Latest news with #MHRA
Miami Herald
2 hours ago
- Health
- Miami Herald
Women on Weight-Loss Drugs Warned of Surprise ‘Ozempic Babies'
Women taking popular weight-loss drugs have been urged to use effective contraception while taking the medication amid reports of a so-called "Ozempic babies" phenomenon. The advice was issued by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, on Thursday. Newsweek reached out to the U.S. Department of Health and Human Services for comment via email. Demand for weight-loss drugs, including GLP-1 medications such as Ozempic, Wegovy, and Mounjaro, has surged in the United States. In May 2024, a KFF Health Tracking Poll found that approximately 6 percent of American adults—about 15 million people—were using GLP-1 agonists such as Ozempic, either for diabetes treatment or weight loss. Some experts have cautioned that women should use effective contraception while taking these medications amid reports that they may be linked to an increase in unexpected pregnancies, The Guardian reported last May. The MHRA issued its alert after receiving 40 reports related to pregnancies while using "GLP-1 medicines," which are known by the brand names Ozempic, Mounjaro, Wegovy, Saxenda, and Victoza. Ozempic and Wegovy contain semaglutide, which mimics the GLP-1 hormone to increase insulin, slow digestion, and suppress appetite. Mounjaro contains tirzepatide, which acts on an additional hormone related to blood sugar and appetite control. The MHRA warned that Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. It received 26 pregnancy-related reports for Mounjaro alone. "Therefore, those taking Mounjaro who are overweight and are using an oral form of contraception are advised to also use a non-oral form of contraception," the agency said. "This only applies to those taking Mounjaro and is especially important for the four weeks after starting Mounjaro and after any dose increase." Hundreds of women have shared personal accounts of unplanned pregnancies while using these medications in online groups, including the Facebook group "I got pregnant on Ozempic." "My ozempic baby...I see so many posts about ozempic and asking for "stories or side effects," but I never see anyone warning about pregnancy... lol," one woman shared on Facebook. "If you don't know, I got pregnant on ozempic and so many other women have too..I was on ozempic for 6 weeks & found out I was pregnant. I was so scared, google had me frightened I would miscarry because of the ozempic. I then came across a group called 'I got pregnant on ozempic'. I started reading all of these stories about women fighting infertility and getting pregnant on ozempic." The Food and Drug Administration has not yet issued similar advisories in the United States. MHRA Chief Safety Officer Dr. Alison Cave said: "Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments. They are not a quick fix to lose weight, and have not been assessed to be safe when used in this way. "Our guidance offers patients a 'one stop shop' for our up-to-date advice on how to use these powerful medicines safely. "This guidance should not be used as a substitute to reading the patient information leaflet or having a conversation with a healthcare professional as part of the prescribing process." Dr. Ilana Ressler, a reproductive endocrinologist at Illume Fertility, told Interesting Engineering on May 22: "There is this phenomenon of Ozempic what I think what's happening is women who may not have been ovulating before with the improvements that the medication is bringing on, that might be helping them to ovulate more regularly and they might be more likely to conceive while on the medication than not—so it is recommended to avoid pregnancy while taking the medication." Dr. Zuri A. Murrell, in a video on X last year: "There is nothing magical about the medicine that's in Ozempic that helps you get pregnant. But what it does is that a lot of times, when people can't, it's because of a hormone weight imbalance. "And so, when you lose weight, and sometimes when you lose weight rapidly, the hormones and the new you aren't in concert. Or they really are in concert, and guess what can happen, pregnancy. "So, it's not the Ozempic itself, it is actually the balancing out of your hormones. That means that you've lost fat, and that the body actually for you is working like it should. So just remember, Ozempic is not something that somebody takes and 'I'm pregnant.' What it does do is cause your body and hormone level to be more in sync and more likely that you can." It remains unclear whether the FDA will follow the MHRA's lead in issuing similar warnings or guidance on contraception. Related Articles Therapist Asks Who Women 'Want To Be Skinny For'-Her Theory Is Eye-OpeningThe Good Life: Weight Loss Wins, But at What Cost?How Ozempic and Other GLP-1 Drugs Are Eating Away at Body PositivityGen Z Is Leading a New Weight Loss Trend: Ozempic Microdosing 2025 NEWSWEEK DIGITAL LLC.
