EU regulator to discuss anaesthesia risk for weight-loss drugs
By Ludwig Burger
FRANKFURT (Reuters) - The European Medicines Agency (EMA) will discuss the risk that patients on Wegovy, Ozempic or similar drugs may suffer certain complications under anaesthesia that can lead to pneumonia, according to an agenda posted on the regulator's website.
The regulator's Pharmacovigilance Risk Assessment Committee (PRAC), which monitors drugs' side effects, will discuss at its monthly series of meetings this week a new "signal of aspiration and pneumonia aspiration" associated with the class of weight-loss and diabetes drugs known as GLP-1 receptor agonists, according to the document posted late on Monday.
A surge in demand for its weight-loss drug Wegovy has helped drugmaker Novo Nordisk become Europe's most valuable listed company, but it is scrambling to boost production to keep up with overwhelming prescription numbers.
Diabetes drug Ozempic, a lower-dose version of Wegovy and part of the GLP-1 class, has also seen a boost in demand from off-label use for weight loss.
The rare complication of stomach contents moving into the respiratory tract, known as aspiration and potentially causing pneumonia, is routinely monitored by physicians when they put patients under general anaesthesia for procedures. It is why patients are typically told not to eat before planned surgery.
But individual cases have recently been described in medical journals where patients on GLP-1 receptor agonists were found not to have an empty gastric tract during surgery despite prior fasting, creating the risk of aspiration and pneumonia.
One of the appetite-suppressing effects of the GLP-1 drug class is that it slows down gastric emptying.
That prompted the American Society of Anesthesiologists to say in June that patients on daily dosing of a GLP-1 drug should not take it on the day of a planned medical procedure requiring anaesthesia, and patients on weekly dosing should not take it a week prior to the procedure.
It cited a limited number of case reports of people on GLP-1 therapy.
The EMA said it could not provide more information "while the assessment of a safety signal is ongoing". Any recommendation would be published when PRAC reaches a conclusion, it added.
The agenda item said that PRAC's deliberations would also cover GLP-1 drugs Mounjaro and Trulicity by Eli Lilly as well as other drugs in the class made by AstraZeneca and Sanofi.
The companies did not immediately respond to requests for comment.
Novo has launched Wegovy, a weekly self-injection drug, in the United States, Norway, Denmark, Germany and Britain.
The side effects flagged on Wegovy's label include a range of gastrointestinal conditions which are mainly temporary and typically occur early during therapy as the dosage is gradually increased.
In July, the EMA began investigating GLP-1 drugs after Iceland's health regulator flagged three cases of patients thinking about suicide or self-harm. Britain's drugs watchdog launched a similar probe later that month.
(Reporting by Ludwig Burger; Editing by Mark Potter)
