The FDA has approved Differin Gel for over-the-counter use. Up until now it has only been available with a prescription. Currently, it is the only available over the counter retinoid on the market.
According to the manufacturer Galderma’s website, Differin Gel is indicated for the topical treatment of acne vulgaris in those who are 12 years of age or older.
Differin Gel was approved by the FDA for prescription use in 1996. Its active ingredient is a synthetic retinoid which helps treat acne.
How does a prescription only medication become available as an over the counter medication?
The process of transferring an FDA approved prescription medication to a nonprescription over-the-counter (OTC) medication is known as Rx-to-OTC switch.
An application known as new drug application (NDA) must be sent to the FDA.
The application is usually submitted by the manufacturer as they have the greatest safety information about the medication. The FDA will then review the submitted application and determine the safety of the medication as an over the counter drug.
What is the difference between retinoids and retinols.
Retinoids have a higher concentration of the active ingredient (retinoic acid).
Retinols can be converted into retinoic acid but it takes some work, these extra steps may cause the product to lose some of its potency.
- Acne is the most common skin condition in the United States.
- Acne can lower self esteem.
- Acne can result in dark spots and scars.
Risk factors for acne
No one knows for certain what causes acne but it is associated with,
- Hormones changes-Androgens contribute to the development of acne through stimulating the secretory function of sebaceous glands.
- A potential role for diet in acne is controversial. Some studies support that carbohydrates and chocolate make acne worse.
- Repetitive scrubbing can worsen acne.
- Family history can increase your risk of acne.
What happens with acne
- Follicular hyperkeratinization (accumulation of cells that block the pores)
- Increased sebum (oil) production
- Bacteria gather (Propionibacterium acni) within the follicle
Treatment of acne
- Topical retinoids
- Topical antibiotics
- Benzoyl peroxide may be combined with antibiotics to decrease resistance.
- Oral antibiotics
- Spironolactone (Aldactone) will decrease androgens (hormones)
When first line medications are not successful oral contraception can be considered for females as well as a stronger medication which have known side effects and require close follow up. An example of this type of medication is called Accutane.
- Requires enrollment in iPLEDGE™ a program initiated by the U.S. Food and Drug Administration (FDA).
- You will need close follow up with your dermatologist as this medication has a few potential complications.
- You will need to sign forms that state you know the risks of taking isotretinoin.
What are the different types of acne?
Inflammatory is a type of acne where your body reacts to a clogged pore, you will see a large red spot. This type of acne responds to benzoyl peroxideor prescriptions. Some studies support that there is no difference between Benzoyl peroxide 2.5% or 10%, both can be irritating to the skin.
Hormonal this type of acne occurs in female as their estrogen levels drop. Acne may be seem on the lower face. Aldactone and birth control pills may be recommended, your doctor can help you decide on treatment.
Cystic this type of acne is difficult to treat. Stronger medications such as Accutane may be recommended.
What have you used for acne?