NDTV
2 hours ago
- Health
- NDTV
UK Warns Women About 'Skinny Jabs' If Trying To Get Pregnant
London: The UK's medicine regulator warned on Thursday against taking "skinny jabs" for weight loss if trying to get pregnant or while breastfeeding because of their unknown effects on babies. The Medicines and Healthcare products Regulatory Agency (MHRA) said popular jabs like Ozempic and Wegovy "must not be taken during pregnancy, while trying to get pregnant, or during breastfeeding". It urged women to use "effective contraception while taking these medicines and, in some cases, for up to two months between stopping the medicine and trying to get pregnant". "Anyone who gets pregnant while using them should speak to their healthcare professional and stop the medicine as soon as possible... because there is not enough safety data to know whether taking the medicine could cause harm to the baby," it added. Rebecca Reynolds, a professor of metabolic medicine at the University of Edinburgh, said there was "hardly any available data from human studies" to know if the weight loss drugs were safe in pregnancy. "The data from animal studies suggests the potential for harm with low birthweight and skeletal abnormalities, though more evidence is needed to assess if there are risks of taking these drugs in humans," she added. The MHRA also warned about the impact of another weight-loss and diabetes injection, Mounjaro, on the effectiveness of oral contraception for people who are overweight. "Therefore, those taking Mounjaro who are overweight and are using an oral form of contraception are advised to also use a non-oral form of contraception," it said. Ying Cheong, a consultant in reproductive medicine at the University of Southampton, called the MHRA's advice "both timely and necessary".
Medscape
2 hours ago
- Business
- Medscape
MHRA Urges Contraception With GLP-1 Weight-Loss Drugs
The Medicines and Healthcare products Regulatory Agency (MHRA) has reiterated that women using weight-loss drugs must use effective contraception, as the risks of these drugs to a foetus remain unclear. The warning follows concerns that some users in the UK may not be taking glucagon-like peptide-1 receptor agonists (GLP-1s) safely. To date, the MHRA has received more than 40 reports relating to pregnancies in women taking these medications. 'These medicines must not be taken during pregnancy, while trying to get pregnant, or during breastfeeding,' the MHRA stated. Women who become pregnant while using these drugs should stop treatment immediately and consult a healthcare professional. There is not enough safety data to determine if the drugs could harm a developing baby, the agency said. Avoid Unregulated Sellers, MHRA Warns The MHRA also warned against buying these drugs from unregulated sources such as beauty salons or via social media. 'Not only does this expose people wanting to lose weight to serious health risks, it is also against the law to sell these medicines in this way,' said Dr Alison Cave, the MHRA's chief safety officer. The agency emphasised that weight-loss drugs should not be taken without first consulting a healthcare professional. 'The only way to guarantee receiving a genuine GLP-1 medicine is to obtain it from a legitimate pharmacy,' Cave said. Pharmacies Seeing High Demand 'Community pharmacies have been experiencing unprecedented levels of interest for weight loss injections,' said Jasmine Shah, medication safety officer at the National Pharmacy Association. 'It is therefore important that regulations and guidance keep pace with this demand.' Mounjaro May Lower Effectiveness of Oral Contraceptives The MHRA noted that Mounjaro (tirzepatide) may reduce the effectiveness of oral contraceptives in people with overweight or obesity. Women taking Mounjaro should use a non-oral contraceptive method for 4 weeks after starting the drug and for 4 weeks after any dose increase. This advice applies only to Mounjaro users. Patients are also advised to be alert for signs of acute pancreatitis. Risks in Pregnancy Remain Unclear 'There is hardly any available data from human studies to be able to advise if these weight loss drugs are safe in pregnancy,' said Rebecca Reynolds, professor of metabolic medicine at the University of Edinburgh. 'The data from animal studies suggests the potential for harm with low birthweight and skeletal abnormalities, though more evidence is needed to assess if there are risks of taking these drugs in humans,' she told the Science Media Centre (SMC). Dr Bassel Wattar, consultant obstetrician and gynaecologist at Epsom and St Helier University Hospitals, supported the MHRA's warning. 'There is some data from animal studies suggesting there is a risk of malformation to the foetus — in animals falling pregnant while taking GLP-1 agonists — but data remains limited in humans,' he said. However, Dr Caroline Ovadia, senior clinical lecturer in obstetrics at the University of Edinburgh, noted to the SMC that existing human cohort studies had not shown clear evidence of harm. Online Buyers May Miss Safety Guidance Although direct evidence linking GLP-1 drugs to contraceptive failure is limited, the high number of users means even a small risk could have public health implications, experts warned. Professor Ying Cheong, consultant in reproductive medicine at the University of Southampton, speaking to the SMC, said that gastrointestinal side effects, such as vomiting and diarrhoea, could impair oral contraceptive absorption, increasing the risk of unintended pregnancy. 'Many people are buying weight loss drugs online and so may not receive this important advice about contraception,' Reynolds pointed out. 'These are not harmless lifestyle drugs,' stressed Cheong. 'The public urgently needs to understand that these medications require proper medical supervision to avoid unintended harm, particularly to reproductive health.'
