Brenda Khan
Qnexa, a weight loss drug, has been considered by the FDA for approval multiple times. The drug, which combines low doses of the stimulant phentermine and the anti-seizure and migraine drug topiramate, has shown to be effective in helping people lose weight. However, there are concerns about potential heart problems and birth defects in babies born to women who take the drug. As a result, the FDA has rejected Qnexa in the past, and it is currently reconsidering its approval. California-based pharmaceutical company Vivus Inc. is now seeking limited approval for Qnexa, which, if approved, would be the only prescription appetite suppressant approved for long-term use in the U.S.
| Characteristics | Values |
|---|---|
| Name of pill | Qnexa |
| Other names | Qsymia |
| Manufacturer | Vivus Inc. |
| Availability | Not approved by the FDA; currently being reconsidered |
| Dosage | Not known |
| Side effects | Kidney stones, gallstones, increased heart rate, suicidal thoughts, depression |
| Precautions | Should not be taken by pregnant women, those with glaucoma, thyroid problems, or those taking certain medicines |
| Effectiveness | Patients on the highest dose lost 10.6% of their weight after one year |
| Price | $98 for a 30-day prescription |
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What You'll Learn
Qnexa's effectiveness as a diet pill
Qnexa is a weight-loss drug 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 medication that also treats binge eating. Clinical trials have shown that Qnexa is effective for weight loss, with patients on the highest dose losing an average of 10.6% of their weight after one year, compared to 1.7% for those on a placebo. This is about twice as much weight loss as other diet pills.
However, Qnexa has faced scrutiny and rejection by the FDA due to safety concerns, including potential heart problems, increased heart rate, and birth defects in babies born to women who take the drug. There are also concerns about the side effects of Qnexa, with 16% of patients on the highest dose dropping out of a study due to these effects. Despite this, Qnexa's maker, Vivus Inc., remains optimistic about its approval, and some experts believe it could be a helpful tool for weight loss when combined with a healthy diet and regular exercise.
Qnexa (renamed Qsymia in 2012) is currently the only prescription appetite suppressant approved for long-term use in the U.S. It is important to note that Qsymia should not be taken by pregnant women or those planning to become pregnant due to the risk of birth defects. It is also not recommended for those with certain medical conditions, such as glaucoma or thyroid problems.
While Qnexa has shown effectiveness in weight loss, it is important to consult with a healthcare professional before taking any weight-loss medication to ensure it is safe and appropriate for your individual needs.
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Qnexa's side effects and safety concerns
Qnexa is a weight-loss drug that combines phentermine, a stimulant that suppresses appetite, and topiramate, an epilepsy and migraine drug that makes patients feel more full. While Qnexa has been shown to produce about twice as much weight loss as other diet pills, it has also been associated with several serious side effects and safety concerns.
One of the main concerns with Qnexa is its potential to cause birth defects. An FDA expert estimated that out of 1,000 women who became pregnant while taking Qnexa, five babies would be born with a cleft lip defect. Qnexa has also been linked to an increased risk of heart problems, including palpitations and increased heart rate, which could lead to heart attacks and strokes. In addition, Qnexa may cause high blood pressure, which is a serious risk factor for heart disease and heart failure.
Other possible side effects of Qnexa include impotence, insomnia, circulatory issues, memory lapses, aggressive behaviour, balance and speech problems, and anorexia. Due to these concerns, Qnexa was initially rejected by the FDA in 2010, but it is currently seeking re-evaluation and approval.
Despite the potential side effects, some argue that the benefits of Qnexa may outweigh the risks, especially given the obesity epidemic in America. However, critics caution that the search for an anti-obesity drug should not replace the need for difficult lifestyle changes. The FDA's decision on Qnexa will be carefully considered, taking into account the potential benefits and risks associated with the drug.
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Qnexa's availability and prescription
Qnexa is a prescription weight-loss drug that combines two existing drugs: phentermine and topiramate. Phentermine is a stimulant approved for short-term use as a weight-loss drug, while topiramate is an epilepsy and migraine drug. The drug was initially rejected by the FDA in 2010 due to safety concerns, particularly the risk of heart problems, birth defects in babies born to women who take the drug, and an increased risk of suicidal thoughts and depression. However, as of June 2023, the FDA is reconsidering approval of the drug for limited use in adults who are not likely to become pregnant.
