Epocrates Drug Updates - Editor's Pick

April 17, 2014
Otezla, Oral PDE4 Inhibitor Approved for Psoriatic Arthritis

The FDA recently approved Otezla (apremilast), available as oral tablets, for the treatment of active psoriatic arthritis in adults. Although its exact mechanism of action is not fully defined, Otezla inhibits phosphodiesterase 4 (PDE4), resulting in increased intracellular cyclic adenosine monophosphate (cAMP).

Otezla, Oral PDE4 Inhibitor Approved for Psoriatic Arthritis

Recent Updates

April 10, 2014
FDA MedWatch Safety Alert for Revatio
Revatio (sildenafil) is a phosphodiesterase inhibitor FDA-approved for pulmonary arterial hypertension (PAH) in adults. The drug has been used to treat PAH in children, which is not an FDA-approved indication. The FDA previously issued a warning after a long-term clinical trial showed an increased risk of mortality with increasing Revatio doses in children with PAH. The FDA is now clarifying its earlier recommendation, stating that while pediatric use is not recommended, there may be situations when the benefits of treatment may outweigh the risks in children with PAH. FDA MedWatch Safety Alert for Revatio

March 27, 2014
Xartemis XR, First Extended Release Oxycodone/Acetaminophen Product Available
The FDA recently approved Xartemis XR (oxycodone/acetaminophen), a Schedule II opioid agonist combo product available as a 7.5 mg oxycodone/325 mg acetaminophen extended-release oral tablet, given as 2 tablets every 12 hours. Xartemis XR is for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Xartemis XR is the first extended-release oxycodone/acetaminophen combo product approved in the US. Xartemis XR, First Extended Release Oxycodone/Acetaminophen Product Available

March 20, 2014
Anoro Ellipta Approved for COPD
The FDA recently approved Anoro Ellipta, a new inhaled combination anticholinergic (umeclidinium) and long-acting beta-2 agonist (vilanterol). Anoro Ellipta is administered once daily to treat chronic obstructive pulmonary disease in adult patients. Anoro Ellipta Approved for COPD

March 13, 2014
MedWatch Safety Alert for Doribax (doripenem)
Doribax (doripenem) is an antibacterial agent FDA-approved for complicated intra-abdominal and urinary tract infections. The drug has been used to treat ventilator-associated bacterial pneumonia (VAP), which is not an FDA-approved indication. A recent clinical trial in patients with VAP was stopped early when results showed an increased risk of mortality and lower clinical cure rates with doripenem compared to impenem/cilastin. The FDA recommends health care professionals should consider whether the benefits of doripenem treatment are likely to exceed its potential risks in patients who develop VAP. MedWatch Safety Alert for Doribax (doripenem)

March 13, 2014
New Drug Monograph for Zohydro ER
The FDA recently approved Zohydro ER (hydrocodone), a Schedule II opioid agonist available as an extended-release oral capsule given every 12 hours. Zohydro ER is for the management of moderate to severe chronic pain that requires daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER is the first single entity extended-release hydrocodone product approved in the US. New Drug Monograph for Zohydro ER

February 27, 2014
New Drug Monograph for Duavee
The FDA recently approved Duavee (estrogens, conjugated/bazedoxifene), a once-daily oral tablet, to treat moderate-to-severe menopausal vasomotor symptoms in women with an intact uterus. It is also indicated for the prevention of postmenopausal osteoporosis. Duavee is the first product in the United States to combine a conjugated estrogen with a selective estrogen receptor modulator (SERM). New Drug Monograph for Duavee

New Drug Monographs

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