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 Gemtesa, Ibsrela, Injectafer and Cyclophosphamide.
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.
Gemtesa (active ingredient: vibegron) tablets
Initial FDA Approval: 2020
Side Effect Update Date: December 18, 2024
Medication Description: Treats overactive bladder (OAB) in adults. OAB causes sudden urges to urinate that may be hard to control. Recently, Gemtesa gained approval as a treatment for overactive bladder in adult males with benign prostatic hyperplasia (BPH or enlarged prostate) who are taking BPH medications.
Updated Side Effects/Safety Information: Includes new warnings about the risk of swelling (angioedema) in the face, lips, tongue and throat, along with other hypersensitivity reactions. Added clinical trial results supporting its new approval for OAB in males with BPH. Clinical trial results that indicate no difference in drug safety between patients aged 65 and older and younger patients were also included.
FDA Safety Announcement: Gemtesa FDA Safety Update and Revised Drug Label
Ibsrela (active ingredient: tenapanor hydrochloride) tablets
Initial FDA Approval: 2019
Side Effect Update Date: January 10, 2025
Medication Description: Treats irritable bowel syndrome with constipation (IBS-C) in adults.
Updated Side Effects/Safety Information: Post-approval reports of hypersensitivity reactions including hives, itching and rash have been added.
FDA Safety Announcement: Ibsrela FDA Safety Update and Revised Drug Label
Injectafer (active ingredient: ferric carboxymaltose) intravenous infusion
Initial FDA Approval: 2013
Side Effect Update Date: January 3, 2025
Medication Description: Treats severe iron deficiency anemia in adults and children; also treats iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise.
Updated Side Effects/Safety Information: Warns about the rare but life-threatening risk of symptomatic hypophosphatemia (low levels of phosphate in the blood). Clinical trial results were also added for adult patients with iron deficiency and heart failure. The patient medication guide was updated — read label for complete information.
Essential Extras: Injectafer’s label states that in most cases, hypophosphatemia resolves within three months. A list of possible risk factors for hypophosphatemia was updated to include: a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect kidneys, hyperparathyroidism, vitamin D deficiency, malnutrition and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). HHT is a genetic disorder affecting the blood vessels.
FDA Safety Announcement: Injectafer FDA Safety Update and Revised Drug Label
Cyclophosphamide (active ingredient: cyclophosphamide) intravenous infusion
Initial FDA Approval: 1959
Side Effect Update Date: December 30, 2024
Medication Description: A chemotherapy medication that treats various kinds of cancer in adults, including Hodgkin’s lymphoma, multiple myeloma, leukemia, and breast cancer.
Updated Side Effects/Safety Information: Warns of potential interactions with radiation therapies: immunosuppression, kidney damage, liver toxicity, and cardio toxicity. The list of potential drug interactions has been updated — read label for complete list.
Essential Extras: This version of cyclophosphamide is not approved for pediatric use due to its alcohol and propylene glycol content. There are other formulations of cyclophosphamide approved for pediatric and adult use.
FDA Safety Announcement: Cyclophosphamide FDA Safety Update and Revised Drug Label
