Menu
Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA SIDE EFFECTS UPDATE: Baqsimi and Serious Hypersensitivity Reactions, Plus More
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
May 7, 2025
0 Comments
republishon this page:
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 Baqsimi, Belsomra, Furoscix, Imfinzi, Pluvicto, Trodelvy, and Tymlos.
As of this article’s publication, updates to the FDA’s Drug Safety Database appear to be stalled. This is one of the last updates we were able to collect. To learn more about the reasons behind the delay, see our article: Medication Safety Updates from the FDA Delayed
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.
Baqsimi (active ingredient: glucagon) single-use intranasal powder
Initial FDA Approval: 1960; this formulation was approved in 2019.
Side Effect Update Date: March 17, 2025
Medication Description: Treats very low blood sugar (hypoglycemia) in adults and children with diabetes.
Updated Side Effects/Safety Information: Includes clinical trial data supporting expanded approval for pediatric patients as young as one year old, lowering the previous age limit from four years. There is also an added warning for serious hypersensitivity reactions, such as hives, difficulty swallowing, dizziness, cough, rapid heartbeat, and facial swelling. Nosebleeds and cough have been added to the list of common side effects.
FDA Safety Announcement: Baqsimi FDA Safety Label Change and Revised Drug Label
Belsomra (active ingredient: suvorexant) tablets
Initial FDA Approval: 2014
Side Effect Update Date: March 10, 2025
Medication Description: Treats insomnia in adults.
Updated Side Effects/Safety Information: New data from a small lactation study shows that the active ingredient, suvorexant, appears in low concentrations in breast milk, with a relative infant dose of less than 1% of the maternal dose. Patients are advised to consult their doctors to determine the best feeding approach while using Belsomra.
FDA Safety Announcement: Belsomra FDA Safety Label Change and Revised Drug Label (PDF)
Furoscix (active ingredient: furosemide) subcutaneous injection
Initial FDA Approval: 1968; this formulation was approved in 2022.
Side Effect Update Date: March 6, 2025
Medication Description: A diuretic that treats edema (water retention) in adult patients with chronic heart failure; also recently approved to treat edema in adult patients with chronic kidney disease.
Updated Side Effects/Safety Information: This update supports the recent approval for use in patients with kidney disease, noting that those with severely impaired kidney function may need additional diuretic therapy. It also adds a warning for patients with liver conditions such as cirrhosis and ascites, as sudden shifts in fluid and electrolyte balance could trigger hepatic encephalopathy and coma. Careful monitoring of electrolytes is recommended for these individuals.
FDA Safety Announcement: Furoscix FDA Safety Label Change and Revised Drug Label
Imfinzi (active ingredient: durvalumab) intravenous infusion
Initial FDA Approval: 2017
Side Effect Update Date: March 28, 2025
Medication Description: Treats different kinds of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), liver cancer, endometrial cancer, and most recently, muscle invasive bladder cancer (MIBC).
Updated Side Effects/Safety Information: This update supports a recent approval for muscle invasive bladder cancer (MIBC), a type of cancer that has spread into the muscle layer of the bladder but not to other parts of the body. The most common side effects when used for MIBC include low red blood cells (anemia), low white blood cells, constipation, increased level of creatinine in the blood, decreased level of magnesium in the blood, decreased appetite, nausea, and more. See revised label for additional clinical trial results.
FDA Safety Announcement: Imfinzi FDA Safety Label Change and Revised Drug Label
Pluvicto (active ingredient: lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use
Initial FDA Approval: 2022
Side Effect Update Date: March 28, 2025
Medication Description: A “radioligand” therapy that treats advanced prostate cancer by delivering radiation directly to the tumor. Patients are screened for treatment eligibility using a companion imaging test.
Updated Side Effects/Safety Information: New clinical trial results support its expanded approval to treat additional metastatic castration-resistant prostate cancer (mCRPC) patients. Pluvicto may now be used by adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor blockers such as Xtandi (enzalutamide) or Erleada (apalutamide), who are eligible to delay taxane-based chemotherapy (paclitaxel, docetaxel and cabazitaxel). Previously, patients were required to have been treated with the taxane-based chemotherapy before taking Pluvicto.
The revised label provides additional warnings about the risk of myelosuppression (decrease in bone marrow’s production of blood cells) and renal toxicity (kidney injury). Patients are advised to remain well hydrated and to urinate frequently. Healthcare providers should perform kidney function laboratory tests and monitor complete blood counts. Extensive changes to clinical trials data; read revised label for complete details.
Essential Extras: FDA issued a press release about the expanded approval of Pluvicto. Novartis expects that with the expanded approval, the number of people eligible for the treatment will triple.
FDA Safety Announcement: Pluvicto FDA Safety Label Change and Revised Drug Label
Trodelvy (active ingredient: sacituzumab govitecan-hziy) for injection, for intravenous use
Initial FDA Approval: 2020
Side Effect Update Date: March 26, 2025
Medication Description: Treats advanced breast cancer.
Updated Side Effects/Safety Information: New updates to the boxed warning about the risk of severe, life-threatening, or fatal neutropenia (low white blood cell count). Patients at an increased risk of febrile neutropenia (neutropenia with fever) are advised to receive a prophylactic (preventative treatment) starting at the first cycle of treatment. The Patient Information section has been updated to add that your heathcare provider may decide to decrease your dose, delay treatment, or permanently stop your treatment with Trodelvy if your white blood cell count is too low, or if your nausea, vomiting or diarrhea is severe and cannot be controlled with medications.
FDA Safety Announcement: Trodelvy FDA Safety Label Change and Revised Drug Label
Tymlos (active ingredient: abaloparatide) injection, for subcutaneous use
Initial FDA Approval: 2017
Side Effect Update Date: March 28,2025
Medication Description: Treats osteoporosis.
Updated Side Effects/Safety Information: New reports that some patients have experienced increased blood pressure.
FDA Safety Announcement: Tymlos FDA Safety Label Change and Revised Drug Label
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- DRUG SAFETY-RELATED LABELING CHANGES (SRLC)
- DRUGS@FDA: FDA APPROVED DRUGS
- ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
- NATIONAL LIBRARY OF MEDICINE’S DAILYMED DRUG LABEL DATABASE
- MERRIAM-WEBSTER MEDICAL DICTIONARY
- Loss of brain function – liver disease: MedlinePlus Medical Encyclopedia. (n.d.)
- Radioligand Therapy. (n.d.). Novartis
- Taxane. (2025, March 19). Cleveland Clinic
- FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. (n.d.). Novartis.
- FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. (n.d.). Novartis.
- Hormone therapy for prostate Cancer fact sheet. (2024, October 4). Cancer.gov.
DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.
While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual’s medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.
on this page:
RECOMMENDED:
DONATE:
Help fund our fight for improved medication safety and transparency by supporting our independent journalism.
Give NowWe seek to create a world where there are safer medications for all and where all people are fully informed about their medication benefits and side effects, using our explanatory and investigative journalism to both inform and stimulate public discussion to drive toward solutions.
WEBINARS
Stream our library on demand, including insights on generic drugs and pain management, straight from experts.
WATCH NOW