Oracea Long Term Use

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Galderma after it acquired Collegenex's brand Oracea, which is described as "Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline," is marketing this as a first line of treatment for rosacea and as the 'only FDA approved oral medication for rosacea."

The Prescribing Information Sheet from Galderma says that "Efficacy beyond 16 weeks and safety beyond 9 months have not been established."

There are numerous reports that Oracea has been prescribed well over 9 months. What do you think about prescribing Oracea beyond the safety threshold described in the sheet mentioned above? Should rosaceans expect to be prescribed Oracea long term in amount such as years?

[Guide]

Replies sent by email:

From:

Robert Brodell,MD

Subject: Re: Questions for the RRDi MAC Members

Date: February 12, 2010 2:49:14 AM HST

To: Barrows Brady

Oracea Long Term Use

How long should Oracea be prescribed?

Oracea is a low-dose doxycycline formulated to have a slow release component so that the level of drug in a patient's system is lopw at any given time. This insures that the doxycycline is working as an anti-inflammatory drug rather than an antibiotic which minimizes side effects including stomach upset, yeast infections, and the potential for developing bacteria that are resistant to this drug. This makes it an excellent drug for rosacea. While physicians never want patients to be on any oral drug longer than they need it, some patients with rosacea require long term treatment. I have patients who have been on Oracea for years since every time I try to stop the medication their condition flares up, despite attempts to suppress their rosacea with a variety of topical medications. So, How long should Oracea be prescribed? Ans> As long as needed to keep rosacea under control....and,.... as short as possible!

Robert Brodell, MD

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