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 Depo Provera, depo-subQ provera 104, Veozah, Vtama and Xofluza.
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. For the Depo-subQ provera 104 update, additional sources related to the side effects not yet recognized by the FDA are listed.
Depo-subQ provera 104 (active ingredient: medroxyprogesterone acetate) subcutaneous injection
Initial FDA Approval: 1959 (active ingredient); 2004 (this product)
Side Effect Update Date: December 16, 2024
Medication Description: Taken to prevent pregnancy in females of reproductive age or to manage endometriosis-associated pain. Endometriosis occurs when cells from the lining of the uterus grow in other parts of the body. This medication is usually administered by a health care provider.
Updated Side Effects/Safety Information: New warning about the risk of skin discoloration at the injection site. Under the Patient Counseling section, patients are advised that scarring and discoloration are uncommon, but may happen.
Essential Extras: Depo-subQ provera 104 is administered once every three months. Another version of the drug, Depo Provera, was approved in 1992 and is still in use. Unlike depo-subQ 104, it is administered as an intramuscular shot, which may be more painful than a subcutaneous (skin-deep) shot. At 150 milligrams of medroxyprogesterone acetate per dose, Depo Provera is more potent than depo-subQ provera 104, which contains 104 milligrams per dose. It is recommended that the drugs not be used longer than two years.
FDA Safety Announcement: Depo SubQ Provera 104 FDA Safety Update and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Additional Safety Announcements: Recent studies published by France’s National Agency for Medicines and Health Products Safety and University of Alabama conclude that medroxyprogesterone acetate injections are associated with a significantly increased risk of developing cerebral meningioma, a type of brain tumor. Although the tumors are usually benign, they can cause seizures, headaches, vision loss, and death.
A lawsuit filed in November 2024 by a 49-year old Nevada mom who took the drug for years alleges that “Pfizer, and other manufacturing companies who make authorized generic versions of Depo-Provera, was aware of the possibility the shot could lead to meningiomas, a type of tumor on the membranes that surround the brain.” Patients taking depo-subQ provera 104 may also be included in upcoming lawsuits.
In December 2024, the European Medicines Agency (the E.U. counterpart to the U.S. FDA) issued a professional communication highlighting the risk of meningioma associated with injectable medroxyprogesterone acetate: EU Safety Communication for Medroxyprogersterone
Veozah (active ingredient: fezolinetant) tablets
Initial FDA Approval: 2023
Side Effect Update Date: December 16, 2024
Medication Description: Reduces the frequency and severity of hot flashes due to menopause.
Updated Side Effects/Safety Information: Boxed warning added about the rare but serious risk of liver injuries (hepatoxicity). The warning states that hepatic lab tests should be performed prior to treatment and at specified intervals during treatment. Patients should discontinue the medication immediately and seek medical attention, including hepatic laboratory tests, if they experience signs or symptoms that may suggest liver injury. Check label for complete list of symptoms associated with liver injury. The post-marketing experience section (reports of side effects that happen after the drug has been approved and is on the market) adds that drug-induced liver toxicity occurred within 40 days of starting Veozah.
Essential Extras: Veozah is a non-hormonal hot flash treatment that comes with a unique set of side effects.
FDA Safety Announcement: Veozah FDA Safety Update and Revised Drug Label
FDA Press Release on Veozah Boxed Warning
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Vtama (active ingredient: tapinarof) cream
Initial FDA Approval: 2022
Side Effect Update Date: December 12, 2024
Medication Description: Treats plaque psoriasis in adults and was recently approved to treat atopic dermatitis in adults and children aged two and up.
Updated Side Effects/Safety Information: Added clinical trial results supporting Vtama’s recent new approval for treating atopic dermatitis, a type of eczema. See the label for complete clinical trial details. The most common side effects experienced by people treated with Vtama for atopic dermatitis were also added, including: upper and lower respiratory tract infections, vomiting, ear infection, headache, red bumps on skin (folliculitis), pain in extremities, asthma, and abdominal pain.
FDA Safety Announcement: Vtama FDA Safety Update and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Xofluza (active ingredient: baloxavir marboxil) tablets
Initial FDA Approval: 2018
Side Effect Update Date: December 19, 2024
Medication Description: Administered within 48 hours of flu symptom onset to treat influenza, or taken as a preventive measure after exposure to someone with the flu.
Updated Side Effects/Safety Information: Corrects specific clinical trial data regarding drug resistance from a pediatric study. The CDC explains that “Influenza Antiviral Drug Resistance” is when an influenza virus changes (or mutates) and becomes less susceptible to an antiviral drug (like baloxavir) used to treat or prevent flu.
In this update, the Xofluza label changes the percent of participants experiencing drug resistance during clinical trials from 43% to 40% among patients under the age of five. Research suggests that the younger the patient, the more likely it is that Xofluza will trigger a mutation of the influenza virus leading to drug resistance. The number of clinical trial participants aged five to 12 experiencing drug resistance was 16%. For patients aged 12 and up, the percent of clinical trial participants experiencing drug resistance decreased to just seven percent. Because of the increased resistance to baloxavir in pediatric patients, the drug is not approved for patients under the age of five. The label states that the potential for transmission of drug-resistant strains of the flu virus in the community has not been determined.
Essential Extras: Read more on Xofluza and a study finding that the drug may cause flu virus mutations.
FDA Safety Announcement: Xofluza FDA Safety Update and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