Daily Record
3 hours ago
- Health
- Daily Record
Urgent contraception warning issued to 'skinny jab' users for one key reason
Weight-loss injections have become incredibly popular in the past year - but the government has warned that they can interact with contraception in new guidelines The government has issued a warning for women taking weight-loss injections and urged them to use effective contraception. A new notice from the Medicines and Healthcare Products Regulatory Agency said that one type of injection, Mounjaro, may reduce the effectiveness of oral contraceptives (the pill) in those who are overweight. Therefore, anyone taking Mounjaro who could get pregnant, should also use a non-oral form of contraception such as the implant, coil, or condoms. This is especially important for the four weeks after starting the injections and after any dose increase. The official government advice says: "Mounjaro may reduce the effectiveness of oral contraceptives in those who are overweight. Therefore, those taking Mounjaro who are overweight and are using an oral form of contraception are advised to also use a non-oral form of contraception. "This only applies to those taking Mounjaro and is especially important for the four weeks after starting Mounjaro and after any dose increase." Weight-loss drugs must also not be taken during pregnancy, while trying to get pregnant, or during breastfeeding. If you get pregnant while on the injections, you should speak with your healthcare provider and stop the medicine as soon as possible, the government advised. It explained: 'This is because there is not enough safety data to know whether taking the medicine could cause harm to the baby.' Dr Alison Cave, MHRA chief safety officer, said: 'Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments. They are not a quick fix to lose weight and have not been assessed to be safe when used in this way.' The new guidance also reminded patients that weight-loss medications should not be bought from unregulated sellers such as beauty salons or via social media. This exposes people wanting to lose weight to 'serious health risks' and is against the law. Legitimate medicines will be provided in pre-filled injection pens - meaning that products supplied as a powder in vials that need to be mixed with a liquid before injection are not authorised. There have also been reports of fake pre-filled pens that appear similar to the licensed medication. The MHRA warned that while these may look genuine, they 'can also be dangerous', adding: 'The only way to guarantee you receive a genuine GLP-1 medicine is to obtain it from a legitimate pharmacy, including those trading online, with a prescription issued by a healthcare professional.' The guidelines also highlighted the importance of being able to recognise symptoms of acute pancreatitis - an uncommon complication that can develop. If you are on weight-loss injections and suddenly get severe pain in your abdomen and feel sick, you should seek immediate help. Dr Cave said: 'This guidance should not be used as a substitute to reading the patient information leaflet or having a conversation with a healthcare professional as part of the prescribing process.' If you are taking a GLP-1 medicine and are set to undergo a surgical procedure, you should inform your healthcare team. This is because the medicine slows the emptying of your stomach, which increases the risk that stomach contents could enter into your airway and lungs during surgery.
Yahoo
3 hours ago
- Health
- Yahoo
Women on blockbuster weight loss drugs warned to use effective contraception
Pregnant women should not take weight loss drugs, the UK's medicines regulator warned amid concerns that people are using the so-called 'skinny jabs' in unsafe ways. The UK Medicines and Healthcare products Regulatory Agency (MHRA) also said women should not take weight loss drugs if they are breastfeeding or trying to get pregnant, because there isn't enough safety data to know whether the medicine could affect their baby. 'Anyone who gets pregnant while using them should speak to their healthcare professional and stop the medicine as soon as possible,' the agency said. Meanwhile, all women taking the jabs should ensure they are using a form of contraception that works, the MHRA said. Related Weight-loss drugs like Wegovy could help serious liver condition that has no cure-all treatment One of the drugs, Mounjaro, may make birth control pills less effective, so the agency says women taking the jab should also use a non-oral form of contraception, like an implant or intrauterine device (IUD). 'Obesity reduces fertility in women. So, women with obesity taking GLP-1 drugs are more likely to get pregnant than before they lost weight,' Dr Channa Jayasena, a reproductive endocrinology researcher at Imperial College London, said in a statement. 'Women are advised to do all they can to prevent pregnancy while taking [these] drugs,' Jayasena added. Related France won't pay for weight loss drug Wegovy. What about other European countries? In the UK, women already receive these warnings when they get their prescriptions for the blockbuster jabs, which include Ozempic, Wegovy, Saxenda, and Victoza as well as Mounjaro. The drugs, known as GLP-1 receptor agonists, work by mimicking hormones that help regulate appetites and make people feel full for longer. They have been approved to treat type 2 diabetes and obesity. Related Why are 1 in 10 French women still smoking during pregnancy despite the health risks? But the MHRA issued the reminder Thursday due to concerns that the drugs' growing popularity means women are buying them illegally online or at beauty salons, without seeing a doctor. 'Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments,' Dr Alison Cave, MHRA's chief safety officer, said in a statement. 'They are not a quick fix to lose weight and have not been assessed to be safe when used in this way,' she added.
