Corticosteroid Safety Label Updates: New Warnings about Risk of Infection - June 2024

Dexamethasone, hydrocortisone, methylprednisolone and prednisone are FDA-approved corticosteroids that are used to treat many medical problems, including autoimmune disease, arthritis, asthma, and some kinds of cancer.  Because corticosteroids suppress the immune system, they can relieve inflammation symptoms such as severe allergic reactions such as swelling and itching. However, suppression of the immune system can bring about unwanted side effects, so the drugs are usually taken short-term. In June 2024, the FDA reported that the following corticosteroid drug labels were updated to strengthen and add to current warnings about the risk of serious infections.

In particular, use of the following drugs increases the risk of infection with various pathogens, including viral, bacterial, fungal, protozoan, or helminthic (parasitic). Click on the link to view the specific new warning information for a drug. If the drug has a specific indication, it is noted.

Agamree Vamorolone (treats Duchenne muscular dystrophy in patients 2 years of age and older)

Alkindi Sprinkle Hydrocortisone (these new warnings apply to the use of a greater than replacement dosage; this is a pediatric medication)

Aristocort Triamcinolone Diacetate (new drug interactions added)

Aristospan Triamcinolone Hexacetonide (injectable solution)

Celestone Soluspan Betamethasone Acetate; Betamethasone Sodium Phosphate (injectable solution)

Cortef Hydrocortisone (pills)

Depo-Medrol Methylprednisolone Acetate (injectable solution)

Emflaza Deflazacort (treats Duchenne muscular dystrophy in patients 2 years of age and older)

Entocort Ec  Budesonide (capsules for treating Chron’s disease)

Flo-Pred Prednisolone Acetate

Hemady Dexamethasone (tablets to treat multiple myeloma, a kind of cancer)

Hexadrol Dexamethasone

Kenalog-10 Triamcinolone Acetonide

Medrol Methylprednisolone

Orapred Odt Prednisolone Sodium Phosphate (disintegrating tablets)

Ortikos Budesonide

Label updates for the above drugs are often similar (but check each one for specifics) and some have been updated to retitle a section as “Immunosuppression and Increased Risk of Infection” and warn that the drug may:

· Reduce resistance to new infections

· Exacerbate existing infections

· Increase the risk of disseminated infections

· Increase the risk of reactivation or exacerbation of latent infections

· Mask some signs of infection

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider drug withdrawal or dosage reduction as needed, or prophylaxis treatment is needed with these infections or exposures to:

Tuberculosis

Varicella Zoster and Measles Viral Infections

Hepatitis B Virus Reactivation

Fungal Infections
Corticosteroids may exacerbate systemic fungal infections; therefore, avoid use in the presence of such infections unless is needed to control drug reactions. For patients on chronic corticosteroid therapy who develop systemic fungal infections, withdrawal or dosage reduction is recommended.

Amebiasis
Corticosteroids, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroids in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation
Corticosteroids, including CORTEF, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.

Cerebral Malaria
Avoid corticosteroids, including CORTEF, in patients with cerebral malaria.

Kaposi’s Sarcoma
Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

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To understand more about corticosteroids, check out this article on MedlinePlus:
https://medlineplus.gov/steroids.html

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Also check out this week’s drug safety labeling updates for multiple sclerosis (MS) drugs: MS Drug Safety Labeling Updates (June 2024)