BioMedPartners’ Post

How many of you have reached for Sudafed PE (phenylephrine) when you’ve had a head cold? Well, it turns out that phenylephrine, Sudafed PE’s main ingredient, was found to be ineffective, yet the FDA decided to keep it on store shelves. I spoke with Nina Del Rio, of @WLTW-FM radio (iHeartRadio), about Sudafed and other cold remedies, as well as my work as the sole Consumer Representative on the FDA Drug Safety and Risk Management Committee. Our conversation covered: 🟩The FDA Approval process for approving drugs 🟩Issues with phenylephrine - the main ingredient in Sudafed PE 🟩Difference between Sudafed and Sudafed PE 🟩ADHD: Questions to ask and non drug treatment Which medicines have you found effective for a cold, COVID or flu? Haneen Arafat Murphy #health #COVID #wellness

Learn about the role of #CompoundingPharmacies in addressing FDA #DrugShortage, offering personalized help with #Semaglutide or #Tirzepatide: https://bit.ly/3uMmj4y #WeightLoss #Diabetes #TCCompound #RamseyNJ #BergenCountyBusiness #WeCompoundQuality

The Drug Regulatory Authority of Pakistan in collaboration with Uppsala Monitoring Centre is launching an annual campaign to raise awareness about medication safety reporting. The National Pharmacovigilance Centre, DRAP, Reigonal and Provincial Pharmacovigilance Centres and our leading teaching Hospitals and Institutions will coordinate with us in running this social media campaign. We encourage all stakeholders to collaborate and promote awareness in the community regarding the reporting of side effects of medications. We particularly invite our esteemed healthcare professionals to participate in this important effort. #SafeMedicationforAllNations #MedSafetyWeek,

The Annual #MedSafetyWeek is fast approaching! Theme: The importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur. Using medicines correctly is essential for safety and effectiveness. Here’s are a few reasons why it’s crucial to take medicines as prescribed: 1. Maximizing Effectiveness: Medicines are designed to work best at specific doses, times, and combinations. Skipping doses, taking more than prescribed, or using medicines inconsistently can reduce their effectiveness. For chronic conditions like hypertension, diabetes, or infections, improper use may lead to treatment failure or worsened health. 2. Preventing Side Effects: Every medication has potential side effects, but these can often be minimized by following instructions precisely. Overuse or combining medications without guidance can increase the risk of side effects, ranging from mild symptoms like nausea to serious reactions like allergic responses or liver damage. 3. Avoiding Interactions: Many medications interact with each other, with foods, or even with supplements. For example, certain antibiotics and dairy products may not mix well, and some medications can cause severe interactions if taken with alcohol. Following instructions reduces the chance of harmful interactions. Following medical instructions and promptly reporting side effects isn’t only about individual health—it also contributes to public health by making medications safer and more effective for everyone. Join us for this campaign next week! #MedSafetyWeek #Pharmacovigilance #PatientSafety Participate and get involved in ensuring medicine safety through #Pharmacovigilance. Dates: 4th to 10th November 2024.

Learn more about the inspection of injectable products for visible particulates in West expert, John Rech's blog!

Learn more about the inspection of injectable products for visible particulates in West expert, John Rech's blog!

The FDA and EMA are increasing scrutiny on extractables and leachables (E&Ls) testing to better protect patient safety. E&Ls from container closure systems (CCS) are of particular concern for parenteral drugs.  Don’t worry if you’ve fallen behind with rapidly evolving regulations. We’ve summed it up for you, as well as the Mass Spectrometry solutions we recommend, in a new article. Read for expert insights into which products and delivery routes are associated with the highest safety risks. #riskassessment #compliance #FDA #EMA #drugdevelopment

FDA issues warning to Kaleo for failing to include essential risk information in an Instagram post regarding Auvi-Q. This incident emphasizes the critical need to follow FDA guidelines on advertising and promotion, ensuring both benefits and risks are transparently communicated. The FDA's updated guidance underscores the importance of presenting benefit and risk information together, especially on platforms with character limitations. By doing so, misleading advertisements are prevented, and the safe use of medical products is promoted. Staying compliant with these regulations is key to upholding transparency and protecting public health. For more details on FDA guidelines for social media advertising of prescription drugs and medical devices, visit the FDA and Policy & Medicine websites. Stay informed and uphold responsible promotional practices. #FDA #MedicalDevices #Pharmaceuticals References: 1. https://lnkd.in/g_TMBAY9 2. https://lnkd.in/ghh9urFM 3. https://lnkd.in/gMWrF-eJ

On 19 September 2024, the Committee for Medicinal Products for Human Use (#CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Synjardy (empagliflozin / metformin). The CHMP adopted a new indication to include treatment of children aged 10 years and older. For information, the full indication will be as follows:1 Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: -in patients insufficiently controlled on their maximally tolerated dose of metformin alone -in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products -in patients already being treated with the combination of empagliflozin and metformin as separate tablets. #Pharmacovigilance #Regulatory_affairs