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Pharmaceutical company Eli Lilly is urging people not to use its tirzepatide medications Mounjaro and Zepbound for cosmetic weight loss.
They said the drugs are designed for serious diseases and can pose potentially serious health risks to people using them for other purposes.
Experts say the benefits of these drugs outweigh the risks for people with obesity, but that balance may not be true for someone trying to lose a minimal amount of weight.
Officials at Eli Lilly have posted an open letter regarding the use of its FDA-approved tirzepatide medications, Mounjaro and Zepbound, for cosmetic weight loss.
The company stated that it was aware of the practice of these drugs being prescribed or used outside of the parameters of the Food and Drug Administration as well as the use of tirzepatide by compounding pharmacies that mix customized medicines.
“Mounjaro and Zepbound are indicated for the treatment of serious diseases; they are not approved for – and should not be used for – cosmetic weight loss,” the statement reads.
“Products claiming to contain tirzepatide, Mounjaro, or Zepbound that are made and/or distributed by compounding pharmacies have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy; are not FDA-approved or approved by global regulatory agencies like Mounjaro and Zepbound; and may expose patients to potentially serious health risks,” the officials added.
Are Mounjaro and Zepbound safe to take for weight loss?
Mounjaro is available in injectable single-dose pens or vials.
It is recommended for adults with type 2 diabetes to improve blood sugar, but it is meant to be combined with dietary and exercise changes.
There is an FDA warning on Mounjaro about a potential increased risk for thyroid cancer.
In referring to drugs containing tirzepatide, Dr. Dan Azagury, FACS, the chief bariatric surgeon and medical director of Stanford University School of Medicine’s Lifestyle and Weight Management Clinic in California, said using the medications for cosmetic purposes is not recommendable.
Aside from the side effects, he said the drugs can create longer-term problems for people who are trying to lose weight quickly rather than applying dietary and exercise regimens over time for overall health.
“We tell our patients that if they start the drug they should do so being comfortable with the idea of staying on it forever,” Azagury told Healthline. “Because often when you stop there is a rebound effect. In particular, if you stop abruptly. Patients who take this just to lose 5 to 10 pounds and stop will then likely regain 10 to 15 pounds, leading to worse long-term outcomes and a yo-yo effect that is unfavorable. I think educating patients in that way would be beneficial.”
Are Mounjaro and Zepbound different than Ozempic?
Ozempic, along with drugs such as Wegovy, are commonly called GLP-1 drugs, or glucagon-like peptide1 receptor agonists. Tirzepatide drugs are part of the GLP-1 class.
Ozempic is meant to be prescribed to adults with type 2 diabetes to help lower risks of heart disease and manage blood sugar levels, but it is also prescribed off-label — where a drug that’s approved for certain conditions is prescribed for another purpose — for weight loss or weight management.
Azagury said that the use of these type of drugs for purposes other than those approved by the FDA can change the risk factors for people.
“Every drug has side effects and potential risks. When the FDA approves a drug, they weight the benefits vs the risks,” Azagury said. “They issue an indication for use based on that equation. If you’re doing it for cosmetic purposes with no health benefit, then that equation is different and the side effects or risks might outweigh the benefits.”
Dr. Mir Ali, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California, said the statement by Eli Lilly will likely make no difference on how people look for cosmetic weight loss treatments.
“Patients seeking these medications for weight loss will try to obtain them regardless of any warnings,” Ali told Healthline. “These medicines are in short supply because the demand is so high. Many patients who do not meet the manufacturers’ guidelines are seeking these medications for weight loss. These medicines are more effective than diet and exercise alone, so people who do not have significant weight view them as a more convenient solution.”
That type of demand, Azagury said, is also creating problems or people for whom tirzepatide drugs would be beneficial for long-term health.
“It’s unfortunate because this is an expensive drug that is extremely beneficial to patients with obesity and they have difficulty accessing it,” he said. “Its use for cosmetic by people who can afford it is increasing disparities and reducing access for patients who would truly benefit.”
