Botox is a popular anti-wrinkle drug derived from a sterilized form of botulinum toxin. The well-known drug works by temporarily paralyzing and impeding muscle movement.

Allergan, Inc. and Solstice Neuroscience, Inc. manufacture and market Botox.

In 2008, the FDA issued a warning on Botox deaths: it discussed an ongoing safety review regarding Botox and Botox Cosmetic. The FDA received reports of systematic adverse reactions including respiratory compromise and death following the use of botulinum toxin types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.

In 2009, the FDA released another warning about Botox, Botox Cosmetic and Myobloc, after some children died or suffered severe injuries when the drug spread away from the injection site. The FDA said that Botox has never been approved for use in pediatric patients—nor was it approved in the doses required to affect a spastic muscle.

Other Side Effects:

  • Anxiety
  • Arm or leg pain
  • Back pain
  • Constipation
  • Dizziness
  • Drowsiness
  • Dry mouth
  • Dry or irritated eyes
  • Facial pain
  • Flu-like symptoms
  • Headache
  • Inability to focus the eyes
  • Increased cough
  • Indigestion
  • Mild sore throat
  • Nausea
  • Neck pain
  • Pain, redness, swelling, or tenderness at the injection site
  • Runny nose
  • Sensitivity to light
  • Stiff or weak muscles at or near the injection site
  • Sweating
  • Tiredness
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