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The IHHS Explains Recent News About Botox Safety
In February 2008, the U.S. Food and Drug Administration (FDA) announced it would be reviewing Botox, a prescription drug that has been used worldwide for 20 years to treat millions of people with conditions ranging from wrinkles, to hyperhidrosis, to debilitating muscle contractions.
The FDA's concerns, as it turns out, were centered around a "handful" of children with cerebral palsy, whose health was already severely compromised when they were treated with Botox for spasticity in their legs.
The FDA says several of these very ill children were hospitalized with adverse reactions believed to be related to the Botox injections they received, and one child died. The investigation, the results of which are pending, also mentions one case of weakness and hospitalization following the cosmetic use of Botox, though the agency is still trying to determine whether Botox was the reason for the hospitalization.
Allergan, Inc., makers of Botox, in a statement issued after the investigation, said it "fully supports the FDA's safety review of these adverse event reports and is working with the FDA to ensure that it has all of the information necessary to make an informed and reasonable judgment regarding them."
Meanwhile, the Irvine, Calif., company also cautions that the health profile of the bulk of the investigated cases is significantly different than the profile of those suffering from other ailments, including hyperhidrosis.
"With respect to the therapeutic use of Botox to treat juvenile cerebral palsy and other lower limb spasticities, one should keep in mind that the population, treatment paradigms and typical dosing of product is significantly greater than some of the other approved uses of the product, including specifically the FDA-approved use of Botox Cosmetic to treat wrinkles between the brows," said Allergan in its statement. "In particular, the FDA on its teleconference pointed out that this population of patients tends to be 'very sick' and that, sadly, this population is generally subject to greater than usual serious adverse events and a higher mortality rate than a healthy population, regardless of the use of the product."
Allergan further states that while the FDA has approved the use of Botox to treat several conditions, juvenile cerebral palsy is not one of them. This does not mean that treating this group of patients with Botox is inappropriate. In fact, treating cerebral palsy is an approved use of Botox in several dozen countries all over the world – Canada, the United Kingdom, Egypt, and Sri Lanka to name a few. This use simply is not approved by either the FDA or Allergan.
"While the use of Botox for the treatment of juvenile cerebral palsy is approved in approximately 60 countries and has been used by health care practitioners in the United States for well over a decade, it is not currently an FDA-approved use of the product in the United States. As the FDA confirmed in its public teleconference, however, the off-label use of the product in the United States for this ailment is left to the medical judgment of the health care practitioner and the FDA's current review should not be interpreted to mean that the FDA is suggesting that this particular use is inappropriate."
Botox and Hyperhidrosis Not Specifically Implicated
While any adverse reaction to an approved drug is of special concern to the medical community, including the International Hyperhidrosis Society, the agency's report does not specifically implicate Botox in association with hyperhidrosis. This is important news to the many hyperhidrosis sufferers who have come to rely on Botox treatment for relief from excessive sweating on the palms of their hands (palmar hyperhidrosis), the soles of their feet (plantar) and under their arms (axillary).
Yet whether Botox is being used to treat excess sweat, frown lines or children with cerebral palsy, St. Louis dermatologist Dr. Dee Anna Glaser, one of the world's leading authorities on hyperhidrosis treatment methods wishes to remind patients that Botox is a strong drug that should always be administered by a qualified physician.
"I feel very secure in the extensive research, both in the U.S. and in Europe: The safety of Botox therapy to treat hyperhidrosis is outstanding," says Dr. Glaser, a founding board member of the International Hyperhidrosis Society. "But what really is the take-home message for patients in all these cases is that Botox should be administered in a medical setting by a medical professional and not in a party-like atmosphere, not in a spa-like atmosphere. Patients should see a reputable, licensed, accredited, board-certified physician who is treating patients within his or her area of expertise."
The History of Botox
To understand the history of Botox is to understand botulinum toxin, a highly potent neurotoxin protein produced by the bacterium, Clostridium botulinum, which comes in seven serologically distinct forms, designated A through G. Researchers first began recognizing the toxin's ability to block neuromuscular transmission 60 years ago. Botox ultimately became the only botulinum toxin Type A product that is approved and licensed by the FDA.