A new study shows women with perinatal depression are associated with a greater risk of dying by suicide, particularly during the first year of their diagnosis.
Many factors affect perinatal depression onset, including hormone changes during and after pregnancy, personal or family history of depression, major life stressors, and marital conflict.
To treat this type of depression, experts recommend psychotherapy and antidepressants in serious cases.
A new study shows that women with clinically diagnosed perinatal depression face an increased risk of death as a result of suicide, especially during the first year after receiving a diagnosis. The results were published January 10 in the BMJ.
Researchers examined data from the Swedish national registry between 2001 and 2018 and found 86,551 women with a first-time diagnosis of perinatal depression and 865,510 women without perinatal depression who gave birth around the same age and during the same year.
They also looked at data for 24,473 of the women who had perinatal depression with 246,113 full sisters who were unaffected by this illness and gave birth to at least one baby throughout the study duration.
The findings demonstrate that women with perinatal depression are more than twice as likely to die compared to women who do not have perinatal depression. The risk appears highest during the first year after being diagnosed.
While suicide is rare for people with perinatal depression, the increase in suicide was nearly six fold compared to people without this mental illness. Those with perinatal depression were also three times as likely to die from an accident, the researchers report.
“This study uses a large dataset from Swedish registries and demonstrates a significant association between peripartum depression and risk of suicidal behavior,” Dr. Khatiya Moon, a psychiatrist at Northwell Health, told Healthline. Moon was not involved in the research.
“A strength of the study is that the investigators tried to control for factors like upbringing and previous history of depression or other psychiatric disorders, which could otherwise confound the results,” she added.
Perinatal depression linked to increased suicide risk
In the study, researchers discovered that women with perinatal depression had a greater risk of mortality.
The findings were consistent regardless of any pre-existing psychiatric conditions, particularly among people who died by suicide and during the first year after being diagnosed.
“Becoming a parent is a major life transition,” Moon said. “Not only are there massive hormonal shifts that affect the brain and body of the postpartum person, the psychological transition to parenthood is among the most dramatic changes most people ever go through.”
“The parenthood transition also changes how a person relates to others and what supports they may need. Without the right support, the postpartum period can be fraught with challenges. This study is another reason to take perinatal depression seriously as a contributor to maternal mortality,” Moon added.
The study also highlights the risks associated with major depression, a recurrent mental illness.
“Major depression is a serious illness associated with high risk for other medical illness and mortality, including suicide,” Dr. Adele Viguera, associate director of the Perinatal and Reproductive Psychiatry Program at Cleveland Clinic, told Healthline. Viguera was not involved in the new research.
“These findings underscore the serious morbidity and elevated mortality associated with major depression, whether postpartum or not. If a person has had one episode of major depression, their risk for developing a subsequent episode is around 50%,” Viguera noted.
“If an individual has experienced at least two episodes, their risk for having another episode increases to 80%. Postpartum depression is no different with respect to these serious consequences, including elevated risk for subsequent recurrences both postpartum and outside of the postpartum period,” Viguera continued.
Michele Goldman, a psychologist with the Hope for Depression Research Foundation, told Healthline while the study highlights the importance of monitoring and intervening in higher-risk populations, “there was a lack of clarity in the study that brings up additional questions about the findings.”
“The study defines depression as people having received a diagnosis by a professional after receiving specialized care or because someone was dispensed an antidepressant medication,” Goldman explained.
“Being on an antidepressant medication does not constitute a diagnosis of depression; further, there are people on antidepressant medications to treat other conditions (not depression). Therefore, their main criteria to categorize women as having depression is not necessarily a sound measure,” Goldman noted.
What causes perinatal depression?
Many factors contribute to perinatal depression, the period before and after the birth of a child.
Moon said the exact causes of perinatal depression are not fully understood but noted the causes may vary from person to person.
“Previous studies looking at this question have suggested that some women with PND may have differences in how their body treats GABA, an important neurotransmitter that is involved in regulating mood,” Moon said.
