Epocrates Drug Updates

New Boxed Warning for Smoking Cessation Aids

Wed, 15 Jul 2009 08:00:00 GMT

The FDA is requiring the manufacturers of varenicline (Chantix) and bupropion (Zyban and generics) to add boxed warnings for the risk of serious neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. Learn more at www.epocrates.com

New Drug Monograph for Exforge HCT

Wed, 8 Jul 2009 08:00:00 GMT

The FDA recently approved the first triple combination calcium channel blocker, angiotensin receptor blocker, and diuretic, Exforge HCT (amlodipine/valsartan/hydrochlorothiazide), to treat hypertension in adult patients who have not achieved adequate blood pressure control on dual therapy. Learn more at www.epocrates.com

New Drug Monograph for Nucynta

Wed, 24 Jun 2009 08:00:00 GMT

Nucynta (tapentadol), an oral mu opioid agonist and norepinephrine reuptake inhibitor, was recently approved for the treatment of acute moderate to severe pain in adult patients. Learn more at www.epocrates.com

New Drug Monograph for Simponi

Wed, 17 Jun 2009 08:00:00 GMT

The tumor necrosis factor inhibitor Simponi (golimumab) was recently approved to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in adult patients. Learn more at www.epocrates.com

New Warning for propylthiouracil

Wed, 10 Jun 2009 08:00:00 GMT

The FDA recently issued a MedWatch Safety Alert regarding the drug propylthiouracil (PTU) and the risk of serious liver injury, including liver failure and death. The FDA recommends that PTU be reserved for patients allergic to or intolerant of methimazole, or in their first trimester of pregnancy. Patients taking PTU should be carefully monitored for signs and symptoms of liver injury, especially in the first six months of therapy. Learn more at www.epocrates.com

New Pediatric Indication for Axert

Wed, 03 Jun 2009 08:00:00 GMT

The FDA recently approved Axert (almotriptan) for the treatment of acute migraine in pediatric patients 12-17 years of age. Learn more at www.epocrates.com

New Drug Monograph for Gelnique

Wed, 27 May 2009 08:00:00 GMT

The anticholinergic drug Gelnique (oxybutynin topical) was recently approved to treat symptoms of overactive bladder in adult patients. Learn more at www.epocrates.com

New Boxed Warning for Botulinum Toxin Products

Wed, 20 May 2009 08:00:00 GMT

Manufacturers of botulinum toxin products (Botox, Botox Cosmetic, Myobloc) will be required by the FDA to add a boxed warning about the potential spread of the product beyond the treatment area. Distant spread of the toxin could result in swallowing and breathing difficulties, including fatal events. Learn more at www.epocrates.com

New Boxed Warning for Topical Testosterone Gel Products

Wed, 13 May 2009 08:00:00 GMT

The FDA is requiring a boxed warning in the labeling for the topical testosterone gels AndroGel and Testim due to the risk of secondary exposure. The boxed warning advises women and children to avoid direct contact with application sites in order to reduce the risk of exposure and subsequent adverse effects. Learn more at www.epocrates.com

New Drug Monograph for Afinitor

Wed, 06 May 2009 08:00:00 GMT

The new oral kinase inhibitor Afinitor (everolimus) was recently launched for the treatment of advanced renal cell cancer in patients refractory to sunitinib or sorafenib therapy. Learn more at www.epocrates.com

Anti-Viral Drug Dosing for Swine Flu

Wed, 29 Apr 2009 08:00:00 GMT

Based on CDC recommendations, dosing for the prophylaxis and treatment of swine influenza A (H1N1) has been added to the monographs for Tamiflu (oseltamivir) and Relenza (zanamivir). Learn more at www.epocrates.com

New Drug Monograph for Savella

Wed, 22 Apr 2009 08:00:00 GMT

The new selective serotonin and norepinephrine reuptake inhibitor drug Savella (milnacipran) was recently launched for the treatment of adult patients with fibromyalgia. Learn more at www.epocrates.com

New Drug Monograph for Rapaflo

Wed, 15 Apr 2009 08:00:00 GMT

The new alpha-blocker drug Rapaflo (silodosin) was recently launched for the treatment of benign prostatic hyperplasia (BPH). Learn more at www.epocrates.com

