Has your doctor ever prescribed you something other than Metrogel, Soolantra, Finacea, Oracea or Mirvaso for rosacea? If so, then your doctor has given you an off-label prescription.
Were you aware that only officially approved FDA treatments for rosacea are the 4 treatments from Galderma – Metrogel, Oracea, Soolantra & and Mirvaso, and one from Bayer Healthcare – Finacea?
Is Off Label Prescribing Allowed?
So is your doctor breaking any rules prescribing you something that hasn’t been approved as a treatment for rosacea?
Not according to the FDA, no. The only requirement is the drug is used in the practice of medicine.
If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.
Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).
However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.
Off Label Rosacea Treatments
Here are some of the most popular off-label treatments for rosacea
Isotretinoin was shown to be effective in patients with treatment-resistant rosacea by Nikolowski and Plewig in 1980 for the first time. Since then, many other studies confirmed its efficacy in a daily dose of 0.5 to 1.0 mg/kg. However, it has also been noted that adverse effects of the drug may limit its use.
Although a commonly prescribed antibioitic, the tetracycline family member doxycycline is not officially approved as a treatment for rosacea. Recently, though, Oracea was approved for use in rosacea. Oracea is a 40mg tablet of doxycycline, containing a 10mg delayed released segment.
A cheaper alternative to Oracea, namely generic doxycycline 50mg a day, can be prescribed by your doctor and should offer a similar benefit.
Macrolide Antibiotics offer alternative treatment options to the well known tetracycline antibiotics. In recent years good studies have shown that some of these macrolides are safe and effective in treating rosacea.
Commonly prescribed Macrolides include: erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), roxithromycin (Rulid, Surlid)
Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR. There are published papers detailing the use of Afrin for the redness of rosacea.
Pregabalin (Lyrica) is a medication normally used to treat epilepsy and is listed as one of the possible treatments for neurogenic rosacea.
Stromectol has been used in dermatology for some time but its use in rosacea is new. Ivermectin has a structure similar to that of macrolide antibiotics, but without antibacterial activity. It is used against a wide range of endoparasites and ectoparasites.
There are but a few treatments for the facial flushing associated with rosacea. Botox blocks the release of acetylcholine, a neural transmitter that is part of the autonomic nervous system and may offer options to sufferers of facial flushing.
Alpha-2 agonist such as clonidine or beta-blockers such as propranolol and nadolol may sometimes be prescribed to help reduce emotionally triggered flushing that is controlled by the autonomic nerves.
Sometimes strong doses of steroids can be used to break a severe case of rosacea or rosacea fulmians.
Only being developed as a treatment for Erythropoietic Protoporphyria and Vitiligio, Scenesse is interesting for rosacea sufferers who have the sun as a severe rosacea trigger and are looking for some system photoprotection.
What worked off-label for you?
Did you doctor prescribed something “unofficial” that really helped your rosacea?
- How do Tetracyclines help Rosacea ?
- Dramatic Results with Low Dose Accutane
- Rosacea Flushing and Propranolol
- Pregabalin (Lyrica) for Neurogenic Rosacea
- Treating Rosacea with Low-Dose Accutane
- How much do Rosacea Prescriptions Really Cost?
- Is Oracea different to 50mg a day of Doxycycline ?
- Macrolides: biaxin, zithromax, dynabac, rulid, surlid
- Prescription topicals go on first
- Demodex Mites, Ivermectin (Stromectol) and its use in Dermatology
- Afrin (Oxymetazoline) Safe Off Label Drug for a Red Face
- Botox for Neural Symptoms and Flushing, User Reviews