Self-Injury and Delirium in Children After Tamiflu
The FDA has notified healthcare practitioners about changes made to the labeling of oseltamivir phosphate (Tamiflu capsules and suspension) to warn of the potential risk for neuropsychiatric events associated with its use.
The warning was based on postmarketing reports primarily from Japan of self-injury and delirium with the use of Tamiflu in patients with influenza.
People with the flu, especially children, may be at increased risk of self-injury and confusion shortly after taking Tamiflu, according to the FDA, and should be closely monitored for signs of unusual behavior.
Medication for Psoriatic Arthritis
Abbott's arthritis treatment adalimumab (Humira) is now approved to inhibit joint damage and improve physical function in patients with psoriatic arthritis. The tumor necrosis factor (TNF)-blocker was approved a year ago to treat psoriatic arthritis.
Adalimumab is also approved for use in moderate-to-severe rheumatoid arthritis and active ankylosing spondylitis.
The new indication was granted based on evidence from a large, 24-week randomized, placebo- controlled trial in patients with psoriatic arthritis who had an inadequate response to nonsteroidal anti-inflammatory therapy. In the trial, patients taking adalimumab had 10 times less average progression to joint damage than patients taking placebo; more than three times as many patients taking placebo experienced joint damage compared with patients taking the medication. Patients taking adalimumab also showed significant improvement in the Health Assessment Questionnaire Disability Index.
Serious infections, sepsis, tuberculosis, and rare cases of opportunistic infections have been reported with the use of TNF-blocking medications, including adalimumab. Consult product labeling for prescribing details and safety information.
Emergency Contraceptive Plan B Now Available
The over-the-counter (OTC) version of Duramed's levonorgestrel (Plan B) emergency contraceptive is now available for women at least 18 years of age. Women under the age of 18 will continue to need a prescription in order to receive Plan B. The dual-labeled OTC/prescription product replaces the Plan B prescription-only product that has been marketed since 1999.
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89% after a single act of unprotected intercourse.
Because Plan B remains a prescription product for women 17 and younger, it is sold only in retail pharmacy outlets from behind the pharmacy counter and under the supervision of a pharmacist.
Duramed has implemented a CARE program to provide information to pharmacists, healthcare providers, and consumers about Plan B.
New Indications for Fexofenadine
Fexofenadine 30 mg/5 mL oral suspension (Allegra) is now approved for the twice-daily treatment of seasonal allergic rhinitis in children 2 to 11 years of age and for uncomplicated chronic idiopathic urticaria in children 6 months to 11 years of age. The product will be raspberry-cream flavored.
The recommended dosing regimen for pediatric patients ages 2 to 11 years with seasonal allergic rhinitis is 30 mg (5 mL) twice daily. Children with decreased renal function should be dosed 30 mg once daily. Twice-daily 30 mg dosing is also recommended for treating chronic idiopathic urticaria in patients aged 2 to 11 years. Children 6 months to 2 years of age should get a reduced twice-daily dose of 15 mg (2.5 mL).
Adverse events reported in clinical trials of the fexofenadine oral suspension were similar to those for placebo and most commonly included vomiting, pyrexia, cough, otitis media, and diarrhea. 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.