First-Time Generic Topiramate Now Available

Wed, 08 Apr 2009 08:00:00 GMT

The generic drug topiramate (brand Topamax) is now available for the treatment of primary generalized tonic-clonic, partial, and Lennox-Gastaut seizures in adults and children over two years old, as well as migraine prophylaxis in adult patients. Learn more at www.epocrates.com

New Indication for Tygacil

Wed, 01 Apr 2009 08:00:00 GMT

Tygacil (tigecycline), indicated for the treatment of complicated intra-abdominal infections and complicated bacterial skin/skin structure infections, has recently been approved for use in adults with community-acquired pneumonia. Learn more at www.epocrates.com

New Pediatric Indication for PEG-Intron and Rebetol Combination Therapy

Wed, 25 Mar 2009 08:00:00 GMT

The FDA recently approved the combination therapy of PEG-Intron (peginterferon alfa 2b) and Rebetol (ribavirin) therapy to treat chronic hepatitis C infection in pediatric patients greater than 3 years of age. Learn more at www.epocrates.com

New Drug Monograph for Kapidex

Wed, 18 Mar 2009 08:00:00 GMT

The FDA recently approved the new proton pump inhibitor Kapidex (dexlansoprazole) for the treatment of GERD and erosive esophagitis in adult patients. Learn more at www.epocrates.com

New Drug Monograph for Toviaz

Wed, 11 Mar 2009 08:00:00 GMT

The FDA recently approved the new drug Toviaz (fesoterodine) for the treatment of overactive bladder in adults. Learn more at www.epocrates.com

New Boxed Warning for Metoclopramide

Wed, 05 Mar 2009 08:00:00 GMT

The FDA recently issued a MedWatch Safety Alert regarding metoclopramide-containing drugs (Reglan, generics) and the risk of tardive dyskinesia associated with long-term and/or high-dose use. Learn more at www.epocrates.com

New Warning for Zonegran

Wed, 25 Feb 2009 08:00:00 GMT

The FDA recently issued a MedWatch Safety Alert regarding the antiepileptic drug Zonegran (zonisamide) and the risk of metabolic acidosis. The risk may be higher in younger patients and patients with renal disease, severe respiratory disorders, diarrhea, surgery, ketogenic diet, or concomitant use of other drugs. The FDA is recommending that prescribers measure serum bicarbonate before therapy is initiated, and periodically during the course of treatment with zonisamide. Learn more at www.epocrates.com

New Drug Monograph for Vectical

Wed, 18 Feb 2009 08:00:00 GMT

The FDA recently approved Vectical (calcitriol topical) for the treatment of mild to moderate plaque psoriasis in adult patients. Learn more at www.epocrates.com

New Drug Monograph for Banzel

Wed, 04 Feb 2009 08:00:00 GMT

The FDA recently approved Banzel (rufinamide) for the adjunct treatment of Lennox-Gastaut seizures in adults and children 4 years and older. Learn more at www.epocrates.com

New Drug Monograph for Latisse

Wed, 28 Jan 2009 08:00:00 GMT

The FDA recently approved the prostaglandin analog Latisse (bimatoprost ophthalmic) for the topical treatment of eyelash hypotrichosis in adults. Learn more at www.epocrates.com

First-Time Generic Available for Zerit

Wed, 21 Jan 2009 08:00:00 GMT

The generic nucleoside reverse transcriptase inhibitor, stavudine, has been recently launched for the treatment of HIV infection in pediatric and adult patients. Learn more at www.epocrates.com

MedWatch Safety Alert for Innohep

Wed, 14 Jan 2009 08:00:00 GMT

A controlled clinical study suggests that Innohep (tinzaparin) may increase the risk of death in elderly patients with renal insufficiency compared to unfractionated heparin. The manufacturer is recommending other alternatives in this patient population when treating deep vein thrombosis, with or without pulmonary embolism. Learn more at www.epocrates.com

New Drug Monograph for Promacta

Wed, 07 Jan 2009 08:00:00 GMT

The FDA recently approved the oral drug Promacta (eltrombopag) for the treatment of chronic idiopathic thrombocytopenia (ITP) in adults. Learn more at www.epocrates.com

First-Time Generic Available for Imitrex

Wed, 24 Dec 2008 08:00:00 GMT

Generic oral sumatriptan was recently launched for the treatment of acute migraine headache in adult patients. Learn more at www.epocrates.com