Qnexa is not yet available on the market as it has not received approval from the FDA. If approved, it would be the only prescription appetite suppressant approved for long-term use in the United States. The drug has shown promising results in clinical trials, with participants losing an average of 10.6% of their weight after one year on the highest dose of Qnexa, compared to 1.7% for those on a placebo.
The availability of Qnexa is dependent on the FDA's approval process, which is currently ongoing. California-based pharmaceutical company Vivus Inc. is seeking limited approval for the drug's use, excluding women in their childbearing years. The FDA is scheduled to make an approval decision in April 2024, and if approved, the drug is expected to be commercially available soon after.
It is important to note that Qnexa is a prescription drug and cannot be purchased over the counter. It should only be taken under the supervision of a healthcare professional and in conjunction with a healthy diet and regular exercise. While Qnexa has shown effectiveness in weight loss, it is not a substitute for a healthy lifestyle and may not be suitable for everyone. Before considering Qnexa or any other weight-loss drug, it is essential to consult with a healthcare professional to assess individual needs and risks.
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Qnexa's ingredients and composition
Qnexa is a fixed-dose combination drug of phentermine and topiramate. Phentermine is an appetite suppressant that reduces food intake by interacting with biogenic amine transporters in the CNS, including the norepinephrine transporter (NET), dopamine transporter (DAT), and serotonin transporter (SERT). Topiramate, a monosaccharide d-fructose derivative, has a range of properties, including modulatory effects on sodium channels, enhancement of GABA-activated chloride channels, and inhibition of excitatory neurotransmission through actions on kainate and AMPA receptors. It is also known to increase satiety and alter taste.
Qnexa is designed to be used in conjunction with diet and exercise and is intended for obese patients (BMI > 30 kg/m2) or overweight patients (BMI > 27 kg/m2) with weight-related comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity).
The drug 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.
Qnexa has been shown to be effective in promoting weight loss. In clinical trials, participants taking the highest dose of Qnexa in combination with a program of diet and exercise lost 10% to 11% of their body weight, compared to 1% to 2% for those on a placebo. Additionally, 48% of those in the higher-dose group lost 15% or more of their body weight, compared to 12% in the lower-dose group and 6% in the placebo group.
However, there are some safety concerns surrounding the drug, particularly regarding increased heart rate, birth defects, and other side effects. The FDA is requiring the company to perform a post-approval cardiovascular outcomes trial to address these concerns.
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Qnexa's approval status and history
Qnexa is a prescription diet pill developed by California-based pharmaceutical company Vivus Inc. It is a combination of two existing drugs: phentermine, a stimulant that is approved for short-term use as a weight-loss drug, and topiramate, an epilepsy and migraine drug sold by Johnson & Johnson under the name Topamax.
In 2010, an advisory committee to the Food and Drug Administration (FDA) voted 10-6 against approving Qnexa due to concerns about potential heart problems and birth defects in babies born to women who take the drug. The FDA rejected the drug, which was the third weight-loss medicine to face trouble that month.
In 2012, the same advisory committee, with a different membership, voted 20-2 in favour of approving Qnexa. The committee was reassured that steps would be taken to minimise the risks, such as making it difficult for pregnant women to obtain the drug.
As of June 2023, Qnexa (now known as Qsymia) has not been approved by the FDA, but the organisation is reconsidering its approval. If approved, it would be the only prescription appetite suppressant approved for long-term use in the US.
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Frequently asked questions
Qnexa is not yet approved by the FDA and therefore cannot be purchased.
Qnexa is a prescription diet pill that combines low doses of the stimulant phentermine with the anti-seizure and migraine drug topiramate.
The side effects of Qnexa are not yet fully known, but it is believed that it could increase the risk of heart problems, stroke, and death. It is also not recommended for those who are pregnant or planning to become pregnant, have glaucoma, have thyroid problems, or are taking certain medications.
Yes, there are several other FDA-approved medications for weight loss and chronic weight management, including Contrave and Saxenda.
