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Shedding Light on the Risks
& Benefits of Medications FDA SIDE EFFECTS UPDATE: Paxlovid And Breast Milk & More
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
December 19, 2024
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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 edition, we take a closer look at Paxlovid, Repatha, Stelara, Vraylar, Zanaflex and Fludaribine.
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.
Fludarabine phosphate (fludarabine phosphate) injection for intravenous administration
Initial FDA Approval: 1991
Side Effect Update Date: November 19, 2024
Medication Description: Treats B-cell chronic lymphocytic leukemia (CLL)
Updated Side Effects/Safety Information: This update includes new and revised treatment indications and dosing regimens. Includes a new section on central nervous system adverse reactions such as coma, seizures, agitation, and confusion. New section on myelosuppression (a decrease in bone marrow activity that reduces blood cell production) and the need for frequent monitoring of blood counts. Includes a warning about fetal toxicity and presents clinical trial data for patients age 65 and older. A boxed warning is moved to the Warnings and Precautions section.
Extensive other label changes; see revised label for details.
Essential Extras: This drug’s label change is part of the FDA’s “Project Renewal,” an effort to update labeling information for older cancer treatments to ensure information is clinically meaningful and scientifically up to date. The other two drugs updated so far under Project Renewal include: Xeloda (capecitabine) tablets for treating colon cancer and other cancer types (revised in December 2022) and Temodar (temozolomide) oral or I.V. chemotherapy medication for treating brain cancer (revised in September 2023).
FDA Safety Announcement: Fludarabine phosphate FDA Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Paxlovid (nirmatrelvir; ritonavir) copackaged tablet
Initial FDA Approval: 2023
Side Effect Update Date: November 19, 2024
Medication Description: Treats mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19.
Updated Side Effects/Safety Information: Updated lactation information from a very small clinical trial study of 8 lactating women. The study found nirmatrelvir and ritonavir are present in human breast milk in small amounts (less than 2%). States there is no available data on the effects of nirmatrelvir or ritonavir on breastfed infants or on milk production.
FDA Safety Announcement: Paxlovid FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Repatha (evolocumab) subcutaneous injection
Initial FDA Approval: 2015
Side Effect Update Date: November 20, 2024
Medication Description: Used to reduce risk of major cardiovascular events, including chest pain requiring hospitalization, heart attacks, and strokes in adults with established cardiovascular disease; used as an adjunct to diet (and sometimes other cholesterol-lowering therapies) to reduce LDL-C cholesterol.
Updated Side Effects/Safety Information: Added latex sensitivity warning. The prefilled single-dose auto-injector and syringe presentations that contain dry natural rubber (a derivative of latex) in the needle cover may cause an allergic reaction in individuals sensitive to latex. Patients are instructed to inform their healthcare provider if they are sensitive to latex.
FDA Safety Announcement: Repatha FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Stelara (ustekinumab) injection for subcutaneous or intravenous use
Initial FDA Approval: 2009
Side Effect Update Date: November 15, 2024
Medication Description: Treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis.
Updated Side Effects/Safety Information: The drug interactions section has been updated for patients also taking CYP450 substrates (enzymes that affect how medication is metabolized in the body). It suggests that healthcare providers monitor for therapeutic effects or drug concentration and adjust the individual dosage of the CYP substrate as needed. In clinical trials, Crohn’s patients taking Stelara along with the CYP450 substances caffeine, warfarin, omeprazole, dextromethorphan midazolam, did not experience the CYP450 drug interactions.
FDA Safety Announcement: Stelara FDA Safety Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Vraylar (cariprazine hydrochloride) capsules
Initial FDA Approval: 2015
Side Effect Update Date: November 22, 2024
Medication Description: Treats schizophrenia; bipolar disorder. Adjunct therapy to antidepressants for major depressive disorder in adults.
