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U.S. Department of Health and Human Services


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Class Labeling for Dibenzazepine of Pharmacologic Agents Known as Tricyclic Antidepressants

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


November 2012

Summary View


Oleptro (trazodone hydrochloride) Extended-Release Tablets
Luvox (fluvoxamine) Tablets
Luvox CR (fluvoxamine maleate) Extended-Release Capsules 



October 2012

Summary View


Anafranil (clomipramine) capsules
Pamelor (nortriptyline HCl) solution and capsules
Tofranil-PM (imipramine pamoate) capsules


  • Starting Anafranil/Pamelor/Tofranil-PM in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.


Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with... drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
  • The concomitant use of Anafranil/Pamelor/Tofranil-PM with MAOIs intended to treat psychiatric disorders is contraindicated. Anafranil/ Pamelor/Tofranil-PM should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg…