April to June 2025 saw the FDA's Adverse Event Reporting System (FAERS) report a series of possible safety signals and new serious risk warnings for a range of medicines. Although these signals do not yet establish causality, they warn regulators, physicians, and patients of possible risks to be evaluated further and warned about.
The collection includes both established drugs and newer therapies in several drug classes, some with severe adverse effects such as anaphylaxis, hepatic necrosis, or bowel obstruction. Below are some of the factors and the risks FDA is currently reviewing.
Acetaminophen-Containing Products
Potential risk: Anaphylactic reactions
FDA is assessing reports of severe allergic responses associated with acetaminophen formulations.
Antidepressants
Potential risk: False-positive diagnostic test interference
Drugs including venlafaxine and desvenlafaxine may affect radioisotope test results, prompting further FDA evaluation.
Barium Sulfate–Based Contrast Agents
Potential risk: Anaphylactic reactions
These imaging agents are under review for rare hypersensitivity responses during diagnostic procedures.
Monoclonal Antibodies and Bispecific Therapies
Potential risks: Progressive multifocal leukoencephalopathy, liver injury, and CNS infections
Biologic treatments such as Briumvi, Kesimpta, Ocrevus, and bispecific antibodies used in oncology are being monitored for rare but serious immune-related complications. Some labeling updates were issued in August 2025 to include liver injury warnings.
BRAF and MEK Kinase Inhibitors
Potential risk: Gingival hypertrophy (gum overgrowth)
Used in cancer treatment, these inhibitors are under evaluation following reports of abnormal gum tissue growth.
Dopaminergic Agents (Levodopa/Carbidopa Combinations)
Potential risk: Seizures
Parkinson’s disease therapies such as Sinemet and Rytary are under review for seizure risk.
GLP-1 Receptor Agonists
Potential risk: Intestinal obstruction and fecal impaction
Widely prescribed for type 2 diabetes and weight management (including Ozempic, Mounjaro, Wegovy), this class is being investigated for reports of severe gastrointestinal complications.
Topiramate-Containing Products
Potential risk: Hypersensitivity reactions
The FDA is reviewing post-marketing cases of allergic responses across formulations including Topamax and Qsymia.
SGLT2 Inhibitors
Potential risk: Fournier’s gangrene (necrotizing infection)
This established but serious risk continues to be monitored in glucose-lowering agents used in diabetes care.
CGRP Antagonists
Potential risk: Anaphylaxis and hypersensitivity
Labeling for Nurtec ODT and Zavzpret was updated in August 2025 to reflect new warnings regarding severe allergic reactions.
Dexmedetomidine-Containing Products
Potential risk: Diabetes insipidus
Used for sedation and anesthesia, dexmedetomidine formulations are under evaluation for rare cases of excessive urination and electrolyte imbalance.
Bone and Mineral Metabolism Agents
Potential risk: Hypercalcemia
Crysvita labeling was updated in August 2025 to include new safety data on elevated calcium levels.
Learn more: FdaApril - June 2025 | Potential Signals of Serious Risks/New Safety Info