New Black Box Warning for Visicol and OsmoPrep

Wed, 17 Dec 2008 08:00:00 GMT

The FDA recently released a MedWatch safety summary regarding the risk of acute kidney injury associated with oral sodium phosphate (OSP) products used for bowel cleansing. The FDA is also recommending that consumers not use over-the-counter laxative OSP products for bowel cleansing. Learn more at www.epocrates.com

FDA Alert for Phenytoin and Fosphenytoin

Wed, 10 Dec 2008 08:00:00 GMT

New data suggests a possible association between HLA-B*1502 and phenytoin or fosphenytoin-induced serious skin reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Because of the known association between phenytoins and SJS/TEN, healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. Learn more at www.epocrates.com

New Pediatric Indication for Videx EC

Wed, 04 Dec 2008 08:00:00 GMT

The FDA recently approved the use of Videx EC (didanosine) for the treatment of HIV in pediatric patients greater than 20 kg. Learn more at www.epocrates.com

Labeling Changes for Ranexa

Wed, 26 Nov 2008 08:00:00 GMT

The FDA recently approved Ranexa (ranolazine) for the first-line treatment of chronic angina. This medication may now be used alone or in combination with beta-blockers, calcium channel blockers, and nitrates. Learn more at www.epocrates.com

New Drug Monograph for Sancuso

Wed, 19 Nov 2008 08:00:00 GMT

The FDA recently approved Sancuso (granisetron transdermal), a patch for the prevention of chemotherapy-induced nausea and vomiting in adults receiving highly- or moderately-emetogenic chemotherapy. Learn more at www.epocrates.com

New Drug Monograph for Akten

Wed, 12 Nov 2008 08:00:00 GMT

The FDA recently approved Akten (lidocaine ophthalmic) a topical anesthetic for use during brief ophthalmic procedures. Learn more at www.epocrates.com

New Drug Monograph for Cleviprex

Wed, 05 Nov 2008 08:00:00 GMT

The FDA recently approved Cleviprex (clevidipine), an intravenous dihydropyridine calcium channel blocker used for the short-term treatment of hypertension when oral therapy is not feasible. Learn more at www.epocrates.com

New Drug Monograph for Nplate

Wed, 22 Oct 2008 08:00:00 GMT

Nplate (romiplostim), a thrombopoietin receptor agonist, was recently launched for the treatment of chronic immune (idiopathic) thrombocytopenia purpura (ITP) in adult patients with an insufficient response to standard therapies and an increased risk of bleeding. Learn more at www.epocrates.com

New Drug Monograph for Primalev

Wed, 08 Oct 2008 08:00:00 GMT

Primalev (acetaminophen/oxycodone) was recently launched for the treatment of moderate to moderate-severe pain, and features a lower strength of acetaminophen compared to similar products. Learn more at www.epocrates.com

New Drug Monograph for Rotarix

Wed, 24 Sep 2008 08:00:00 GMT

The FDA has approved Rotarix (rotavirus vaccine, live oral), a vaccine for the prevention of rotavirus gastroenteritis in infants and children. Learn more at www.epocrates.com

New Drug Monograph for Fusilev

Wed, 17 Sep 2008 08:00:00 GMT

The FDA has approved Fusilev (levoleucovorin), a folate analog indicated for rescue therapy after high-dose methotrexate. Learn more at www.epocrates.com

New Drug Monograph for Alvesco

Wed, 20 Aug 2008 08:00:00 GMT

The FDA has approved Alvesco (ciclesonide inhaled), an inhaled corticosteroid for maintenance therapy of asthma in adults and adolescents 12 years and older. Learn more at www.epocrates.com

New Drug Monograph for Ocella

Wed, 13 Aug 2008 08:00:00 GMT

The FDA has approved Ocella (drospirenone/ethinyl estradiol), a branded generic for Yasmin, for oral contraception. Learn more at www.epocrates.com

New Drug Monograph for Pentacel

Wed, 06 Aug 2008 08:00:00 GMT

The FDA has approved Pentacel (diphtheria/tetanus toxoids and acellular pertussis/poliovirus, inactivated/Haemophilus b vaccine) for immunization against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b for children 6 weeks through 4 years of age. Learn more at www.epocrates.com

