SINGAPORE, April 2 (The Straits Times/ANN): Wegovy, a higher-dose version of diabetes medication Ozempic whose weight loss side effects drew social media attention, has been approved by the Health Sciences Authority (HSA).
Adults who are obese, or who are overweight with at least one weight-related comorbidity such as high blood pressure, type 2 diabetes or high cholesterol, are eligible to take Wegovy.
The clinical trial results from using Wegovy have led it to be touted as a “blockbuster” drug, just like Ozempic, though the latter was designed to be an antidiabetic drug.
Twitter owner Elon Musk has even admitted that he used Wegovy, in addition to fasting, to help him shed weight.
Both drugs are developed by Denmark-headquartered pharmaceutical firm Novo Nordisk and contain the same active ingredient – semaglutide.
Mimicking a natural hormone called glucagon-like peptide-1, semaglutide regulates blood sugar levels and works in the brain to induce the sensation of fullness, making the user eat less and curb appetite.
Self-administered weekly via a pre-filled injection pen, the dosage for both Ozempic and Wegovy typically starts at 0.25mg and is gradually increased over several months.
The maximum dosage for Wegovy, which was approved here in February, is 2.4mg. The United States Food and Drug Administration (FDA) approved Wegovy for use, and recommended its use, in addition to a reduced calorie diet and increased physical activity, in 2021.
Ozempic was approved by the FDA in 2017 to have a maximum recommended dosage of 1mg weekly. In 2022, it approved a higher dosage of 2mg to provide additional blood sugar control.
Ozempic, which was approved for use in Singapore in April 2021, gained traction last year after users and celebrities raved about its weight loss attribute on TikTok.
The hashtag #ozempic on the platform has more than 741 million views, while #ozempicweightloss has racked up some 267 million views.
The surge in popularity caused a shortage of Ozempic in the United States, Australia and Europe, as doctors prescribed the drug off-label to non-diabetic individuals looking to lose weight. Diabetic patients scrambled to get their prescription or viable alternatives.
The term “off-label use” means that a drug is tapped for a medical condition or age group that it is not approved to treat, or administered in a different route or dosage not specified in the approved label.
The craze seems to have hit Singapore, with sellers on local e-commerce platforms looking to cash in. The HSA has removed four listings of Ozempic and Wegovy since the start of 2023.
Both drugs can be supplied only by a doctor or obtained through a prescription from a pharmacist.
An HSA spokesman said: “They contain potent ingredients which could lead to adverse effects if taken without medical supervision.”
Anyone who contravenes the prohibition on sale of prescription medicines may be fined up to $50,000 and/or jailed for up to two years under the Health Products Act, if convicted.
Many doctors worldwide have voiced concerns about the drugs. Some adverse reactions reportedly include gastrointestinal effects, liver and bile disorders, inflammation of the pancreas, increased heart beat and fatigue.
Users have also reported gaining back the weight they lost after dropping off either drug.
The HSA spokesman added: “(We) conduct careful and thorough evaluation to ensure that therapeutic products meet the requirements for safety, efficacy and quality, and that the benefits outweigh the risks, before they are approved for use in Singapore.”
Ozempic has been designated by the authority to treat insufficiently controlled type 2 diabetes mellitus, but it is allowed for off-label use.
However, the HSA stressed that doctors must use their clinical discretion, for which they are accountable. There must be a justifiable medical indication that using the drug off-label is in the patient’s best interest, that there is a rational basis for such use, and patients must be properly informed and agree to its use. - The Straits Times/ANN