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New Drug Monograph for Belviq
The FDA recently approved Belviq (lorcaserin), the first drug indicated for the long-term treatment of obesity in adult patients. Belviq tablets are taken twice daily in addition to lifestyle...
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MedWatch Safety Alert for Olmesartan Medoxomil Products
The FDA recently reported that products containing the angiotensin II receptor blocker (ARB), olmesartan medoxomil (Azor, Benicar, Benicar HCT, and Tribenzor), can cause intestinal problems. Patients...
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New Pediatric Indication for Mycamine
The FDA recently approved the echinocandin antifungal drug, Mycamine (micafungin), for use in pediatric patients greater than 4 months old to treat candidemia, acute disseminated candidiasis, candidal...
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MedWatch Safety Alert for Ketoconazole
The FDA recently issued warnings about the oral antifungal agent, ketoconazole (previously marketed as Nizoral, now only available as a generic), due to concerns about serious hepatotoxicity, adrenal...
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New Monograph for Bloxiverz
The FDA recently approved Bloxiverz, the first approved version of neostigmine. Previous versions were grandfathered products under the FDA act of 1938. Neostigmine is commonly used to reverse the...
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New Indication for Latuda
The second generation antipsychotic, Latuda (lurasidone), was recently approved to treat adults with major depressive episodes associated with bipolar I disorder, either as monotherapy or in...
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New Monograph for Tivicay
The FDA recently approved a new oral integrase strand transfer inhibitor (INSTI), Tivicay (dolutegravir), to treat HIV-1 infection. The drug is indicated for adults and children aged 12 years and older...
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New Monograph for Mirvaso
The FDA recently approved the first-in-class topical alpha-2 adrenergic agonist, Mirvaso (brimonidine topical), to treat adult patients with persistent facial erythema from rosacea. Learn more at...
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New Drug Monograph for Breo Ellipta
The FDA recently approved Breo Ellipta, a new inhaled combination corticosteroid (fluticasone furoate) and long-acting beta-2 agonist (vilanterol). Breo Ellipta is administered once daily to treat...
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MedWatch Safety Alert for Tygacil
A new boxed warning was recently added to Tygacil (tigecycline) after an FDA analysis showed a higher risk of death due to worsening infections, infection complications, or other underlying medical...
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New Indications Abound
Several drugs were recently approved to treat new indications, including Botox Cosmetic (onabotulinumtoxinA) for moderate to severe lateral canthal lines; Cimzia (certolizumab pegol) for psoriatic...
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New Indication for Cimzia
The FDA recently approved the tumor necrosis factor alpha inhibitor, Cimzia (certolizumab pegol), to treat ankylosing spondylitis in adult patients. Cimzia is also indicated to treat moderate to severe...
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MedWatch Safety Alert for Low Molecular Weight Heparins
The FDA recently issued recommendations to healthcare professionals about the timing of spinal catheter placement and removal in patients taking anticoagulants to decrease the risk of epidural or...
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MedWatch Safety Alert for Rosiglitazone-Containing Products
The FDA recently removed some prescribing and dispensing restrictions for rosiglitazone-containing drugs, including Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), and Avandaryl...
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MedWatch Safety Alert for Cardiac Nuclear Stress Test Agents
The FDA recently warned about the rare but serious risk of heart attack and death associated with the use of Lexiscan (regadenoson) and Adenoscan (adenosine) for cardiac nuclear stress tests in...
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MedWatch Safety Alert for Sodium Phosphate Products
The FDA recently issued a warning about the risk of severe dehydration and electrolyte disturbances that can lead to acute kidney injury, arrhythmias, or death from the use of OTC sodium phosphate...
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MedWatch Safety Alert for Prescription Acetaminophen Combination Drug Products
The FDA recently recommended that healthcare professionals consider prescribing combination drug products that contain 325 mg or less of acetaminophen per dosage unit. Limiting the amount of...
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New Drug Monograph for Farxiga
The FDA recently approved Farxiga (dapagliflozin), a once-daily oral tablet, to treat type 2 diabetes in adults. Farxiga is the second sodium-glucose cotransporter 2 (SGLT2) inhibitor to be available...
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New Drug Monograph for Otrexup
The FDA recently approved Otrexup (methotrexate), a new single-dose auto injector for once-weekly subcutaneous administration. It is indicated in adults with severe rheumatoid arthritis and children...
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New Indication for Imbruvica
The FDA recently expanded the approved use of Imbruvica (ibrutinib) to include treatment of chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy. Imbruvica is an...
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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...
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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...
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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),...
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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...
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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 every...
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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...
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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...
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MedWatch Safety Alert for Epidural Corticosteroid Injections
The FDA is warning providers that epidural administration of injectable corticosteroids to treat pain may result in rare, but serious neurologic adverse events, such as vision loss, stroke, paralysis,...
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Sublingual Allergen Immunotherapies Grastek, Oralair, and Ragwitek Approved
The FDA recently approved three once-daily sublingual immunotherapies for the treatment of allergic rhinitis with or without conjunctivitis: Grastek (timothy grass pollen allergen extract), Oralair...