New Monograph for Kinrix

Wed, 30 Jul 2008 08:00:00 GMT

The FDA has approved Kinrix (diphtheria/tetanus toxoids and acellular pertussis/poliovirus, inactivated vaccine) for combination immunization in children 4-6 years old. Learn more at www.epocrates.com

New Monograph for zaleplon

Wed, 23 Jul 2008 08:00:00 GMT

First-time generic formulations for zaleplon are now available. Zaleplon is equivalent to Sonata, which is indicated for the short-term treatment of insomnia (sleep-onset type). Learn more at www.epocrates.com

New Monograph for Risperidone

Wed, 16 Jul 2008 08:00:00 GMT

The FDA has approved first-time generic formulations for risperidone. Risperidone is equivalent to Risperdal, which is indicated for the treatment of schizophrenia and the acute mania of bipolar disorder in adults and children. It is also approved for irritability symptoms in children with autistic disorder. Learn more at www.epocrates.com

New Monthly Dosing for Actonel

Wed, 09 Jul 2008 08:00:00 GMT

The FDA has approved once-monthly dosing of Actonel (risedronate) for the prevention and treatment of postmenopausal osteoporosis. Learn more at www.epocrates.com

New Black Box Warning for Conventional Antipsychotics

Wed, 02 Jul 2008 08:00:00 GMT

The FDA has reviewed data indicating that conventional antipsychotics are also associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In 2005, the same black box warning was added to the atypical antipsychotics. Neither conventional nor atypical antipsychotics are approved for dementia-related psychosis. Learn more at www.epocrates.com

Expanded Indication for Advair Diskus

Wed, 25 Jun 2008 08:00:00 GMT

The FDA has approved Advair Diskus (fluticasone/salmeterol inhaled) for maintenance therapy of COPD, which now includes the treatment of emphysema as well as chronic bronchitis. Learn more at www.epocrates.com

New Black Box Warning for Regranex

Wed, 18 Jun 2008 08:00:00 GMT

The prescribing information for Regranex (becaplermin topical) now includes a black box warning. An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex in a post-marketing retrospective cohort study. Regranex should only be used when the benefits can be expected to outweigh the risks. Use with caution in patients with known malignancy. Learn more at www.epocrates.com

New Drug Monograph for Relistor

Wed, 11 Jun 2008 08:00:00 GMT

The FDA has approved Relistor (methylnaltrexone) to treat opioid-induced constipation. Learn more at www.epocrates.com

Additional Indication for Amitiza

Wed, 04 Jun 2008 08:00:00 GMT

The FDA has approved Amitiza (lubiprostone) to treat irritable bowel syndrome with constipation in women, making it the first drug to win approval for this condition. Learn more at www.epocrates.com

New Dosage Form for Paroxetine

Wed, 28 May 2008 08:00:00 GMT

The FDA has approved a first-time generic extended-release form of paroxetine. Paroxetine ER is equivalent to Paxil CR, which is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysmorphic disorder. Learn more at www.epocrates.com

New Drug Monograph for Ropinirole

Wed, 21 May 2008 08:00:00 GMT

The FDA has approved first-time generic formulations for ropinirole. Ropinirole is equivalent to Requip, which is indicated for the treatment of moderate to severe primary restless legs syndrome and for Parkinson's disease. Learn more at www.epocrates.com

Adult Indication and Additional Capsule Sizes for Vyvanse

Wed, 14 May 2008 08:00:00 GMT

The FDA has approved Vyvanse (lisdexamfetamine) for the treatment of ADHD in adults. It is also now available in 20 mg, 40 mg, and 60 mg capsule strengths. Learn more at www.epocrates.com

New Drug Monograph for Pristiq

Wed, 07 May 2008 08:00:00 GMT

The FDA has approved Pristiq (desvenlafaxine), the major active metabolite of venlafaxine, for the treatment of major depressive disorder in adults. Learn more at www.epocrates.com

New Drug Monograph for Fenoglide

Wed, 30 Apr 2008 08:00:00 GMT

The FDA has approved Fenoglide (fenofibrate) for the treatment of hyperlipidemia, mixed dyslipidemia, or hypertriglyceridemia. Learn more at www.epocrates.com

Pediatric Indication for Reyataz

Wed, 23 Apr 2008 08:00:00 GMT

The FDA has approved Reyataz (atazanavir) for the treatment of HIV infection in patients 6-17 years of age. Learn more at www.epocrates.com

