Madeleine Hull
Qnexa is a prescription diet pill that combines two existing drugs: phentermine, an appetite-suppressing stimulant, and topiramate, an anti-seizure medication that also affects appetite. The drug was initially rejected by the Food and Drug Administration (FDA) in 2010 due to safety concerns about potential heart problems and birth defects. However, the FDA is reconsidering its approval, and Qnexa has been shown to be effective for weight loss in clinical trials. If approved, Qnexa would be the only prescription appetite suppressant approved for long-term use in the U.S.
| Characteristics | Values |
|---|---|
| Name | Qnexa (renamed Qsymia when launched in 2012) |
| Type | Prescription diet pill |
| Manufacturer | Vivus Inc. |
| Ingredients | Phentermine (a stimulant), Topiramate (an anti-seizure and migraine medication) |
| Function | Appetite suppressant |
| Target Group | Patients with a body mass index (BMI) greater than 30 kg/m2 or a BMI of 27 kg/m2 or greater with weight-related comorbidities |
| Concerns | Potential heart problems, increased risk of birth defects, increased heart rate |
| Status | Rejected by FDA in 2010, under reconsideration |
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What You'll Learn
Qnexa's effectiveness and side effects
Qnexa is a combination pill of phentermine and extended-release topiramate. Both drugs have been proven to aid weight loss and are synergistic when combined. Qnexa has been repeatedly proven to be a safe and effective appetite suppressant.
In a study submitted to the FDA, patients who took the highest dosage of Qnexa for a year lost, on average, about 14% of their body weight. They also showed improvements in blood pressure, cholesterol, triglycerides, and blood sugar. The mean percent weight loss was 9.8% for the high-dose group and 7.8% for the mid-dose group. Another study, SEQUEL, tested Qnexa on 676 patients with overweight or obesity for 108 weeks. The average weight loss was 10.5% for the high-dose group and 9.3% for the mid-dose group.
However, Qnexa has faced scrutiny from the FDA due to safety concerns. The most commonly reported side effects were tingling, dry mouth, constipation, and a tinny taste in the mouth. There is also an increased risk of cleft lip, with a 1.6% risk compared to a 0.6% baseline risk. The FDA has also expressed concern about possible adverse side effects, including suicidal thoughts, heart palpitations, and memory lapses. The FDA has asked for proof that the increased heart rate observed with the drug does not increase long-term risks for cardiovascular events.
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Qnexa's ingredients
Qnexa, also known as Qsymia, is a combination of two drugs: phentermine and topiramate. Phentermine is a stimulant and appetite suppressant, while topiramate is an anti-seizure medication that is generally prescribed to control epilepsy but also affects appetite. Qnexa is designed to be used alongside a reduced-calorie diet and increased physical activity in patients with a body mass index (BMI) of greater than 30 kg/m2 or a BMI of 27 kg/m2 or greater who also have at least one weight-related comorbidity.
Phentermine interacts with the central nervous system's biogenic amine transporters, including the norepinephrine transporter (NET), dopamine transporter (DAT), and serotonin transporter (SERT), causing a release of the respective neurotransmitter. This results in reduced appetite. Phentermine was first approved for the short-term treatment of obesity in 1959 and has been available for decades.
Topiramate, on the other hand, is an antiepileptic agent. It is chemically designated as 2,3:4,5-di-O-isopropylidene-β-d-fructopyranose sulfamate. Topiramate has been approved for the treatment of seizures since 1996 and for migraine prophylaxis since 2004. It is also sometimes used "off-label" to treat binge eating.
Qnexa combines low doses of phentermine with topiramate. It is available in three dosage strengths: low (3.75 mg phentermine/23 mg topiramate), mid (7.5 mg phentermine/46 mg topiramate), and high (15 mg phentermine/92 mg topiramate). The mid-dose is the proposed recommended maintenance dose.
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Qnexa's safety concerns
Qnexa is a prescription diet pill that combines two existing drugs: phentermine, a stimulant that suppresses appetite and is approved for short-term use as a weight-loss drug; and topiramate, an anti-seizure and migraine drug that increases feelings of fullness and is generally prescribed to control epilepsy.
Qnexa has faced several safety concerns and scrutiny from the Food and Drug Administration (FDA). In 2010, the FDA rejected Qnexa due to safety concerns about potential heart problems and an increased risk of birth defects in babies born to women who take the drug. The FDA advisory committee voted 10-6 against approving Qnexa, citing worries about its potential side effects, including an increased heart rate.