Updated Side Effects/Safety Information: Adds dosage modifications (dosage reduction) for patients also taking a strong or moderate CYP3A4 inhibitor, which may increase the concentration of Vraylar in the blood. Examples include antifungal medications like ketoconazole, Itraconazole, voriconazole, and posaconazole, protease inhibitors used to treat HIV, along with some antibiotics like clarithromycin and grapefruit juice components. Recommends not taking with a CYP3A4 inducer, as it may decrease the concentration of Vrayar in the blood. Examples include phenobarbital, phenytoin, rifampicin, St. John’s Wort, and glucocorticoids.
FDA Safety Announcement: Vraylar FDA Safety Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Zanaflex: (tizanidine hydrochloride) tablets and capsules
Initial FDA Approval: 1996
Side Effect Update Date: November 20, 2024
Medication Description: Treats muscle spasms in adults.
Updated Side Effects/Safety Information: A new warning that the FDA has received postmarketing reports of decreased blood pressure (hypotension) and hallucinations has been added. Drug interaction information was added, as well as drugs to avoid while taking Zanaflex. Juvenile animal study toxicity data added; pediatric safety and effectiveness have not been established. Extensive prescribing information updated based on FDA regulation, guidance and current recommendations. See revised label for all changes.
Essential Extras: Frequently used by patients with multiple sclerosis, cerebral palsy, or those with spinal cord injuries.Used off-label for migraines.
FDA Safety Announcement: Zanaflex FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- DRUG SAFETY-RELATED LABELING CHANGES (SRLC)
- DRUGS@FDA: FDA APPROVED DRUGS
- ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
- NATIONAL LIBRARY OF MEDICINE’S DAILYMED DRUG LABEL DATABASE
- MERRIAM-WEBSTER MEDICAL DICTIONARY
- Definition of myelosuppression – NCI Dictionary of Cancer Terms. (n.d.). Cancer.gov
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While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual’s medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.
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Article HTML
<!-- wp:paragraph -->
<p>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 edition, we take a closer look at Paxlovid, Repatha, Stelara, Vraylar, Zanaflex and Fludaribine.</p>
<!-- /wp:paragraph --><!-- wp:heading -->
<h2 class="wp-block-heading" id="h.bfs426nnx0aa">How to Read This Report</h2>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm" target="_blank" rel="noreferrer noopener">SrLC database</a>. 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.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>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.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Fludarabine phosphate (fludarabine phosphate) injection for intravenous administration</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1991</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 19, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats B-cell chronic lymphocytic leukemia (CLL)</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: This update includes new and revised treatment indications and dosing regimens. Includes a new section on central nervous system adverse reactions such as coma, seizures, agitation, and confusion. New section on <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/myelosuppression" target="_blank" rel="noreferrer noopener">myelosuppression</a> (a decrease in bone marrow activity that reduces blood cell production) and the need for frequent monitoring of blood counts. Includes a warning about fetal toxicity and presents clinical trial data for patients age 65 and older. A boxed warning is moved to the Warnings and Precautions section.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Extensive other label changes; see revised label for details.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: This <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-fludarabine-phosphate-under-project-renewal" target="_blank" rel="noreferrer noopener">drug’s label change</a> is part of the FDA’s “<a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-fludarabine-phosphate-under-project-renewal" target="_blank" rel="noreferrer noopener">Project Renewal</a>,” an effort to update labeling information for older cancer treatments to ensure information is clinically meaningful and scientifically up to date. The other two drugs updated so far under <a href="https://www.fda.gov/about-fda/oncology-center-excellence/project-renewal#Project%20Renewal%20Approvals" target="_blank" rel="noreferrer noopener">Project Renewal</a> include: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-updated-drug-labeling-including-new-indications-and-dosing" target="_blank" rel="noreferrer noopener">Xeloda</a> (capecitabine) tablets for treating colon cancer and other cancer types (revised in December 2022) and <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal" target="_blank" rel="noreferrer noopener">Temodar</a> (temozolomide) oral or I.V. chemotherapy medication for treating brain cancer (revised in September 2023).</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3048" target="_blank" rel="noreferrer noopener">Fludarabine phosphate FDA Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022137s015lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Paxlovid (nirmatrelvir; ritonavir) copackaged tablet</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2023</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 19, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Updated lactation information from a very small clinical trial study of 8 lactating women. The study found nirmatrelvir and ritonavir are present in human breast milk in small amounts (less than 2%). States there is no available data on the effects of nirmatrelvir or ritonavir on breastfed infants or on milk production.