Additional Indication for Aloxi

Wed, 16 Apr 2008 08:00:00 GMT

The FDA has approved Aloxi (palonosetron) for the prevention of postoperative nausea and vomiting for up to 24 hours following surgery. Learn more at www.epocrates.com

New Drug Monograph for Renvela

Wed, 09 Apr 2008 08:00:00 GMT

The FDA has approved Renvela (sevelamer) for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Learn more at www.epocrates.com

New Drug Monograph for Treanda

Wed, 02 Apr 2008 08:00:00 GMT

The FDA has approved Treanda (bendamustine) for the treatment of chronic lymphocytic leukemia (CLL) in adult patients. Learn more at www.epocrates.com

New Dosage Forms for OxyContin

Wed, 26 Mar 2008 08:00:00 GMT

OxyContin is now available in an expanded array of tablet strengths. The new extended-release tablets are 15 mg, 30 mg, and 60 mg. The 60 mg tablets are only to be used in opioid-tolerant patients. Learn more at www.epocrates.com

Additional Pediatric Indication for Abilify

Wed, 19 Mar 2008 08:00:00 GMT

The FDA has approved Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in patients 10-17 years of age. Learn more at www.epocrates.com

Neuropsychiatric Events with Tamiflu

Wed, 12 Mar 2008 08:00:00 GMT

The occurrence of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza, has been noted by the FDA. These symptoms, as described in post marketing data, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatalities. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. Learn more at www.epocrates.com

Hepatotoxicity Warning for Tysabri

Wed, 05 Mar 2008 08:00:00 GMT

The FDA has reported liver injury during use of Tysabri. Signs included markedly elevated hepatic enzymes and total bilirubin, which occurred as early as six days after the first dose. These elevated lab values, without evidence of obstruction, are recognized as an important predictor of severe injury that may lead to death or the need for a transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Learn more at www.epocrates.com

New Drug Monograph for Pantoprazole

Wed, 27 Feb 2008 08:00:00 GMT

The FDA has approved first-time generic tablet formulations for pantoprazole. Pantoprazole is equivalent to Protonix, and is indicated for erosive esophagitis and hypersecretory conditions. Learn more at www.epocrates.com

New Drug Monograph for Balsalazide

Wed, 20 Feb 2008 08:00:00 GMT

The FDA has approved first-time generic formulations for balsalazide. Balsalazide is equivalent to Colazal, which is indicated for mild-moderate active ulcerative colitis in both adults and children. Learn more at www.epocrates.com

New Drug Monograph for Alendronate

Wed, 13 Feb 2008 08:00:00 GMT

The FDA has approved first-time generic formulations for alendronate. Alendronate is equivalent to Fosamax, which is indicated for the prevention and treatment of osteoporosis and the treatment of osteotic Paget's disease. Learn more at www.epocrates.com

Suicidality and Antiepileptic Drugs

Wed, 06 Feb 2008 08:00:00 GMT

The FDA has analyzed reports of suicidality from placebo-controlled clinical studies of drugs used to treat epilepsy as well as other conditions. Patients receiving AEDs had approximately twice the risk of suicidal behavior or ideation. The relative risk was higher in patients with epilepsy compared to patients who were treated for other conditions. All patients currently taking or starting any AED should be closely monitored for behavior changes that could indicate the emergence or worsening of suicidal thoughts, behavior or depression. Learn more at www.epocrates.com

Additional Neuropsychiatric Warnings for Chantix

Wed, 30 Jan 2008 08:00:00 GMT

The labeling for Chantix has been updated with a warning to observe patients for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as a worsening of pre-existing psychiatric illness, may be complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Learn more at www.epocrates.com

Amantadine and Rimantadine on Hold for Influenza A Therapy and Prophylaxis

Wed, 23 Jan 2008 08:00:00 GMT

On the recommendation of the ACIP (Advisory Committee on Immunization Practices), for 2007-08 neither amantadine nor rimantadine should be used for the treatment or prevention of influenza type A in the United States. Currently circulating influenza A viruses show widespread resistance to these medications. Learn more at www.epocrates.com

New Drug Monograph for Granisetron

Wed, 16 Jan 2008 08:00:00 GMT

The FDA has approved first-time generic formulations for granisetron. Granisetron is equivalent to Kytril, which is indicated for post-operative nausea and vomiting as well as nausea and vomiting associated with chemotherapy, and x-ray therapy. Learn more at www.epocrates.com

