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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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Pharmaceutical company Eli Lilly will begin offering an “end-to-end” healthcare experience called LillyDirect.
The service will help patients get access to doctors and to the company’s medicines, including weight loss drug Zepbound.
Obesity doctors welcomed the announcement, saying it will help expand access for many Americans.
American pharmaceutical company Eli Lilly will begin offering a suite of healthcare services, including access to independent telehealth providers and free shipping on medication.
The company announced the launch of LillyDirect on January 4, 2024, and bills it as an “end-to-end digital healthcare experience.” The program is targeted at individuals with obesity, migraine, and diabetes.
It will offer pharmacy and healthcare services, including convenient access to medications like insulin and the recently approved obesity medication Zepbound.
“With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes. LillyDirect offers more choices in how and where people access healthcare, including a convenient home delivery option to fill Lilly medicines they have been prescribed,” David A. Ricks, Eli Lilly’s chair and CEO said in a press release.
Services offered by LillyDirect include:
Access to an online pharmacy for the company’s medicines with free shipping.
Educational information about disease management.
Tools to find independent healthcare providers via both telehealth and in-person settings.
Manufacturer savings on medicines
Eli Lilly has partnered with telehealth company Form Health for telehealth options and Healthgrades for in-person doctors. They also make it clear that all healthcare providers are independent of Eli Lilly.
“The LillyDirect listing is not an endorsement or recommendation of the independent clinician networks or telehealth clinicians. The telehealth service providers and healthcare professionals listed through the “find in-person care” feature on LillyDirect are independent and separate from Lilly. Treatment decisions and prescribing practices are made at the discretion of the provider’s care team,” a representative for Eli Lilly told Healthline in an emailed statement.
A welcome addition to obesity care
Dr. Caroline Apovian, MD, a Professor of Medicine at Harvard Medical School and the co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, welcomed the announcement.
“I think this is a great move. Lilly is really helping patients by getting them to a telemedicine program run by doctors who can get them access,” she told Healthline.
Those sentiments were echoed by other experts contacted for this story.
“From my perspective, anything that helps patients have access to care, and in particular to specialized high quality care and drugs is positive,” said Dr. Dan Azagury, MD, section chief of Minimally Invasive and Bariatric Surgery and medical director for the Bariatric and Metabolic Interdisciplinary clinic at Stanford University.
Both Apovian and Azagury disclosed that they are medical consultants to Form Health.
Lowering barriers to access
Telehealth services that sprang to life during the pandemic are now important to obesity care. Both Azagury and Apovian say that telehealth is now essential to help them keep up with the demand for care.
“I would say, in general, obesity care lends itself very well to telehealth. I’ll tell you that my practice has switched to telehealth because of COVID, but we’ve never switched back,” said Azagury.
“There are many people out there who want our services. We are hiring more physician assistants and nurse practitioners to help the MDs and hiring more MDs because clearly with 42% of Americans who need obesity treatment, we don’t have enough obesity medicine specialists to do it,” said Apovian.
Apovian told Healthline that telehealth services also give her greater freedom to see patients who require more complex care and have serious comorbidities.
“My slots in my center to see in-person patients can be reserved for patients with congestive heart failure and obesity or kidney failure with obesity,” she said.
Ongoing obesity drug shortages
LillyDirect could also help play a role in ensuring that patients who need medication can reliably get it.
Novel diabetes and obesity medications known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), have proven to be exceptionally effective for weight loss. They have simultaneously grown in popularity and burst into pop culture and headlines across the United States.
However, the popularity of the drugs has been a blessing and a curse. Novo Nordisk, the Danish pharmaceutical company behind Ozempic and Wegovy has faced numerous shortages and supply chain issues while attempting to keep up with demand.
Just this week, Ricks said that Zepbound had reached 25,000 new prescriptions per week and that the company’s current output might not meet demand. While the company is investing in more manufacturing infrastructure, how much of the drug they can actually produce is unclear.
The bottom line
American pharmaceutical company Eli Lilly will begin offering healthcare services through their new program LillyDirect.
LillyDirect services include an online pharmacy, tools for finding in-person and telehealth doctors, and some financial incentives like free shipping and manufacturer savings on medication.
Obesity experts contacted by Healthline were supportive of the initiative, saying that it would help expand access and help meet surging demand for obesity drugs, including Zepbound.
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New research indicates that chronic pain patients using medical cannabis are at a higher risk of heart arrhythmia than non-users.
The Danish study noted a two-fold increase in the risk of arrhythmia, although the overall risk was still low.
More research is needed to establish a link between cannabis and cardiovascular disease.
People who use medical cannabis for chronic pain are more likely to experience atrial fibrillation and other forms of heart arrhythmia compared to non-users.
However, the authors noted that data on medical cannabis is still lacking due to legality issues, and more research is needed to support the findings.
Additionally, the authors also noted that the study did not address whether the risk is linked specifically to smoking cannabis, ingesting cannabis edibles, or a combination of both.
Another major limitation that the authors noted is that the study was not able to look at “disease severity, clinical measures, blood tests, and lifestyle factors,” all of which could contribute to an increased risk of heart issues independent of cannabis use.
Although the risk of arrhythmia among medical cannabis users was still low, it was statistically significant.
