Even as Danish biopharmaceutical major Novo Nordisk faces lawsuits in the US against alleged side effects of its blockbuster weight loss and diabetes drug Semaglutide, which is sold under the brand names like Ozempic, medical experts in India say the benefits of the injectable drug – recently launched in India under the brand name Wegovy - far exceeds its known side effects and there is no reason why qualified medical professionals should avoid prescribing the drug to the right patient. 

Semaglutide belongs to glucagon-like-peptide-1 (GLP-1) receptor agonist class of medicine that is the most sought-after choice for obesity treatment in the developed world. The lawsuits in the US started after several patients, especially the ones under obesity treatment, started complaining about severe side effects, including gastrointestinal issues like nausea and vomiting. Some patients even linked sudden vision loss to the use of the drug. Medical experts say the side effects, apart from complaints of vision loss which is still being investigated, are all known and manageable for patients under proper medical supervision.

“Semaglutide has been in the US for more than eight years now. In India also, the oral version of this molecule is there for more than 3 years. It is one of the most well studied compounds”, says Dr Shashank R Joshi, a Mumbai based endocrinologist and medical researcher.

On complaints of side effects, Dr Joshi said that if a drug works, it will have effects and side effects. “Whenever you are giving these agents, you educate the patient on possible side effects like nausea, vomiting, diarrhea, constipation. Tell them that if you have risk, you should avoid the drug”, he said.

According to Dr Joshi, these drugs should not be taken over the counter (without a doctor’s prescription). “They should be taken under the prescription of a medical endocrinologist. And one needs to be pharmacovigilant”, he says.

A Delhi based endocrinologist endorsed this view. “If you go to your doctor, who is qualified in this area, then there won’t be a problem. In case there are effects of the drug, the patient will be evaluated and based on that should be recommended whether to use that drug or not. Hence following doctor’s orders and being vigilant is important”, he said.

Meanwhile, in an official response, Novo Nordisk pointed out that Semaglutide has been extensively examined in robust clinical development programmes, large real-world-evidence studies and has cumulatively over 33 million patient years of exposure. “Semaglutide’s efficacy and safety have been extensively demonstrated in people with obesity/overweight with robust evidence for improving health outcomes. Semaglutide has demonstrated improvements in CV death, stroke and myocardial infarction”, the company said in a statement.

 Terming that the allegations in the lawsuits are without merit, Novo Nordisk said the company ‘intend to vigorously defend against these claims’. “Patient safety is our top priority at Novo Nordisk, and we work closely with the US Food and Drug Administration to continuously monitor the safety profile of our medicines. Novo Nordisk remains confident in the benefit-risk profile of our GLP-1 medicines, when used consistent with their indications and product labeling”, the statement said.