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Prozac FDA News

The label for Proxac includes warnings regarding suicidal ideation, eye problems and serotonin syndrome. Use of the drug while pregnancy may increase the risk of complications including persistent pulmonary hypertension of the newborn.

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Added Prozac Boxed Warning

In October 2004, the U.S. Food & Drug Administration (FDA) asked manufacturers of certain antidepressants to include a “boxed” warning statement that recommends close observation for worsening depression or thoughts of suicide in adult and pediatric patients treated with these drugs. Prozac (fluoxetine) was included in this warning, and the labeling was subsequently changed to reflect the new warning requirements. 1

Angle Closure Glaucoma

In July 2014, the FDA required drug manufacturers to include an additional warning on the labels of medicines that treat major depressive disorder (including Prozac). The warning is related to a potential complication caused by pupillary dilation, a side effect antidepressants, called angle-closure glaucoma. 2 Primary angle-closure glaucoma is projected to affect as many as 5.3 million people throughout the world by 2020. 3

Visual problems associated with angle-closure glaucoma may include:

  • Redness or swelling in or near the eye
  • Eye pain
  • Vision changes

Not everyone will be susceptible to this condition. Contact your primary physician or specialist if you have any questions.

Prozac Antidepressant Risks

In January 2013, the FDA approved updated labeling information for Prozac to reflect the following in the full prescribing information:

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)]

5.2 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).

8.1 Pregnancy

Non-teratogenic Effects: ….. Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). 4

Do not take Prozac if you take a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid. If you are not sure whether you take an MAOI, speak with your healthcare provider or pharmacist.

  1. U.S. Food & Drug Administration. “Postmarket Drug Safety Information for Patients and Providers: Worsening Depression and Suicidality in Patients Being Treated With Antidepressants.” (Aug 7, 2009) FDA.gov. Accessed July 30, 2013.
  2. U.S. Food & Drug Administration. “Drugs to Treat Major Depressive Disorder — Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER).” (Aug. 15, 2014) FDA.gov. Accessed Oct. 22, 2014.
  3. See, Jovina L. S. “Management of angle closure glaucoma.” (Jan. 2011) Indian Journal of Ophthalmology. Accessed Oct. 22, 2014
  4. U.S. Food & Drug Administration. “Safety Information, Prozac (fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules and Prozac (fluoxetine HCl) delayed-release 90 mg capsules.” (Jan. 13, 2013) Accessed Aug. 1, 2013.