Kinney Drugs’ Post

Akums Drugs& Pharmaceuticals Ltd has taken a significant stride in #maternalhealthcare by unveiling a specialized solution to alleviate the persistent challenge of #nausea and vomiting during #pregnancy . The newly launched #Doxylamine + #Pyridoxine #tablets , approved by both the CSDcom and USFDA & UKMHRA Certified Generic Medicine, aim to address these common yet taxing symptoms experienced by expectant mothers. #Doxylamine + #Pyridoxine tablets, a blend of Doxylamine—a histamine H1 receptor inhibitor—and #PyridoxineHydrochloride (Vitamin B6), specifically target and manage nausea and vomiting associated with #pregnancy. These symptoms, which often extend beyond the initial trimester, pose risks to the health of both the mother and the fetus, potentially leading to a condition known as #HyperemesisGravidarum (HG). Sanjeev Jain, Joint Managing Director at Akums, highlighted, "Our combination therapy is designed to empower mothers, ensuring a smoother and healthier pregnancy journey by effectively addressing these challenging symptoms." Sandeep Jain, also a Joint Managing Director at Akums Drugs and Pharmaceuticals, emphasized the importance of this innovative solution for pregnant women who might not respond adequately to conventional management methods. He stated, "For expectant mothers encountering challenges with existing remedies, our offering aims to provide much-needed relief and comfort." The introduction of the #Doxylamine + #Pyridoxine tablets signifies a pivotal step in catering to the specific needs of pregnant women experiencing persistent nausea and vomiting. Akums Drugs& Pharmaceuticals Ltd' commitment to maternal well-being underscores the importance of specialized #healthcare solutions in ensuring a safer and more comfortable pregnancy experience for women facing these common yet burdensome symptoms. #News #Healthnews #Healthcare #Health #Medlr

Call to Action: Harmonisation of Pharmacovigilance Regulations for Post-marketing Pregnancy and Breastfeeding Safety Studies Amalia Alexe, Osa Eisele, Maria Fernanda Scantamburlo Fernandes, Anju Garg, Birgit Kovacs, Keele Wurst, Leesha Balramsingh-Harry, Nadezda Abramova, Yenlik Zheteyeva, David Lewis First published: 04 October 2023 https://lnkd.in/eMhSGmJf Abstract Globally, more than 200 million women become pregnant each year, most of whom receive medications despite limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine exclusion of this population from clinical trials due to scientific, ethical, regulatory and legal concerns. Consequently, at the time of initial drug approval, there may be scant safety data to inform the drug benefit-risk balance to the mother, foetus, or infant. Although momentum is growing to include this underrepresented population in clinical trials, most information on drug exposure outcomes comes from data collected in the post-marketing setting. Regulatory guidance and legislation on medication use in pregnancy and breastfeeding were reviewed globally by TransCelerate IGR PV Pregnancy and Breastfeeding Team. ICH standards and CIOMS guidelines served as benchmarks for national safety regulations and guidance. The landscape assessment identified a lack of harmonisation of global regulations on research in pregnant and breastfeeding women and lack of specific regulations on this topic in the majority of the territories included in the assessment. This articlefocuses on the ambiguities and lack of harmonisation in global regulations on post-marketing pregnancy and breastfeeding safety studies. There is currently no ICH standard to guide these types of safety studies and, in most regions reviewed, there are no clear regulations or guidance on when and how to conduct them. While a challenging undertaking, greater clarity and harmonisation would facilitate more timely completion of post-marketing pregnancy safety studies that would ultimately generate the critical data needed to optimize benefit-risk decisions for women who may conceive. pregnant and breastfeeding women.

While expecting mothers often turn to cannabis to relieve their nausea and pain — especially now that many states have legalized the substance — new data reveal a link to unfavorable pregnancy outcomes. The study, published in JAMA , analyzed urine samples from more than 9,000 pregnant individuals between 2010 and 2013. Unfavorable birth outcomes occurred at a rate of 25.9% with cannabis use vs. 17.4% without. Particular concern was the especially robust association between cannabis use and low birth rate, although preterm birth, stillbirth, and preeclampsia were identified as other poor outcomes. It's important that we get the message out there that cannabis use in pregnancy is not recommended. https://lnkd.in/e2HMdUGT