In 2002, Botox was approved for cosmetic use. Two years later, the FDA approved Botox for treating hyperhidrosis patients, finding that the drug works to temporarily block the secretion of the chemical in the nervous system that is responsible for "turning on" the body's sweat glands. By blocking, or interrupting, this chemical messenger, botulinum toxin "turns off" sweating at the area where it has been injected.
Additional approved uses of the drug include treating uncontrollable blinking, or blepharospasm, a localized movement disorder that causes abnormal muscle spasms and affects approximately 25,000 people in the United States. Botox is also used to control cervical dystonia, a movement disorder characterized by involuntary contractions of the neck muscles affecting more than 300,000 people in North America. Botox is undergoing clinical trials for the treatment of several urologic disorders, including overactive bladder, affecting some 33 million Americans, as well as lower urinary tract symptoms due to benign prostatic hyperplasia, a non-cancerous disease of the prostate that can interfere with urination and is one of the most common diseases among men.
To date, more than one million patients worldwide have been helped by Botox, as thousands of people safely receive Botox injections every day to treat a range of conditions. Medical literature indicates that Botox is "remarkably safe" and that the vast majority of consumers (96.7%) who have received Botox injections felt unstressed by the procedure.
Like any drug, Botox when used for the treatment of hyperhidrosis, does not come without the potential for side effects, the most common being stinging, bruising and discomfort at the site. There have been no reported cases of death or severe illness related to Botox treatment for hyperhidrosis. The most serious potential side effect is related to palmar hyperhidrosis treatment, which may cause muscle weakness that can last from a few hours to several weeks. This side effect, however, is infrequent when the treatment is administrated by an experienced physician and is usually mild and usually temporary.
As for the long-term effects of Botox treatment on hyperhidrosis patients, a four-year study was co-conducted by Dr. Glaser and presented in February 2007 at the 65th Annual Meeting of the American Academy of Dermatology. The study, which focused on 150 patients with severe primary axillary hyperhidrosis receiving repeated Botox treatments over a four-year period, said there were no "serious treatment related effects over the course of the four years. Nor did anyone drop out of the study because of treatment-related adverse effects."
While the safety of Botox specifically related to hyperhidrosis is not mentioned in the FDA's teleconference report, Dr. Glaser says she has fielded a handful of concerns from her St. Louis hyperhidrosis patients. Additional concerns followed recent news reports about a study released in April by the Italian National Research Council's Institute of Neuroscience. This study found that when the whisker muscles of rats were injected with botulinum toxin, the toxin migrated to the brain, causing concern about the path botulinum toxin might take in the human body after it has been injected.
In response to the Italian study, Allergan states that the "botulinum toxin injected into the rats was incorrectly reported to be Botox. In fact, in the study, authors used toxic high doses of a laboratory preparation of botulinum toxin and did not use the FDA-approved medical product Botox, and data suggests that different preparations of botulinum toxin type A react differently in both the laboratory and in clinical practice. Furthermore, other published studies using botulinum toxin type A contradict these findings. Therefore, it would be inaccurate to apply the results of this animal study to Botox."
All these cases and studies, and the concerns they raise, are reminiscent of an incident three years ago when a California woman died after being injected by her hairstylist with phony Botox. "The hairstylist should never have been administering Botox or anything resembling Botox to begin with," said Dr. Glaser.
Indeed, while Dr. Glaser commends the FDA for its careful review of adverse effects related to Botox, and while she is always concerned about the safety of any product she administers, her greatest concern for her own patients is focused on safe administration of the drug.
"When you look at the millions and millions of people treated with Botox, you do get a really good sense that Botox, when administered correctly, is a very safe therapy. Hyperhidrosis patients should rest assured that the therapeutic options we are using are good. They just need to find a qualified physician to take them through their options."
Physician Training Available
The IHHS reminds interested physicians that a training video for administering Botox is available through our online learning library. The IHHS also conducts several continuing education training events throughout the year, including an event this September in Paris, sponsored by the European Academy of Dermatology and Venereology. At this conference, physicians will have the opportunity to receive hands-on training from the world's leading hyperhidrosis practitioners, many of them members of our IHHS board. As a bonus, physicians who attend any of our educational events not only receive hands-on training, they receive a gold star beside their names in our Web site's physician finder database, a symbol that lets patients know they are up-to-date on the most current treatment methods.
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Find a doctor who treats excessive sweating. |
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