You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.
 

CME

FDA Safety Changes: Asmanex Twisthaler, Advair HFA, Avelox

  • Authors: News Author: Yael Waknine
    CME Author: Yael Waknine
  • CME Released: 7/24/2008
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 7/24/2009
Start Activity


Target Audience and Goal Statement

This article is intended for primary care clinicians, pulmonologists, infectious disease specialists, ophthalmologists, cardiologists, dermatologists, and other specialists who care for patients with asthma and those with infections requiring broad-spectrum antimicrobial therapy.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Identify various risks associated with the use of inhaled corticosteroids such as mometasone furoate.
  2. Describe drug interactions that can increase the risk for cardiovascular adverse events in patients receiving treatment with fluticasone propionate plus salmeterol xinafoate inhalation aerosol.
  3. Describe the risk for photosensitivity and phototoxicity associated with quinolone antibiotics such as moxifloxacin HCl.

 


Disclosures

As an organization accredited by the ACCME, Medscape, LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Yael Waknine

    Yael Waknine is a freelance writer for Medscape.

    Disclosures

    Disclosure: Yael Waknine has disclosed no relevant financial relationships.

Reviewer(s)

  • Laurie Barclay, MD

    Laurie Barclay, MD is a freelance reviewer and writer for Medscape.

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Editor(s)

  • Brande Nicole Martin

    Brande Nicole Martin is the News CME editor for Medscape Medical News.

    Disclosures

    Disclosure: Brande Nicole Martin has disclosed no relevant financial information.

CME Author(s)

  • Yael Waknine

    Yael Waknine is a freelance writer for Medscape.

    Disclosures

    Disclosure: Yael Waknine has disclosed no relevant financial relationships.


Accreditation Statements

    For Physicians

  • Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Medscape, LLC designates this educational activity for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity. Medscape Medical News has been reviewed and is acceptable for up to 300 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins 09/01/07. Term of approval is for 1 year from this date. This activity is approved for 0.25 Prescribed credits. Credit may be claimed for 1 year from the date of this activity. AAFP credit is subject to change based on topic selection throughout the accreditation year.


    AAFP Accreditation Questions

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 5 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

CME

FDA Safety Changes: Asmanex Twisthaler, Advair HFA, Avelox

Authors: News Author: Yael Waknine CME Author: Yael WaknineFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME Released: 7/24/2008

Valid for credit through: 7/24/2009

processing....

This activity is part of an ongoing CME/CE initiative to provide information on labeling changes reported by the FDA. Activities of this nature will be posted on Medscape on a weekly basis.

July 24, 2008 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to emphasize certain warnings associated with the use of mometasone furoate inhalation powder, drug interactions that can increase the risk for cardiovascular adverse events in patients receiving salmeterol xinafoate plus fluticasone propionate inhalation therapy, and the risks for photosensitivity and phototoxicity in patients receiving treatment with quinolone antibiotics such as moxifloxacin HCl.

 

Mometasone Furoate Inhalation Powder (Asmanex Twisthaler) Warnings Strengthened

On February 26, the FDA approved safety labeling revisions for mometasone furoate inhalation powder (Asmanex Twisthaler; Schering-Plough Corp) that place additional emphasis on warnings and precautions associated with its use.

Because of the risk for local Candida albicans infection of the mouth and pharynx (incidence in clinical studies, 6.5%), the FDA advises that patients receiving mometasone therapy rinse their mouth after each dose. If oropharyngeal candidiasis develops, systemic antifungal therapy should be initiated while continuing treatment with mometasone.

Inhaled corticosteroids such as mometasone should be used with caution, if at all, in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex, the FDA warned, noting the potential for clinical worsening. In a similar fashion, chickenpox or measles have been reported with increased severity and some fatalities in susceptible patients. Prophylaxis with varicella zoster immune globulin or pooled intramuscular immune globulin prophylaxis should be considered for patients exposed to disease.

The FDA also warned of the risk for impaired adrenal function when switching from oral steroids (eg, prednisone tablets) to inhaled corticosteroids such as mometasone. Systemic agents should be slowly tapered and patients carefully observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea, vomiting, and hypotension. Transfer from systemic therapy to mometasone may also unmask previously suppressed allergic or other immunologic conditions such as rhinitis, conjunctivitis, eosinophilic conditions, eczema, and arthritis.

Decreases in bone mineral density (BMD) have been observed with long-term use of inhaled corticosteroids, including mometasone. Although the clinical significance of small changes in BMD on long-term outcome remains unknown, caution and regular monitoring is advised for patients with major risk factors for decreased bone mineral content such as prolonged immobilization, family history of osteoporosis, or chronic use of agents that can reduce bone mass (eg, anticonvulsants).