⚠ A multicenter observational cohort study involving over 9000 persons found that the composite adverse pregnancy outcome (small-for-gestational-age birth, medically indicated preterm birth, stillbirth, or hypertensive disorders of pregnancy) was more frequent in pregnant individuals with cannabis exposure ascertained by a urine drug assay (25.9%; n = 610) compared with unexposed individuals (17.4%; n = 8647). The risk for an adverse outcome was higher among those who continued to use cannabis beyond the first trimester. ⚠ Meaning  Cannabis use should be avoided during pregnancy to optimize maternal and neonatal outcomes. https://lnkd.in/eD8DrqT7

Pregnancy and vaping post: A study lead by researchers at Queen Mary's University of London concludes that vaping or nicotine patches while pregnant does not increase risk of harm to mum or baby suggesting that they should be recommended to pregnant mums who usually smoke. Prof Hajek said: ‘E-cigarettes helped pregnant smokers quit without posing any detectable risks to pregnancy, compared with stopping smoking without further nicotine use. ‘Using nicotine-containing aids to stop smoking in pregnancy thus appears safe. 'The harms to pregnancy from smoking, in late pregnancy at least, seem to be due to other chemicals in tobacco smoke rather than nicotine.’ Co-investigator Professor Linda Bauld, from the University of Edinburgh, said: ‘Clinicians, pregnant women and their families have questions about the safety of using nicotine replacement therapy or e-cigarettes during pregnancy. ‘Women who continue to smoke during pregnancy often find it difficult to stop but products like NRT or e-cigarettes can help them to do so. ‘These results suggest that NRT or vaping can be used as part of a quit attempt without adverse effects. ‘Our findings should be reassuring, and provide further important evidence to guide decision-making on smoking cessation during pregnancy.’ #Smokefree pregnancy #evidencebasedpractice #vaping #reassurance

Cannabis and Pregnancy Even though I am a man, this topic has always been very important to me, particularly due to its controversial nature and the emotional reactions it often elicits. Unlike many who might form opinions based purely on emotions, I prefer to delve into what the research and data have to say. Upon reviewing various studies and publications, it becomes evident that there is no straightforward answer to the question of whether using cannabis during pregnancy (and/or breastfeeding) is safe for the child. According to these studies, 1-5% of women (depending on the source) consume cannabis during their pregnancy and while breastfeeding. Most research concludes that cannabis use during pregnancy is linked to an increased risk of lower birth weight and reduced fetal growth. Moreover, a study in the Hamilton area of Ontario revealed that a majority of the surveyed women were aware that cannabis could be transferred to the fetus via the placenta (94.3%) or to the infant through breastmilk (91.2%) (Bartlett et al., 2020), both of which pose risks to the infant's development. Nevertheless, despite this high level of awareness, 4.2% of them continued to use cannabis while pregnant. Certainly, raising awareness about the potential risks of cannabis use during pregnancy is crucial, but equally important is creating a judgment-free environment. The stigma surrounding cannabis use before, during, or after pregnancy can often deter women from seeking information or support. By fostering an atmosphere of understanding and support, rather than judgment, we can encourage open discussions and ensure that women feel comfortable seeking advice and making informed decisions about their health and the well-being of their children. This approach not only educates but also empowers women by respecting their choices and providing them with the necessary resources to make those choices safely. CBD DURING PREGNANCY To the best of my knowledge, there is no evidence to suggest that consuming CBD alone poses a health risk to the fetus, nor is there conclusive evidence to the contrary. As always, more data is needed to reach an informed conclusion. **I am not licensed or qualified to provide medical advice!** This topic is not within my expertise and I welcome any additional insights, experiences, and opinions that you are willing to share. Sources: https://lnkd.in/ey98JzXS https://lnkd.in/eY_rp45V https://lnkd.in/e-YU345V CCSA-Cannabis-Use-Pregnancy-Breastfeeding-Report-2022-en.pdf

