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 Zepbound, Ibrance, Imbruvica and Imfinzi.
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.
Zepbound (active ingredient: tirzepatide)
Initial FDA Approval: 2022
Side Effect Update Date: December 20, 2024
Medication Description: Zepbound is a GLP-1 weekly injection used for weight loss in people living with obesity or for weight loss in those living with extra weight who have at least one related condition, such as hypertension, cardiovascular disease, or abnormal blood lipid levels. Recently, Zepbound was approved to treat moderate to severe obstructive sleep apnea (OSA) in patients with obesity. OSA occurs when a person’s upper airway becomes blocked, causing pauses in breathing during sleep.
Updated Side Effects/Safety Information: New clinical trial results were added related to Zepbound’s expanded approval for treating moderate to severe obstructive sleep apnea (OSA) in people with obesity. The results show that similar rates of severe hypersensitivity and adverse reactions were observed in Zepbound placebo-controlled clinical trials for OSA compared with those observed in placebo-controlled clinical trials for weight reduction.
Essential Extras: Zepbound is the first FDA-approved medication to treat obstructive sleep apnea. It is meant to be used in combination with a reduced-calorie diet and increased physical activity. In clinical trials, Zepbound reduced the number of apnea-type events by an average of 25 per hour compared with a reduction of just five per hour in the placebo group. Read the complete revised drug label for more clinical trials results.
FDA Safety Announcement: Zepbound FDA Safety Update and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Ibrance (active ingredient: palbociclib) capsules and tablets
Initial FDA Approval: 2015
Side Effect Update Date: December 20, 2024
Medication Description: Used in conjunction with an aromatase inhibitor (estrogen-blocking) drug or fulvestrant (brand name, Faslodex) to treat advanced or metastatic breast cancer.
Updated Side Effects/Safety Information: The adverse reaction of venous thromboembolism (blood clots) was identified in clinical trials. Venous thromboembolism includes both deep vein thrombosis (DVT or blood clots in the legs) and pulmonary embolism (PE). PE happens when a blood clot travels to the lungs.
FDA Safety Announcement: Ibrance FDA Safety Update and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Imbruvica (active ingredient: ibrutinib) tablet, capsule, or liquid suspension
Initial FDA Approval: 2013
Side Effect Update date: December 20, 2024
Medication Description: Treats leukemia and lymphoma blood cancers.
Updated Side Effects/Safety Information: Warns that there have been post-marketing reports of the skin disorder cutaneous vasculitis (inflammation of blood vessels in the skin).
FDA Safety Announcement: Imbruvica FDA Safety Update and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Imfinzi (active ingredient: durvalumab) intravenous infusion
Initial FDA Approval: 2017
Side Effect Update date: December 12, 2024
Medication Description: Treats different kinds of cancer, including NSCLC (non-small cell lung cancer), small cell lung cancer (SCLC), liver cancer and endometrial cancer. Recently, Imfinzi was approved to treat limited-stage small cell lung cancer (LS-SCLC). Small cell lung cancer (SCLC) is a fast-growing type of lung cancer.
Updated Side Effects/Safety Information: New clinical trial results were added related to expanded approval for treating limited-stage small cell lung cancer (LS-SCLC). Pneumonitis (lung inflammation), an immune-related side effect, was observed during clinical trials. Read the revised drug label for complete trial results. It is also noted that the most common side effects when used for LS-SCLC are inflammation in the lungs and fatigue or weakness.
Essential Extras: On December 4, 2024, the FDA issued a press release about Imfinzi’s approval for limited-stage small cell lung cancer in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. This is the first immunotherapy approved for LS-SCLC.
FDA Safety Announcement: Imfinzi FDA Safety Update and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
