Label Changes for:

Sarafem (fluoxetine hydrochloride) Tablets

July 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

July 2013

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors (MAOIs)
  • The use of MAOIs intended to treat psychiatric disorders with SARAFEM or within 5 weeks of stopping treatment with SARAFEM is contraindicated because of an increased risk of serotonin syndrome. The use of SARAFEM within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting SARAFEM in a patient who is being treated with MAOIs such as linezolid or intravenousmethylene blue is also contraindicated because of an increased risk of serotonin syndrome.

WARNINGS AND PRECAUTIONS

Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including SARAFEM, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and 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). Serotonin syndrome symptoms may include mental status changes (for example, agitation, hallucinations, delirium, and coma), autonomic instability (for example, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (for example, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (for example, nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The concomitant use of SARAFEM with MAOIs intended to treat psychiatric disorders is contraindicated.

SARAFEM should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue ...

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Non-teratogenic Effects: ..... Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).

MEDICATION GUIDE

Who should not take SARAFEM?

Do not take SARAFEM if you:

  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
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