“This was part of the rationale in the development of zuranolone and brexanolone, which are both FDA approved for [the] treatment of postpartum depression and both involved in GABA modulation,” he added.
The postpartum period also brings a rapid shift in hormones such as estrogen, progesterone, and allopregnanolone. Postpartum depression affects around 1 in 8 pregnancies, according to the Centers for Disease Control and Prevention (CDC).
“As these hormones influence mood-regulating neurotransmitters, it is thought they may play a role in postpartum depression,” Viguera said.
“However, studies find no consistent link between hormone levels and mood issues after birth. Still, some think certain women are extra sensitive to postpartum hormonal shifts, making them vulnerable to postpartum depression and related mood problems during menstruation and menopause,” she added.
Beyond hormones, other factors also seem to be at play.
“Consistently, women who report marital dissatisfaction, insufficient social support, and stressful events during or after pregnancy have higher rates of postpartum depression,” Viguera said.
“The condition likely indicates an underlying susceptibility to depressive disorders. Women with histories of depression or bipolar disorder are at greater risk, and women who develop postpartum depression often have recurring depressive episodes unrelated to reproduction.”
While hormones may contribute to perinatal and postpartum depression onset, psychological and social factors also affect risk a person’s risk.
All new birthing parents are at risk for developing postpartum depression regardless of age, relationship status, education, or income level. However, certain risk factors may increase a person’s likelihood of developing this debilitating mental health condition. According to Viguera, these include:
previous postpartum depression
depression during pregnancy
personal or family history of depression
recent major stressors
inadequate social support system
marital conflict
How is perinatal depression treated?
Perinatal and postpartum depression is treatable, especially when diagnosed early.
“It is imperative to evaluate and diagnose postpartum mood disturbances,” Viguera said.
“Often, a first step is screening, followed by referral to an expert in this area. The approach to treatment is multi-prolonged and can include a variety of treatment modalities, usually in combination such as with talk therapy, medications, involving family members to provide support at home and community support services.”
Antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are commonly prescribed for treating perinatal and postpartum depression.
“These can help manage symptoms and regulate mood,” said Viguera.
“An exciting development in the treatment of postpartum depression is the recent release of the first-ever FDA-approved antidepressant indicated for postpartum depression called zuranolone (Zurzuvae), the first rapid-acting oral short-course treatment specifically for moderate to severe [postpartum depression] PPD. Onset of action is seen as early as day 3 in clinical trials,” she noted.
Various psychotherapies can also be very helpful in treating postpartum depression.
In many cases, the combination of talk therapy and medication provides a better outcome for recovery than either modality alone. Other helpful interventions for perinatal depression may include:
“Having a strong support system is also crucial,” Viguera said. “Partners, family, and friends can provide emotional support and practical help with child care to alleviate stress. In general, treatment is tailored to each woman’s needs and symptoms with the goal of restoring mood and daily functioning.”
Moon added that pre- and post-natal care appointments “go a long way” for most people.
“Pregnancy and parenthood also provide the opportunity to connect with people in one’s community in a new way, and it can be helpful to build networks of other parents through childbirth and parenting classes, support groups, and mother-infant classes,” Moon said.
If you’re experiencing symptoms of peripartum anxiety and depression, it’s important to seek treatment and bring up concerns to your healthcare team, such as an OB-GYN.
Takeaway
A new Swedish study shows an increased risk of death, particularly death by suicide, among people diagnosed with perinatal depression.
The findings highlight the mortality risks associated with perinatal, postpartum, and major depression, which are debilitating mental health disorders when untreated.
“It is well known that people with mental disorders experience excess mortality compared with the general population,” Viguera said. “Postpartum depression is no different with respect to these serious consequences.”
Help is out there
If you or someone you know is in crisis and considering suicide or self-harm, please seek support:
Not in the United States? Find a helpline in your country with Befrienders Worldwide.
Call 911 or your local emergency services number if you feel safe to do so.
If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.
If you are not in the same household, stay on the phone with them until help arrives.
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