Table Of Content
Patients with a history of bariatric surgery (a risk factor for hypoglycemia) had more events of serious hypoglycemia while taking WEGOVY (2.3%, 2/87) than placebo (0%, 0/97). WEGOVY was evaluated in a 68-week, double-blind, randomized, parallel group, placebo-controlled, multi-center trial in 201 pediatric patients aged 12 years and older with obesity [see Clinical Studies]. Baseline characteristics included a mean age of 15.4 years; 38% of patients were male; 79% were White, 8% were Black or African American, 2% were Asian, and 11% were of other or unknown race; and 11% were of Hispanic or Latino ethnicity.
Open discussions between providers and patients are needed
The Canadian Journal of Anesthesia released a statement in July 2023 raising the alarm about patients under anesthesia accidentally inhaling gastric contents during surgery since their stomachs can’t empty fully. There doesn’t appear to be much research on any potential connection between taking GLP-1 drugs and a person’s food going down the wrong pipe. The Food and Drug Administration (FDA) is currently reviewing popular drugs such as Ozempic and Wegovy over possible links to suicidal ideation, hair loss, and aspiration. Read this Medication Guide and Instructions for Use before you start using WEGOVY and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. The mean age was 15 years; 38% of patients were male; 79% were White, 8% were Black or African American, 2% were Asian, and 11% were of other or unknown race; and 11% were of Hispanic or Latino ethnicity.
Risk of thyroid tumors or thyroid cancer
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. The good news is that hair loss or hair shedding (telogen effluvium) is usually a temporary side effect of rapid weight loss with these medicines. It’s also relatively uncommon, occurring in less than 5% of people, based on available clinical data, and typically only affects hair on the scalp. Ozempic and Wegovy are both brand names for the drug semaglutide, which has been prescribed for several years to treat type 2 diabetes (Ozempic) and, since 2021, to those who are overweight or have obesity (Wegovy). The treatment’s aim is to reduce the risk of health complications posed by a large amount of excess body fat, such as heart and liver disease and certain cancers. The drug curbs hunger and food intake by mimicking a hormone, released by the gut after eating, that affects brain regions involved in appetite and reward.
Does Novo Nordisk offer a support program for Wegovy® patients?
If you’d like to learn more about Wegovy, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of taking the drug. Although most side effects are mild, it’s possible for serious side effects to occur as well.
Stomach problems
WEGOVY is contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY [see ADVERSE REACTIONS]. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions. Monitor renal function in patients with renal impairment reporting any adverse reactions that could lead to volume depletion.
FDA examining side effect reports with Lilly, Novo obesity drugs - FiercePharma
FDA examining side effect reports with Lilly, Novo obesity drugs.
Posted: Thu, 04 Jan 2024 08:00:00 GMT [source]
To continue to afford coverage of the drugs for weight loss, the state would have had to raise premiums to nearly $50 per month for about 750,000 employees and their dependents covered by the state health plan. But Price, who works at East Carolina University, worries all her progress may be short-lived. North Carolina's health insurance program for state employees is reeling from the cost and widespread use of these prescription drugs. To cut costs, the state has discontinued coverage for the prescription weight-loss medications Wegovy and Saxenda beginning April 1.
FDA investigating unusual side effects from diabetes, weight loss drugs - WBAY
FDA investigating unusual side effects from diabetes, weight loss drugs.
Posted: Thu, 04 Jan 2024 08:00:00 GMT [source]
Researchers and clinicians often view GLP-1 agonists as lifelong treatments. People might lose the means to pay for the costly drugs, experience brutal side effects, be affected by continuing shortages or be offered limited-term prescriptions. The UK National Health Service (NHS), for instance, provides only two years of coverage for people taking the drugs for weight loss. As for hair loss, while it’s not listed as an official side effect of semaglutide and therefore Ozempic and Wegovy, experts say it can happen. Suicidal behavior and ideation have been reported in clinical trials with other weight management products.
Here are some frequently asked questions about the drug’s side effects and their answers. If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988. If you develop serious side effects while taking Wegovy, call your doctor right away.
What are the most common side effects with these drugs?
You and your doctor may need to more closely monitor your blood sugar during treatment with Wegovy. If you experience stomach side effects with Wegovy that bother you, worsen or do not go away, call your healthcare provider for further evaluation. The good news is that for most people these side effects are mild, temporary and will not interfere with long-term treatment. Wegovy works by acting like the natural hormone called incretin that targets areas of the brain involved in controlling your appetite and food intake. Wegovy is recommended to be used with healthy eating and an exercise program to maximize its benefits.
Adult and pediatric patients treated with WEGOVY had a mean increase from baseline in amylase of 15-16% and lipase of 39%. The clinical significance of elevations in lipase or amylase with WEGOVY is unknown in the absence of other signs and symptoms of pancreatitis. The majority of events were reported as diabetic retinopathy (4.0%, 2.7%, and 2.7%, respectively) and non-proliferative retinopathy (0.7%, 0%, and 0%, respectively). Episodes of hypoglycemia have been reported with GLP-1 receptor agonists in adult patients without type 2 diabetes mellitus. In WEGOVY clinical trials in adult patients without type 2 diabetes mellitus, there was no systematic capturing or reporting of hypoglycemia. Table 4 shows adverse reactions reported in greater than or equal to 3% of WEGOVY-treated pediatric patients and more frequently than in the placebo group from a study in pediatric patients aged 12 years and older.
In total, 96.9% of patients completed the trial, and vital status was available for 99.4% of patients. A total of 31% of WEGOVY-treated patients and 27% of placebo-treated patients permanently discontinued study drug. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the MRHD (rabbit) and greater than or equal to 2-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data).
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. The pharmacokinetics of semaglutide were evaluated following a single dose of 0.5 mg semaglutide in a study of patients with different degrees of hepatic impairment (mild, moderate, severe) compared with subjects with normal hepatic function. Semaglutide lowers body weight with greater fat mass loss than lean mass loss. In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.2-, 0.4-, and 2-fold the exposure at the MRHD). Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see BOX WARNING and WARNINGS AND PRECAUTIONS].
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