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FDA approves adjunctive therapy to treat partial-onset seizures

The FDA approved brivaracetam (Briviact) as adjunctive treatment to other medications to treat partial-onset seizures in patients age 16 and older with epilepsy. Brivaracetam's effectiveness was studied in three clinical trials involving 1,550 participants. Brivaracetam, taken along with other medications, was shown to be effective in reducing the frequency of seizures.


Brivaracetam must be dispensed with a Medication Guide for patients, which provides important information about the medication's use and risks. The most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.


The hypersensitivity reactions, bronchospasm and angioedema, have been reported in patients taking brivaracetam. If the patient develops a hypersensitivity reaction, the drug should be discontinued. The most common adverse reactions reported by patients taking brivaracetam in clinical trials included drowsiness, dizziness, fatigue, nausea, and vomiting. Brivaracetam is marketed by UCB, Inc. of Smyrna, Georgia.


Once-daily acne gel approved

The FDA approved Allergan's dapsone gel, 7.5% (Aczone), a new prescription topical treatment for acne in patients age 12 and older. Aczone Gel, 7.5% (available nationwide in May 2016), demonstrated efficacy to treat both inflammatory and noninflammatory acne, with a new concentration of dapsone in a once-daily application delivered via pump.

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The safety and efficacy of Aczone Gel, 7.5%, were shown in randomized, multicenter, double-blind, vehicle-controlled clinical trials, and the drug was approved by the FDA based on coprimary endpoints of the Global Acne Assessment Score (GAAS) and lesion counts (20 to 50 inflammatory and 30 to 100 noninflammatory lesions at baseline). At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%) versus 13.9 lesions with just vehicle (48.1%); noninflammatory lesions were reduced by 20.7 lesions (45.1%) versus 18.0 lesions with vehicle (39.4%). The GAAS success rate in patients was 29.8% versus 21.1% with vehicle.


Aczone has a favorable tolerability profile. Patients who used Aczone Gel, 7.5%, 1.1% experienced mild application-site dryness versus 1.0% for the patients who received vehicle, and 0.9% experienced pruritus versus 0.5% with vehicle.


The most common adverse reactions of Aczone Gel, 7.5%, are dryness and itching of the skin being treated. Serious adverse reactions can include methemoglobinemia and hemolysis in those who have glucose-6-phosphate dehydrogenase deficiency. Healthcare providers should consult for important prescribing information.


Injectable NSAID approved for pediatric patients

Ibuprofen (Caldolor) injection was approved by the FDA for pediatric patients age 6 months and older for managing pain and reducing fever. The approval was based on data submitted to the FDA as part of a postmarketing commitment following approval of the drug in adults in 2009.

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The recommended dosing for pediatric patients ages 6 months to 12 years is 10 mg/kg up to a maximum single dose of 400 mg of ibuprofen infusion every 4 to 6 hours as necessary. The maximum daily dose in patients ages 6 months to 12 years is 40 mg/kg or 2,400 mg, whichever is less. The recommended dosing for managing pain and/or reducing fever for patients ages 12 to 17 is 400 mg of ibuprofen infusion every 4 to 6 hours as necessary, with a maximum daily dose of 2,400 mg. The product is diluted and administered I.V. over a 10-minute infusion.


Ibuprofen infusion has a box warning for the risk of serious cardiovascular and gastrointestinal (GI) events and should be used with caution in patients with prior history of ulcer disease or GI bleeding; in patients with fluid retention or heart failure; in older adults; in patients with kidney dysfunction or liver impairment; and patients taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers. BP should be monitored during ibuprofen treatment.