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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of June 12, 2020)

Bridion (sugammadex) injection

Arteriospasm coronary (coronary vasospasm)

FDA is evaluating the need for regulatory action.

 

  • 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

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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Plaquenil (hydroxychloroquine sulfate)
Generic products containing hydroxychloroquine

Phospholipidosis

FDA is evaluating the need for regulatory action.

Proton pump inhibitors

  • Aciphex (rabeprazole sodium)
  • Dexilan (dexlansoprazole)
  • Esomeprazone 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

Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

FDA is evaluating the need for regulatory action.

Solosec (secnidazole)

Alcohol interaction

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Vascular endothelial grown 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

FDA is evaluating the need for regulatory action.

Xiaflex (collagenase clostridium histolyticum)

Skin necrosis

FDA is evaluating the need for regulatory action.

Yervoy (ipilimumab)

Hemophagocytic lymphohistiocytosis

FDA is evaluating the need for regulatory action.

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

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