Are Corticosteroids FDA Approved? Understanding Their Status

In the United States, about one in five adults in a commercially insured plan receives a prescription for short-term oral corticosteroids over a three-year period [1.9.4]. Yes, many corticosteroids are FDA approved for a wide variety of conditions, administered through different routes like oral, topical, and inhaled forms [1.2.3, 1.4.1].

Quick Summary

Many corticosteroids have received FDA approval to treat numerous inflammatory and autoimmune conditions [1.2.3]. This approval depends on the specific drug, its dosage form, and the medical condition it is intended to treat [1.4.1].

Key Points

• FDA Approval is Specific: Yes, many corticosteroids are FDA approved, but this approval is specific to the drug, its dosage form (oral, topical, inhaled), and the medical condition being treated [1.2.3, 1.4.1].

• Variety of Uses: Approved uses range from treating inflammatory conditions like asthma, arthritis, and skin rashes to preventing organ rejection and managing certain cancers [1.4.1, 1.4.3].

• Multiple Formulations Exist: Corticosteroids are available in many forms, including oral tablets (prednisone), inhalers (fluticasone), topical creams (hydrocortisone), and injections (methylprednisolone) [1.2.2].

• Off-Label Use is Common: Physicians can prescribe corticosteroids for uses not officially approved by the FDA ("off-label"), based on their clinical judgment, though drug makers cannot promote these uses [1.7.1, 1.7.2].

• Risks are Significant: Side effects are common and can be serious, especially with long-term use. They include weight gain, osteoporosis, increased infection risk, and high blood pressure [1.5.2, 1.11.3].

• Not All Uses Are Approved: The FDA has not approved all potential uses. For example, epidural corticosteroid injections are not FDA-approved due to safety concerns [1.3.2].

• Benefits vs. Risks: The decision to use corticosteroids involves weighing their powerful anti-inflammatory benefits against their potential side effects, a discussion that should occur with a healthcare provider [1.4.1].

The Role of the FDA in Drug Approval

The U.S. Food and Drug Administration (FDA) is responsible for ensuring that drugs sold in the United States are safe and effective for their intended use [1.3.4]. The approval process for a new drug is extensive, involving comprehensive data from laboratory testing and multiple phases of clinical trials. A New Drug Application (NDA) is submitted to the FDA, which then has 6 to 10 months to review the information and decide on approval [1.3.4]. This rigorous process applies to corticosteroids, which are a class of drugs that mimic the effects of the cortisol hormone produced by the adrenal glands [1.8.4]. They are widely used for their potent anti-inflammatory and immunosuppressive properties [1.4.2].

Are Corticosteroids FDA Approved?

Yes, numerous corticosteroids are FDA-approved to treat a wide range of medical conditions [1.2.3]. The approval is specific to the drug, its formulation (e.g., oral tablet, topical cream, inhaler), and the disease it is intended to treat. For example, prednisone is an FDA-approved oral corticosteroid used for conditions like asthma, allergies, arthritis, and certain types of cancer [1.4.3, 1.4.5]. Inhaled corticosteroids like fluticasone and budesonide are standard treatments for controlling asthma-related inflammation [1.6.4]. Topical corticosteroids are available in various potencies to treat skin conditions such as eczema and psoriasis [1.2.5, 1.4.2].

However, not every use of a corticosteroid is FDA-approved. For instance, the FDA has not approved corticosteroids for injection into the epidural space of the spine, citing potential risks [1.3.2].

Approved Uses and Formulations

Corticosteroids are incredibly versatile and come in many forms depending on the condition being treated [1.4.1, 1.8.2]:

• Oral: Pills, capsules, or syrups like prednisone and methylprednisolone are used for systemic conditions like rheumatoid arthritis, lupus, and inflammatory bowel disease [1.2.2, 1.4.2].
• Inhaled: Aerosols and nasal sprays (e.g., fluticasone, budesonide) are used to manage inflammation in asthma and nasal allergies directly in the respiratory tract [1.6.1, 1.6.4]. In January 2023, the FDA approved Airsupra, the first combination of an inhaled corticosteroid (budesonide) and a short-acting beta-agonist (albuterol) for as-needed treatment in adults with asthma [1.6.5].
• Topical: Creams, ointments, and lotions containing hydrocortisone or mometasone are applied directly to the skin to treat inflammatory skin conditions [1.2.5].
• Injectable: Injections are often used to treat localized inflammation in muscles and joints, such as tendinitis [1.4.1]. Common injectable corticosteroids include methylprednisolone, hydrocortisone, and triamcinolone [1.3.2].

Understanding "Off-Label" Use

Physicians in the U.S. can legally prescribe medications for uses other than those officially approved by the FDA; this is known as "off-label" use [1.7.2]. While the FDA does not regulate the practice of medicine, it does prohibit pharmaceutical companies from marketing their drugs for unapproved uses [1.7.1]. Off-label prescribing is common and often represents the standard of care for certain conditions [1.7.3]. However, it means the FDA has not formally reviewed the drug's safety and efficacy for that specific purpose. A physician's decision to prescribe a drug off-label is based on their professional judgment and scientific rationale [1.7.4].

