Label Changes for:

Prozac (fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules Prozac (fluoxetine HCl) delayed-release 90 mg capsules

January 2013

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

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

 

January 2013

4 CONTRAINDICATIONS

4.1 Monoamine Oxidase Inhibitors (MAOIs)
  • Starting PROZAC in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.10) and Warnings and Precautions (5.2)]

5 WARNINGS AND PRECAUTIONS

5.2 Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including PROZAC, 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).

8 USE IN SPECIFIC POPULATIONS

8.1 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 PROZAC?

Do not take PROZAC 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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