Popular Anti-Wrinkle Drug Botox Gets FDA Warning

By Michael Dorausch, D.C.

The Food and Drug Administration (FDA) has issued a warning on the use of Botox and Myobloc, two drugs, made popular for their anti-wrinkle effects. The FDA has reported that the drugs, have been linked to dangerous botulism symptoms in some users, with cases so bad that a few children have died.

Both products contain drugs that use botulinum neurotoxin protein to block nerve impulses, causing muscles to relax. In reported rare cases, the neurotoxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect.

botulinum toxin and strabismusBrand name Botox is best known for minimizing wrinkles by paralyzing facial muscles, but the popular botulinum toxin is also used to treat a variety of muscle-spasm conditions, such as cervical dystonia (spasm of the muscles of the neck) and strabismus (misaligned or lazy eyes).

According to the FDA, deaths being investigated all involve children, mostly cerebral palsy patients receiving treatment for spasticity in their legs. The FDA has not formally approved the use of botulinum toxin for such treatment, but some other countries reportedly have.

Botulinum Toxin
Botulinum toxin is a neurotoxin protein produced by the bacterium Clostridium botulinum. It is one of the most poisonous naturally occurring substances in the world, and it is the most toxic protein known to man. The FDA first licensed botulinum toxin as Oculinum in December of 1989 for treating two eye conditions–blepharospasm and strabismus–characterized by excessive muscle contractions. It is now marketed under the trade name Botox (Botulinum Toxin Type A) or Myobloc (Botulinum Toxin Type B).

Medical Use
Small doses of the toxin are injected into the affected muscles. As happens with botulism, the toxin binds to the nerve endings, blocking the release of the chemical acetylcholine, which would otherwise signal the muscle to contract. The toxin thus paralyzes or weakens the injected muscle but leaves the other muscles unaffected. Effects are usually first noticed within 72 hours and injections typically last on average of 3-6 months.

In 1994, the FDA reportedly denounced the promotion of botulinum toxin use as a wrinkle remedy, claiming use was unapproved and “an egregious example of promoting a potentially toxic biologic for cosmetic purposes.”

Botox and Myobloc injections are not to be confused with Collagen injections, also used in treating fine lines and wrinkles, and popular for giving women that full plumped lip look.

FDA Botulinum Resources:
Botulinum Toxin: A Poison That Can Heal
By Luba Vangelova — FDA Consumer magazine (December 1995)

Botox Cosmetic: A Look at Looking Good
By Carol Lewis — FDA Consumer magazine (August 2002)

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