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Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications
FDA SIDE EFFECTS UPDATE: Botox, Briumvi, Fragmin, Heparin, Jubbonti
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
November 8, 2024
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Welcome to the FDA Side Effects Update. This new series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications.
Here’s How the FDA’s Safety Reporting Works
When a new drug is approved, the FDA makes the decision that the benefits of the drug outweigh its risks. Known risks of side effects and safety information must be included on the FDA-approved drug label. As time goes on and people use the drug in the real world, additional suspected side effects frequently emerge. In most cases, with the FDA’s approval, the drug’s sponsor revises the drug’s official label with the new safety information, and these changes are also logged into the FDA’s Drug Safety-related Labeling Changes (SrLC) database.
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.
Botox Cosmetic (active ingredient: onabotulinumtoxinA)
Initial FDA Approval: 1989 (2002 for cosmetic treatment)
Side Effect Update Date: October 18, 2024
Medication Description: Injectable used to improve the appearance of forehead lines, frown lines, crow’s feet lines, and most recently, platysma bands. Platysma bands are vertical bands that occur between the jaw and neck.
Updated Side Effects/Safety Information: Cases of dry eye have been reported when the injection is in or near the orbicularis oculi muscle, which is the muscle around the eye that closes the eyelids and drains tears.
A new warning section about reported adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes, was added.
The clinical trials experience section was updated.
Health care providers are warned not to use in the presence of infection at the injection site or when the injection site is inflamed or has muscle weakness. Patients with preexisting neuromuscular disorders should be monitored closely because of increased risk of side effects.
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Essential Extras: The Botox Cosmetic label had extensive changes to the clinical trial and adverse events sections, so for all changes, please refer to the entire drug label using the Approved Drug Label (PDF) link on the FDA Safety-Related Labeling Change page.
FDA Safety Announcement: Botox Cosmetic 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.
Briumvi (active ingredient: ublituximab-xiiy)
Initial FDA Approval: 2022
Side Effect Update Date: October 20, 2024
Medication Description: Treats Multiple Sclerosis (MS).
Updated Side Effects/Safety Information: A new safety update warns patients about potential safety risks to a fetus and notifies patients about the new Pregnancy Exposure Registry that monitors pregnancy outcomes in women exposed to Briumvi during pregnancy or when becoming pregnant within six months following their last dose.
FDA Safety Announcement: Briumvi 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.
Fragmin (active ingredient: dalteparin sodium, subcutaneous)
Initial FDA Approval: 1994
Side Effect Update Date: October 15, 2024, and October 20, 2024
Medication Description: Fragmin is classified as a “low molecular weight heparin” (LMWH), and is used for the prevention of various blood-clotting conditions, including deep vein thrombosis (DVT), a type of blood clotting that usually occurs in the veins of the legs. The drug is often given before abdominal or hip replacement surgery for patients at risk of DVT.
Updated Side Effects/Safety Information: Heparin medications, including Fragmin, can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised levels of potassium), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days. Note that additional heparin medications (see the next entry) also had a new warning about the risk of hyperkalemia.
Providers are also advised to ask that patients read the FDA-approved medication guide section on the risk of hemorrhage, including spinal or epidural hematomas (abnormal pooling of blood outside a blood vessel).
Updates on pediatric clinical trials were added to the label. Fragmin is now approved to treat patients from birth (35 weeks gestational age) and up with symptomatic venous thromboembolism (VTE). VTE includes deep vein thrombosis and pulmonary embolism (blood clots in the lungs). Prior to this label change, it was approved for ages one month and up.
Essential Extras: Fragmin has a boxed warning about the risk of spinal or epidural hematomas.
FDA Safety Announcement: Fragmin 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.
Heparin Sodium (heparin sodium) injection
Initial FDA Approval: 1939
Side Effect Update Date: October 24, 2024
Medication Description: Heparin drugs are anticoagulants that prevent blood clots or keep them from getting worse.
Updated Side Effects/Safety Information: Heparin medications can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised potassium levels), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days.
FDA Safety Announcements: Heparin Sodium 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.
Similar updates:
Heparin Lock Flush FDA Safety Label Change
Liquaemin Sodium FDA Safety Label Change
Liquaemin Lock Flush FDA Safety Label Change
Jubbonti (active ingredient: denosumab-bbdz)
Initial FDA Approval: 2024
Side Effect Update Date: October 24, 2024
Medication Description: Treats bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause and bone loss in men who are at high risk for bone fracture. Jubbonti is a biosimilar (biological generic) for the osteoporosis drug Prolia.
Updated Side Effects/Safety Information: Reports that in clinical trials of postmenopausal women, the most common adverse reactions are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
FDA Safety Announcement: Jubbonti 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.
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Article HTML
<!-- wp:paragraph -->
<p>Welcome to the FDA Side Effects Update. This new series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications.</p>
<!-- /wp:paragraph -->
<!-- wp:heading -->
<h2 class="wp-block-heading">Here’s How the FDA’s Safety Reporting Works</h2>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p>When a new drug is approved, the <a href="https://www.fda.gov/drugs/development-approval-process-drugs" target="_blank" rel="noreferrer noopener">FDA makes the decision</a> that the benefits of the drug outweigh its risks. Known risks of side effects and safety information must be included on the FDA-approved drug label. As time goes on and people use the drug in the real world, additional suspected side effects frequently emerge. In most cases, with the FDA’s approval, the drug’s sponsor revises the drug’s official label with the new safety information, and these changes are also logged into the FDA’s Drug Safety-related Labeling Changes (SrLC) database.</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 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">Botox Cosmetic (active ingredient: onabotulinumtoxinA)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1989 (2002 for cosmetic treatment)<br><strong>Side Effect Update Date</strong>: October 18, 2024<br><strong>Medication Description</strong>: Injectable used to improve the appearance of forehead lines, frown lines, crow’s feet lines, and most recently, platysma bands. Platysma bands are vertical bands that occur between the jaw and neck.<br><strong>Updated Side Effects/Safety Information</strong>: Cases of dry eye have been reported when the injection is in or near the orbicularis oculi muscle, which is the muscle around the eye that closes the eyelids and drains tears.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>A new warning section about reported adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes, was added.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>The clinical trials experience section was updated.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>Health care providers are warned not to use in the presence of infection at the injection site or when the injection site is inflamed or has muscle weakness. Patients with preexisting neuromuscular disorders should be monitored closely because of increased risk of side effects.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: The Botox Cosmetic label had extensive changes to the clinical trial and adverse events sections, so for all changes, please refer to the entire drug label using the <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf" target="_blank" rel="noreferrer noopener">Approved Drug Label (PDF)</a> link on the FDA Safety-Related Labeling Change page.</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=31" target="_blank" rel="noreferrer noopener">Botox Cosmetic FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.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">Briumvi (active ingredient: ublituximab-xiiy)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval:</strong> 2022<br><strong>Side Effect Update Date</strong>: October 20, 2024<br><strong>Medication Description</strong>: Treats Multiple Sclerosis (MS).<br><strong>Updated Side Effects/Safety Information</strong>: A new safety update warns patients about potential safety risks to a fetus and notifies patients about the new Pregnancy Exposure Registry that monitors pregnancy outcomes in women exposed to Briumvi during pregnancy or when becoming pregnant within six months following their last dose.</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=3042" target="_blank" rel="noreferrer noopener">Briumvi FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761238s011lbl.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">Fragmin (active ingredient: dalteparin sodium, subcutaneous)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1994<br><strong>Side Effect Update Date</strong>: October 15, 2024, and October 20, 2024<br>Medication Description: Fragmin is classified as a “low molecular weight heparin” (LMWH), and is used for the prevention of various blood-clotting conditions, including deep vein thrombosis (DVT), a type of blood clotting that usually occurs in the veins of the legs. The drug is often given before abdominal or hip replacement surgery for patients at risk of DVT.<br><strong>Updated Side Effects/Safety Information</strong>: Heparin medications, including Fragmin, can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised levels of potassium), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days. Note that additional heparin medications (see the next entry) also had a new warning about the risk of hyperkalemia.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>Providers are also advised to ask that patients read the FDA-approved medication guide section on the risk of hemorrhage, including spinal or epidural hematomas (abnormal pooling of blood outside a blood vessel).</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>Updates on pediatric clinical trials were added to the label. Fragmin is now approved to treat patients from birth (35 weeks gestational age) and up with symptomatic venous thromboembolism (VTE). VTE includes deep vein thrombosis and pulmonary embolism (blood clots in the lungs). Prior to this label change, it was approved for ages one month and up.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: Fragmin has a boxed warning about the risk of spinal or epidural hematomas.</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=280" target="_blank" rel="noreferrer noopener">Fragmin FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020287s081lbl.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">Heparin Sodium (heparin sodium) injection</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1939<br><strong>Side Effect Update Date</strong>: October 24, 2024<br><strong>Medication Description</strong>: Heparin drugs are anticoagulants that prevent blood clots or keep them from getting worse.<br><strong>Updated Side Effects/Safety Information</strong>: Heparin medications can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised potassium levels), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcements</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1061" target="_blank" rel="noreferrer noopener">Heparin Sodium FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017037s201lbl.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:paragraph -->
<p><strong>Similar updates</strong>:<br><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3040" target="_blank" rel="noreferrer noopener">Heparin Lock Flush FDA Safety Label Change</a><br><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3038" target="_blank" rel="noreferrer noopener">Liquaemin Sodium FDA Safety Label Change</a><br><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3037" target="_blank" rel="noreferrer noopener">Liquaemin Lock Flush FDA Safety Label Change</a></p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Jubbonti (active ingredient: denosumab-bbdz)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2024<br><strong>Side Effect Update Date</strong>: October 24, 2024<br><strong>Medication Description:</strong> Treats bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause and bone loss in men who are at high risk for bone fracture. Jubbonti is a biosimilar (biological generic) for the osteoporosis drug Prolia.<br><strong>Updated Side Effects/Safety Information:</strong> Reports that in clinical trials of postmenopausal women, the most common adverse reactions are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.</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=3036" target="_blank" rel="noreferrer noopener">Jubbonti FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s001lbl.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 -->