January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Bridion (sugammadex) injection Arteriospasm coronary (coronary vasospasm)

The “Adverse Reactions” section of the labeling was updated in January 2021 to include coronary spasm.

Bydureon (exenatide)
Bydureon BCise (exenatide)
Byetta (exenatide)

Thrombocytopenia The “Contraindications,” "Warnings and Precautions," “Adverse Reactions,” “Patient Counseling Information,” and “Medication Guide,” sections of the exenatide labeling were updated in February 2020 to include thrombocytopenia.
Example: Bydureon labeling

Central Nervous System (CNS) stimulants and atomoxetine

Amphetamine
Amphetamine aspartate
Amphetamine aspartate monohydrate
Amphetamine sulfate
Atomoxetine
Atomoxetine hydrochloride
Dexmethylphenidate
Dexmethylphenidate hydrochloride
Dextroamphetamine
Dextroamphetamine resin complex
Dextroamphetamine saccharate
Dextroamphetamine sulfate
Lisdexamfetamine dimesylate
Methamphetamine
Methamphetamine hydrochloride
Methylphenidate
Methylphenidate hydrochloride

Drug interaction between CNS stimulants or atomoxetine and concomitant use of antipsychotics resulting in hyperkinetic movements

The “Drug Interactions” section of methylphenidate and dexmethylphenidate labeling were updated in June 2021 and July 2021 to include information about monitoring for signs of extrapyramidal symptoms (EPS) with the combined use of risperidone.

Example: Concerta labeling

Eucrisa (crisaborole) Contact dermatitis The “Adverse Reactions” section of the Eucrisa labeling was updated in March 2020 to include allergic contact dermatitis.
Eucrisa labeling Lipiodol (ethiodized oil) Hypothyroidism

The “Warnings and Precautions”, “Adverse Reactions”, and “Use in Specific Populations” sections of the labeling were updated in June 2020 to include information about hypothyroidism.

Lipiodol labeling

Plaquenil (hydroxychloroquine sulfate)
Generic products containing hydroxychloroquine Phospholipidosis

The “Warnings and Precautions” section of the labeling was updated in May 2022 to include information about phospholipidosis.

Plaquenil labeling

Proton pump inhibitors

Aciphex (rabeprazole sodium)
Dexilant (dexlansoprazole)
Esomeprazole strontium
Nexium (esomeprazole magnesium)
Prevacid (lansoprazole)
Protonix (pantoprazole sodium)
Vimovo (esomeprazole magnesium and naproxen)
Yosprala (aspirin and omeprazole)
Zegerid (omeprazole and sodium bicarbonate)
Generic products containing proton pump inhibitors

Prilosec (omeprazole sodium, omeprazole magnesium)*

Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in March 2022 to include information about hyponatremia.

Example: Protonix labeling

*An administrative error resulted in the omission of Prilosec from the initial quarterly report.

Solosec (secnidazole) Alcohol interaction

The “Adverse Reactions”, “Drug Interactions”, and “Patient Counseling Information” sections of the labeling were updated in June 2021 to include information about interaction with alcohol.

Solosec labeling

Trogarzo (ibalizumab-uiyk) Anaphylactic Reaction The “Contraindications,” “Warnings and Precautions,” “Adverse Reactions,” “Patient Counseling Information,” and “Patient Information”sections of the Trogarzo labeling were updated in April 2020 to include hypersensitivity reactions including infusion-related reactions and anaphylactic reactions.

Trogarzo labeling

Tysabri (natalizumab) Thrombocytopenia

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in June 2020 to include information about thrombocytopenia.

Tysabri labeling

Vascular endothelial growth factor (VEGF) inhibitors

Inlyta (axitinib)
Avastin (bevacizumab)
Cabometyx (cabozantinib)
Caprelsa (vandetanib)
Cometriq (cabozantinib)
Cyramza (ramucirumab)
Iclusig (ponatinib)
Lenvima (lenvatinib)
Mvasi (bevacizumab-awwb)
Nexavar (sorafenib tosylate)
Ofev (nintedanib)
Stivarga (regorafenib)
Sutent (sunitinib malate)
Votrient (pazopanib)
Zaltrap (ziv-aflibercept)
Zirabev (bevacizumab-bvzr)

Aneurysm and artery dissection

The “Adverse Reactions” section of the labeling was updated between June 2020 and April 2021 to include arterial (including aortic) aneurysms, dissections, and rupture.

Example: Inlyta labeling

FDA determined that no action is necessary at this time for Ofev based on available information. FDA is continuing to monitor the issue.

Xiaflex (collagenase clostridium histolyticum) Skin necrosis

The “Warnings and Precautions” section of the labeling was updated in August 2021 to include information about skin necrosis.

Xiaflex labeling

Yervoy (ipilimumab) Hemophagocytic lymphohistiocytosis

The “Adverse Reactions” section of the labeling was updated in August 2020 to include hemophagocytic lymphohistiocytosis (HLH).

Yervoy labeling

Zonegran (zonisamide) Acute myopia and secondary angle closure glaucoma The "Warnings,” “Information for Patients,” “Pediatric Use,” “Adverse Reactions; Postmarketing Experience,” and “Medication Guide” sections of the Zonegran labeling were updated in April 2020 to include acute myopia and secondary angle closure glaucoma.

Zonegran labeling

Zonegran (zonisamide) Hyperammonemia and encephalopathy The "Warnings,” “Clinical Pharmacology,” “Information for Patients,” “Pediatric Use,” “Adverse Reactions; Postmarketing Experience,” and “Medication Guide” sections of the Zonegran labeling were updated in April 2020 to include hyperammonemia and encephalopathy.

Zonegran labeling