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 edition, we have updates on Arimidex, Aromasin, Femara, Paxil, Rybelsus, Tofidence and Tyenne.
How to Read This Side Effects 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.
Arimidex (anastrozole) tablets; Aromasin (exemestane) tablets; Femara (letrozole) tablets
Initial FDA Approval: 1995 (Arimidex); 1997 (Femara); 1999 (Aromasin)
Side Effects Update Date: December 16, 2024
Medication Description: Treats breast cancer in postmenopausal women.
Updated Side Effects/Safety Information: Tendon-related disorders, including tendon rupture, tendonitis and tenosynovitis stenosans (trigger finger) were added to the Adverse Reactions, Postmarketing Experience section of the drug label.
Essential Extras: Arimidex, Aromasin and Femara work by reducing the production of estrogen. They are called aromatase inhibitors. Reduced estrogen helps to slow or reverse the growth of some breast cancers.
FDA Safety Announcement: Arimidex FDA Safety Label Change and Revised Drug Label
Aromasin FDA Safety Label Change and Revised Drug Label
Femara FDA Safety Label Change and Revised Drug Label
Paxil (paroxetine) tablets and oral suspension
Initial FDA Approval: 1992
Side Effects Update Date: December 2, 2024
Medication Description: treats major depression and anxiety disorder in adults.
Updated Side Effects/Safety Information: Data from published literature show adverse effects from paroxetine in human milk. Infants exposed to paroxetine through breast milk have experienced agitation, irritability, poor feeding and poor weight gain.
The patient medication guide was updated to add warnings about taking Paxil while pregnant. Taking it during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem. Taking it in the third trimester may cause breathing and lung problems, temperature, feeding problems, low muscle tone, and irritability.
A new section called “Infertility” warns that clinical studies show that Paxil may affect sperm quality and may impair fertility in males; it is not known if the effect is reversible.
Essential Extras: There is a pregnancy registry for women who are exposed to Paxil during pregnancy. This registry collects information to monitor the effects of the medication on both mothers and their babies. For more details or to participate, visit the National Pregnancy Registry for Antidepressants.
FDA Safety and Side Effects Announcement: Paxil FDA Safety Label Change and Revised Drug Label
Rybelsus (semaglutide) once-daily pills
Initial FDA Approval: 2019
Side Effects Update Date: December 9, 2024
Medication Description: Treats type 2 diabetes in adults.
Updated Side Effects/Safety Information: Results from a required lactation study show that an ingredient in Rybelsus, salcaprozate sodium (SNAC) and/or its metabolites, are present in human milk. Breastfeeding while taking Rybelsus is not recommended.
A section on severe gastrointestinal adverse reactions reported in people who use Rybelsus was also added
The side effects of alopecia (hair loss) and dysesthesia (abnormal or distorted sense of touch) were added to the Postmarketing Experience section of the drug label.
FDA Safety Announcement: Rybelsus FDA Safety Label Change and Revised Drug Label
Tofidence (tocilizumab-bavi) and Tyenne (tocilizumab-aazg) (Actemra biosimilar)
Initial FDA Approval: 2023 (Tofidence) and 2024 (Tyenne)
Side Effects Update Date: December 3 and December 13, 2024
Medication Description: Treats rheumatoid arthritis (GA), giant cell arteritis (GCA) and other autoimmune diseases in adults and polyarticular juvenile arthritis (PJIA) in children two years and older. GCA, also known as temporal arteritis, is an inflammatory disorder involving blood vessels that supply blood to the head, neck, upper body and arms.
Updated Side Effects/Safety Information: Warns about the risk of “drug reaction with eosinophilia and systemic symptoms” (DRESS). DRESS iis a rare but potentially life-threatening drug-induced hypersensitivity reaction that not only affects the skin but can also involve organs such as the liver, heart, and lungs. Patients are advised to get emergency help right away if experiencing fever, severe itching, skin rash, hives, redness, or swelling outside of the injection site area, dizziness or fainting, fast heartbeat, or sweating. These are signs of a serious hypersensitivity reaction.
The patient information guide added a section on the risk of gastrointestinal perforation (a hole in your digestive tract). Patients should tell their healthcare provider right away if they have fever along with new stomach-area pain that does not go away and a change in bowel habits. See label for all changes.
Essential Extras: The FDA is requiring that the risk of DRESS be included in the labels for tocilizumab-containing products. The rheumatoid arthritis drug Actemra (tocilizumab) had a similar label update in September 2024. Tyenne and Tofidence are biosimilars (biological generic) to Actemra.
FDA Safety and Side Effects Announcement: Tyenne FDA Safety Label Change and Revised Drug Label
Tofidence FDA Safety Label Change and Revised Drug Label
