Botox, Re-lox, black box; new toxins, new controversies

Pop quiz: What do Botox, Xerox, Kleenex, and Clorox have in common (besides alliteration)? The answer is they all are brand names that are interchangeable for the product itself. True, we most often say “photocopy” now instead of Xerox, but it is still common to ask for a Kleenex instead of a “facial tissue,” no? Similarly, Allergan’s Botox has become synonymous with Botulinum toxin type A, and the brand celebrates its 20th anniversary since FDA approval. But the FDA welcomed a new member to the family with yesterday’s approval of Dysport from competitor Medicis, best known for the popular wrinkle filler Restylane.

But as we have come to expect from our friends at the FDA, what the one hand gives the other takes away. Both products will come with what is called a boxed warning regarding potentially serious side effects. Given that there is a 20-year record of remarkable safety for Botulinum toxin, why the sudden concern? You can thank Ralph Nader’s misguided lobby, Public Citizen, which a year ago petitioned the FDA to look into reports of adverse reactions from Botox. These are of course the same people who stirred up all the trouble with silicone breast implants, which were completely vindicated in scientific studies.

Is there really a safety issue with Botulinum toxin? Most people know it only as a wrinkle reducer, which requires tiny doses and is harmless when properly used. But at least half of the market for this product is to treat spastic muscles associated with such conditions as cerebral palsy, which requires large doses, often in children, and a much greater potential for side effects. But the good that is done, improving quality of life for thousands to millions by increasing mobility for the disabled to preventing migraine headaches needs to be taken into consideration. The FDA’s acting deputy director of the Office of Drug Evaluation stated that “we don’t mean in any way to discourage” the use of these products, but given the way these things are misinterpreted by a public primed for panic, it rings hollow. I do take the FDA’s guidance seriously, I just want them to acknowledge and take seriously the political influences under which they operate.

Whether the new product will carve out a slice of the market remains to be seen. There are some subtle differences between the products from Allergan and Medicis, but clinical experience will tell if these are important.