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.
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.
Jylamvo (active ingredient: methotrexate) oral solution
Initial FDA Approval: 1953
Side Effect Update Date: October 23, 2024
Medication Description: An oral liquid formulation of methotrexate for adults with acute lymphoblastic leukemia, severe psoriasis, Hodgkin’s lymphoma, and other conditions. With this label update, it is also now approved for pediatric acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen, and is also approved for polyarticular juvenile idiopathic arthritis (pJIA).
Updated Side Effects/Safety Information: Clinical trial data reveals the most common adverse reactions reported in patients aged two to 18 with juvenile idiopathic arthritis: Elevated liver tests 14%; gastrointestinal reactions (nausea, vomiting, diarrhea) 11%; stomatitis 2%; leukopenia 2%; headache 1.2%; alopecia 0.5%; dizziness 0.2%; rash 0.2%.
Essential Extras: Most pediatric patients in the clinical trial for pJIA also received NSAIDs (such as ibuprofen) and some also received corticosteroids.
FDA Safety Announcement: Jylamvo 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.
Limbitrol (active ingredient: amitriptyline hydrochloride; chlordiazepoxide)
Initial FDA Approval: 1977
Side Effect Update Date: October 28, 2024
Medication Description: Treats moderate to severe depression that’s associated with moderate to severe anxiety. Its ingredient amitriptyline HCL is also used to treat migraines and is contained in drugs like Elavil and Endep. Limbitrol also contains chlordizepoxide, a long-acting benzodiazepine that treats anxiety.
Updated Side Effects/Safety Information: New warning about the risk of “drug reaction with eosinophilia and systemic symptoms (DRESS),” a rare but serious allergic reaction to a medication that is usually accompanied by skin rash and affects internal organs.
Essential Extras: This medication is currently only marketed as a generic.
FDA Safety Announcement: Limbitrol 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.
Liptruzet (active ingredient: atorvastatin calcium; ezetimibe)
Initial FDA Approval: 2013
Side Effect Update Date: October 28, 2024
Medication Description: Treats treat high cholesterol.
Updated Side Effects/Safety Information: Rare post-approval reports have been received for cases of either new-onset or symptom exacerbation of myasthenia gravis, including ocular myasthenia. Myasthenia gravis is a disease that causes general muscle weakness, weakness in muscles used for breathing, and sometimes eye muscle weakness (ocular myasthenia). There have been reports of recurrence when the same or a different statin was administered.
Post-approval information about elevated liver enzymes was also updated: Elevations more than 5X ULN (or five times above upper normal limits) have been reported.
Extensive changes were made to the Patient Information section of the label; please refer to the label for complete information.
Essential Extras: Liptruzet is sold under the branded generic name Lypqozet.
FDA Safety Announcement: Liptruzet 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.
Lysodren (active ingredient: mitotane)
Initial FDA Approval: 1970
Side Effect Update Date: October 28, 2024
Medication Description: Treats patients with adrenal gland tumors.
Updated Side Effects/Safety Information: Clinical trial data was updated to include: Reports of dyspnea (shortness of breath).
Cardiac disorder reports of QT prolongation, which occurs when the heart muscle takes longer to contract and relax than usual.
FDA Safety Announcement: Lysodren 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
Noxafil (active ingredient: posaconazole), Sporanox (active ingredient: itraconazole), and Tolsura (active ingredient: itraconazole)
Initial FDA Approval: 2006 (Noxafil); 1992 (Sporanox and Tolsura)
Side Effect Update Date: October 22, 2024
Medication Description: Treats or prevents a variety of fungal infections.
Updated Side Effects/Safety Information: Risk of new or worsening high blood pressure and low potassium levels in the blood (pseudoaldosteronism). It is also recommended that your healthcare provider should check your blood pressure and potassium levels.
FDA Safety Announcement: Noxafil FDA Safety Label Change and Revised Drug Label
Sporanox FDA Safety Label Change and Revised Drug Label
Tolsura 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
