Recalls and warnings
A warning that rare but serious allergic reactions have been reported with skin antiseptic products containing chlorhexidine gluconate. The number of such reports has increased in recent years. The FDA is requesting that manufacturers add a label warning about this risk on over-the-counter antiseptic products containing chlorhexidine gluconate. Clinicians should always ask patients if they've ever had an allergic reaction to an antiseptic before recommending or prescribing products containing chlorhexidine gluconate.
A class I recall of the Comprehensive Reverse Shoulder device due to higher fracture rates than stated in the labeling. The recall includes more than 3,650 shoulder replacement devices manufactured between Aug. 25, 2008, and Sept. 27, 2011, and distributed from October 2008 to September 2015.
Brodalumab (Siliq) to treat adults with moderate-to-severe plaque psoriasis. The injection is intended for patients who are candidates for systemic therapy or phototherapy but have not responded or have stopped responding to other systemic therapies. The active ingredient, brodalumab, binds to a protein that causes inflammation, thereby inhibiting the inflammatory response involved in the development of plaque psoriasis. Safety and efficacy were established in three randomized, placebo-controlled trials of 4,373 adults. More patients who received the drug compared to those treated with placebo had skin that was clear or almost clear after treatment. Suicidal ideation and behavior, including completed suicides, occurred in patients treated with brodalumab during clinical trials, and those with a history of suicidality or depression had an increased incidence of these side effects compared to users without such history. Because of this observed risk, the drug label includes a boxed warning, and the drug is only available under the Siliq Risk Evaluation and Mitigation Strategy (REMS) Program. The most common adverse reactions include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and fungal infections.
Deflazacort (Emflaza) tablets and oral suspension to treat patients ages 5 and older with Duchenne muscular dystrophy. Designated as an orphan drug, the corticosteroid works by decreasing inflammation and reducing immune system activity. Effectiveness was shown in two studies of 225 male patients, who demonstrated improvements in average muscle strength when treated with the drug compared with placebo. Side effects are similar to those of other corticosteroids (e.g., Cushingoid appearance, weight gain, upper respiratory tract infection), and less common side effects include problems with endocrine function, increased susceptibility to infection, and elevation in blood pressure.
First-time generic approvals
Levetiracetam in sodium chloride injection (500 mg/100 mL, 1,000 mg/100 mL, 1,500 mg/100 mL), an antiepileptic drug indicated for adjunct therapy in adults ages 16 and older with certain seizure types when oral administration is temporarily not feasible. (Brand names: Keppra, Levetiractam)
Sodium oxybate oral solution (500 mg/mL) to treat cataplexy and excessive daytime sleepiness in narcolepsy. (Brand name: Xyrem)
Dalfampridine extended-release tablets (10 mg) to improve walking in patients with multiple sclerosis. (Brand name: Ampyra)
Memantine hydrochloride and donepezil hydrochloride extended-release capsules (14 mg/10 mg, 28 mg/10 mg) to treat moderate to severe dementia of the Alzheimer's type. (Brand name: Namzaric)
Cefixime for oral suspension USP (500 mg/5 mL) to reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension. (Brand name: Suprax)
Logilia ulipristal acetate (30 mg) for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. (Brand names: Ella, Esmya)