Milly Gaines
Belviq, also known as Lorcaserin, is a weight-loss drug developed by Arena Pharmaceuticals. It was approved by the FDA in 2012 and was used in conjunction with a reduced-calorie diet and exercise to help people lose weight. Belviq was designed to promote weight loss in obese and overweight patients by acting as a selective serotonin 2C agonist and reducing appetite. It was available in the form of regular tablets, taken twice per day, and extended-release tablets, taken once per day. In 2020, Belviq was withdrawn from the US market at the request of the FDA due to concerns about an increased occurrence of cancer among its users.
| Characteristics | Values |
|---|---|
| Brand Name | Belviq |
| Generic Name | Lorcaserin |
| Manufacturer | Arena Pharmaceuticals |
| Treatment For | Obesity |
| Treatment Type | Diet, exercise, weight control, blood sugar testing |
| Dosage | 10 mg two times a day |
| Side Effects | Hypoglycemia, prolonged or painful erection |
| Interactions | St. John's Wort, prescription drugs, over-the-counter medicines, herbal products |
| Restrictions | Not for pregnant or breastfeeding women, not for those under 18 |
| Withdrawal | Voluntarily withdrawn in 2020 at the request of the FDA due to increased occurrence of cancer |
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What You'll Learn
Belviq's effectiveness and safety
Belviq (lorcaserin) is a prescription drug that was developed by Arena Pharmaceuticals to help overweight or obese people lose weight. It is a selective 5-HT2C receptor agonist that reduces appetite by activating the 5-HT2C receptor in the hypothalamus, a region of the brain known to control appetite. Belviq was approved by the FDA in 2012 and was meant to be used in conjunction with diet and exercise to treat obesity.
Belviq's effectiveness was evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks. The results showed that compared to a placebo, treatment with Belviq for up to one year was associated with an average weight loss ranging from 3% to 3.7%. Additionally, about 47% of patients without type 2 diabetes lost at least 5% of their body weight compared to about 23% of patients treated with a placebo. In people with type 2 diabetes, about 38% of patients treated with Belviq and 16% treated with a placebo lost at least 5% of their body weight.
However, in 2020, the FDA requested that Belviq be withdrawn from the market due to safety concerns. A safety clinical trial showed a possible increased risk of cancer in patients taking Belviq. During the course of the trial, 462 (7.7%) patients treated with lorcaserin were diagnosed with 520 primary cancers compared to the placebo group, in which 423 (7.1%) patients were diagnosed with 470 cancers. There was an increase in all types of cancers among Belviq patients, but pancreatic, colorectal, and lung cancers were the most diagnosed.
It is important to note that the exact mechanism of appetite regulation by 5-HT2C receptors was not known as of 2005. While Belviq was found to be effective in promoting weight loss, it is crucial to carefully consider the benefits and risks of the drug before prescribing or continuing treatment, especially in light of the potential increased risk of cancer.
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Belviq and cancer risk
Belviq (lorcaserin) is a weight-loss drug developed by Arena Pharmaceuticals. It was approved in 2012 and prescribed to patients with obesity, diabetes, high cholesterol, or high blood pressure. Belviq was meant to be used in conjunction with a reduced-calorie diet and exercise.
In 2020, Belviq was recalled and removed from the market due to an increased risk of cancer detected in users of the drug. The FDA alerted the public that results from a clinical trial assessing safety showed a possible increased risk of cancer. The trial found that 7.7% of lorcaserin subjects developed cancer, compared to 7.1% in the placebo group. This difference corresponds to 476 cases of cancer in 10,342 subjects in the lorcaserin group and 438 among 9429 individuals in the placebo group. While this difference is small, it indicates a higher risk of developing cancer among Belviq users.
The CAMELLIA-TIMI 61 trial found that the Belviq group had a higher risk of lung and pancreatic cancer, but not colon cancer. However, another study observed increases in several different types of cancers, including pancreatic, colorectal, and lung.
It is important to note that the exact cause of the cancer is uncertain, and it is still unclear whether lorcaserin directly increases the risk of cancer. The FDA has not recommended any special cancer screening or testing for individuals who have taken Belviq. However, individuals who have taken the drug are advised to stop taking it and consult their doctor for guidance.
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Belviq's side effects
Belviq, also known as lorcaserin, was a weight-loss drug developed by Arena Pharmaceuticals. It was approved in 2012 and removed from the market in 2020 due to an increased risk of cancer detected in its users.
Side Effects
Some of the side effects of Belviq include:
- Signs of an allergic reaction: hives, rash, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood pressure: a very bad headache, dizziness, passing out, or change in eyesight.
- Mood changes: new or worse behavior or mood changes like depression or thoughts of suicide, hallucinations (seeing or hearing things that are not there).
- Heart problems: slow heartbeat, fast heart rate, trouble breathing, dizziness, ongoing weakness, or swelling in your arms, hands, legs, or feet.
