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Choose An Archived Content Update

While Clinical Pharmacology OnHand's content is updated daily, we post
content and feature updates to this website for review on a quarterly basis.

Content Updates
Version 2.29, February 2010

WHAT'S NEW:

None at this time.

NEW DRUG MONOGRAPHS INCLUDE:

  • aliskiren; valsartan (Valturna) – new FDA approval; combination direct renin inhibitor and angiotensin II receptor antagonist for hypertension

  • amlodipine; telmisartan (Twynsta) – new FDA-approval; combination calcium channel blocker and angiotensin II receptor antagonist for hypertension

  • chenodiol (Chenodal) – new FDA approval; oral formulation of a naturally occurring human bile acid for the dissolution of radiolucent gallstones

  • cholecalciferol, vitamin D3 – oral, non-prescription vitamin D analog

  • ecallantide (Kalbitor) – new FDA approval; kallikrein inhibitor for acute hereditary angioedema attacks

  • fospropofol (Lusedra) – water soluble prodrug of propofol for monitored anesthesia care in patients undergoing diagnostic and therapeutic procedures

  • H1N1 influenza A (swine flu) virus vaccine – new FDA approval; inactive or live-attenuated vaccine to help protect against the novel 2009 H1N1 influenza A virus

  • ofatumumab (Arzerra) – new FDA approval; CD20 targeted monoclonal antibody for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab

  • pazopanib (Votrient) – new FDA approval; oral multikinase inhibitor for advanced renal cell carcinoma

  • peramivir – investigational antiviral for H1N1 infection; FDA has issued an Emergency Use Authorization for hospitalized patients not responding to or unable to take oral drugs

  • pralatrexate (Folotyn) – new FDA approval; anti-folate agent for relapsed or refractory peripheral T-cell lymphoma

  • romidepsin (Istodax) – new FDA approval; histone deacetylase inhibitor cutaneous T-cell lymphoma in patients who have failed at least one prior systemic treatment

  • telavancin (Vibativ) – new FDA approval; anti-infective for complicated skin and skin structure infections caused by susceptible gram positive bacteria

  • tranexamic acid (Lysteda) – new FDA approved formulation and indication; oral hemostatic agent for cyclic heavy menstrual bleeding (menorrhagia)

  • ustekinumab (Stelara) – new FDA approval; interleukin 12 and interleukin 23 antagonist for plaque psoriasis in adults
UPDATED DRUG MONOGRAPHS INCLUDE:

  • albendazole (Albenza) – precautions updated for risk of seizures when used for neurocysticercosis

  • alfentanil (Alfenta) – monograph updated for risk of potential interaction with MAOIs and MAOI-active drugs

  • almotriptan (Axert) – monograph updated for dosing in patients with renal impairment and contraindicated use in patients with cerebrovascular or peripheral vascular disease

  • aripiprazole (Abilify) – monograph updates include off-label use in acute psychosis and FDA approval for autism-related irritability in children 6 years of age and older

  • candesartan (Atacand) – monograph updated for FDA-approval in the treatment of hypertension in adolescents and children older than one year of age

  • capsaicin (Quenza) – monograph updated for FDA approval of 8% dermal patch for post-herpetic neuralgia (PHN)

  • clopidogrel (Plavix) – interactions updated for FDA’s warning regarding concomitant use with proton pump inhibitors and other CYP2C19 inhibitors

  • colesevelam (Welchol) – monograph updated for new FDA-approved oral suspension and for FDA-approved use in pediatric patients with heterozygous familial hypercholesterolemia (FH)

  • deferasirox (Exjade) – contraindications updated for a potential increased risk of kidney failure, gastrointestinal hemorrhage, and death in patients with myelodysplastic syndrome

  • desvenlafaxine (Pristiq) – monograph updated for new dosage adjustment recommendations in renal impairment

  • dexmethylphenidate (Focalin XR) – indications and dosage updated for new maximum daily dosage information for the extended release formulation

  • diclofenac (Pennsaid) – monograph updated for new FDA-approved topical solution for osteoarthritis of the knees

  • dolasetron (Kytril) – ADRs updated for post-marketing reports of ventricular tachycardia, ventricular fibrillation, and cardiac arrest after IV use

