- Metal-on-Metal Hip Implants: Safety Communication - Updated Safety Recommendations
FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel meeting.
- Fungal Meningitis Outbreak - FDA provides NECC Customer List
[UPDATE 10/22/2012] FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.
- FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update [Update 10/18/2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC. The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.
- Massachusetts Pharmacy Linked to Meningitis Outbreak: A rare form of fungal meningitis has killed five people and sickened 30 across six states, and more are expected, health officials said. The steroid came from the New England Compounding Center in Framingham, Mass., a specialty pharmacy that has recalled three lots of the drug and shut down operations. Twenty-five of the meningitis cases -- three of them lethal -- have been in Tennessee, where more than 900 residents received the drug in the past three months.
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Food and Drug Administration (FDA): Patient Safety News
- Recalls and Safety Alerts: Update on Femur Fracture Risk with Bisphosphonates
- Recalls and Safety Alerts: Recall of Actavis Fentanyl Patches
- Recalls and Safety Alerts: New Precaution when Calculating Carboplatin Doses
- Recalls and Safety Alerts: Update on Radiation Overdoses from CT Perfusion
- Recalls and Safety Alerts: Diabetes/Cardiovascular Risk with Prostate Cancer Drugs
Food and Drug Administration--Recalls/Safety Alerts
- Golden Glen Creamery Issues Voluntary Recall Of Red Pepper Onion & Garlic Cheddar Because Of Potential Health Risk
- Unilever Issues Allergy Alert On Pints Of Ben & Jerry's Chocolate Nougat Crunch Ice Cream: Sweet Cream Ice Cream with Fudge Covered Wafer Cookies & a Chocolate Nougat Swirl
- Best Maid Cookie Company Issues Allergy Alert On Undeclared Walnut In Product
- Voluntary Recall Of Pasta Mix Products
- Botanical Laboratories Inc. Recalls Wellesse Digestive 3 in 1 Health® Because of Possible Health Risk
FDA Consumer Health Information Updates
- Children and Asthma: The Goal Is Control Though asthma in children is being diagnosed more frequently, FDA-approved drugs and devices used to treat it, as well as awareness of the conditions that trigger symptoms, can help kids with asthma to lead more active, independent lives.
- MedWatch Safety Alerts, May 2012 The Food and Drug Administration (FDA) announces safety alerts and reviews for some widely used medications. A counterfeit ADHD drug has the wrong active ingredients, some hepatitis C and HIV drugs are less effective when used together, one manufacturer’s dietary supplements have been recalled due to an undeclared ingredient, and FDA is reviewing cases involving possible deaths from an antibiotic and a drug for multiple sclerosis.
- Benzocaine and Babies: Not a Good Mix Parents should avoid using benzocaine products to relieve teething pain for children under 2. They are at risk for the disease methemoglobinemia.
- Consumer Update Analytics This page contains links to all past Consumer Update Analytics web pages.
- Database Is One-Stop Resource on Kids' Medications A new FDA database pulls the science on drug labels for kids into one place.
MedWatch Safety Alert RSS Feed
- Digestive 3 in 1 Health Liquid Dietary Supplement: Recall - Potential for Contamination With Salmonella Risk of serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems.
- Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw Risk of an unintended pregnancy for a patient taking the wrong tablet over several days.
- Reumofan Plus: Recall - Undeclared Drug Ingredient Product contains potentially harmful active pharmaceutical ingredients that may interact with other medications and result in serious adverse events.
- MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid Device malfunction may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy, leading to serious adverse health consequences, including death.
- Other-Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination UPDATED 05/30/2012. Class I Recall issued. Exposure to contaminated product may lead to serious infections.