In response to the FDA's initial rejection, Qnexa's manufacturer, Vivus Inc., suggested approving the drug only for use in men and women of non-childbearing age. However, this proposal did not satisfy the FDA, which requested a thorough evaluation of the drug's potential for causing birth defects and heart problems.
Despite the safety concerns, some specialists supported Qnexa's approval due to its effectiveness in producing weight loss. Clinical trials showed that patients taking the highest dose of Qnexa lost an average of 10.6% to 14.4% of their weight after one year, compared to 1.7% for those taking a placebo. Additionally, Qnexa was found to improve blood pressure, cholesterol, triglycerides, and blood sugar levels.
In 2012, the FDA reconsidered Qnexa, and an advisory panel voted 20-2 in favor of the drug. Panelists acknowledged the potential benefits of the medication but stressed the need for a large, follow-up study of the pill's effects on the heart. As of 2012, the FDA was expected to issue its decision on Qnexa, with some hoping for approval despite the remaining safety concerns.
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Qnexa's prescription status
Qnexa (now known as Qsymia) is a prescription weight-loss drug that combines two existing drugs: phentermine, an appetite-suppressing stimulant, and topiramate, an anti-seizure medication that also affects appetite. The drug was initially rejected by the FDA in 2010 due to safety concerns about potential heart problems and an increased risk of birth defects in babies born to women who take the drug.
Qnexa's maker, Vivus Inc., has since sought approval for the drug, with the FDA reconsidering its decision in 2022 and 2023. If approved, Qnexa would be the only prescription appetite suppressant approved for long-term use in the U.S. Clinical trials have shown that Qnexa is effective for weight loss, with participants losing an average of about 14% of their body weight. However, some participants regained some weight in the second year of the trial.
Qnexa's potential side effects have been a subject of debate. While it has been shown to improve blood pressure, cholesterol, triglycerides, and blood sugar, it also comes with risks. The drug's combination of phentermine and topiramate has been associated with an increased risk of heart rate and cardiovascular problems, similar to other diet drugs that have been pulled from the market. Topiramate also increases the risk of oral clefts and other birth defects when used by pregnant women.
To address these concerns, Vivus Inc. suggested approving the drug only for men and women of non-childbearing age. However, this proposal did not satisfy the FDA, which asked the company to find a way to prevent pregnant women from using the drug. As of 2023, the FDA is still reconsidering Qnexa, and it is unclear if and when it will be approved for prescription use.
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Qnexa's manufacturer
Qnexa is a weight-loss drug manufactured by California-based pharmaceutical company Vivus Inc. The drug is a combination of two existing drugs: phentermine, an appetite-suppressing stimulant, and topiramate, an anti-seizure medication that is generally prescribed to control epilepsy but also affects appetite.
Qnexa was initially named Qnexa but was changed to Qsymia when it was launched in 2012. The drug is intended to be used as an adjunct to a reduced-calorie diet and increased physical activity in patients with a body mass index (BMI) of greater than 30 kg/m2 or a BMI of 27 kg/m2 or greater, who also have at least one weight-related comorbidity.
Vivus Inc. first sought approval for Qnexa from the Food and Drug Administration (FDA) in 2010, but it was rejected due to safety concerns about heart problems and birth defects. The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against approving Qnexa, and the agency asked Vivus Inc. to conduct a clinical trial on cardiovascular risks prior to approval.
In 2023, Vivus Inc. asked the FDA to reconsider Qnexa for limited approval. Clinical trials have shown that Qnexa is effective for weight loss, with participants taking the highest dosage of Qnexa for a year losing on average about 14% of their body weight. They also showed improvements in blood pressure, cholesterol, triglycerides, and blood sugar. However, there are still concerns about the potential side effects of Qnexa, including an increased risk of oral clefts in the children of women who take the drug during pregnancy.
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Frequently asked questions
Qnexa is a prescription diet pill that combines the stimulant Phentermine and Topiramate, an anti-seizure medication. It is intended to be used alongside a reduced-calorie diet and increased physical activity.
The FDA initially rejected Qnexa in 2010 due to safety concerns about heart problems and birth defects. In 2023, the FDA reconsidered Qnexa for the second time, reviewing the data on the weight-loss medication.
The potential side effects of Qnexa include an increased risk of heart rate, birth defects, and oral clefts in the children of women who take the drug.
Clinical trials suggest that Qnexa is effective for weight loss. In one trial, participants who took the highest dosage of Qnexa for a year lost, on average, about 14% of their body weight.
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