FDA Watch List Adds Drugs With Anaphylaxis, Herpes, Fetal Death Risk

Marcia Frellick

October 28, 2019

The US Food and Drug Administration (FDA) has updated its quarterly watch list with four dozen drugs and drug classes because it has received new safety information or identified possible signs of serious risk — including serious risks from conditions such as anaphylaxis, herpes zoster, and fetal death.

The latest updates, which span April to June 2019, were created from the FDA Adverse Event Reporting System (FAERS).

Six drugs/drug classes were added to the list for potential risk of fetal death. They were ferumoxytol (Feraheme); sodium ferric gluconate (Ferrlecit); iron dextran (INFeD); ferric carboxymaltose (Injectafer); iron sucrose (Venofer); and generic products containing sodium ferric gluconate.

A drug's appearance on this list does not mean the FDA has concluded it has the listed risk, but that the FDA has identified a potential safety issue.

The FDA writes in its FAERS information that after evaluation, "the FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market."

For all the drugs listed here except one, the FDA is evaluating the need for regulatory action, as of information received by September 19.

The exception is with naltrexone hydrochloride (Vivitrol), and in that case, action has been taken. The carton labeling sections of the product, including "dosing and administration," "warnings and precautions," "adverse reactions," "how supplied/storage and handling" and patient counseling and the medication guide were updated to emphasize that naltrexone hydrochloride must be injected by a healthcare provider. The drug was included on this warning list because of patient self-medication errors.

Following is the updated list:

Active Ingredient (Trade Name) or Product Class

Potential Signal of a Serious Risk/New Safety Information

  • Sulfamethoxazole and trimethoprim (Bactrim DS)

  • Sulfamethoxazole and trimethoprim (Septra)

  • Generic products containing sulfamethoxazole and trimethoprim

Hypersensitivity/Acute respiratory failure 

Benralizumab  (Fasenra)

Flu-like illness

Benralizumab (Fasenra)

Herpes zoster

  • Ferumoxytol (Feraheme)

  • Sodium ferric gluconate (Ferrlecit)

  • Iron dextran (INFeD)

  • Ferric carboxymaltose (Injectafer)

  • Iron sucrose (Venofer)

  • Generic products containing sodium ferric gluconate

Fetal death

Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified]

Increased hypersensitivity reactions in patients receiving certain product lots

Fingolimod (Gilenya)

Tumefactive multiple sclerosis

Fingolimod (Gilenya)

Thrombocytopenia

HMG-CoA reductase inhibitors

  • Lovastatin (Altoprev)

  • Amlodipine besylate and atorvastatin calcium (Caduet)

  • Rosuvastatin calcium (Crestor)

  • Rosuvastatin (Ezallor)

  • Fluvastatin sodium (Lescol)

  • Fluvastatin sodium (Lescol XL)

  • Atorvastatin and ezetimibe (Liptruzet)

  • Pitavastatin (Livalo)

  • Pitavastatin

  • Pravastatin sodium (Pravachol)

  • Simvastatin (Zocor)

  • Pitavastatin magnesium (Zypitamag)

  • Generic products containing HMG-CoA reductase inhibitors

Immune-mediated necrotizing myopathy

Mecasermin (Increlex)

Malignancies

 

  • Pitavastatin (Livalo)

  • Pitavastatin magnesium (Zypitamag)

Drug hypersensitivity

Glecaprevir and pibrentasvir (Mavyret)

Hypersensitivity: angioedema and anaphylaxis

Ixazomib (Ninlaro)

Thrombotic microangiopathy (TMA)

  • Pentostatin (Nipent)

  • Generic products containing pentostatin

 

Thrombotic microangiopathy (TMA)

  • Clobazam (Onfi)

  • Generic products containing clobazam

 

Drug rash with Eosinophilia and Systemic Symptoms (DRESS)

Abatacept (Orencia)

Angioedema

Oritavancin diphosphate (Orbactiv)

Anaphylaxis

       ·  Cinacalcet   hydrochloride (Sensipar)

      ·  Generic products containing cinacalcet hydrochloride

Chondrocalcinosis pyrophosphate

Dimethyl fumarate (Tecfidera)

Serious herpes infection

  • Pegfilgrastim, CHS- 1701 (Udeynca)

  • Denosumab (Xgeva)

Medication error – Labeling confusion (wrong drug errors)

 Sucroferric oxyhydroxide (Velphoro)

Hemoglobin increased

Naltrexone hydrochloride (Vivitrol)

Medication Error - Patient self-administration errors

Baloxavir marboxil (Xofluza)

Anaphylaxis and angioedema

Baloxavir marboxil (Xofluza)

Medication error - Labeling confusion (wrong dose errors)

Trabectedin (Yondelis)

Interstitial lung disease and mucositis

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