  • duloxetine (Cymbalta) – monograph updated for FDA approval for maintenance treatment of generalized anxiety disorder (GAD)

  • exenatide (Byetta) – monograph updated for FDA-approved use as monotherapy

  • fenoprofen (Nalfon) – indications and dosing updated for revised FDA-approved dosing in rheumatoid arthritis and osteoarthritis

  • fentanyl (Actiq, Duragesic, Sublimaze, and others) – monograph updates include risk of potential interaction with MAOI-active drugs and contraindicated use of Actiq for headache or migraine pain

  • fosamprenavir (Lexiva) – ADRs updated for myocardial infarction, nephrolithiasis, and angioedema

  • ganciclovir (Zirgan) – monograph updated for new FDA-approved ophthalmic gel formulation

  • granisetron (Kytril) – monograph updated for warnings of QT prolongation

  • haemophilus influenza type b conjugate vaccine (ActHIB) – monograph updated for dosing recommendations in children whose booster dose was deferred due to vaccine shortage

  • influenza vaccine virus (Agriflu, Fluzone, Fluvirin) – monograph updates include new dosing recommendations in children 6 months to < 9 years for Fluzone and Fluvirin and for FDA-approval of Agriflu, an inactive, seasonal influenza vaccine for use in adults

  • levonorgestrel (Mirena) – monograph updated for new FDA-approved use for menorrhagia (heavy menstrual bleeding)

  • maraviroc (Selzentry) – monograph updated for FDA-approved, expanded indication for treatment-naïve patients with HIV

  • metformin; sitagliptin (Janumet) – monograph updated for risk of pancreatitis

  • methylene blue (Urolene Blue) – monograph updated for data indicating that methylene blue is a potent, reversible inhibitor of the monoamine oxidase A enzyme (MAO-A)

  • metoclopramide (Metozolv ODT) – monograph updated for the new FDA-approved oral disintegrating tablet

  • metronidazole (Flagyl) – monograph updated for risk of aseptic meningitis, encephalopathy, and Stevens-Johnson syndrome

  • olanzapine (Zyprexa) – monograph updated for FDA approval for schizophrenia and bipolar I disorder in adolescents

  • omeprazole; sodium bicarbonate (Zegerid OTC) – monograph updated for FDA approval of an over-the-counter formulation

  • paliperidone (Invega) – indications and dosage updated for new dosage adjustments in patients with renal impairment

  • pantoprazole (Protonix) – monograph updated for FDA-approval for erosive esophagitis in children;

  • propofol (Fresenius Propoven 1%) – monograph updated for non-FDA approved propofol product allowed for use in the US to help alleviate propofol shortage

  • quetiapine (Seroquel XR) – monograph updated for new FDA approval for depressive disorder in patients with an inadequate response to antidepressant treatment alone

  • quinine (Qualaquin) – monograph updated for boxed warning against use for leg cramps

  • raltegravir (Isentress) – indications and dosage updated for FDA-approved expanded indication for treatment in both treatment-experienced and treatment-naïve patients

  • ribavirin (Rebetol) – indications and dosage updated for weight-based dosing recommendations

  • rosuvastatin (Crestor) – monograph updated for FDA-approval in pediatric patients with heterozygous familial hypercholesterolemia (FH)

  • sildenafil (Revatio) – monograph updated for FDA-approved intravenous formulation for use in patients with pulmonary hypertension

  • sitagliptin (Januvia) – monograph updated for risk of pancreatitis

  • sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous (Osmoprep, Visicol) – precautions updated for new boxed warning for increased risk of acute phosphate nephropathy

  • telmisartan (Micardis) – monograph updated for FDA-approval for cardiovascular risk reduction in patients unable to take angiotensin-converting enzyme (ACE) inhibitors

  • zanamivir (Relenza) – precautions updated to warn against administering as a nebulized solution or in patients on mechanical ventilation

  • zidovudine (Retrovir) – monograph updated for expanded FDA-approved pediatric dosing to include infants as young as 4 weeks of age

  • ziprasidone (Geodon) – monograph updated for new FDA approval for the maintenance treatment of bipolar disorder in adults
IV COMPATIBILITY:
None at this time.
SPECIFIC CONTENT ISSUES:
Selected content issues include, but are not limited to:

  • FDA MedWatch: Drug Safety Alerts and Label Changes

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