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FDA to Require Botox Safety Warnings

The Federal Drug Administration has issued a warning that use of Botox for unapproved uses like treatment of muscle spasms has potential health hazards. The agency has required makers of Botox and other similar drugs to have stronger warnings about these hazards.

The Botulinum toxin was administered to children suffering from cerebral palsy to treat uncontrolled muscular spasms. They were also given to adults to treat neck pain and uncontrollable twitches. According to the FDA, the complications could arise if the toxin Botulinum spreads beyond the injection side elsewhere into the body. These complications can result in paralysis in the muscles used for breathing and swallowing. Additional complications can include suffering from breathing and swallowing difficulties, muscular weakness, vision problems, loss of bladder control, and even death. According to the agency, there have been deaths that have been linked to such unapproved use of these drugs.

The FDA has, over the past 20 years, approved the use of Botox for the treatment of several conditions. The most common use of the drug is for the treatment of frown lines and wrinkles. Millions across the world have made use of Botox injections to erase these lines off their faces by freezing the muscles that are responsible for them. Although Botox is generally known as a cosmetic treatment and this is its most popular use, the drug, which is made by Irvine based Allergen Inc., is also approved for the treatment of muscles spasms in the foot, neck, and eye as well as muscle pain and excessive sweating. The Botulinum toxin locks nerve impulses, causing muscles to relax.

The FDA has said that Allergen, Solstice Neurosciences and Medicis need to include stronger warning on their products warning against unapproved uses of their drug. Allergen has released a statement announcing that the safety and efficacy of Botox are well known. Any reports, the company says, of the toxin spreading beyond the injection site and through the rest of the body, are extremely rare.

The side effects were reported when the drug was injected to treat spasticity in the legs in children who suffer from Cerebral Palsy. In adults, the drug was injected to treat spasticity as well as a condition called cervical dystonia in which there are neck spasms. Both of these uses are not approved by the FDA.

Using a drug for unapproved process is not exactly rare. Doctors are allowed to prescribe a drug for purposes which have not been approved by the agency. Companies however are not allowed to promote unapproved uses of their drug. So far, the cases have been restricted to excessive doses of Botox. The cosmetic use of the drug requires very small doses of the drug and so, the agency says, may not pose a risk.

Ever since Botox burst on the scene in the 1980’s there have been several controversies surrounding the anti-wrinkle drug. Concerns about its long-term effects have always been around, but there has never been any conclusive evidence that the drug has any dangerous side effects.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of recalled products. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

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