Off-Label Use of Medications and Therapies in Wound Care

     The preceding review article, Off-Label Use of Prescription Medication, highlights many of the frustrations wound care practitioners experience today. Despite the many wound treatment products available, we still do not have a “magical cure” for wounds that is equally effective for all patients. This sends the thoughtful wound care practitioner searching for treatments that may be unproved yet seem appropriate for the patient or the condition. A word of caution must be interjected at this point because great care must be taken when utilizing unproven treatments. The time honored rule of “do no harm” must be realized no matter which therapy is considered. With that being said, the thoughtful, science-based use of certain medications for originally unintended uses can produce excellent, and many times, unexpected results. As one researcher has noted, “Blind discovery is a necessary condition…”¹ An illustration of this involves the chemical phenolphthalein, the pH indicator that turns a purple-red color in the presence of an alkaline solution. The story goes that the Hungarian wine industry had been decimated by a loss of their vineyards. The wine makers began marketing artificial wine colored with dyes. The Hungarian government got wind of this and added phenolphthalein to the wine to detect the fakes. Shortly after an epidemic of diarrhea swept the country. Obviously, the use of phenolphthalein in the wines was discontinued when the purgative effect was realized, but it spawned a new industry—laxatives. Phenolphthalein-containing laxatives such as ex-Lax and Feen-A-Mint are well known today.²      Another classic, more recent example involved the anti-anginal drug from Pfizer, sildenafil citrate. In clinical trials the medication proved disappointing for the treatment of angina, but the participants in the trial who got the active drug all had smiles on their faces at each follow-up. The drug did improve circulation but not to the heart muscle! As you know, that anti-anginal medication is now known as Viagra.³ What started as an off-label use of a medication became one of the best selling medications in history.⁴      Successful uses of medications and treatments in off-label situations abound within wound care. Dr. Greg Schultz and his group at the University of Florida have shown that doxycycline in a cream form applied topically to wounds improves the wound microenvironment by decreasing metalloproteinases.⁵ While the use of corticosteroids in the treatment of the draining wound is an off-label, it is an effective approach to a difficult problem.⁶ Tissue engineered skin products are approved for limited use, but experience has proven that the treatment of all types of wounds from acute wounds to keloid scars can benefit from these products.⁷      These are just a few of the examples of the “creative,” off-label use of medications and treatments. Great care must be taken when utilizing new therapies to do no harm. The patient must be fully informed of the treatment and full consent must be given. A formal evaluation should be conducted if the off-label treatment proves to be beneficial. As healthcare providers it remains our obligation to treat patients with the best evidence-based care available, but to remain mindful that new and innovative therapies are waiting to be discovered. We must continue to search for tomorrow’s best evidence-based therapy. The off-label use of some current medications and therapies may be a good starting point.