- Digestive problems: upset stomach, diarrhea, or constipation.
- Other: feeling dizzy, sleepy, tired, or weak, pain when passing urine, passing urine more often, nipple discharge, enlarged breasts in males, and prolonged or painful erection.
In addition, Belviq may cause an increased risk of cancer. Clinical trials have shown that more patients taking Belviq were diagnosed with cancer compared to those taking a placebo.
If you experience any side effects, it is important to seek medical help or consult a doctor.
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Belviq's usage instructions
Belviq, also known as Lorcaserin, is a weight-loss drug that was approved by the FDA in 2012. It was removed from the market in 2020 due to concerns about an increased risk of cancer in patients. Belviq is designed to promote weight loss in obese and overweight patients with a BMI of ≥ 27 kg/m2 and at least one weight-related comorbidity. It is meant to be used in conjunction with a reduced-calorie diet and increased physical activity.
Dosage
The dosage of Belviq will vary depending on the patient. It is important to follow the doctor's instructions and not change the dosage unless advised to do so. The recommended dosage for adults is 10 mg taken twice daily. The regular tablet is usually taken twice per day, while the extended-release tablet is taken only once per day. Belviq can be taken with or without food.
Duration
Belviq is meant to be taken long-term for weight loss. In clinical trials, the drug was administered for 52 to 104 weeks. Patients should expect to take the medication for at least 12 weeks to assess its effectiveness. If a patient does not lose at least 5% of their body weight in the first 12 weeks, they are unlikely to achieve significant weight loss and should discontinue the medication.
Precautions
Belviq is not suitable for everyone and should be used with caution. It is important to disclose your full medical history to your doctor before taking Belviq. The drug is not recommended for pregnant women as weight loss during pregnancy can harm an unborn baby. Additionally, it should not be used by those who are allergic to lorcaserin. Patients with diabetes should closely monitor their blood sugar levels as weight loss can increase the risk of hypoglycemia. It is also important to disclose all medications and supplements you are taking to avoid potential drug interactions.
Side Effects
Belviq is generally well-tolerated, with less than 1% of patients discontinuing treatment due to dizziness and about 2% due to headaches. However, more serious side effects may occur, such as a prolonged or painful erection lasting 4 hours or more, which requires immediate medical attention.
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Belviq's withdrawal from the market
Belviq (lorcaserin) is a weight-loss drug developed by Arena Pharmaceuticals. It was approved by the FDA in 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with obesity or overweight in the presence of at least one weight-related co-morbid condition. Belviq was evaluated in several randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks. The trials found that treatment with Belviq for up to one year was associated with average weight loss ranging from 3% to 3.7%.
However, in 2020, the FDA requested the withdrawal of Belviq and Belviq XR from the U.S. market due to safety concerns. A long-term clinical trial called the CAMELLIA-TIMI 61 trial found an increased occurrence of cancer in patients taking Belviq compared to those taking a placebo. The trial studied approximately 12,000 men and women over five years with established cardiovascular disease or at high risk for cardiovascular disease. The FDA's analysis of the data from this trial led to a change in the risk-benefit assessment of Belviq, resulting in the decision to withdraw the drug from the market.
Eisai Inc., the manufacturer of Belviq, voluntarily agreed to withdraw the product from the U.S. market, despite their interpretation of the data differing from that of the FDA. They worked closely with the FDA on the withdrawal process and advised patients to stop taking Belviq and consult their healthcare providers about alternative weight-loss medications and weight management programs.
The withdrawal of Belviq highlights the potential risks associated with weight-loss medications and the importance of ongoing safety evaluations and clinical trials. While Belviq was initially believed to have a positive benefit-risk profile, the long-term trial revealed unforeseen safety concerns that outweighed its benefits. This serves as a reminder that the safety profile of medications may evolve over time and underscores the necessity of rigorous monitoring and evaluation even after a drug has been approved and introduced to the market.
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Frequently asked questions
Belviq is a weight-loss drug developed by Arena Pharmaceuticals. It is a selective serotonin 2C agonist that works by reducing appetite.
Belviq works by activating the 5-HT2C receptor in the hypothalamus, a region of the brain that controls appetite. This makes you feel more full, so you eat less.
Belviq is for adults who are obese (BMI ≥ 30 kg per m2) or who are overweight (BMI ≥ 27 kg per m2) with at least one weight-related comorbidity.
Belviq is taken as a tablet, usually two times per day. It can be taken with or without food. It is important to follow your doctor's instructions and not share your medication with others.
Belviq is generally well-tolerated, but some people may experience dizziness, headaches, or other adverse effects. There is also a risk of serotonin syndrome if taken with other serotonergic drugs such as antidepressants. Belviq was withdrawn from the US market in 2020 due to an increased risk of cancer detected in users of the drug.
