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Update on Botulinum Toxin Safety Warnings

By Oguz Ozdemir

On August 3, 2009 the U.S. Food and Drug Administration (FDA) updated their previous warning with regards to the safety of four botulinum products. All of the products in question now carry updated warnings on their labels and include Medication Guides for anyone who uses these products.

The new boxed warnings alert users to complications of using botulinum toxin. Most commonly recognized as Botox, which is used to reduce lines and wrinkles on the surface of the skin, mostly the face, botulinum can actually spread from the injection site and could result in symptoms of botulism. These complications are serious and life threatening and begin with breathing and swallowing difficulties. These side effects could result in death.

While no reports of these complications have been reported in its use as a dermatology remedy for wrinkles or its use in controlling above normal underarm sweating, the injuries have been reported in its use in children with cerebral palsy. Botulinum is administered to cerebral palsy victims to control muscle spasticity but the FDA did not approve the use of botulinum for this use. Reports of adverse symptoms are on record for adults who have used this product for approved and non-approved use.

The products that require the updated warning labels include: Botox (onabotulinumtoxinA), Myobloc (rimabotulinumtoxinB) and Botox Cosmetic (onabotulinumtoxinA). The fourth product, Dysport (abobotulinumtoxinA) was just approved for use in April 2009 and already carries the updated boxed warning label.

Botulinum has been used as a topical injection for cosmetic reasons to reduce the effects of frown lines and wrinkles in the face and has had some serious side effects with adverse reactions from patients in the past resulting in disfigurement.

The product has also been used to control eyelid twitching and as a correction for crossed eyes. Administered in the correct dosage, these applications have not resulted in symptoms of botulism.

After the FDA's investigation and conclusion to update warning labels, the United States Adopted Names Council revised the previous names for each botulinum toxin product to prevent any confusion and to reinforce the separate identity of each product. The new names are identified above and these products are not interchangeable.

If you have used a botulinum product and have experienced any type of side effects as a result, you should notify your physician or health care professional. If you have suffered from any adverse effects as a result of an approved use of botulinum toxin you should notify your physician and you should consider contacting the law firm of Napoli Bern Ripka LLP at 1-888-LAW-IN-NY.

We have a legal team of experts who have a working knowledge and solid experience in dealing with adverse reactions and life threatening effects as a result of using FDA medications. You shouldn't have to suffer due to the negligence of pharmaceutical manufacturers. Our lawyers are able to provide you with a complimentary consultation and can guide you in receiving compensation you may be entitled to for any injuries or side effects you may have become victim to.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on August 11, 2009 (boomark / email).