TGA alerts to suicidal thoughts, possible reduced contraception effectiveness
But the advisory committee found “a complex interaction between mental illness and chronic endocrine disorders” (which GLP-1 RAs may be used to treat) and “the potential association between weight loss and suicidal or self-harm ideation.”
He noted that product information on this class of drugs is inconsistent and needs to be “harmonized.” It recommended updating safety advice after considering the advantages and disadvantages of doing so, including validating community concerns and the potential risks of causing unnecessary alarm where evidence is lacking.
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Mounjaro’s product warning will also be updated after the TGA’s investigation found the drug’s potential to make oral contraception less effective “cannot be ruled out”.
2024 review It included a study that found tirzepatide reduced the amount of ethinylestradiol (the synthetic estrogen in the combined oral contraceptive pill) in the bloodstream by 20 percent. The other five studies showed no statistically or clinically significant differences.
Another study found that tirzepatide increased the time it took for ethinylestradiol to be fully absorbed into the bloodstream by two to four hours; This may be due to the drug’s effect of slowing gastric emptying because ethinylestradiol is mostly absorbed in the stomach. small intestine.
Patients will now be advised to switch to non-oral contraception or use a barrier method (such as a condom) for birth control for four weeks after first taking the drug and for four weeks after increasing the dose.
“None of the GLP-1 RAs should be used during pregnancy, and individuals of childbearing potential are advised to use effective contraception during treatment with GLP-1 RA,” the warning states.
The British medicines regulator advised all individuals of childbearing age in August to ensure they do not become pregnant while taking GLP-1 RAs because there was not enough safety data to know whether these drugs could harm fetuses. The regulator has received more than 40 reports of unwanted pregnancies by women using the drug.
Novo Nordisk, which owns Ozempic, said semaglutide has been the subject of robust studies in its clinical development programs.
“Given the totality of evidence from clinical studies, post-marketing reports, and observational studies, Novo Nordisk believes that the benefit-risk profile of semaglutide remains favorable,” said Ana Svensson, the company’s vice president of clinical, medical and regulatory.
“We remain committed to patient safety and transparency by maintaining up-to-date safety information and collaborating closely with health authorities and regulatory bodies worldwide.”
Mounjaro’s producer, Eli Lilly, has been contacted for comment.
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