jean-michel Dogné’s Post

The risks and benefits of medication use in pregnancy are typically established through the postmarketing product-life cycle. Here is an example of the crucial importance of reporting drug exposure during pregnancy and how risks can be confounded by indication and improper management of chronic diseases. #Pharmacovigilance #Pregnancy #Diabetes #AdverseOutcomes

Gestational diabetes should be taken care of from the initial stages of pregnancy as it will have an impact on the fetus. To learn about diabetes medication, drug monitoring, and pharmacovigilance activities, log on to truelessons.io #truelessons#pharmacovigilance#drugmonitoring#diabetes#phase4clinical trial

𝗪𝗵𝘆 𝗔𝘃𝗼𝗶𝗱𝗶𝗻𝗴 💊𝗡𝗦𝗔𝗜𝗗𝘀 𝗔𝗳𝘁𝗲𝗿 𝟮𝟬 𝗪𝗲𝗲𝗸𝘀 𝗶𝘀 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗳𝗼𝗿 𝗘𝘅𝗽𝗲𝗰𝘁𝗮𝗻𝘁 𝗠𝗼𝘁𝗵𝗲𝗿𝘀 Being pregnant 🤰and sick simultaneously can be pretty stressful. With immune system changes during pregnancy, women become more susceptible to colds, flu, and anxiety, making this period particularly challenging. ⚠️It's essential to be cautious with medications, as not all are safe for the developing baby. ✅Our latest blog post highlights the importance of avoiding nonsteroidal anti-inflammatory drugs (NSAIDs) after 20 weeks of pregnancy. Despite repeated warnings from regulatory authorities worldwide, the safety of #NSAIDs during pregnancy remains a critical issue. Medical literature 📚further supports this, documenting instances of NSAID use in late pregnancy. Recently, the #DrugCard platform uncovered such a case, highlighting the ongoing relevance of this issue. 👉Read more in our blog to stay updated on the latest insights: https://lnkd.in/g_vPvnEi #pharmacovigilance #GVP

Today is #WorldPreeclampsiaDay raising awareness so we can better prevent, predict and prevail over this, the second leading direct cause of maternal mortality globally. At the Monash Quality of Medicines Initiative, we are supporting these efforts through a study to investigate issues of poor quality for medicines used to manage hypertensive disorders of pregnancy (including preeclampsia and eclampsia). Partnering with the Burnet Institute and USAID Global Health Supply Chain Program-Procurement and Supply Management and led by Pooja Maharjan, this study will investigate the quality of key preeclampsia medicines across five low-resource countries with the aim to identify and mitigate against causes of poor quality products. #PreeclampsiaAwarenessMonth Monash University Monash Institute of Pharmaceutical Sciences Joshua Vogel Annie McDougall Michelle McIntosh Siobhan Perkins Brittany Stollar

🧐Case 9 || Medication for Constipation during Pregnancy Follow for More ❤️ Pharmacozyme Related Tags: #pharmacozyme #pharmacology #medicine #pharmacy #medical #quiz #quiztime #NIPERJEE #GPAT2021 #PEARSON #pharmd #pharmacists #pharmacology #GPAT #gdc #medtheory #gpatnotes #gpat2021 #pharmacist #druginspectorexam #pharmacy #pharmacytech #pharmacymemes #pharmacylife #pharmacyproblems #pharmacy #pharmacognosy #pharmacologynotes #pharmacologyexam #organicchemistry #gpat2019 #gpatexam #gpat2020 #niperdonniolvido #mbbs #medical #nurse

The use of medications in pregnancy and lactation presents a challenge to all health care providers. Human data about medical product safety in pregnancy at the time of market approval are limited or absent.  – Pregnant women are usually actively excluded from clinical trials.  – Women who become pregnant during clinical trials are discontinued but followed. • Consequently, almost all clinically relevant human data are collected post-approval. Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal, and infant risk–benefit considerations. This is especially true with the long-standing pregnancy risk categories A, B, C, D, and X, which make risk–benefit ratio assessment difficult. To address the need for updated risk categories, FDA published a final rule entitled which is known simply as the “Pregnancy and Lactation Labeling Rule” (PLLR), in December 2014.The PLLR became effective on June 30, 2015. • Important goal of the PLLR conversion process is to have accurate and up-to-date labeling recommendations which reflect the post-approval experience. Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule. #pharmacovigilance #drugsafety #patientsafety

𝐋𝐮𝐩𝐢𝐧 𝐠𝐞𝐭𝐬 𝐔𝐒𝐅𝐃𝐀 𝐧𝐨𝐝 𝐟𝐨𝐫 𝐩𝐫𝐞𝐠𝐧𝐚𝐧𝐜𝐲 𝐩𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐨𝐧 𝐝𝐫𝐮𝐠 📌The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of strengths 0.1 mg/0.02 mg and 36.5 mg 📌The drug is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC, it added. 📌Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy. #usfda #lupin #anda

Data harmonisation for pregnancy #pharmacovigilance could be feasible as discussed in this article by affiliates of the ConcePTION Project. Using the Common Data Model and Core Data Elements developed by IMI ConcePTION, the authors discovered a significant alignment between data variables and definitions from various pregnancy-specific data access providers and the reference framework. Open access 🌐 https://lnkd.in/gRYXBYb4