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Generic Rx-only version of emergency contraceptive

The FDA has approved the first generic version of the emergency contraceptive levonorgestrel (Plan B) 0.75 mg for prescription treatment of women age 17 and under. The generic tablet is made and marketed by Watson Laboratories, Inc. Watson plans to call its generic prescription product Next Choice.


Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure.


Duramed's Plan B was first approved in 1999 for prescription use only for women of all ages. In 2006, Plan B was approved for nonprescription use for women age 18 and older. Plan B remained available as prescription-only for women ages 17 and under.


Infection risk with TNF-alpha blockers

Centocor Ortho Biotech and the FDA have reminded healthcare professionals of the risk of serious fungal infections associated with TNF-alpha blockers, including golimumab (Simponi). The FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-alpha blockers including certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade). This has caused delays in appropriate antifungal treatment, sometimes resulting in death.


The agency informed practitioners that all adverse events potentially associated with Simponi should be reported so that the adverse event profile can be updated appropriately as data are gathered.


Centocor encourages reporting adverse events to the company at 1-800-457-6399 or to the FDA Medwatch program at 1-800-332-1088.


Injectable form of ibuprofen approved

Caldolor, a product of Cumberland Pharmaceuticals, is the first injectable dosage form of ibuprofen approved for the treatment of pain and fever. The drug is an alternative to injectable opioid pain therapy.


Caldolor will be available for hospital use only. It is approved for administration in 400-mg to 800-mg doses over 30 minutes every 6 hours for acute pain. For treatment of fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100 to 200 mg every 4 hours as necessary.

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In a clinical trial of women who had undergone elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when they were given Caldolor.


The most common adverse events reported were nausea, flatulence, vomiting, and headache. It has also been associated with high BP, serious skin reactions, and serious allergic reactions, according to the FDA.


Caldolor should be used with caution in patients with heart failure, kidney impairment, those at risk for thromboembolism, and those who have a history of ulcers or gastrointestinal bleeding.


Medication Update alerts readers to new drug approvals and other timely drug information. Healthcare providers should not make clinical decisions from these announcements, as they are not comprehensive.


Labeling changes for leukotriene modifiers

The manufacturers of leukotriene modifiers have been asked by the FDA to include a precaution on their medications' labeling regarding neuropsychiatric events that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).


The events include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

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Patients and healthcare providers should be aware of the potential for neuropsychiatric events with these medications. The FDA recommends that healthcare professionals consider discontinuing these medications if patients develop neuropsychiatric symptoms.