Botox, Similar Drugs Have Stronger Warnings, New Chemical Names

Botox, the blockbuster cosmetic drug used by millions of people who want to look and feel younger, and similar drugs now carry prominent warnings on their packaging to warn doctors and patients of the risks of serious injury.

The products also have new generic names that look a lot like alphabet soup but are used to identify the chemical makeup of brand-name drugs.

In April, the Food and Drug Administration ordered the makers of Botox, Botox Cosmetic, Mybloc, and Dysport to include stronger warnings on the products’ packaging to alert users about the risks of breathing difficulty, trouble swallowing, and even death.

Today, the FDA issued an update saying that the companies had abided by the FDA order and added the so-called “Black Box” warnings to the products. The companies also had developed medication guides for patients, per FDA orders, the agency said.

Botox and similar drugs are forms of botulinum toxin that work by temporarily paralyzing muscles to reduce the appearance of facial skin wrinkles caused by repeated movement of the muscles. When the drugs migrate inside the body and reach the lungs or throat, they can result in life-threatening complications.

High Dose, Unapproved Uses Linked to Injuries and Deaths

The deaths and severe injuries associated with the drugs have involved high doses of Botox and other drugs given to children with cerebral palsy. The drugs are not FDA-approved to treat muscle spasticity in cerebral palsy patients, but many doctors use Botox or other drugs to do so.

There have been no such cases reported among patients who received the Botox injections at recommended doses to reduce frown lines, treat severe underarm sweating, crossed eyes, or eye twitching, the FDA said.

Same Drugs, New Names

In addition to the new labeling warning requirements, the FDA said it also has developed new chemical names for Botox and similar drugs. While the chemical composition of the drugs has not changed, the new generic names are:

• Botox (onabotulinumtoxinA)

• Botox Cosmetic (onabotulinumtoxinA)

• Myobloc (rimabotulinumtoxinB)

• Dysport (abobotulinumtoxinA)

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