Reading Room

NuvaRing® Safety Labeling Changes

Jon 7687

NuvaRing® is a vaginal ring contraceptive medication that was approved by the FDA in October 2001. The drug is manufactured by Organon USA, Inc., based in New Jersey, which was acquired by Schering-Plough Corporation in 2007. Since its initial FDA approval and use on the market, NuvaRing® has been linked to serious venous thromboembolic events including blood clots, pulmonary embolism, stroke and myocardial infarction, or heart attack.
 

Cephalon Changes Label of Provigil for Additional Side Effects

Jon 5991

PROVIGIL is a medication that has the active ingredient of Modanifil and is used to treat excessive sleepiness caused by certain sleep disorders. These sleep disorders are narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. In addition to its wakefulness-promoting effects, PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other central nervous system stimulants.

Cephalon Changes Label of Provigil for Additional Side Effects

Jon 5984

PROVIGIL is a medication that has the active ingredient of Modanifil and is used to treat excessive sleepiness caused by certain sleep disorders. These sleep disorders are narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. In addition to its wakefulness-promoting effects, PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other central nervous system stimulants.

Medtronic Announces Defect in Sprint Fidelis Defibrillation Leads

Jon 6594

On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have

Medtronic Announces Defect in Sprint Fidelis Defibrillation Leads

Jon 6598

On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have

Recall Of Certain Composix® Kugel® Mesh Patches Used In Hernia Repair

Jon 7526

Specific lot numbers of the Composix® Kugel® Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, were recently recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. The recall occurred after it was discovered that the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
 

Recall Of Certain Composix® Kugel® Mesh Patches Used In Hernia Repair

Jon 7527

Specific lot numbers of the Composix® Kugel® Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, were recently recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. The recall occurred after it was discovered that the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
 

ConAgra Foods Issues Pot Pie Recall

Jon 5761

Following pleas from state health officials after the Centers for Disease Control linked at least 165 cases of Salmonella in 31 states to ConAgra produced pot pies, the company finally recalled the products on Thursday, October 11, 2007.

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