Medication Monitor

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Generic Name (Trade Name—Company)
  • August 29, 2018

    Ortho Dermatologics announced FDA approval of tretinoin 0.05% lotion as a topical treatment of acne vulgaris in patients aged 9 years and older.

    The product, the first formulation of a tretinoin in a lotion, has been shown to be effective and generally well tolerated. It spreads easily and is quickly absorbed into the skin, allowing patients with acne to easily incorporate the once-daily treatment into their skin care regimen, stated the news release. 

    Extensive clinical data have shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness, peeling, and sensitivity.

    Tretinoin lotion was evaluated in two identical multicenter, randomized, double-blind, vehicle-controlled Phase III studies totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that use of the product resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with placebo.

    The most common adverse reactions, occurring in greater than 1% of participants and greater than placebo, were dryness, pain erythema, irritation, and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided.

    The product is expected to become available during the fourth quarter of 2018. 

  • August 29, 2018

    Kala Pharmaceuticals announced FDA approval of loteprednol etabonate ophthalmic suspension 1% under the trade name Inveltys for the treatment of postoperative inflammation and pain following ocular surgery. It is the first twice-daily ocular corticosteroid approved for this indication.

    In a news release, Kala stated that all other ocular steroids are approved for four-times-a-day dosing only, a dosing requirement that can lead to issues for both doctors and patients. Corticosteroids are the foundation of therapy for postocular surgery care, with the key goal of controlling inflammation and pain caused by surgical trauma to the eye.

    In clinical trials, the most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure.

  • August 28, 2018

    Tetraphase Pharmaceuticals announced FDA approval of eravacycline for the treatment of complicated intra-abdominal infections (cIAI) in patients aged 18 years and older.

    In clinical trials, eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical noninferiority to two widely used comparators—ertapenem and meropenem.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of eravacycline and other antibacterial drugs, eravacycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Eravacycline is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity reactions have been reported with use of the drug.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion-site reactions, nausea, and vomiting. 

  • August 28, 2018

    FDA approved lanadelumab, the first monoclonal antibody approved in the United States to treat patients aged 12 years and older with types I and II hereditary angioedema (HAE).

    HAE is a rare and serious genetic disease that affects an estimated 1 in 50,000 men and women with low levels of and poorly functioning C1-INH proteins. This results in recurrent, unpredictable episodes of severe swelling in different areas of the body, including the stomach, limbs, face, and throat.

    Type I is the most common and accounts for 85% of cases. Symptoms of HAE typically begin in childhood and worsen following puberty. Some patients may have many attacks each month, while others will go months without an attack.

    FDA based its approval on data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 125 patients with HAE. Patients who received lanadelumab had clinically meaningful and statistically significant reductions in the rate of investigator-confirmed HAE attacks compared with placebo over a 6-month treatment period.

    The most common adverse reactions in clinical trials were injection-site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness, and diarrhea.

  • August 28, 2018

    FDA approved stiripentol for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy. Stiripentol is indicated for use in patients aged 2 years and older who are taking clobazam. There are no clinical data to support the use of stiripentol as monotherapy in Dravet syndrome.   

    Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures. Later, other types of seizures typically appear, including myoclonic seizures. In addition, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.

    The most common adverse effects reported with stiripentol are somnolence, decreased appetite, agitation, impaired coordination and balance, weight loss, low muscle tone, nausea, tremor, dysarthria, and insomnia.   

    Stiripentol must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks. As is true for many other drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.