This largest study to date examining #cannabis use during #pregnancy and its association with adverse health outcomes in mothers utilized health data from Kaiser Permanente Northern California and included about 20,000 cannabis users, who were expectant mothers. The most worrisome results indicate that marijuana use during pregnancy is associated with adverse outcomes for the baby, such as lower birth weight, preterm birth, and higher admission rates to neonatal intensive care units. Additionally, cannabis users during early pregnancy were found to have a 17% greater risk of gestational hypertension and an 8% greater risk of preeclampsia. Many pregnant women use marijuana to alleviate symptoms such as nausea, pain, stress, and sleep difficulties. Research has shown that the prevalence of use during pregnancy has more than doubled over the last two decades. Researchers pointed out that “pregnant women are bombarded with inaccurate messages from social media, cannabis retailers and peers suggesting that cannabis use during pregnancy is safe. Our study provides timely and important data that adds to the growing body of evidence indicating that cannabis use during pregnancy is not safe.” #obstetricsandgynecology #substanceuse #medicine #neonatology #pharmacy

Key takeaways: Each doubling of opioid morphine milligram equivalents (MME) vs. no exposure was tied to increasing spontaneous preterm birth odds. One hundred or more MME significantly increased spontaneous preterm birth odds. Pregnant women who were prescribed opioid drugs had increased likelihood of spontaneous preterm delivery, and odds increased as total dose increased, according to case-control study results published in JAMA Network Open. “ Data derived from Bosworth OM, et al. JAMA Netw Open. 2024;doi:10.1001/jamanetworkopen.2023.55990. Bosworth and colleagues conducted a retrospective case-control study with data from a cohort of pregnant patients enrolled in Tennessee Medicaid aged 15 to 44 years who had a singleton birth at 24 weeks gestation or later from 2007 to 2019. Researchers linked enrollment files with health care encounters, hospital discharge information, birth certificate data and opioid prescription records. Researchers matched spontaneous preterm birth cases with up to 10 control cases based on pregnancy start date, race, ethnicity, age at delivery and preterm birth history. Primary outcome was spontaneous preterm birth and its association with total opioid morphine milligram equivalents (MME) filled in the 60 days before the index date. Overall, 25,391 patients (median age, 23 years) had spontaneous preterm birth and were matched with 225,696 controls (median age, 23 years). Of patients with spontaneous preterm birth, 58.1% were white, 38.7% were Black, 2.6% were Hispanic and 0.5% were Asian. Overall, 7.4% of patients filled an opioid prescription within 60 days before the index date. Researchers noted that each doubling of nonzero opioid MME was associated with a 4% increase in spontaneous preterm birth odds compared with no opioid exposure (adjusted OR = 1.04; 95% CI, 1.01-1.08). In addition, compared with no opioid prescriptions, the most commonly filled opioid MME prescriptions were associated with statistically significantly higher spontaneous preterm birth odds, with evidence showing significantly increased spontaneous preterm birth odds above 100 MME, the researchers wrote. “We found a continuous positive association between total prescription opioid MME dose exposure and the odds of spontaneous preterm birth,” they wrote. “Our findings support guidance to prescribe the lowest dose necessary to manage pain.”

🆕New findings about marijuana use during pregnancy and the risk to your baby. A study, published in the Journal of the American Medical Association (JAMA), revealed that cannabis exposure during pregnancy is associated with an increased risk of unhealthy outcomes including low birth weight, stillbirth and pregnancy-related high blood pressure. 🌐Click on this link to read the report's findings ➡️ https://nbcnews.to/3GF7bbG 🌐Click on this link to read the Cooperative President & CEO's guidance to the New Jersey Cannabis Regulatory Commission regarding cannabis use during pregnancy ➡️ https://bit.ly/3RFNarD #HealthyPregnancy #HealthyPregnancies #SubstanceUse #PerinatalSubstanceUse

The increasing use of medications during pregnancy poses potential risks to fetal development, emphasizing the need for more predictive and accurate models to assess these risks. The placenta, a unique organ with dual blood supply, develops rapidly during pregnancy and features highly branched villi for essential exchanges. Currently, research is limited to using tissue cultures from delivered placentas, which lacks human translatability and leads to gaps in safety data. In this poster, we present our 3D placenta-on-a-chip model to study drug delivery and to execute risk assessment that we developed. This in vitro placental model enables precise, membrane-free cultivation of cells, offering a closer mimic to human conditions. This advancement is key for screening drug-induced toxicity and ensuring medication safety during pregnancy. 📥 Download the poster and see how we're transforming prenatal risk assessments: https://lnkd.in/gZWgWcRr #PlacentaModel #ToxScreening #MaternalHealth