By guest blogger Michael Cohen:
Practically everyone has heard of Botox. Its popular cosmetic form, called Botox Cosmetic, is injected in small doses into certain facial muscles to reduce wrinkles and frown lines. Another form, called Botox, is injected into muscles to treat individuals suffering from migraine headaches or for certain conditions where muscle stiffness and spasticity exist. Botox is a block-buster drug. The combination of cosmetic and therapeutic uses of Botox produced a total of $1.3 billion in annual sales as of March this year.
What people may not be familiar with is the fact that both forms carry warnings about serious side effects that can be life threatening, mimicking what might be seen in patients suffering from botulism, a disease caused by the same bacteria from which Botox is derived.
FDA recommends that before you start using Botox, and again each time you use it, you should read the Medication Guide that comes along with it. The guide warns that, in some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. Symptoms may include:
• Loss of strength and muscle weakness all over the body
• Double vision
• Blurred vision and drooping eyelids
• Hoarseness or change or loss of voice
• Trouble saying words clearly
• Loss of bladder control
• Trouble breathing
• Trouble swallowing
Indeed, in the first quarter of 2010, my colleagues and I identified 6 reported deaths, 18 cases of disability, and 100 other reports of serious injury associated with botulinum toxin products. The complete details are available in our latest QuarterWatch report, which looks at domestic case reports of adverse drug events that are classified under federal regulation as “serious,” which means events that resulted in death, permanent disability, a birth defect, required hospitalization, were life threatening, required intervention to prevent harm, or had other medically serious consequences. The reports involving Botox included cases indicating that the nerve toxin was paralyzing muscles distant from the intended sites, causing difficulty swallowing, speaking, breathing, and incontinence. According to the Medication Guide, these adverse effects may continue for months. Among the reported cases, 64% involved Botox, 21% involved Botox Cosmetic, and 14% involved Dysport, a similar botulinum-derived product.
FDA believes that botulinum toxins are safe when administered for approved uses at approved doses. However, botulinum toxin products are widely used off label and Allergan, the manufacturer of the Botox products, pleaded guilty in September 2010 to illegal off-label promotion of Botox and agreed to pay $600 million in criminal fines and penalties.
The reports seen during the first quarter of 2010 raise questions about potentially misleading safety claims. The prescribing information for healthcare practitioners states: “No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox/Botox Cosmetic at the labeled dose of 20 units (for glabellar lines)...have been reported." The patient’s Medication Guide states: "There has not been a confirmed serious case of spread toxin effect away from the injection site when…Botox Cosmetic has been used at the recommended dose to treat frown lines.” My coauthors and I believe that these statements might lead doctors and patients to discount safety warnings, including an FDA-required boxed warning, about the spread of the toxin beyond the site of injection that appears elsewhere in the Medication Guide and prescribing information.
We believe that FDA should not allow blanket safety claims that no “confirmed” or “definitive” cases of spread of the toxin beyond the site of injection with botulinum toxins have been “reported.” Instead, the agency should require a summarization of the data from valid studies the agency has independently evaluated. In addition, the Medication Guide should be revised so it, too, does not downplay the risks associated with spread of the toxin beyond the site of injection.
For information on ISMP's consumer web site go www.consumermedsafety.org
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