New FDA Watch List Has Insulin Pens, Muscle Relaxants, and More

Marcia Frellick
July 31, 2018

Updates to the US Food and Drug Administration's (FDA's) watch list include 27 drugs or drug classes for which there is new safety information or possible signs of serious risk.

The latest updates, which span October 2017 through March 2018, were created from the FDA Adverse Event Reporting System.

This year's list includes 13 insulin pen products. The reason stated for inclusion is that people are using the products incorrectly and are not removing the inner needle cover. The FDA is evaluating whether regulatory action regarding the products is needed.

Twelve muscle relaxants were on the list because of the potential risk for serotonin syndrome or because of too much nerve cell activity, which can cause a potentially deadly array of symptoms.

Five forms of the type 2 diabetes drug metformin made the list because of reports of serious skin reactions.

For many drugs on the list, the FDA is currently evaluating whether regulatory action is needed, or it has determined that no action is necessary. For other drugs, the potential risk has resulted in labeling changes.

The FDA emphasized that the listing of a drug and the noting of a potential signal of a serious risk/new safety information on their website does not mean that the FDA has determined that the drug has the risk. The FDA is not suggesting that healthcare providers stop prescribing the drug or that patients should stop taking it while potential safety problems are evaluated. Patients with questions about drugs on the list should contact their healthcare provider.

Active Ingredient (Trade Name) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information (as of April 27, 2018)
  • Polidocanol (Asclera) injection
  • Sodium tetradecyl sulfate (Sotradecol) injection
  • Polidocanol injectable foam (Varithena)
Cardiovascular adverse events For Asclera and Sotradecol, the Warnings and Precautions section of labeling was updated to include the risk for arterial embolism. No regulatory action was warranted for Varithena.
Misoprostol (Cytotec) tablets High fevers (greater than 104 degrees Fahrenheit or 40 degrees Celsius) The Precautions section of labeling was updated to include fevers greater than 104 degrees Fahrenheit or 40 degrees Celsius.
Fosaprepitant (Emend) for injection Infusion site reactions FDA is evaluating the need for regulatory action.
Erythromycin lactobionate (Erythrocin Lactobionate – IV) for injection Drug interaction with HMG-CoA reductase inhibitors (lovastatin and simvastatin) extensively metabolized by CYP3A4 (enzyme) resulting in myopathy and rhabdomyolysis FDA is evaluating the need for regulatory action.
  • Metformin hydrochloride (Fortamet ) extended-release tablets
  • Metformin hydrochloride (Glucophage) tablets
  • Metformin hydrochloride extended-release tablets (Glucophage XR)
  • Metformin hydrochloride (Glumetza) extended-release tablets
  • Metformin hydrochloride (Riomet) oral solution
Serious skin reactions FDA is evaluating the need for regulatory action.
Lamotrigine (Lamictal ) tablets Confusion/medication errors regarding the name labetalol-lamotrigine associated with the serious outcomes FDA decided that no action is necessary at this time.
Regadenoson (Lexiscan) injection Serious cardiac adverse events following prolonged Lexiscan administration (>10 seconds) FDA is evaluating the need for regulatory action.

Muscle relaxants

  • Cyclobenzaprine hydrochloride (Amrix) extended-release capsules
  • Aspirin and meprobamate (Amrix) tablets
  • Chlorphenesin carbamate (Maolate) tablets
  • Metaxalone tablets
  • Orphenadrine citrate (Norflex) extended-release tablets
  • Orphenadrine citrate (Norflex) injection
  • Aspirin, caffeine, orphenadrine citrate (Norgesic) tablets
  • Chlorzoxazone (Parafon Forte DSC) tablets
  • Methocarbamol injection (Robaxin)
  • Methocarbamol (Robaxin) tablets
  • Metaxalone (Skelaxin) tablets
  • Carisoprodol (Soma) tablets
Serotonin syndrome FDA is evaluating the need for regulatory action.
Methylene blue (ProvayBlue) injection Inappropriate dilution of medication FDA is evaluating the need for regulatory action.
Montelukast sodium (Singulair) tablets Neuropsychiatric adverse reactions FDA is evaluating the need for regulatory action.

