FDA SIDE EFFECTS UPDATE: Antipsychotic Drugs and Breast Cancer Risk

Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Erzofri, Fanapt, Geodon, Haldol, Invega, Lybalvi, Molindone, Risperidone, Saphris, Secuado, Seroquel, Symbax and Zyprexa.

How to Read This Report

This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.

Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.

Additional Details for This Update: FDA Mandates New Safety Labeling for Many Antipsychotics

The FDA now mandates that updated safety information regarding the link between hyperprolactinemia (elevated prolactin levels) and breast cancer be added to the labeling of many antipsychotic medications.

Hyperprolactinemia is a recognized side effect of many antipsychotics and can lead to various health issues, including fertility problems, reduced libido, and breast tissue growth. Prolonged use has also been linked to an increased risk of osteoporosis.

Some studies have found that prolonged periods of antipsychotic-induced elevated prolactin may result in the development of breast cancer, while other studies have not found a link. However, the FDA has determined that the evidence is sufficient to warrant a label warning on antipsychotic drugs known to increase prolactin levels.

For each drug listed in this update, its propensity to elevate prolactin levels has been categorized as high, medium, or low, using information from a recent study. Newer antipsychotics, known as “atypical” or second-generation, generally have a lower risk of causing hyperprolactinemia compared to older antipsychotic medications.

Erzofri (active ingredient: paliperidone palmitate) extended release injection

Initial FDA Approval: 2006

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia and schizoaffective disorder in adults.

Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer, adding that “published studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.”

Essential Extras: Paliperidone has a “high” propensity for prolactin elevation.

FDA Safety Announcement: Erzofri FDA Safety Label Change and Revised Drug Label

Fanapt (active ingredient: iloperidone)

Initial FDA Approval: 2009

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia and bipolar 1 in adults.

Updated Side Effects/Safety Information: A section describing this medication’s risk of  of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Iloperidone has a “medium” propensity for prolactin elevation.

FDA Safety Announcement:  Fanapt FDA Safety Label Change and Revised Label

Geodon (ziprasidone) capsules or intramuscular injection

Initial FDA Approval: 2001

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia and bipolar 1 disorder in adults. Injection is used for acute treatment of agitation or manic episodes in adults with schizophrenia or bipolar 1 disorder.

Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Sleepwalking (or somnambulism) was added as an adverse reaction in the postmarketing experience section.

A new warning section was added on the risk of serotonin syndrome, which is a potentially life-threatening condition. The risk is increased with the concomitant use of other drugs, such as MAOIs (linezolid), SSRIs, SNRIs, triptans, amphetamines, St. John’s Wort and more. See revised label for complete details.

Essential Extras: Ziprasidone has a “low” propensity for prolactin elevation.

FDA Safety Announcement: Geodon FDA Safety Label Change and Revised Drug Label

Haldol (active ingredient: haloperidol decanoate) intramuscular injection

Initial FDA Approval: 1986

Side Effect Update Date: January 22, 2025

Medication Description: Treats individuals with schizophrenia who require prolonged parenteral (bypassing the digestive system) antipsychotic therapy.

Updated Side Effects/Safety Information: A section describing this medication’s risk of  hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Haloperidol has a “high” propensity for prolactin elevation.

FDA Safety Announcement: Haldol FDA Safety Label Change and Revised Drug Label

Invega extended release tablets, Invega Sustena, Invega Trinza, Invega Hafyera (active ingredient: paliperidone palmitate) intramuscular injection

Initial FDA Approval: 2009 (injection) 2006 (tablets)

Side Effect Update Date: January 23, 2025

Medication Description: Treats schizophrenia or schizoaffective disorder in adults. Tablets are approved as treatment for schizophrenia or schizoaffective disorder in adults or adolescents.

Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Paliperidone has a “high” propensity for prolactin elevation

FDA Safety Announcement: Invega FDA Safety Label Change and Revised Drug Label

Lybalvi (active ingredient: olanzapine; samidorphan l-malate) tablets

Initial FDA Approval: 2021

Side Effect Update Date: January 27, 2025

Medication Description: Treats schizophrenia and bipolar disorder in adults.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Also, sleepwalking (or somnambulism) and fecal incontinence were added as adverse reactions in the postmarketing experience section.

Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation

FDA Safety Announcement: Lybalvi FDA Safety Label Change and Revised Drug Label

Molindone hydrochloride tablets (formerly brand name Moban, which has been discontinued)

Initial FDA Approval: 1974

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Molindone has a “high” propensity for prolactin elevation.

FDA Safety Announcement: Moban FDA Safety Label Change and Revised Drug Label

Risperidone (brand names Perseris kit subcutaneous injection, Uzedy subcutaneous injection Rykindo, Risvan Intramuscular extended release, Risperdal tablets and oral solution)

Initial FDA Approval: 1993

Side Effect Update Date: January 25, 2025

Medication Description: Treats schizophrenia. Some of the products also treat bipolar disorder in adults. Risperdal is also approved to treat irritability associated with autistic disorder.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Risperidone has a “high” propensity for prolactin elevation.

FDA Safety Announcement:

Perseris FDA Safety Label Change and Revised Drug Label
Rykindo FDA Safety Label Change and Revised Drug Label
Risvan FDA Safety Label Change and Revised Drug Label
Risperdal FDA Safety Label Change and Revised Drug Label
Uzedy FDA Safety Label Change and Revised Drug Label

Saphris (active ingredient: asenapine maleate) sublingual tablets

Initial FDA Approval: 2009

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia in adults and bipolar I disorder in adults and adolescents.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Asenapine has a “low” propensity for prolactin elevation.

FDA Safety Announcement: Saphris FDA Safety Label Change and Revised Drug Label

Secuado (active ingredient: asenapine) transdermal patch

Initial FDA Approval: 2019

Side Effect Update Date: January 22, 2025

Medication Description: Treats adults with schizophrenia.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Essential Extras: Asenapine has a “low” propensity for prolactin elevation.

FDA Safety Announcement: Secuado FDA Safety Label Change and Revised Drug Label

Seroquel (active ingredient: quetiapine) tablets and Seroquel XR (active ingredient: quetiapine) extended release tablets

Initial FDA Approval: 1997

Side Effect Update Date: January 22, 2025

Medication Description: Treats schizophrenia and bipolar disorder in adults and adolescents. Treats major depressive disorder in adults (with adjunct antidepressant medications).

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Also, fecal incontinence was added as an adverse reaction in the postmarketing experience section.

Essential Extras: Quetiapine has a “low” propensity for prolactin elevation.

FDA Safety Announcement: Seroquel FDA Safety Label Change and Revised Drug Label

Symbax (active ingredients: fluoxetine hydrochloride; olanzapine)

Initial FDA Approval: 2003

Side Effect Update Date: January 22, 2025

Medication Description: Treats bipolar disorder and treatment-resistant depression in adults and children age 10 and up.

Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Sleepwalking (or somnambulism) and fecal incontinence were added as adverse reactions in the postmarketing experience section.

Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation

FDA Safety Announcement:  Symbax FDA Safety Label Change and Revised Drug Label

Zyprexa (active ingredient: olanzapine) pills, orally disintegrating tablets, short-acting intramuscular injection; Zyprexa Relprevv (active ingredient: olanzapine pamoate) extended release intramuscular injection

Initial FDA Approval: 1996

Side Effect Update Date: January 22, 2025

Medication Description: Zyprexa treats schizophrenia and bipolar disorder in adults and adolescents and treats major depression in adults in conjunction with fluoxetine. Zyprexa Relprevv (extended release intramuscular injection) is used only to treat schizophrenia.

Updated Side Effects/Safety Information:  The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.

Sleepwalking (or somnambulism) and fecal incontinence were also added as adverse reactions in the postmarketing experience section.

Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation

FDA Safety Announcement: Zyprexa FDA Safety Label Change  Change and Revised Drug Label

Zyprexa Relprevv FDA Safety Label Change and Revised Drug Label