Re: Provigil warning from FDA

[Guest guest]

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FDA MedWatch - The January 2008 FDA Patient Safety News Is Now Available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda. gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the January 2008 edition include:

Serious Skin and Hypersensitivity Reactions with Provigil (modafinil)

Used to reduce excessive sleepiness in adults with narcolepsy and other sleep disorders, Provigil can cause life-threatening skin and hypersensitivity reactions…

Sudden Hearing Loss from Erectile Dysfunction Drugs

Sudden hearing loss reported with PDE5 inhibitors Viagra, Levitra and Cialis…

Certain Welch Allyn Defibrillators Recalled

Defects in certain AED 10 automatic external defibrillators may cause a malfunction, and in some cases the device could fail to deliver a shock…

Marketing of Trasylol (aprotinin) Suspended

Preliminary results of a Canadian study indicate that patients may have a greater risk of death than patients taking either of two other antifibrinolytic drugs…

Warning on Fentora Buccal Tablets

Life-threatening respiratory depression can occur if fentanyl buccal tablets are used in patients who are not opioid-tolerant…

Recall of Thoratec Implantable Ventricular Assist

Devices

Air leaks may develop in the driveline when the IVAD is used outside the patient's body…

Ongoing Safety

Review of Maxipime (cefepime)

Recent study raises the possibility of an increased risk of death

among patients taking the drug…

Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment

Fires and other damage can occur to wide range of equipment, including infusion pumps, ventilators, analgesia pumps, computer workstations and monitoring equipment…

What to Do about Unretrieved Device Fragments

The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place…

For more FDA Patient Safety News, visit http://www.fda. gov/psn . Please send any comments, questions or suggestions about the program to PSNews@...

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