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Revisions / archive

What the FDA changed in 2014

Revisions the regulator issued in 2014 for the labels behind this catalog. The main record carries the latest changes and explains how this is tracked.

Revisions
2
Label sections changed
3
Labels affected
2
  1. 6 October 2014From the archive

    Qsymia

    label of 8 November 20136 October 2014published 6 October 2014, reconstructed from the DailyMed archive

    Adverse reactions

    Added in this revision

    • Added: Qsymia Psychiatric Disorders Suicidal ideation, Suicidal behavior Ophthalmic disorders Acute angle closure glaucoma Increased intraocular pressure Phentermine Allergic adverse reactions Urticaria Cardiovascular adverse reactions Elevation of blood pressure, Ischemic events Central nervous system adverse reactions Euphoria, Psychosis, Tremor Reproductive adverse reactions Changes in libido, Impotence Topiramate Dermatologic disorders Bullous skin reactions (including erythema multiforme,...

    Removed in this revision

    • Removed: Phentermine Allergic adverse reactions Urticaria Cardiovascular adverse reactions Elevation of blood pressure, Ischemic events Central nervous system adverse reactions Euphoria, Psychosis, Tremor Reproductive adverse reactions Changes in libido, Impotence Topiramate Dermatologic disorders Bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), Pemphigus Gastrointestinal disorders Pancreatitis Hepatic disorders Hepatic failure (including...
  2. 18 March 2014From the archive

    Nexium

    label of 4 December 201218 March 2014published 18 March 2014, reconstructed from the DailyMed archive

    Warnings and precautions

    Added in this revision

    • Added: Concomitant use of NEXIUM with St.
    • Added: John's Wort or rifampin) can substantially decrease esomeprazole concentrations.
    • Added: John's Wort or rifampin.

    3 entries reworded without a change of meaning.

    Drug interactions

    Added in this revision

    • Added: In a cross-over study in 12 healthy male subjects, St.

    7 entries reworded without a change of meaning.