FDA Patient Safety News

FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products. Huber needles are used to access ports implanted in chronically ill patients to withdraw blood and infuse ...

The manufacturer Encompass Group is alerting healthcare professionals that Thermoflect products should not be used in an MRI environment. These products, such as blankets and apparel, are intended to prevent hypothermia by keeping patients warm usin...

FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and...

To help clinicians weigh the benefits and risks of the diabetes drug Byetta (exenatide), FDA is requiring that information about the risk of renal impairment be added to the drug's labeling. From April 2005 to October 2008, FDA received 78...

Here's information about a recall of certain lots of Cleviprex injectable emulsion, an antihypertensive drug made by The Medicines Company. Vials in the recalled lots may contain particulate matter which has been found to be inert stainless ste...

FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for ove...

An article by the Institute for Safe Medication Practices (ISMP) reminds healthcare practitioners how dangerous it can be to misread the letters and numbers on prescriptions, drug orders and medical records. Unfortunately, these mistakes are easy to...

You can easily find them on the internet - products sold 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. That might make y...

FDA is warning people not to use ear candles because they can cause serious injury. An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax or paraffin. They are promoted and sold in health food stores, health ...

FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or a...

GlaxoSmithKline is notifying healthcare professionals that Lexiva (fosamprenavir calcium), a protease inhibitor, has been associated with an increased risk of myocardial infarction and dyslipidemia in HIV infected adults. The company's letter recomm...

Update 02/02/10: FDA is extending to 18 months the total recommended time period for transitioning from Steris Corporation?s modified System 1 processor (SS1) to legally-marketed alternative devices. See "Additional Information" link below. FDA ha...

FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in th...

In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine. The devices were recalled after ...

Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). The section on overdosage now notes that overdoses of this drug have resulted in a higher death rate ...

The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The commun...

The Institute for Safe Medication Practices (ISMP) has reported medication errors due to name confusion between Kapidex (dexlansoprazole) and Casodex (bicalutamide). Kapidex is used to treat erosive esophagitis and gastroesophageal reflux disease. ...

FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subty...

FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from...

GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophyl...