Original Post For Immediate Release: July 17, 2023 Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to…
Read MoreOriginal Post For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by…
Read MoreOriginal Post The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use The rechargeable Walnut Wearable Smart Thermometer is a reusable thermometer that is paired with an application on a mobile phone. It is intended…
Read MoreOriginal Post For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth…
Read MoreOriginal Post Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek…
Read MoreOriginal Post Summary Company Announcement Date: May 13, 2023 FDA Publish Date: May 14, 2023 Product Type: Food & Beverages Reason for Announcement: Potential Cronobacter sakazakii contamination Company Name: Associated Wholesale Grocers, Inc. Brand Name: Gerber Good Start Product Description: Powdered Infant Formula Company Announcement On March 17, 2023, the Perrigo Company issued a voluntary…
Read MoreOriginal Post For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. “Agitation is one of the most common and challenging aspects…
Read MoreOriginal Post Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes you an opioid pain medicine, such as hydrocodone, oxycodone or morphine. Opioid medicines approved by the U.S. Food and Drug Administration can be used to treat certain kinds of acute…
Read MoreOriginal Post Date Issued: May 4, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home…
Read MoreOriginal Post [5/1/2023] FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These products are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. FDA has received reports of adverse…
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