Comparison of Common Corticosteroids

Corticosteroids differ in their anti-inflammatory potency, duration of action, and potential side effects [1.2.4]. They are broadly classified as glucocorticoids, which primarily have anti-inflammatory effects, and mineralocorticoids, which regulate salt and water balance [1.8.4].

Corticosteroid	Potency (Anti-inflammatory)	Common Formulations	Common FDA-Approved Uses [1.4.3, 1.4.4]
Hydrocortisone	Low	Oral, Topical, Injectable	Skin rashes (eczema), adrenal insufficiency, inflammatory bowel disease
Prednisone	Medium	Oral (tablets, solution)	Asthma, allergies, arthritis, lupus, certain cancers
Methylprednisolone	Medium-High	Oral, Injectable	Allergic reactions, skin diseases, asthma, arthritis
Dexamethasone	High	Oral, Injectable, Ophthalmic	Severe inflammation, cerebral edema, eye inflammation, certain cancers
Triamcinolone	Medium-High	Injectable, Topical, Inhaled	Joint inflammation, skin conditions, mouth sores
Fluticasone	High	Inhaled, Topical	Asthma, nasal allergies, skin conditions (eczema, psoriasis)
Budesonide	High	Inhaled	Asthma, COPD

Benefits vs. Risks

While corticosteroids are effective at reducing inflammation and suppressing the immune system, they carry a risk of side effects, especially with long-term use at high doses [1.4.1, 1.11.4].

Benefits:

• Rapidly reduces inflammation and pain [1.4.2].
• Effective for a wide range of inflammatory and autoimmune diseases [1.4.3].
• Life-saving in cases of severe allergic reactions or asthma exacerbations [1.5.5].
• Prevents organ rejection in transplant recipients [1.4.1].

Risks and Side Effects: The risk and severity of side effects are often dose-dependent and time-dependent [1.10.2].

• Short-term use: Increased appetite, weight gain, fluid retention, mood swings, and elevated blood sugar [1.5.2, 1.5.5]. Even short-term use is associated with an increased risk of sepsis, blood clots, and fractures [1.9.4].
• Long-term use: Osteoporosis (thinning bones), cataracts, glaucoma, high blood pressure, increased risk of infections, skin thinning, and Cushing syndrome [1.5.2, 1.11.3]. Long-term use can also suppress the body's natural production of cortisol, requiring a gradual tapering of the dose when stopping the medication to avoid withdrawal symptoms [1.11.3].

Contraindications: Corticosteroids are generally contraindicated in patients with systemic fungal infections, known hypersensitivity, or when receiving live virus vaccines (if on immunosuppressive doses) [1.10.2]. They should be used with caution in patients with conditions like diabetes, uncontrolled hypertension, peptic ulcer disease, and certain psychiatric illnesses [1.10.2, 1.10.3].

Conclusion

To answer the question, Are corticosteroids FDA approved? – the answer is a definitive yes, for many specific drugs and indications. The FDA has approved a wide array of corticosteroid medications in oral, topical, inhaled, and injectable forms to treat conditions ranging from asthma and allergies to autoimmune diseases and cancer [1.2.3, 1.4.3]. This approval signifies that the drug has been proven safe and effective for a particular use. However, it's crucial to distinguish between FDA-approved uses and "off-label" uses, which are at the discretion of the prescribing physician. Patients should always discuss the benefits and risks of corticosteroid therapy with their healthcare provider to make informed decisions [1.4.1].

For more information on the FDA's role, you can visit the U.S. Food & Drug Administration's website.

Frequently Asked Questions

Are all corticosteroids FDA approved?

No, while a large number of corticosteroid drugs are FDA-approved for specific conditions and in specific formulations (like pills, creams, or inhalers), not every single corticosteroid or every potential use has FDA approval [1.2.3, 1.3.2].

Is prednisone an FDA-approved drug?

Yes, prednisone is an FDA-approved corticosteroid available by prescription. It is used to treat a wide variety of conditions, including asthma, allergic reactions, arthritis, and inflammatory bowel diseases [1.4.3, 1.4.5].

What is the difference between an approved use and an 'off-label' use?

An FDA-approved use is a condition for which the drug has been formally tested and deemed safe and effective by the FDA [1.3.4]. An 'off-label' use is when a physician prescribes a drug for a condition not listed on its official label, based on their medical judgment. This practice is legal and common, but the use is not officially endorsed by the FDA [1.7.2, 1.7.4].

Are topical corticosteroids FDA approved?

Yes, many topical corticosteroids in various strengths are FDA-approved for treating inflammatory skin conditions like eczema and psoriasis [1.2.5, 1.4.2].

Are there any corticosteroid uses the FDA has warned against?

Yes, the FDA has specifically warned about the risks of injecting corticosteroids into the epidural space of the spine for pain management, as this use is not approved and can lead to rare but serious neurological problems [1.3.2].

What does it mean for a drug to be 'FDA-approved'?

FDA approval means the agency has determined that the benefits of the drug for a specific use outweigh its known risks. This decision is based on a review of extensive scientific data and clinical trials submitted by the drug manufacturer [1.3.4].

Do I need a prescription for FDA-approved corticosteroids?

Most potent FDA-approved corticosteroids, such as oral prednisone or prescription-strength topical creams, require a prescription from a healthcare provider. Some low-strength formulations, like certain hydrocortisone creams, are available over-the-counter [1.4.5, 1.8.2].