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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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New Vaccine Monograph for Afluria
The FDA has approved Afluria, a new influenza vaccine, for active immunization against influenza virus subtypes A and type B in individuals >18 years of age for the 2007-2008 flu season. Learn more...
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Epocrates ID Update
The following sections of Epocrates ID have recently been reviewed and revised: CNS, ENT, Genital, Lung, Other, Skin/Soft Tissue, Systemic, and Urinary Tract. Furthermore, there are new additions to...
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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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New Warnings for Provigil
The prescribing information for Provigil (modafinil) has recently been revised to include warnings on serious rash, including Stevens-Johnson Syndrome, hypersensitivity reactions, and psychiatric...
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Reports of Acute Pancreatitis with Byetta Use
The FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), and an association between Byetta and acute pancreatitis is suspected. Byetta is indicated for...
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Omacor (omega-3-acid ethyl esters)
Used for the treatment of hypertriglyceridemia, has been confused with Amicar (aminocaproic acid), a drug used to treat excessive bleeding from fibrinolysis, in part because both are available in 1 g...
View ArticleRevised ACIP Recommendations for Meningococcal Vaccination
The Advisory Committee on Immunization Practices (ACIP) recently revised their recommendations to include routine vaccination of all individuals 11-18 years of age with one dose of the meningococcal...
View ArticleNew Black Box Warnings for Thiazolidinediones
The FDA has determined that the thiazolidinedione class of anti-diabetics needed updated labeling with a boxed warning emphasizing the risk of heart failure. Patients should be observed carefully for...
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Additional indications for Risperdal in Children and Adolescents
The FDA has approved the use of Risperdal (risperidone) for the treatment of schizophrenia in adolescents aged 13-17 years old and for the treatment of acute manic or mixed episodes associated with...
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