Sodium-glucose cotransporter?2 (SGLT-2) Inhibitors

  • Dapagliflozin (Farxiga) tablets
  • Empagliflozin and linagliptin (Glyxambi) tablets
  • Canagliflozin (Invokana) tablets
  • Canagliflozin and metformin hydrochloride (Invokamet) tablets
  • Canagliflozin and metformin hydrochloride extended-release tablets (Invokamet XR)
  • Empagliflozin (Jardiance) tablets
  • Dapagliflozin and saxagliptin (Qtern) tablets
  • Empagliflozin and metformin hydrochloride (Synjardy) tablets
  • Empagliflozin and metformin hydrochloride extended-release tablets (Synjardy XR)
  • Dapagliflozin and metformin hydrochloride extended-release tablets (Xigduo XR)
Fournier's gangrene FDA is evaluating the need for regulatory action.
Eluxadoline (Viberzi) tablets Anaphylaxis and hypersensitivity The Warnings and Precautions and the Adverse Reactions sections of labeling were updated to include hypersensitivity. The Medication Guide was updated to include serious allergic reactions.
  • Albuterol sulfate (AccuNeb) inhalation solution
  • Ipratropium bromide and albuterol (Combivent Respimat) inhalation spray
  • Ipratropium bromide/albuterol sulfate (DuoNeb) inhalation solution
  • Albuterol sulfate (ProAir HFA) inhalation aerosol
  • Albuterol sulfate inhalation powder, for oral inhalation use (Proair respiclick)
  • Albuterol sulfate (Proventil HFA) aerosol
  • Albuterol sulfate (Ventolin HFA) inhalation aerosol
  • Levalbuterol tartrate inhalation aerosol for oral inhalation use (Xopenex HFA)
Albuterol sulfate and serious skin reactions On the basis of available information, FDA decided that no action is necessary at this time.
  • Tocilizumab (Actemra) injection
  • Rilonacept (Arcalyst) injection
  • Canakinumab (Ilaris) injection
  • Sarilumab (Kevzara) injection
  • Anakinra (Kineret) injection
IL-1 and IL-6 inhibitors and pulmonary hypertension, interstitial lung disease, pulmonary alveolar proteinosis FDA is evaluating the need for regulatory action.
Riociguat (Adempas) tablets Syncope FDA decided that no action is necessary at this time.
  • Zolpidem tartrate (Ambien) tablets
  • Eszopiclone (Lunesta) tablets
  • Zaleplon (Sonata) capsules
Somnambulism, abnormal sleep-related event FDA is evaluating the need for regulatory action.
Barium sulfate (Volumen) Name confusion with Voluven (hydroxyethyl starch) FDA is evaluating the need for regulatory action.
  • Bosutinib (Bosulif) tablets
  • Imatinib mesylate (Gleevec) tablets
  • Ponatinib (Iclusig) tablets
  • Dasatinib (Sprycel) tablets
  • Nilotinib (Tasigna) capsules
Thrombotic microangiopathy FDA is evaluating the need for regulatory action.
Sugammadex (Bridion) injection Labeling confusion — total strength listed on vial is obscured by peel-off sticker intended for syringe; potential risk for laryngospasm and bronchospasm FDA is evaluating the need for regulatory action.
  • Levocarnitine (Carnitor) injection
  • Levocarnitine (Carnitor) oral solution
  • Levocarnitine (Carnitor) tablets
  • Levocarnitine (Carnitor SF) sugar-free oral solution
Hypersensitivity and anaphylaxis The Warnings and Adverse Reactions sections of labeling were updated to include hypersensitivity reactions.

Insulin pen products

  • Insulin glulisine (Apidra) injection
  • Insulin glargine (Basaglar) injection
  • Insulin aspart (Fiasp) injection
  • Human isophane insulin and human insulin (Humulin ) injectable suspension
  • Insulin lispro (Humalog) injection
  • Insulin glargine (Lantus) injection
  • Insulin detemir (Levemir) injection
  • Insulin aspart (Novolog) injection
  • Insulin degludec and insulin aspart (Ryzodeg) injection
  • Insulin glargine and lixisenatide (Soliqua) injection
  • Insulin glargine (Toujeo) injection
  • Insulin degludec (Tresiba) injection
  • Insulin degludec and liraglutide (Xultophy) injection
Product use error — failure to remove inner needle cover FDA is evaluating the need for regulatory action.
Sincalide (Kinevac) for injection Anaphylaxis, anaphylactic shock, and other hypersensitivity reactions The Contraindications, Warnings, and Adverse Reactions sections of labeling were updated to include anaphylaxis and hypersensitivity reactions.
Lamotrigine (Lamictal) tablets Hemophagocytic lymphohistocytosis The Warnings and Precautions section of labeling has been updated to include hemophagocytic lymphohistocytosis.
Ixazomib (Ninlaro) capsules Product packaging quantity issues (empty unit dose blister cells) FDA decided that no action is necessary at this time.
  • Posaconazole (Noxafil) delayed-release tablets
  • Posaconazole (Noxafil) injection
  • Posaconazole (Noxafil) oral suspension
  • Itraconazole (Sporanox) capsules
  • Itraconazole (Sporanox) injection
Mineralocorticoid excess FDA is evaluating the need for regulatory action.
Propylthiouracil tablets Fatal cases of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis FDA is evaluating the need for regulatory action.
  • Rolapitant (Varubi) tablets
  • Rolapitant (Varubi) injectable emulsion, for intravenous use
Infusion related and hypersensitivity reactions FDA is evaluating the need for regulatory action.
Source: FDA
Reviewed on 8/1/2018

SOURCE: Medscape, July 31, 2018. New FDA Watch List Has Insulin Pens, Muscle Relaxants, and More - Medscape - Jul 31, 2018.

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