FDA SIDE EFFECTS UPDATE: Stelara and Alpha-Gal Allergy; Seizure Medication Linked to Severe Skin Reactions

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<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 Stelara and Tegretol.</p>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">How to Read This Report</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<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"> 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>
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<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>
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<h2 class="wp-block-heading">Updated Side Effect Warning for Plaque Psoriasis/Ulcerative Colitis Drug</h2>
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<h3 class="wp-block-heading">Stelara (ustekinumab) injection for subcutaneous or intravenous use</h3>
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<p><strong>Initial FDA Approval</strong>: 2009<br><strong>Side Effect Update Date</strong>: July 15, 2026<br><strong>Medication Description</strong>: Treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Stelara works by blocking inflammatory proteins. It is administered by a healthcare provider every 8 or 12 weeks, depending on the condition being treated.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning that serious allergic reactions have been reported in some patients with <a href="https://www.cdc.gov/alpha-gal-syndrome/about/">alpha-gal syndrome</a>, which is an allergy to mammalian meat such as beef, pork, or lamb that may have been triggered by a tick bite. Individuals who have been diagnosed with an alpha-gal allergy should tell their healthcare provider before starting Stelara.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1304">Stelara FDA Safety Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125261s174lbl.pdf">Revised Drug Label<br></a>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h2 class="wp-block-heading">Updated Side Effect Warning for Seizure Drug</h2>
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<h3 class="wp-block-heading">Tegretol (carbamazepine tablets, oral solution) and Tegretol XR (carbamazepine extended-release tablets)</h3>
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<p><strong>Initial FDA Approval</strong>: 1968 (Tegretol); 1996 (Tegretol-XR)<br><strong>Side Effect Update Date</strong>: July 15, 2026<br><strong>Medication Description</strong>: Prevents and controls seizures; sometimes used for nerve pain.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). With repeated use of Tegretol, the condition may progress to a more serious reaction known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. The rash can recur in the same area of the skin each time the medicine is taken. Patients who notice a new or recurring rash should stop taking Tegretol and contact their healthcare provider.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1493">Tegretol FDA Safety Label Change</a>, <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1494">Tegretol-XR FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020234s57lbl.pdf">Revised Drug Label</a> (covers both formulations)<br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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