CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses

AUDIENCE: Eye Care, Consumer

ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira (enfilcon A) Sphere Soft Contact Lens. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

BACKGROUND: Used for the correction of myopia or hyperopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

On November 19, 2011, the firm sent a recall notification letter to the US...

AUDIENCE: Consumer

ISSUE: FDA lab analysis for Lot 10090571 found Virility Max to contain sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches...

Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury

AUDIENCE: Risk Managers, Surgery, Orthopedics

ISSUE: FDA notified health professionals of a Class I Recall of Mizuho OSI Modular Table Systems because of reports of patient injury related incidents. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Patient falls or unanticipated movement may result in serious injury or death.

BACKGROUND: Mizuho OSI Modular...

Trilipix (fenofibric acid): Drug Safety Communication - Label Change

 
AUDIENCE: Family Practice, Cardiology, Pharmacy

ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone.

Information from the trial has been added to the Important Limitations of Use and Warnings...

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation

AUDIENCE: Critical Care Medicine, Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.

BACKGROUND: The CareFusion EnVe...

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. 

Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. 

All remaining Xigris product should be returned to the supplier from whom it was purchased. 

In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit...

Chantix (varenicline)

Audience: Healthcare professionals, consumers

FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; e.g., NicoDerm patches). However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events (see the 10/24/2011 Drug Safety Communication below...