FDA Patient Safety News

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 ...

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...

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...

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...

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...

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...

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...

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 ...

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...

FDA has approved a new formulation of the controlled-release drug OxyContin that is designed to be more difficult to manipulate by someone trying to misuse or abuse the medication. OxyContin tablets contain the opioid analgesic oxycodone, which is r...

FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. The patch is called TachoSil and it is made by Nycomed. The patch provides an additional tool for surgeons t...

Through a new boxed warning, the FDA is alerting healthcare professionals about a subgroup of patients who cannot effectively metabolize the anti-platelet drug Plavix (clopidogrel). These patients, called "poor metabolizers," have little or no a...

FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. Simvastatin is sold as Zocor, and is also an i...

FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dos...

Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade (deferasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from m...

Baxter Healthcare and Cangene Corporation are notifying healthcare professionals that intravascular hemolysis (IVH), which can be fatal, has occurred in patients with immune thrombocytopenic purpura treated with WinRho SDF, an intravenous immune glob...

A recent FDA article in the journal Nursing2010 describes a variety of problems associated with temporary pacing leads. Temporary pacing is used during emergency treatment of some bradyarrhythmias and tachyarrhythmias, and also used prophylactically...

Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, ...

FDA is informing healthcare practitioners and patients that certain metered-dose inhalers used to treat asthma and chronic pulmonary obstructive disease will be gradually removed from the market because they use chlorofluorocarbons (CFCs) as propella...

FDA has approved a new pneumococcal vaccine that provides broader protection for infants and young children ages six weeks through five years. The new vaccine, called Prevnar 13, is effective against 13 serotypes of the bacterium Streptococcus pneum...