Botox Wrongful Death and Serious Injury - FDA "Early Communication is not a Botox Recall - Free Consultation Regarding Product Liability and Medical Malpractice Claims

Below is an FDA “early communication” about Botox. This is not a Botox recall. According to the FDA early communication, patients have had adverse reactions to botox treatments, some resulting in hospitalization and death. Most of the serious cases have involved children treated for cerebral-palsy-associated limb spasticity.

The FDA early communication is being reprinted here (with comments) by Pritzker | Olsen, P.A.. Our law firm has a national reputation, and lawyers at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA and other publications. Attorneys Fred Pritzker, Elliot Olsen and Eric Hageman have been named “Super Lawyers” by Law & Politics magazine. And Fred Pritzker is also listed in The Best Lawyers in America. To contact the firm, please call toll-free at 1-888-377-8900 or submit the firm’s free case consultation form.

Below is the FDA early communication regarding botox treatments. Comments by Pritzker | Olsen, P.A. are in brackets ([]).

Early Communication about an Ongoing Safety Review
Botox and Botox Cosmetic (Botulinum toxin Type A) and
Myobloc (Botulinum toxin Type B)

FDA preliminary comment: This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. [Contact our law firm regarding malpractice and unapproved use of drugs.]

These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses. FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature.

Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established.

FDA is aware of the body of literature describing the use of botulinum toxins to treat limb spasticity in children and adults. The safety, efficacy and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.
The current prescribing information (labeling) for Botox, Botox Cosmetic and Myobloc describes adverse reactions occurring in regions near the site of injection for each product’s approved uses, such as dysphagia (difficulty swallowing) after injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for glabellar frown lines or for strabismus and blepharospasm.

The Warnings sections of the labeling for both botulinum toxin products note that important systemic adverse effects, including severe difficulty swallowing and difficulty breathing have occurred in patients with neuromuscular disorders after local injection of typical doses of botulinum toxin. FDA now has evidence that similar, potentially life-threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with other underlying conditions such as those with cerebral palsy associated limb spasticity. [FDA evidence may be used as evidence in court.] Systemic toxicity has been reported in children, several of whom required feeding tubes and/or ventilation (breathing) support.

Until such time that FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should:

Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
Understand that these effects have been reported as early as one day and as late as several weeks after treatment
Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

What does FDA know now about these data?
The FDA has reviewed post-marketing cases from its Adverse Event Reporting System (AERS) database and from the medical literature of pediatric and adult patients diagnosed with botulism following a local injection with a marketed botulinum toxin product.

The pediatric botulism cases occurred in patients less than 16 years old, with reported symptoms ranging from dysphagia to respiratory insufficiency requiring gastric feeding tubes and ventilatory support. Serious outcomes included hospitalization and death. The most commonly reported use of botulinum toxin among these cases was treatment of limb muscle spasticity associated with cerebral palsy. For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in these cases. For Myobloc, reported doses were from 388 to 625 U/kg.

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities. Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported. The doses for Botox ranged from 100 to 700 Units and for Myobloc from 10,000 to 20,000 U.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions after the review of the data are completed. [Pritzker | Olsen, P.A. will continue to monitor this situation and report any additional FDA communications or a botox recall.]

[If you would like Pritzker | Olsen, P.A. to report the serious, adverse event on your behalf, please contact the firm by calling toll-free at 1-888-377-8900 or submitting the firm's free case consultation form.] Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report/hcp.htm, by faxing (1-800-FDA-0178), by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20853-9787),
or by telephone (1-800-FDA-1088)

Free Case Consultation

Firm News

Fred Pritzker Listed in The Best Lawyers in America

Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.

Attorney Elliot Olsen Speaks at Conference

Attorney Elliot Olsen recently spoke at the Seventh Annual LifeScience Alley Conference in Minneapolis on Preemption and the Future of Medical Device Litigation. He appeared with Randall Pattee of Lindquist and Vennum and Jean Lance, VP of corporate legal and general counsel for Boston Scientific.

Zicam Lawsuit

Several lawsuits have been filed alleging Zicam caused loss of smell (anosmia) and taste, and our lawyers are reviewing potential claims. We are gathering information about Zicam smell loss. Read more about Zicam: Zicam class action lawsuit, warning letter from the FDA to Matrixx Initiatives, Inc. regarding Zicam Cold Remedy nasal spray and gel swabs, Zicam recall.

After only one use of a Zicam Cold Remedy product, Bonnie Blodgett lost her sense of smell. A gradening writer and foodie, her life was drastically changed. She recently published Remembering Smell: A Memoir of Losing--and Discovering--the Primal Sense in which she chronicals her experience with losing her sense of smell and then slowly getting it back again.

Bonnie's experience with Zicam is similar to many of our other clients. They experienced a burning sensation during the first use of a Zicam product and then lost their sense of smell (anosmia). Most of them were not as fortunate as Bonnie and have not regained their sense of smell.

For more information about Remembering Smell, please click on the image of the book.

Ortho Evra Lawsuit: Ortho Evra Birth Control Patch

The Ortho Evra birth control patch has been linked to an increased risk of blood clots that can lead to pulmonary embolism, stroke and heart attack.

Fentanyl Lawsuit and Fentanyl Recall

There have been a number of recalls regarding fentanyl due to the risk of a fentanyl overdose.

This is attorney advertising. Past results do not guarantee a similar outcome. The result of each case is determined by the specific facts and the applicable law.