Bisphosphonates and Severe Musculoskeletal Pain

Wed, 09 Jan 2008 08:00:00 GMT

The FDA has emphasized the possibility of severe and sometimes incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, this association may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Learn more at www.epocrates.com

DEA Restricts Distribution of 40 mg Methadone Tablet

Wed, 02 Jan 2008 08:00:00 GMT

Due to a reported increase in methadone-related adverse events, manufacturers have agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. The 40 mg methadone formulation is only indicated for the detoxification and maintenance treatment of opioid addiction. The 5 mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. Learn more at www.epocrates.com

Additional Black Box Warning for Carbamazepine

Wed, 19 Dec 2007 08:00:00 GMT

The FDA has informed healthcare professionals that the risk of dangerous or even fatal skin reactions (e.g., Stevens Johnson syndrome and toxic epidermal necrolysis) are higher in patients with the HLA-B*1502 allele. This allele occurs almost exclusively in Asian patients. Thus, patients with genetically at-risk ancestry should be screened before starting treatment with carbamazepine. Patients testing positive should not start therapy unless benefit outweighs risk. Learn more at www.epocrates.com

Updated Labeling for Desmopressin Adds Warnings and Removes Indication

Wed, 12 Dec 2007 08:00:00 GMT

The FDA has requested the prescribing information for all desmopressin products (DDAVP, Minirin, Stimate, generics) be updated to include important information about the risk of severe hyponatremia and seizures. Due to these warnings, desmopressin should not be used in patients with hyponatremia or a history or hyponatremia. Additionally, the desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis. Learn more at www.epocrates.com

Reports of Suicidal Ideation, Aggressive Behavior, and Drowsiness with Chantix

Wed, 05 Dec 2007 08:00:00 GMT

The FDA is reviewing recent reports of suicidal ideation and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product approved in May 2006. In addition, there are reports of patients on Chantix experiencing drowsiness that affected their ability to drive or operate machinery. The FDA recommends monitoring patients on Chantix for mood and behavioral changes and informing patients to use caution when driving or operating machinery. Learn more at www.epocrates.com

Updated Black Box Warnings for Erythropoiesis-Stimulating Agents

Wed, 28 Nov 2007 08:00:00 GMT

The FDA has recently approved revised labeling for Aranesp, Epogen, and Procrit, erythropoiesis-stimulating agents (ESA) used to treat certain types of anemia. The updated black box warnings discuss tumor growth and shortened survival in cancer patients and an increased risk of serious cardiovascular events and mortality in chronic renal failure patients when Hgb >12 g/dL are achieved with ESA therapy. Learn more at www.epocrates.com

Additional Black Box Warning for Avandia

Wed, 21 Nov 2007 08:00:00 GMT

The black box warning for Avandia has been updated to include new information on the potential increased risk of myocardial ischemic events. While available data are inconclusive at this time, healthcare professionals are advised to closely monitor patients for cardiovascular risks. Learn more at www.epocrates.com

Zyrtec-D Approved for OTC Use

Wed, 14 Nov 2007 08:00:00 GMT

The FDA has approved Zyrtec-D (cetirizine/pseudoephedrine) for nonprescription use for the relief of symptoms due to hay fever or other respiratory allergies, for reducing swelling of nasal passages, for the relief of sinus congestion and pressure, and for restoring freer breathing through the nose. Zyrtec-D will be subject to sales restrictions imposed by the federal Combat Methamphetamine Epidemic Act because it contains pseudoephedrine. Learn more at www.epocrates.com

Trasylol Withdrawn from US Market

Wed, 07 Nov 2007 08:00:00 GMT

The FDA has announced that the marketing for Trasylol (aprotinin) has been suspended pending a review of preliminary results from the Canadian study suggesting an increased risk of death. Trasylol was used to control bleeding during coronary artery bypass graft surgery. Learn more at www.epocrates.com

New Warnings for Provigil

Wed, 31 Oct 2007 08:00:00 GMT

The prescribing information for Provigil (modafinil) has recently been revised to include warnings on serious rash, including Stevens-Johnson Syndrome, hypersensitivity reactions, and psychiatric symptoms. Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Learn more at www.epocrates.com