Researchers did not find any association between medical cannabis and acute coronary disease (ACS), an umbrella term that includes serious cardiovascular events like heart attack and unstable angina.
“There is very insufficient evidence related to medical cannabis and cardiovascular side-effects. Clinically, associations have previously been found with recreationalcannabis use, but to our knowledge, this is the first study investigating associations with prescribed medicalcannabis,” Dr. Anders Holt, MD, of Copenhagen University in Denmark, and author of the study told Healthline.
A Two-fold increase in arrhythmia risk
The study found that risk of new-onset arrhythmia, which included conditions like atrial fibrillation, flutter, and paroxysmal tachycardia, was doubled in those who used medical cannabis to manage chronic pain compared to a control group.
Holt and his team utilized health data from national Danish health registries to investigate the link between medical cannabis and arrhythmia. Medical cannabis is not formally approved for chronic pain management in Denmark, but a government program has allowed physicians to prescribe it for that reason.
Researchers looked at data from more than 1.8 million patients with chronic pain.
Out of that group, only a very small number of patients received medical cannabis: about 5,000 people.
The group of medical cannabis users were matched 1:5 with 27,000 patients that had similar characteristics, including age, sex, and use of other pain medications.
In large, population-based studies like this, it is impossible to remove all confounding factors, but the goal is to remove as many as possible.
Patients in the study did not have a history of arrhythmia, nor had they previously been prescribed medical cannabis.
Over a 180-day follow-up period, 42 patients who used medical cannabis developed an arrhythmia; in three out of four cases, it was atrial fibrillation.
Overall 0.8% of medical cannabis patients experienced an arrhythmia compared to 0.4% in the control group. The risk was greatest in patients with cancer and cardiometabolic conditions like diabetes.
No association was found between medical cannabis and acute coronary syndrome.
“These findings should spur further investigations into the viable use of cannabis treatment for chronic pain and particularly into possible side effects. It should be paramount to physicians that the ongoing legalization of cannabis meant for therapeutic use is kept purely scientific and not political,” said Holt.
Statistical versus clinical risk
Although the study demonstrates an increase in risk, questions remain about how this risk should factor into patient care.
“You need to distinguish statistical significance from clinical significance,” said Dr. Rod Passman, MD, a Professor of Medicine and Director of the Center for Arrhythmia Research at Northwestern University. Passman wasn’t affiliated with the study.
“If you tell someone their risk is double, that’s really important. But if you tell someone their risk goes from 0.4% to 0.8%, most of us would not believe that that is a major increase in risk that would impact clinical decision making like whether I would take a medication or not,” he said.
He notes that many pain medications, even over-the-counter nonsteroidal (NSAID) medications like ibuprofen, are associated with arrhythmia.
Opioids, pervasive and powerful pain medicines like morphine, codeine, and fentanyl, are too.
A 2018 review found that even at low doses could increase the risk of arrhythmia.
Patients and healthcare professionals will always need to assess risks and benefits when assessing treatment needs.
“I don’t think that I would take someone who was in chronic pain, which failed typical therapies, and prevent them from getting medical marijuana because of the potential risk of exacerbating their atrial fibrillation when that risk is going to be relatively low,” he said.
A dearth of data on medical cannabis
Both Passman and Holt acknowledge that good data on medical cannabis is sorely lacking. Prior research has tended to focus on recreational cannabis usage. With the rise of legalization in Europe and the United States, use of medical cannabis is steadily increasing.
“This is of increasing interest given the increasing use of cannabis, both for medical and recreational purposes…Often there’s a lot of problems with these studies because, historically, this has been an illegal medication. So we don’t have a lot of good, solid data on it,” said Passman.
“Prescribed medical treatment must be founded on sufficient evidence of effect, including considerable knowledge on side-effects which this study adds a sliver of, but more is certainly needed,” said Holt.
The American Heart Association has stated that there are “no cardiovascular benefits” to using cannabis, either recreationally or medicinally. In a scientific statement on cannabis and cardiovascular health issued in 2020, the AHA points out that in a variety of studies, cannabis consumption has been associated with atrial fibrillation and cardiovascular disease. They too, acknowledge a need for more and higher quality data and that there is “an urgent need for carefully designed, prospective short- and long-term studies.”
AHA spokesperson Robert L. Page II, PharmD, a Professor at the University of Colorado and Chair of the AHA’s 2020 scientific statement on cannabis, told Healthline that the Danish research “absolutely” aligns with the AHA’s statement.
“I treat cannabis use (particularly when vaped or smoked) as a potential risk factor for heart disease, which is why I do not recommend smoking or vaping any form of cannabis. Thus, medical providers should be screening for underlying cardiovascular risk factors or underlying conditions that could contribute to a heart attack, stroke or heart rhythm disturbance in anyone who uses cannabis,” he said.
The Bottom Line
A European study found that patients with chronic pain who used medical cannabis were more likely to experience heart arrhythmia than a control group.
While the risk of arrhythmia was still low (0.8%) among the medical cannabis group, it was a two-fold increase over the control group (0.4%).
Researchers and organizations, including the American Heart Association, say there is a tremendous need for more studies and high quality data on the association between cannabis and cardiovascular disease.