Do Ozempic, Wegovy, Mounjaro, and Zepbound cause hair loss?
Brief:
The FDA is currently looking into possible health risks related to such common weight-loss drugs as Zepbound, Wegovy, Ozempic, and Mounjaro. The investigation focuses on the negative effects that users have claimed, including hair loss, aspiration following surgery, and even suicidal thoughts. The companies that make several of these drugs, Novo Nordisk and Eli Lilly, emphasize how committed they are to safety. The constant observation emphasizes how crucial it is to keep an eye on people who are using GLP-1 receptor agonists to help them lose weight in order to ensure their wellbeing. To maintain a balanced approach to weight control, stay up-to-date on the most recent advancements in drug safety.
FDA: Unveiling Potential Side Effects, from Hair Loss to Suicidal Thoughts
The Food and Drug Administration is investigating the possibility that three health problems or side effects, such as hair loss,aspiration, and suicidal thoughts, are related to a class of drugs called Ozempic, Wegovy, Mounjaro, and Zepbound, which have become extremely popular due to their usage in weight reduction.
The FDA revealed the investigation into these problems in a quarterly report on Tuesday. It stated that the agency is looking into reports of suicidal ideation in patients who took the medications, as well as alopecia, a condition that causes hair loss, and aspiration, a surgical complication in which patients inhale food or other objects into their airway.
“Even after approval, the FDA monitors pharmaceutical safety throughout the whole research process. “In addition, the FDA maintains a system of post-marketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” an email from FDA spokesperson Chanapa Tantibanchachai said.
Even though the agency’s investigations into problems can amount to little more than false alarms, the FDA has frequently updated a drug’s label or warnings or requested more research on the matter as a result of the agency’s prior investigations into reported adverse effects.
“If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data,” Tantibanchachai added.
The drugs, known as GLP-1 receptor agonists, or GLP-1 RA, are also useful in the treatment of diabetes, and the agency has previously investigated other complaints of problems that may have been brought on by them.
The FDA announced last year that it had discovered a potential indication of intestinal blockages associated with the drug in complaints to its FDA Adverse Event Reporting System, or FAERS. The illness, which medical professionals refer to as ileus, was noted on Ozempic’s label.
A representative for Novo Nordisk, the company that makes Wegovy and Ozempic, sent out an email stating, “We are aware that, as part of those monitoring efforts, the FDA is evaluating several potential signals related to GLP-1 RA medicines and has posted information about those ongoing assessments on its website.”
According to the representative, Novo Nordisk “works closely” with the FDA to monitor the safety of their drugs. The representative also reiterated the FDA’s caution that a health issue’s reporting to FAERS does not always suggest a causal relationship has been established.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” said a spokesperson.
The company that makes Zepbound and Mounjaro, Eli Lilly, released a statement stating that the recently discovered safety signal came about as a result of “rigorous study for many years in clinical trials and a robust approval process” of the drugs.
The FDA is now examining information about specific possible hazards associated with GLP-1 receptor-agonist medications. Our first goal is patient safety, and we are working with the FDA to investigate these possible indicators,” the representative stated in a statement.
Suicidal Thoughts
Experts and health authorities have previously spent months closely examining the possible risk of suicidal ideation associated with GLP-1 RA medicines such as Ozempic and Wegovy.
The European Medicines Agency announced last month that it has contacted foreign producers of GLP-1 RA drugs to request further information on the possibility of suicidal thoughts. At its April meeting this year, the European regulator’s medicines monitoring panel is anticipated to revisit the matter after a months-long examination that started in July 2023.
As of right now, “no conclusion can be drawn on a causal association” between the drugs and suicidal thoughts, according to the European authority.
According to FDA statistics, patients using drugs containing semaglutide, the main active component in Ozempic and Wegovy, or tirzepatide, the substance in Zepbound and Mounjaro, had reported 201 instances of suicide or suicidal thoughts through September.
Only patient, healthcare provider, and pharmaceutical company reports are totaled in the FAERS database up to September. It is anticipated that reports covering the final three months of 2023 will not be released until the end of January.
Alopecia (loss of hair)
The term “alopecia,” which is used by doctors to refer to hair loss, is mentioned in at least 422 reports of patients using tirzepatide or semaglutide that are contained in FDA data.
Several other drugs, such as birth control tablets and certain antidepressants, have also been connected to hair loss.
Hair loss and thinning were among the side effects that were reported more often by semaglutide-treated clinical trial participants than by placebo-treated individuals, according to an FDA evaluation conducted prior to Wegovy’s clearance.
Physicians have also observed that in Eli Lilly’s studies on tirzepatide for obesity, a greater proportion of patients experienced baldness.
Aspiration
In the FDA database, aspiration—the term for when someone inhales food or other items into their airway—is mentioned in just 18 instances of patients receiving tirzepatide or semaglutide.
Among these is a case report from Canadian physicians that was released in March, detailing a patient who fasted for eighteen hours before surgery yet still had an excess of food in their stomach. Two months prior, the patient started receiving injections of semaglutide to aid with weight loss.
Prior to general anesthetic operations, doctors advise patients not to eat since there is a chance that food may be vomited up and get into the lungs.
Due to the possibility of problems, the American Society of Anesthesiologists recommended in June that patients cease using GLP-1 RA drugs before elective surgery.