Reports of Acute Pancreatitis with Byetta Use

Wed, 24 Oct 2007 08:00:00 GMT

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 the treatment of type 2 diabetes mellitus in adult patients. Learn more at www.epocrates.com

IV Compatibility Information

Wed, 17 Oct 2007 08:00:00 GMT

The IV compatibility information in Epocrates Rx has recently been updated. Additions include 3 new drugs (aripiprazole, caspofungin, and ropivacaine) in the IV compatability checker and new information for cefepime and nesiritide. Learn more at www.epocrates.com

Epocrates ID Update

Wed, 10 Oct 2007 08:00:00 GMT

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 the Pediatrics sections of ID, including neonatal meningitis, omphalitis, and septic shock. In the coming months, the Epocrates Infectious Disease team will be adding significantly more treatments for pediatric patients. Learn more at www.epocrates.com

New Vaccine Monograph for Afluria

Wed, 10 Oct 2007 08:00:00 GMT

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 at www.epocrates.com

New Drug Monograph for Xyzal

Wed, 03 Oct 2007 08:00:00 GMT

The FDA has approved Xyzal (levocetirizine) for the symptomatic relief of seasonal and perennial allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children at least 6 years old. Learn more at www.epocrates.com

New Lower Strength of Soma Approved

Wed, 26 Sep 2007 08:00:00 GMT

The FDA has approved a 250 mg strength of Soma (carisoprodol) for the relief of discomfort associated with acute, painful musculoskeletal conditions. Learn more at www.epocrates.com

Additional Indications for Short Course Levaquin Therapy

Wed, 19 Sep 2007 08:00:00 GMT

The FDA has approved Levaquin 750 mg as a 5-day, once daily regimen for the treatment of complicated urinary tract infection and acute pyelonephritis. Learn more at www.epocrates.com

New Drug Monograph for Carvedilol

Wed, 12 Sep 2007 08:00:00 GMT

The FDA has approved first-time generic formulations for carvedilol. Carvedilol is equivalent to Coreg, which is indicated for the treatment of hypertension, chronic heart failure, and left ventricular dysfunction following myocardial infarction. Learn more at www.epocrates.com

New Drug Monograph for Bendroflumethiazide/Nadolol

Wed, 05 Sep 2007 08:00:00 GMT

The FDA has approved first-time generic formulations for bendroflumethiazide/nadolol for the treatment of hypertension in adult patients. Bendroflumethiazide/nadolol is equivalent to Corzide. Learn more at www.epocrates.com

Additional indications for Risperdal in Children and Adolescents

Wed, 29 Aug 2007 08:00:00 GMT

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 bipolar disorder in children and adolescents aged 10-17 years old. Learn more at www.epocrates.com

New Black Box Warnings for Thiazolidinediones

Wed, 22 Aug 2007 08:00:00 GMT

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 signs and symptoms of heart failure after initiation of therapy. Use of these drugs should be reconsidered if heart failure develops, and use is not recommended in patients with symptomatic heart failure. Learn more at www.epocrates.com

Revised ACIP Recommendations for Meningococcal Vaccination

Wed, 15 Aug 2007 08:00:00 GMT

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 conjugate (MCV4) vaccine. Children 11-12 years of age should be routinely vaccinated at their 11-12 year healthcare visit. Previously unvaccinated individuals 11-18 years of age should be vaccinated at the earliest opportunity. Learn more at www.epocrates.com

Omacor (omega-3-acid ethyl esters)

Wed, 08 Aug 2007 08:00:00 GMT

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 oral dosage forms. To minimize potential errors in the future, the brand name Omacor has been changed to Lovaza, which is now available. Learn more at www.epocrates.com

ceftriaxone (Rocephin, generic)

Wed, 01 Aug 2007 08:00:00 GMT

Updated monographs based on recent MedWatch Safety Alert regarding revisions to ceftriaxone prescribing information; revisions include new information on the risk associated with concomitant use of ceftriaxone and parenteral calcium or calcium-containing products. Learn more at www.epocrates.com

ProQuad (measles/mumps/rubella/varicella vaccine, live)

Wed, 25 Jul 2007 08:00:00 GMT

Updated monograph to reflect current availability status; vaccine will be unavailable through the remainder of 2007. Learn more at www.epocrates.com