The FDA also warned that use of orally inhaled corticosteroids, such as mometasone, may cause a reduction in pediatric growth velocity. Pediatric growth should be monitored routinely via methods such as stadiometry, and treatment should be titrated to the lowest effective dose.

Because glaucoma, increased intraocular pressure, and cataracts have been reported in clinical trials of mometasone (incidence, 0.27%), close monitoring is warranted in patients with vision changes or a history of these conditions.

Mometasone inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Drug Interactions With Salmeterol Xinafoate Component of Advair HFA Linked to Cardiovascular Events

On March 20, the FDA approved safety labeling revisions for fluticasone propionate plus salmeterol xinafoate inhalation aerosol (Advair HFA, GlaxoSmithKline) to warn of drug interactions with salmeterol that may increase the risk for cardiovascular adverse events.

Salmeterol is a long-acting β2-adrenergic agonist that is extensively metabolized to α-hydroxysalmeterol (aliphatic oxidation) by the cytochrome P450 3A4 (CYP3A4) isoenzyme. Concomitant use of CYP3A4 inhibitors, such as ketoconazole, may therefore increase salmeterol exposure and the risk for drug-related adverse events.

In a drug interaction study of 20 healthy subjects, coadministration of ketoconazole (400 mg once daily) with salmeterol (50 µg twice daily) for 7 days yielded a 16-fold increase in salmeterol total exposure (area under the curve), with a 1.4-fold increase in peak blood levels.

Three participants were withdrawn from the study because of β2-adrenergic agonist adverse events; 2 subjects had prolonged QTc intervals, and 1 experienced palpitations and sinus tachycardia. Although there was no statistically significant effect on mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration vs salmeterol and placebo administration.

Because of the potential increased risk for cardiovascular adverse events, concomitant use of salmeterol with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, or telithromycin) is not recommended.

Salmeterol plus fluticasone inhalation aerosol is indicated for the long-term, twice-daily maintenance treatment of asthma in patients aged 12 years and older.

Quinolones, Including Moxifloxacin HCl (Avelox), Linked to Risk for Phototoxicity

On February 15, the FDA approved safety labeling revisions for moxifloxacin HCl tablets and moxifloxacin in sodium chloride injection (Avelox, Bayer Pharmaceuticals Corp) to warn of the risk for photosensitivity and phototoxicity associated with quinolone antibiotics.

In addition to moderate to severe photosensitivity, the agency has received postmarketing reports of phototoxicity reactions that can manifest as exaggerated sunburn reactions such as burning, erythema, exudation, vesicles, blistering, and edema that involve areas exposed to light (eg, the face, "V" area of the neck, extensor surfaces of the forearms, and dorsa of the hands). These reactions can be associated with the use of quinolones after sun or ultraviolet light exposure.

Excessive exposure to these sources of light should therefore be avoided, and treatment should be discontinued if photosensitivity or phototoxicity occurs.

Patients should be advised to minimize or avoid exposure to natural or artificial sunlight (eg, tanning beds or ultraviolet A/B light treatment) while taking quinolones. Those who need to be outdoors during therapy should wear loose-fitting clothes that protect skin from sun exposure and adopt other sun protection measures such as sunscreen if possible.

Moxifloxacin is a broad-spectrum fluoroquinolone antimicrobial agent indicated for use in adults to treat infections caused by susceptible strains of designated microorganisms. Indications include acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated and complicated skin or skin structure infections, and complicated intraabdominal infections.

Asmanex Twisthaler Prescribing Information

Advair Prescribing Information

Avelox Prescribing Information

Pearls for Practice

  • Use of orally inhaled corticosteroids, such as mometasone furoate, is linked to risks for oropharyngeal candidiasis, worsening of preexisting infections, decreased bone mineral density, and reductions in pediatric growth velocity. Patients switching from systemic therapy should be observed for signs of adrenal insufficiency; previously suppressed allergic conditions may be unmasked.
  • Because of the potential increased risk for cardiovascular adverse events, concomitant use of salmeterol xinafoate with strong cytochrome P450 3A4 isoenzyme inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, or telithromycin) is not recommended.
  • Phototoxicity reactions have been reported with use of quinolone antibiotics such as moxifloxacin HCl. These reactions can manifest as exaggerated sunburn that involves areas exposed to light and can be associated with the use of quinolones after sun or ultraviolet light exposure. Excessive exposure to these sources of light should therefore be avoided and treatment discontinued if photosensitivity/phototoxicity occurs.

CME Test

  • Print