[ad_1]
The Meals and Drug Administration is wanting into whether or not three doable well being points or negative effects, together with hair loss and ideas of suicide, may be linked to a bunch of medicines which have boomed in reputation for his or her use in weight reduction, together with Ozempic, Wegovy, Mounjaro and Zepbound.
The probe into these points was disclosed Tuesday in a quarterly report by the FDA, which revealed that the company is investigating experiences of alopecia, a hair loss situation; aspiration, a complication throughout surgical procedure when folks inhale meals or different objects into their airway; and suicidal ideation in individuals who used the medicines.
“The FDA screens the security of medication all through their life cycle, together with post-approval. As well as, the FDA maintains a system of postmarketing surveillance and threat evaluation packages to establish and consider hostile occasions that didn’t seem throughout the drug improvement course of,” FDA spokesperson Chanapa Tantibanchachai mentioned in an e mail.
Whereas points investigated by the company generally turn into little greater than false alarms, the company’s earlier probes of reported negative effects have additionally usually led to the FDA updating a drug’s labels or precautions, or calling for extra research of the difficulty.
“If newly recognized security indicators are recognized, the FDA will decide what, if any, actions are applicable after an intensive overview of accessible information,” Tantibanchachai added.
The company has beforehand adopted up on different experiences of points that may be attributable to the medicines, referred to as GLP-1 receptor agonists or GLP-1 RA, that are additionally efficient for treating diabetes.
Final yr, the FDA mentioned it had recognized a doable sign of intestinal obstructions linked to the treatment in experiences to its FDA Adversarial Occasion Reporting System, or FAERS. Ozempic’s label was up to date to acknowledge experiences of the situation, which medical doctors name ileus.
“We’re conscious that, as a part of these monitoring efforts, FDA is evaluating a number of potential indicators associated to GLP-1 RA medicines and has posted details about these ongoing assessments on its web site,” a spokesperson for Novo Nordisk, which manufactures Ozempic and Wegovy, mentioned in an emailed assertion.
Novo Nordisk “works intently” with the FDA to watch the security of their medicines, the spokesperson mentioned, and echoed the company’s warning that simply because a well being concern is reported to FAERS didn’t imply a causal hyperlink had been confirmed.
“Novo Nordisk stands behind the security and efficacy of all of our GLP-1 RA medicines when they’re used as indicated and when they’re taken below the care of a licensed healthcare skilled,” the spokesperson mentioned.
A spokesperson for Eli Lilly, which produces Zepbound and Mounjaro, mentioned the newly recognized security sign adopted “rigorous research for a few years in scientific trials and a sturdy approval course of” of the medicines.
“At the moment, the FDA is reviewing information on sure potential dangers for GLP-1 receptor agonist medicines. Affected person security is our precedence, and we’re collaborating with the FDA on these potential indicators,” the spokesperson mentioned in an announcement.
Suicidal ideas
The potential threat of suicidal ideation from taking GLP-1 RA medicines like Ozempic and Wegovy has already drawn months of scrutiny from specialists and well being authorities.
Abroad, the European Medicines Company mentioned final month it had requested for additional clarifications from producers of GLP-1 RA medicines in regards to the threat of suicidal ideas. The European regulator’s drug oversight panel is anticipated to debate the difficulty once more at its April assembly this yr, following a monthslong overview that started in July 2023.
Thus far, the European regulator says “no conclusion might be drawn on a causal affiliation” between the medicines and ideas of self-harm.
The FDA’s information tally 201 experiences via September of experiences of suicide or suicidal ideation from sufferers taking medicines with semaglutide, the important thing energetic ingredient of Ozempic and Wegovy, or tirzepatide, the ingredient for Zepbound and Mounjaro.
Data within the FAERS database solely tally experiences from sufferers, well being care suppliers and drugmakers via September. Studies for the final three months of 2023 are usually not anticipated to be printed till the top of January.
Alopecia (hair loss)
In FDA’s information there are a minimum of 422 experiences about sufferers taking semaglutide or tirzepatide that point out the time period alopecia, which medical doctors use to explain hair loss.
Numerous different medicines have been linked to inflicting hair loss, together with some antidepressants and contraception tablets.
FDA’s overview forward of Wegovy’s approval flagged hair loss and thinning among the many points that have been reported extra with members who got semaglutide in Novo Nordisk’s scientific trial, in comparison with those that received a placebo.
Docs have additionally famous the upper variety of sufferers who reported alopecia in Eli Lilly’s trials of tirzepatide for weight problems.
Aspiration
Solely 18 experiences of sufferers taking semaglutide or tirzepatide in FDA’s database point out aspiration, which refers to when folks inhale meals or different objects into their airway.
They embody a case report printed in March from medical doctors in Canada of a affected person who had an excessive amount of meals left of their abdomen regardless of fasting for 18 hours earlier than an operation. The affected person had begun injections of semaglutide for weight reduction two months earlier than.
Docs inform sufferers to cease consuming earlier than surgical procedures that require normal anesthesia due to the danger it could possibly be vomited up and find yourself within the lungs.
The American Society of Anesthesiologists referred to as in June for sufferers to cease taking the GLP-1 RA medicines earlier than elective operations, over the potential threat it might result in issues.
In a information launch, the group cited “anecdotal experiences that the delay in abdomen emptying could possibly be related to an elevated threat of regurgitation and aspiration of meals into the airways and lungs throughout normal anesthesia and deep sedation.”
[ad_2]
Source link