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FDA to Investigate Concerns of Violations of Approval Process With Menaflex Device
The FDA says there were inconsistencies in the approval process for the Menaflex device; the safety of the device is not in question, and the device will stay on the market, pending a review.
News, September 2009
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Potential Dosing Errors With Oseltamivir in Children
US clinicians usually prescribe liquid medicines in milliliters (mL) or teaspoons, but Tamiflu is dosed in milligrams (mg), and the dispenser is marked only in 30, 45, and 60 mg.
News, September 2009
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Cocaine Laced With Levamisole Increasing, Poses Risk for Agranulocytosis
Levamisole used as an adulterant in cocaine has resulted in 20 confirmed or probable cases of agranulocytosis, including 2 deaths.
News, September 2009
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Natalizumab Associated With Ongoing Cases of PML
Rare but ongoing cases of PML continue to be associated with the use of natalizumab, according to the FDA.
News, September 2009
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FDA Adds Boxed Warning to Injectable Promethazine
Intravenous administration of promethazine can cause severe tissue injury, including gangrene, requiring fasciotomy, skin graft, and/or amputation, according to the FDA.
News, September 2009
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FDA Recalls Portex Ventilation Tubes
Portex uncuffed pediatric-sized tracheal tubes in sizes 2.5, 3.0, and 3.5 mm were the subject of a voluntary recall because the tube diameters are slightly smaller than indicated on the label.
News, September 2009
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Recall of Certain ConMed Surgical Tool Accessories
The products have been recalled because of a malfunction that could cause attachments, such as surgical saws and drills, to turn on by themselves or continue running after the trigger is shut off.
News, September 2009
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FDA Recalls Certain Lots of Covidien Carbon Dioxide Detector
The FDA announced that the device could malfunction by increasing the resistance of airflow into the lungs, resulting in ineffective ventilation, which could cause serious or even fatal complications.
News, September 2009
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FDA Warns of Potential Inaccurate Readings by Philips Avalon Fetal Monitor
Fetal monitors made by Philips Healthcare, Avalon Models FM20, FM30, FM40, and FM50 and ultrasound transducer, may produce inaccurate readings, the FDA has announced.
News, September 2009
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FDA Posts Q&As on Cancer Risk With TNF Blockers in Children
The FDA announced yesterday it has posted supplemental Q&As on the increased risk for lymphoma and other cancers in children and adolescents receiving the tumor necrosis factor (TNF) blockers infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), and golimumab (Simponi).
News, September 2009
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FDA Revises Warning for Etravirine
The FDA has issued an alert to warn of severe skin reactions and possible life-threatening adverse events in patients who use etravirine.
News, August 2009
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FDA to Investigate Liver-Related Adverse Events Seen With Orlistat
The FDA has warned healthcare professionals about the potential for liver-related adverse events with the weight-loss drug orlistat.
News, August 2009
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Accusure Insulin Syringes Voluntarily Recalled
Accusure insulin syringes distributed nationwide from January 2007 through June 2008 are undergoing voluntary recall because of the detachment of needles from the syringes.
News, August 2009
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GDH-PQQ Glucose Test Strips May Produce Falsely Elevated Results
The FDA is warning of possible falsely elevated blood glucose results from GDH-PQQ glucose test strips in patients receiving products containing certain nonglucose sugars.
News, August 2009
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FDA Updates Warnings for TNF Blockers and Cancer Risk
The FDA is requiring stronger warnings regarding the risk for cancer associated with tumor necrosis factor blockers.
News, August 2009
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Botulinum Toxin Safety Warnings Updated and Name Changes Issued
The FDA has announced revisions to both the prescribing information and the names of botulinum toxin products.
News, August 2009
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Omalizumab May Be Linked to Cardiovascular Adverse Events
Results of an interim analysis suggest that omalizumab (Xolair) may be associated with a disproportionate increase in the incidence of certain cardiovascular adverse events.
News, July 2009
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FDA Adds Infection Warnings to Immunosuppressant Labels
Makers of several immunosuppressant agents will be required to update their labeling to emphasize that patients who take them are at increased risk for infections and associated complications.
News, July 2009
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Tissue Retained in Arthroscopic Shavers After Cleaning, FDA Warns
The FDA has alerted healthcare professionals about the possibility of pieces of tissue remaining in arthroscopic shavers after cleaning.
News, July 2009
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FDA Adds Stronger Warnings to Propoxyphene
The FDA is adding stronger warnings to pain medications that contain propoxyphene, such as Darvon and Darvocet, because of new data on fatal overdoses linked to propoxyphene products.
News, July 2009
