Rosacea sufferers learnt recently that Allergan’s Oxymetazoline based topical (likely to be called Azultro) has been submitted for FDA approval and could be approved in the first half of 2017. For those wanting to try this claimed gentler-than-Mirvaso treatment for a red face, waiting for another year can seem like an eternity.
If you are considering trying out a topical that contains the same active ingredient as the oxymetazoline 1% cream undergoing FDA approval, then a review of similar experiments in the recent past ought to temper your experimentation.
We’ve been here before – Brimonidine vs. Mirvaso
Back in 2011 when rosacea sufferers were waiting for Mirvaso to finish development and make its way through the approval process, several rosacea sufferers experimented with the glaucoma treatment Alphagan P to attempt to emulate the effect of the active ingredient brimonidine. These experiments did not end well. Many suffered from rebound redness, some quite severe. Read one of the threads discussing brimonidine experiments – More news about Brimonidine.
Indeed some rosacea sufferers have also gone on to suffer significant adverse reactions to the final formulation of brimonidine as available in Mirvaso. There are few guarantees with rosacea treatments.
Is trying Oxymetazoline illegal?
Using prescription drugs off-label is not illegal, but their use is not regulated by the FDA.
Here are some good reasons that you should be careful with off label drugs;
- the bad reaction profile of the drug is not yet understood
- the final dosage and frequency of treatment information is not known
- you may not get insurance coverage for off-label usage
- the full safety profile of a drug might not be know until several years after it has become available.
So this post is a warning to those who can’t wait until 2017 to try Azultro with the support of your doctor. As we have seen with Alphagan P, being too quick to experiement with related drugs can lead to terrible adverse reactions.
This warning is not really new, but worth restating here and now. Here is one thread covering oxymetazoline experiments as far back as 2007 – Successful Treatment of the Erythema and Flushing of Rosacea.
- Off Label Treatments for Rosacea
- Oxymetazoline: what about rebound redness ?
- Sansrosa delayed, sufferers make their own Brimonidine, BEWARE
- Allergan’s Oxymetazoline gentler than Mirvaso
- Afrin (Oxymetazoline) Safe Off Label Drug for a Red Face
- Oxymetazoline good for 6 hours and safe for 3 months
- How to Cure a Red Face (Facial Erythema)
- Mirvaso User Reviews
- Report adverse reactions to Mirvaso to the FDA and Galderma
- New adverse allergic contact reaction to Mirvaso noted in JAAD