US FDA Patient Safety News
New Medical Products: New Cellular Immunotherapy for Advanced Prostate Cancer
The FDA has approved a new therapy for certain men with advanced prostate cancer called Provenge (sipuleucel-T). Provenge, an autologous cellular immunotherapy, is manufactured by Dendreon Corporation. It is intended for men with asymptomatic or mi...…
Recalls and Safety Alerts: Warning on Liver Injury with Propylthiouracil
In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil. This drug, which is used to treat hyperthyroidism, is considered second-line therapy ...…
Recalls and Safety Alerts: Medication Guide Required for Vivitrol
The pharmaceutical company Alkermes has developed a Medication Guide for patients being treated with Vivitrol. Vivitrol (naltrexone for extended-release injectable suspension) is administered intramuscularly to treat alcohol dependence. The Medi...…
Recalls and Safety Alerts: Certain AQUA+FLEX Humidifiers Recalled
Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers. These devices are passive humidifiers used during mechanical ventilation to warm and humidify inspired gas. The company has received complaints that ...…
Recalls and Safety Alerts: Recall of Shiley Cuffed Tracheostomy Tubes
Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air. If a cuff does not stay inflated, a patient's ventilation could be compromised, which could lea...…
Recalls and Safety Alerts: Using External Infusion Pumps Safely
External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. They can improve patient care by delivering drugs and other substances with a high level of control, accuracy, and precision. But...…
Preventing Medical Errors: Parent Errors in Measuring Children?s Doses
The Institute for Safe Medication Practices (ISMP) recently reported on a study of the errors parents make when measuring children's doses of oral medications. In the study, 300 parents were observed as they attempted to measure liquid doses using d...…
Advice for Patients: Warning on Swallowing Benadryl Topical Gel
FDA is warning people not to swallow Benadryl Extra Strength Itch Stopping Gel, an OTC product that should only be used on the skin. FDA has received a number of reports where people experienced serious side effects after mistakenly swallowing t...…
Advice for Patients: Warning about Lipodissolve Products
FDA is cautioning the public about products used in lipodissolve procedures. Lipodissolve is a cosmetic procedure where people are given a series of injections with the intent of dissolving pockets of fat in the body. The process, also known as lip...…
