Botox

FDA Notifies Public of Adverse Reactions Linked to Botox Use

Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place.

The U.S. Food and Drug Administration (FDA) recently announced that it would undertake a safety review of Botox, Botox Cosemtic and Myobloc. The announcement came after the FDA received reports of serious adverse reaction, including respiratory failure and even death. If you or a loved one has suffered as a result of using one of these products, please CLICK HERE for a free consultation.

• Botox (botulinum type A) is approved by the FDA for treatment of conditions such as blepharospasm (spasms of the eyelids) and cervical dystonia (severe neck muscle spasms).
• Botox Cosmetic also, botulinum type A is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
• Myobloc or botulinum type B is approved for treatment of adults with cervical dystonia.

According to FDA the adverse reactions involved Botox injections for FDA approved and non-approved or “off label” usages. Off-label uses, though not prohibited or necessarily inappropriate, are not FDA approved. Some of the most serious injuries occurred in children treated for limb spasticity associated with cerebral palsy. Treatment of spasticity is not an FDA approved use of Botulism toxins in adults or children.

The adverse events appear to be related to the spread of the toxin to areas in the body beyond the injection site and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The agency is not advising health care professionals to discontinue prescribing these products at this time. It will continue its review of safety data from clinical studies submitted by the drug’s manufacturer, post marketing adverse events reports and medical literature before issuing any public notice regarding it’s conclusions, recommendations and any regulatory actions.

If you or a loved one suffered a serious injury or death as a possible result of using Botox or Myobloc, you may want to contact a Botox attorney or a Myobloc attorney. A lawyer familiar with new developments in the investigation of these products may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.