Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication

Date Issued: November 14, 2018 Audience: Patients who have an implanted pump that delivers medicine into the spinal fluid to treat or manage pain Caregivers of these patients Health care providers who manage the care of these patients Compounders Specialties: Anesthesiologists, General Surgeons, Neurosurgeons, Neurologists, Nurses and Nurse Practitioners, Orthopaedic Surgeons, Pain Management Specialists, Pharmacists,…

Fecal Microbiota for Transplantation: New Safety Information – Regarding Additional Protections for Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2

[Posted 04/09/2020] AUDIENCE: Patient, Health Professional ISSUE: Because of the potential risk of transmission of SARS-CoV-2 via Fecal Microbiota for Transplantation (FMT), FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy.  …

Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You

[embedded content] Español 简体中文 Tagalog 한국어 Việt If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. Health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have…

Ivermectin Intended for Animals: Letter to Stakeholders – Do Not Use in Humans as a Treatment for COVID-19

[Posted 04/10/2020] AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.  BACKGROUND: The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the…

How You Can Make a Difference During the Coronavirus Pandemic

Image The COVID-19 pandemic has created challenges in our everyday lives. As we each do our part to help slow the spread of coronavirus disease, we look to the helpers all around us and wonder if we, too, could do more.  Here are some ways you and your family can help. Protect Yourself and Others…

All Ranitidine Products (Zantac): Press Release – FDA Requests Removal

[Posted 04/01/2020] ISSUE:  The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.  This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen…

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture

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 Pipeline Flex Embolization Device (Available in the US) and Pipeline Flex Embolization Device with Shield Technology (Not Available in the US) Product Codes: Pipeline Flex Embolization Device:…