Early Communication on Adverse Events from Botox and Myobloc

PDF E-mail

FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product was used, and not to a defect in the manufacturing process. The events occurred one day to several weeks after treatment, and from a wide range of dosages.

In the affected patients, the botulinum toxin may have spread beyond the injection site and caused symptoms associated with botulism, including dysphagia and respiratory insufficiency. The most severe effects were seen in children, and the most commonly reported use in children was for limb spasticity in cerebral palsy, which is an unapproved use. Adverse reactions also occurred in patients receiving the drug for approved indications.

FDA is evaluating all the adverse event reports, as well as the medical literature in this area, and will let health professionals and the public know about any new information or conclusions.

In the meantime, healthcare professionals who use botulinum toxins should be alert to the potential for systemic effects from local injections, including dysphagia, dysphonia, weakness, dyspnea, or respiratory distress. They should tell patients and caregivers about the symptoms of botulism and to seek immediate medical attention if they occur.

Finally, practitioners should understand that the potency of botulinum toxin, which is expressed in "Units" ("U"), is not comparable from one botulinum toxin product to the next.

Article source:  FDA MedWatch Safety Alert. Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B). February 8, 2008.   http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox


Additional Information:

FDA:  Early Communication about an Ongoing Safety Review of Botox

FDA Press Release:  FDA Notifies Public of Adverse Reactions Linked to Botox Use, Feb 8, 2008


In all personal injury cases, it is extremely important that measures be taken promptly to preserve evidence, investigate the accident or toxic exposure in question, and to enable physicians, attorneys, or other expert witnesses to thoroughly evaluate any injuries.  If you or a loved one or friend is injured and may have a potential legal claim, call The Mulligan Law Firm now at 1-866-LAW-0001.  The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds.  You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.  Do not delay!  If you delay, and the statute of limitations time period expires, you may lose all your rights to file any claim for compensation of any kind.

If you need additional help, please fill out our form on this website of call us for help at 1-866-LAW-0001 (1-866-529-0001) 

A member of our firm will call you as soon as possible to help you determine the possibility of filing a potential claim.

For a free, no-obligation consultation with an experienced attorney regarding cases of personal injury and wrongful death, please submit our potential case intake form on this website for a free evaluation of your situation. We will respect the confidentiality of your information to the fullest extent. Form submissions are relayed to us through our highly secure servers.

If you prefer, you may contact us at (214) 219-9779 or (866) 529-0001. 

The Mulligan Law Firm's affiliated attorneys represent clients throughout the United States in conjunction with local counsel licensed in other jurisdictions:

Alabama Alaska Arizona Arkansas
California Colorado Connecticut Delaware
Florida Georgia Hawaii Idaho
Illinois Indiana Iowa Kansas
Kentucky Louisiana Maine Maryland
Massachusetts Michigan Minnesota Mississippi
Missouri Montana Nebraska Nevada
New Hampshire New Jersey New Mexico New York
North Carolina North Dakota Ohio Oklahoma
Oregon Pennsylvania Rhode Island South Carolina
South Dakota Tennessee Texas Utah
Vermont Virginia Washington West Virginia
Wisconsin Wyoming


It is possible that you know about cialis cost. Many young men know it as Sildenafil. A spread form of sexual dysfunction among men is the erectile dysfunction. Luckily many problems with sexual soundness can be treated by cost of cialis. Spinal cord injuries can promote to erectile dysfunction. A overall class of antidepressants, which include Paxil — may cause problems in bed. If you have annoyance getting an erection, it's considerable to see a certified doc before pursuing any sort of medications.


Quick Call Back

Free Case Review

Mulligan Family Foundation

The Mulligan Family Foundation was established by Patrick J. Mulligan to support kids in need throughout the United States, and especially in California and Texas. For more information, click here.

Top Attorneys in Texas 

Super Lawyers

Do You Have A Case?