Botox

Botulinum Toxin Drug Products

A “Botox shot” has become one of the most commonly performed cosmetic procedures in the country, with an estimated 4.6 million procedures performed annually in the United States by dermatologists, plastic surgeons, cosmetic physicians, nurses, physician assistants and medical spas, according to the American Society of Plastic Surgeons. However, there are many serious health and safety concerns associated with botulinum toxin drug products, which has prompted the U.S. Food and Drug Administration (FDA) to take important measures to protect patients.

Botulinum toxin is a medication and protein produced by the bacterium Clostridium botulinum, which is one of the world’s most toxic substances. Despite this toxicity, this substance has been developed and sold to be used in small doses for a range of treatments. For instance, a Botox shot blocks the release of a chemical that triggers muscle contractions, which is called acetylcholine. By blocking the chemical’s release, the Botox paralyzes the muscle and erases wrinkles.

The four most widely known botulinum toxin drug products and their FDA-approved names and uses are:

• Botox (onabotulinumtoxinA): This is used for spasms of the eyelids (blepharospasm), severe neck muscle spasms (cervical dystonia) and excess sweating (severe primary axillary hyperhydrosis).
• Botox Cosmetic (onabotulinumtoxinA): This is used for temporary improvement in the appearance of moderate to severe facial frown lines, or wrinkles.
• Myobloc (rimabotulinumtoxinB): This is used to treat severe neck muscle spasms (cervical dystonia) in adults; it has not been approved by the FDA for treatment of children.
• Dysport (abobotulinumtoxinA): This is used for temporary improvement of forehead wrinkles and frown lines.

Botox and Botox Cosmetic are both sold by Allergen, Inc., while Myoblock is sold by Solstice Neuroscience and Dysport by Ipsen.

In 2008, the FDA received reports of “systemic adverse reactions,” including respiratory problems and death, following the use of botulinum toxins for both FDA-approved and non-approved (or “off-label”) uses. The reported reactions suggested botulism, or poisoning, which would occur when the botulinum toxin spread in the body beyond the site where it was injected and caused swallowing and breathing difficulties. The most serious cases included death in children treated for cerebral palsy-associated limb spasticity, or severe arm and leg muscle spasms, which is not an FDA-approved use.

As a result of the reports, the FDA conducted a safety evaluation of the botulinum toxin products and issued a new set of prescription requirements in July 2009, mandating that the drug companies:

• Place a Boxed Warning on the label, warning of the possibility of potentially life-threatening distant spread of the drug’s toxin effect from the injection site
• Provide a Medication Guide to patients to help them understand the risks and benefits of botulinum toxin products; and
• Change the established drug names to reinforce that the products were not interchangeable.

Furthermore, the prescribing information for these products describes adverse reactions that can occur in regions near the injection site for each product’s approved uses, such as difficulty swallowing (dysphagia) after injections to treat severe neck muscle spasms or drooping eyelids (ptosis) after injections for frown lines or spasm of the eyelids.

A lawsuit recently filed in federal court in California has alleged that the “Botox business model” promotes multiple-patient use of single-use vials, creating “an unacceptable and unreasonable risk of serious and debilitating injuries and illnesses, including HIV and Hepatitis B and C.”

Contact Us Today

If you have experienced side effects or complications consistent with warnings and concerns about Botox, Botox Cosmetic, Myobloc or Dysport, including swallowing or breathing problems, you should contact the Pennsylvania dangerous drug and product liability attorneys at Munley, Munley, & Cartwright to discuss your legal options. We will meet with you to evaluate your information and determine if you have a case. We fight to protect the rights of consumers and patients.

For a free consultation, contact us by calling 877-421-9173 or by using our convenient online form.