http://ir.vivus.com/releasedetail.cfm?ReleaseID=662825
- ↑ http://ir.vivus.com/releasedetail.cfm?ReleaseID=407933
- ↑ http://www.msnbc.msn.com/id/39905030/ns/health-diet_and_nutrition/
- ↑ 5.0 5.1 5.2 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdf
- ↑ http://www.webmd.com/drugs/drug-4151-Phentermine.aspx?drugid=4151&drugname=Phentermine
