Proton Pump and VEGF Inhibitors Among Adds to FDA Watch List

Marcia Frellick

July 30, 2020

The new watch list from the US Food and Drug Administration (FDA) includes almost two dozen drugs or drug classes for which there is a potential sign of serious risk or new safety information.

The watch list, updated to cover the period from October 2019 to March 2020, is generated from the FDA Adverse Event Reporting System and is posted on the FDA website.

Just because a drug appears on the list does not mean the FDA has found that it is associated with the corresponding risk, only that the agency has identified a potential safety problem. If further review shows that it is associated with risk, the FDA can take action — including requiring label changes, restricting the drug's use, or, in rare cases, removing it from the market.

Many proton pump inhibitors (PPIs) were listed; for some, more than one potential risk were identified. One group of 10 PPIs was associated with potential risk for the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Another group of 13 PPIs was associated with potential acute generalized exanthematous pustulosis (AGEP).

Hydroxychloroquine sulfate (Plaquenil), which has been controversial with regard to its use in the treatment of COVID-19, and generic products containing hydroxychloroquine were listed because the FDA identified a potential risk for phospholipidosis.

Crisaborole (Eucrisa), widely used for mild to moderate eczema, was linked with potential contact dermatitis. The adverse reactions section of the labeling was updated in March 2020 to include allergic contact dermatitis

The following is the full updated list.

Active ingredient (trade name) or product class Potential sign of a serious risk/new safety information Additional onformation (as of June 12, 2020)
Sugammadex (Bridion) injection Arteriospasm coronary (coronary vasospasm) FDA is evaluating the need for regulatory action.
  • Exenatide (Bydureon, Bydureon BCise, and Byetta)

Thrombocytopenia Several sections of the 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.
Crisaborole (Eucrisa) Contact dermatitis The adverse reactions section of the labeling was updated in March 2020 to include allergic contact dermatitis.
Eucrisa labeling
Ethiodized oil (Lipiodol) Hypothyroidism

FDA is evaluating the need for regulatory action.
 
Hydroxychloroquine sulfate (Plaquenil)
Generic products containing hydroxychloroquine
Phospholipidosis FDA is evaluating the need for regulatory action.
Proton pump inhibitors
  • Rabeprazole sodium (Aciphex)

  • Dexlansoprazole (Dexilant)

  • Esomeprazone strontium

  • Esomeprazole magnesium (Nexium)

  • Lansoprazole (Prevacid)

  • Pantoprazole sodium (Protonix)

  • Esomeprazole magnesium and naproxen (Vimovo)

  • Aspirin and omeprazole (Yosprala; Aralez)

  • Omeprazole and sodium bicarbonate (Zegerid)

  • Generic products containing proton pump inhibitors

Syndrome of inappropriate antidiuretic hormone secretion (SIADH) FDA is evaluating the need for regulatory action.
Secnidazole (Solosec) Alcohol interaction FDA is evaluating the need for regulatory action.
Ibalizumab-uiyk (Trogarzo) Anaphylactic reaction Several sections of the labeling were updated in April 2020 to include hypersensitivity reactions including infusion-related reactions and anaphylactic reactions.
Trogarzo labeling
Natalizumab (Tysabri) Thrombocytopenia FDA is evaluating the need for regulatory action.
Vascular endothelial grown factor (VEGF) inhibitors
  • Axitinib (Inlyta)

  • Bevacizumab (Avastin)

  • Cabozantinib (Cabometyx)

  • Vandetanib (Caprelsa)

  • Cabozantinib (Cometriq)

  • Ramucirumab (Cyramza)

  • Ponatinib (Iclusig)

  • Lenvatinib (Lenvima)

  • Bevacizumab-awwb (Mvasi)

  • Sorafenib tosylate (Nexavar)

  • Nintedanib (Ofev)

  • Regorafenib (Stivarga)

  • Sunitinib malate (Sutent)

  • Pazopanib (Votrient)

  • Ziv-aflibercept (Zaltrap)

  • Bevacizumab-bvzr (Zirabev)

Aneurysm and artery dissection FDA is evaluating the need for regulatory action.
Collagenase clostridium histolyticum (Xiaflex) Skin necrosis FDA is evaluating the need for regulatory action.
Ipilimumab (Yervoy) Hemophagocytic lymphohistiocytosis FDA is evaluating the need for regulatory action.
Zonisamide (Zonegran) Acute myopia and secondary angle closure glaucoma Several sections of the labeling were updated in April 2020 to include acute myopia and secondary angle closure glaucoma.
Zonegran labeling
Zonisamide (Zonegran) Hyperammonemia and encephalopathy Several” sections of the labeling were updated in April 2020 to include hyperammonemia and encephalopathy.
Zonegran labeling
Erenumab-aooe (Aimovig) Hypertension FDA is evaluating the need for regulatory action.
Suvorexant (Belsomra) Fall, serious injuries Several sections of the labeling were updated January 2020, to include falls.
Belsomra label
Sofosbuvir and velpatasvir (Epclusa) Ledipasvir and sofosbuvir (Harvoni) Sofosbuvir, velpatasvir, and voxilaprevir (Vosevi) Interaction with bariatric surgery: treatment failure FDA is evaluating the need for regulatory action.
Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs)
  • Lixisenatide (Adlyxin)

  • Exenatide (Byetta, Bydureon, Bydureon BCise)

  • Semaglutide (Ozempic, Rybelsus)

  • Liraglutide (Saxenda)

  • Insulin glargine and lixisenatide (Soliqua)

  • Albiglutide (Tanzeum)

  • Dulaglutide (Trulicity)

  • Liraglutide (Victoza)

  • Insulin degludec and liraglutide (Xultophy 100/3.6)

Diabetic ketoacidosis FDA is evaluating the need for regulatory action.
Miltefosine (Impavido) Eye disorders FDA is evaluating the need for regulatory action.
Insulin human in 0.9% sodium chloride (Myxredlin) Medication error: labeling confusion FDA is evaluating the need for regulatory action.
Ocrelizumab (Ocrevus) Serious herpes viral infection FDA is evaluating the need for regulatory action
Proton pump inhibitors
  • Rabeprazole sodium (AcipHex, AcipHex Sprinkle)

  • Dexlansoprazole (Dexilant)

  • Esomeprazole magnesium (Nexium)

  • Esomeprazole sodium (Nexium IV)

  • Esomeprazole magnesium (Nexium 24 HR)

  • Lansoprazole (Prevacid, Prevacid 24HR, Prevacid SoluTab)

  • Omeprazole (Prilosec)

  • Omeprazole magnesium (Prilosec OTC)

  • Pantoprazole sodium (Protonix, Protonix IV)

  • Esomeprazole magnesium and naproxen (Vimovo)

  • Aspirin and omeprazole (Yosprala)

  • Omeprazole and sodium bicarbonate (Zegerid, Zegerid OTC)

  • Generic products containing proton pump inhibitors

Acute generalized exanthematous pustulosis (AGEP) FDA is evaluating the need for regulatory action.
Riluzole (Rilutek, Tiglutik) Pancreatitis FDA is evaluating the need for regulatory action.
Vasopressin (Vasostrict) Diabetes insipidus The warnings and precautions and adverse reactions sections of the labeling were updated to include the risk for diabetes insipidus.
Vasostrict labeling

 

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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