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FDA MedWatch Safety Alert for Pradaxa
A recent FDA study of over 134,000 Medicare patients found lower risk of stroke and death, but higher risk of gastrointestinal bleeding for Pradaxa (dabigatran etexilate) when compared to warfarin. The...
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FDA MedWatch Safety Alert for Eszopiclone
The FDA recently announced a new warning that insomnia drug Lunesta (eszopiclone) can cause impairment of next-day alertness at the higher 3 mg dose. Changes to the prescribing information include a...
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Nexium 24HR Approved for OTC Use
The FDA has approved nonprescription Nexium 24HR (esomeprazole) for the treatment of frequent heartburn in adults. Nexium 24HR is available as 20 mg delayed-release capsules. Nexium 20 mg and 40 mg...
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Sivextro Approved for Acute Bacterial Skin and Skin Structure Infections in...
The FDA recently approved Sivextro (tedizolid phosphate), a new oxazolidinone antibacterial for skin and skin structure infections caused by certain gram-positive microorganisms, including...
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FDA MedWatch Safety Alert for Docetaxel
The FDA recently warned that docetaxel products contain ethanol (alcohol), potentially causing patients to feel intoxicated during and after treatment. Providers should consider the ethanol content...
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Dalvance Approved for Acute Bacterial Skin and Skin Structure Infections in...
The FDA recently approved Dalvance (dalbavancin), a new lipoglycopeptide antibacterial for skin and skin structure infections caused by certain gram-positive microorganisms, including...
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Zontivity (Oral PAR-1 Inhibitor) Approved for Thrombotic Cardiovascular Events
The FDA recently approved Zontivity (vorapaxar), a once-daily, first-in-class protease-activated receptor-1 (PAR-1) antagonist for the prevention of heart attack and stroke in patients with peripheral...
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Beleodaq Approved for Relapsed or Refractory Peripheral T-cell Lymphoma
The FDA recently approved Beleodaq (belinostat), a new histone deacetylase (HDAC) inhibitor for the treatment of relapsed or refractory peripheral T-cell lymphoma. Beleodaq is given as an IV infusion...
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Zydelig Approved for Three Types of Blood Cancers
The FDA recently approved Zydelig (idelalisib) for the treatment of three types of relapsed blood cancers: chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small...
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Errata
The Delsym Cough + Cold Day Time monograph has been updated to correct the dosing for patients >12 years old to 20 mL PO q4h prn, with a maximum dose of 120 mL/24h. The Delsym Night Time...
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Tramadol Declared Schedule IV Drug
The DEA designated the synthetic opioid analgesic tramadol a Schedule IV substance, effective August 18, 2014. Its opioid activity and abuse potential are attributable to both the parent compound and a...
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Avastin Approved for Advanced Cervical Cancer
The FDA recently approved a new indication for Avastin (bevacizumab) as treatment for persistent, recurrent, or metastatic cervical cancer when used in combination with paclitaxel and cisplatin or with...
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First-Time Generic for Precedex Available
The FDA recently approved dexmedetomidine injection, the first-time generic for Precedex. Precedex is a selective alpha-2 adrenergic agonist approved for ICU sedation and sedation of non-intubated...
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Keytruda Approved for Metastatic Melanoma
The FDA recently approved Keytruda (pembrolizumab) for melanoma deemed unresectable or progressing after therapy with ipilimumab and/or a BRAF inhibitor. Keytruda is a first-in-class monoclonal...
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Obesity Treatment Contrave Approved
Contrave, an extended-release combination of naltrexone and bupropion hydrochloride was recently approved for the treatment of obesity in conjunction with a reduced-calorie diet and exercise. Contrave...
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Xolair FDA Medwatch Safety Alert
A recent FDA review of a 5-year safety study found a slightly increased risk of serious cardiovascular and cerebrovascular adverse events in patients treated with Xolair (omalizumab). Reported adverse...
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Hydrocodone Combination Products Now Schedule II
Effective October 6, 2014, the DEA has moved hydrocodone combination products from Schedule III to Schedule II. Hydrocodone combination products are among the most widely prescribed drugs in the United...
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Harvoni, New Combination Approved for Hepatitis C
The FDA recently approved Harvoni (ledipasvir/ sofosbuvir), a once-daily oral combination tablet for the treatment of chronic hepatitis C genotype 1 infection. Harvoni contains ledipasvir, a...
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Ofev and Esbriet, First Drugs Approved for Idiopathic Pulmonary Fibrosis
The FDA recently approved Ofev (nintedanib) and Esbriet (pirfenidone), two "first-in-class" agents for the treatment of idiopathic pulmonary fibrosis (IPF). Both drugs have been shown to slow...
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Long-term Antiplatelet Therapy FDA Medwatch Safety Alert
The FDA is reviewing preliminary data from the Dual Antiplatelet Therapy (DAPT) study, which showed that long-term antiplatelet therapy following drug-eluding coronary stent implantation reduced MI and...
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Erratum
The OxyContin and generic oxycodone monographs have been updated to correct the dosing for patients with hepatic impairment. The start dose should be decreased by 50-66% and titrated slowly in these...
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