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=downloadDetails.page&DrugNameID=3049" target="_blank" rel="noreferrer noopener">Paxlovid FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s009lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Repatha (evolocumab) subcutaneous injection</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2015</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 20, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Used to reduce risk of major cardiovascular events, including chest pain requiring hospitalization, heart attacks, and strokes in adults with established cardiovascular disease; used as an adjunct to diet (and sometimes other cholesterol-lowering therapies) to reduce LDL-C cholesterol.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Added latex sensitivity warning. The prefilled single-dose auto-injector and syringe presentations that contain dry natural rubber (a derivative of latex) in the needle cover may cause an allergic reaction in individuals sensitive to latex. Patients are instructed to inform their healthcare provider if they are sensitive to latex.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=297" target="_blank" rel="noreferrer noopener">Repatha FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125522s044lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Stelara (ustekinumab) injection for subcutaneous or intravenous use</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2009</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 15, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: The drug interactions section has been updated for patients also taking <a href="https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers" target="_blank" rel="noreferrer noopener">CYP450 substrates</a> (enzymes that affect how medication is metabolized in the body). It suggests that healthcare providers monitor for therapeutic effects or drug concentration and adjust the individual dosage of the CYP substrate as needed. In clinical trials, Crohn’s patients taking Stelara along with the CYP450 substances caffeine, warfarin, omeprazole, dextromethorphan midazolam, did not experience the CYP450 drug interactions.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1304" target="_blank" rel="noreferrer noopener">Stelara FDA Safety Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125261s166,761044s014lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Vraylar (cariprazine hydrochloride) capsules</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2015</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 22, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats schizophrenia; bipolar disorder. Adjunct therapy to antidepressants for major depressive disorder in adults.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Adds dosage modifications (dosage reduction) for patients also taking a strong or moderate <a href="https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table2-2" target="_blank" rel="noreferrer noopener">CYP3A4 inhibitor</a>, which may increase the concentration of Vraylar in the blood. Examples include antifungal medications like ketoconazole, Itraconazole, voriconazole, and posaconazole, protease inhibitors used to treat HIV, along with some antibiotics like clarithromycin and grapefruit juice components. Recommends not taking with a<a href="https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table2-3" target="_blank" rel="noreferrer noopener"> CYP3A4 inducer</a>, as it may decrease the concentration of Vrayar in the blood. Examples include phenobarbital, phenytoin, rifampicin, St. John’s Wort, and glucocorticoids.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=857" target="_blank" rel="noreferrer noopener"> Vraylar FDA Safety Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204370s012lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Label<br></a>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Zanaflex: (tizanidine hydrochloride) tablets and capsules</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1996</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 20, 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats muscle spasms in adults.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: A new warning that the FDA has received postmarketing reports of decreased blood pressure (<a href="https://medshadow.org/frequently-asked-questions-about-blood-pressure/" target="_blank" rel="noreferrer noopener">hypotension</a>) and hallucinations has been added. Drug interaction information was added, as well as drugs to avoid while taking Zanaflex. Juvenile animal study toxicity data added; pediatric safety and effectiveness have not been established. Extensive prescribing information updated based on FDA regulation, guidance and current recommendations. See revised label for all changes.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: Frequently used by patients with multiple sclerosis, cerebral palsy, or those with spinal cord injuries.Used off-label for migraines.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2374" target="_blank" rel="noreferrer noopener">Zanaflex FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020397s029,021447s017lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label<br></a>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->