FDA Orders Stronger Warning Labels for Botox and Myobloc
The U.S. Food and Drug Administration has just announced that it will require the blockbuster wrinkle-fighting drug Botox and a similar product called Myobloc to carry stronger warning labels about the risks of severe complications if the paralyzing injections spread through the body.
Botox, made by Allergan Inc., and Myobloc, made by Solstice Neurosciences Inc., are purified forms of botulinum toxin that are widely used for cosmetic purposes to temporarily reduce the appearance of facial wrinkles. The drugs also are used to control muscle spasticity in children suffering from cerebral palsy and to treat adults for cervical dystonia.
The FDA decided to crack down on the products after investigating several deaths and hospitalizations of children who were treated with Botox or Myobloc to reduce the muscle rigidity associated with cerebral palsy, officials said.
Botox and Myobloc work by temporarily stopping muscle movements, since repetitive movement can cause wrinkles or creases to form in the skin. However, when the drugs spread through the body from the injection site and reach the lungs or other vital organs, they can halt breathing, swallowing, and other vital functions.
The FDA said “no definitive serious adverse events” have been linked to the spread of Botox given for dermatological use when the drug is used at approved doses. Millions of Americans get Botox shots every year to reduce wrinkles around the eyes, nose, and mouth.
In February 2008, the FDA said that Botox and Myobloc would be further investigated after reports of adverse side effects in people using the products.
New Botox-Competitor Approved in U.S.
In a strange and ironic twist, on the same day the FDA ordered Botox and Myobloc to carry stronger safety warnings, the agency approved another drug that is nearly identical to Botox for sale in the United States. Dysport, which had been sold in Australia but was not approved for use in the U.S., won FDA approvals for for both aesthetic and therapeutic uses.
In December 2008, health officials in Australia said Dysport can cause severe birth defects in children whose mothers receive the injections during pregnancy. Dysport is a botulinum toxin-based drug just like Botox and Mybloc. According to Australian officials, the use of Dysport by pregnant mothers resulted in deafness, blindness, and other injuries in at least one newborn.
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