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FDA SIDE EFFECTS UPDATE: Remicade and the Onset of New Autoimmune Diseases, Plus More

Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language

Katie Rowley

March 26, 2025

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Safety updates sourced directly from the FDA’s Drug Safety Database, presented in clear and accessible language

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 Lybalvi, Neffy, Nplate, Remicade, and TNKase.

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.

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

Initial FDA Approval: 2021

Side Effect Update Date: February 28, 2025

Medication Description: Treats schizophrenia and bipolar 1 disorder in adults.

Updated Side Effects/Safety Information: The lactation section has been updated, with a new note explaining that samidorphan and olanzapine have been found in human breast milk. Infants exposed to Lybalvi should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements).

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

Neffy (epinephrine) nasal spray

Initial FDA Approval: 1939 (epinephrine); nasal spray version approved in 2024

Side Effect Update Date: March 5, 2025

Medication Description: Treats emergency allergic reactions, including anaphylaxis, in adults and children aged four and older.

Updated Side Effects/Safety Information: This update supports the approval of a new dosage formulation (one milligram per spray) for patients four and older weighing at least 15 kg (33 pounds) and less than 30 kg (66 pounds). In a clinical trial of pediatric patients in this weight range, the most common adverse reactions were nasal congestion (19%), upper respiratory tract congestion (14%), dry throat (10%), nasal dryness (10%), and paresthesia (prickling skin sensation) (10%).

Essential Extras: Neffy is the first nasal spray version of epinephrine (brand name “Epi-Pen”). The original two milligram per spray dose is approved for children weighing at least 30 kg (66 pounds) and adults. The most common side effects are different for adults; see revised label for complete details.

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

Drug Name: Nplate (romiplostim) subcutaneous injection

Initial FDA Approval: 2008

Side Effect Update Date: February 21, 2025

Medication Description: Treats low blood platelet levels in adults and children with immune thrombocytopenia (ITP), a condition where the immune system attacks blood platelets, resulting in inadequate blood clotting response. Nplate should be used only by those who have had an insufficient response to other treatments (such as corticosteroids, antibody medications, or spleen removal). Nplate is also used to increase survival after suspected or confirmed exposure to myelosuppressive radiation (radiation that causes damage to bone marrow).

Updated Side Effects/Safety Information: Because Nplate might raise blood platelet levels too much, causing dangerous clotting, there is a warning of the risk of thromboembolic complications, including blood clots in the leg veins (DVT or deep vein thrombosis) or lungs (PEP or pulmonary embolism). There is also a warning that portal vein thrombosis, or blood clots in the veins of the liver, is a risk in patients with and without chronic liver disease.

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

Remicade (infliximab) for intravenous use

Initial FDA Approval: 1998

Side Effect Update Date: February 28, 2025

Medication Description: Treats Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.

Updated Side Effects/Safety Information: New warnings have been added regarding the onset of immune-related disorders, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease.

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

TNKase (tenecteplase) for intravenous administration

Initial FDA Approval: 2000

Side Effect Update Date: February 28, 2025

Medication Description: Treats acute stroke in adults. Also used to reduce the risk of death associated with acute ST elevation, a type of heart attack.

Updated Side Effects/Safety Information: This update supports expanded approval for treating stroke in adults. A new section has been added about the risk of internal or external bleeding, which can occur one or more days after administering TNKase. Bleeding may occur at medication puncture sites. Patients should contact a healthcare provider if they experience signs of bleeding, such as unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds; or symptoms of stroke.

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

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Article HTML

<!-- wp:paragraph -->
<p>Safety updates sourced directly from the FDA’s Drug Safety Database, presented in clear and accessible language</p>
<!-- /wp:paragraph --><!-- 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 installment, we’re highlighting safety updates concerning Lybalvi, Neffy, Nplate, Remicade, and TNKase.</p>
<!-- /wp:paragraph --><!-- wp:heading -->
<h2 class="wp-block-heading">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</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>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">Lybalvi (active ingredient: olanzapine; samidorphan l-malate) tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2021</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: February 28, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats schizophrenia and bipolar 1 disorder in adults.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: The lactation section has been updated, with a new note explaining that samidorphan and olanzapine have been found in human breast milk. Infants exposed to Lybalvi should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements).</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcemen</strong>t:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2853" target="_blank" rel="noreferrer noopener"> Lybalvi FDA Safety Label Change</a>  and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213378s008lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Neffy (epinephrine) nasal spray</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval:</strong> 1939 (epinephrine); nasal spray version approved in 2024</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 5, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats emergency allergic reactions, including anaphylaxis, in adults and children aged four and older.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: This update supports the approval of a new dosage formulation (one milligram per spray) for patients four and older weighing at least 15 kg (33 pounds) and less than 30 kg (66 pounds). In a clinical trial of pediatric patients in this weight range, the most common adverse reactions were nasal congestion (19%), upper respiratory tract congestion (14%), dry throat (10%), nasal dryness (10%), and paresthesia (prickling skin sensation) (10%).</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: Neffy is the first nasal spray version of epinephrine (brand name “Epi-Pen”). The original two milligram per spray dose is approved for children weighing at least 30 kg (66 pounds) and adults. The most common side effects are different for adults; see revised label for complete details.</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=3087" target="_blank" rel="noreferrer noopener">Neffy FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697s001lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Drug Name: Nplate (romiplostim) subcutaneous injection</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2008</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: February 21, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats low blood platelet levels in adults and children with immune thrombocytopenia (ITP), a condition where the immune system attacks blood platelets, resulting in inadequate blood clotting response. Nplate should be used only by those who have had an insufficient response to other treatments (such as corticosteroids, antibody medications, or spleen removal). Nplate is also used to increase survival after suspected or confirmed exposure to myelosuppressive radiation (radiation that causes damage to bone marrow).</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Because Nplate might raise blood platelet levels too much, causing dangerous clotting, there is a warning of the risk of thromboembolic complications, including blood clots in the leg veins (DVT or deep vein thrombosis) or lungs (PEP or pulmonary embolism). There is also a warning that portal vein thrombosis, or blood clots in the veins of the liver, is a risk in patients with and without chronic liver disease.</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=200" target="_blank" rel="noreferrer noopener"> Nplate FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125268s176lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Remicade (infliximab) for intravenous use</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1998</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: February 28, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New warnings have been added regarding the onset of immune-related disorders, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease.</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=1315" target="_blank" rel="noreferrer noopener">Remicade FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103772s5412lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">TNKase (tenecteplase) for intravenous administration</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2000</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: February 28, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats acute stroke in adults. Also used to reduce the risk of death associated with <a href="https://www.nature.com/articles/s41572-019-0090-3" target="_blank" rel="noreferrer noopener">acute ST elevation</a>, a type of heart attack.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: This update supports expanded approval for treating stroke in adults. A new section has been added about the risk of internal or external bleeding, which can occur one or more days after administering TNKase. Bleeding may occur at medication puncture sites. Patients should contact a healthcare provider if they experience signs of bleeding, such as unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds; or symptoms of stroke.</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=1461" target="_blank" rel="noreferrer noopener">TNKase FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1461" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->

FDA SIDE EFFECTS UPDATE: Remicade and the Onset of New Autoimmune Diseases, Plus More

How to Read This Report