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U.S. Department of Health and Human Services

Safety

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Sarafem (fluoxetine hydrochloride) Tablets

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

December 2014

Summary View

WARNINGS AND PRECAUTIONS

Angle-Closure Glaucoma
  • The pupillary dilation that occurs following use of many antidepressants and Sarafem may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

PATIENT COUNSELING INFORMATION

Angle-Closure Glaucoma
  • Patients should be advised that taking Sarafem can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

MEDICATION GUIDE

*The following was added:

Visual Problems
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

 

July 2013

Summary View

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