Navigation Links
FDA Warns of Children's Deaths Linked to Botox
Date:2/8/2008

Anti-wrinkle drug and competitor Myobloc under agency safety review

FRIDAY, Feb. 8 (HealthDay News) -- U.S. health officials are investigating reports of children's deaths and severe side effects for others treated for a variety of conditions with the wrinkle-erasing drug Botox and related products.

Most of the children were being treated with botulinum toxin products to control limb spasms caused by cerebral palsy, the U.S. Food and Drug Administration said Friday. The agency hasn't approved the use of the drugs for such treatment, officials added.

The FDA said it was reviewing the safety of Allergan Inc.'s Botox and Botox Cosmetic (botulinum toxin type A) and Solstice Neurosciences Inc.'s Myobloc (botulinum toxin type B) after reports of the adverse reactions, which included respiratory failure.

The FDA said that the adverse reactions may be due to overdosing and there was no indication they were related to defects in the products.

The reactions appeared to be related to the spread of the botulinum toxin to areas away from the site of injection, and mimic symptoms of botulism poisoning, which can include difficulty swallowing, weakness and breathing problems.

"We have become aware of a number of reports of serious adverse reactions related to the use of botulinum toxin products," Dr. Russell Katz, director of the FDA's Division of Neurology Products at the Center for Drug Evaluation and Research, said during a Friday afternoon teleconference. "These are reactions that involve parts of the body physically distant from the site of injection."

Currently, the drugs' label warns against using these products in people with neuromuscular disorders, Katz said.

"However, we have seen hospitalization and death among people who do not have a neuromuscular disorder," he said. "Most of the cases that are serious are among pediatric patients who have been treated for spasms, usually in the lower limbs, which is an off-label use."

Katz declined to give the number of deaths or adverse events associated with the products.

However, the FDA's Adverse Event database for Botox and Myobloc found 180 adverse events in the United States, including 16 deaths, and four of these deaths occurred in children under 18, according to a petition filed last month by Public Citizen's Health Research Group. The petition asked the FDA to place a black box warning -- the strictest warning -- on these products.

In 2002, the FDA approved the use of Botox to improve the appearance of moderate to severe frown lines between the eyebrows. Two years later, the agency signed off on Botox as a treatment for severe underarm sweating, known as "primary axillary hyperhidrosis." The drugs work by using botulinum toxin, which blocks nerve impulses to muscles, causing them to relax.

FDA officials said Friday that they weren't advising health-care professionals to stop prescribing these products. However, they are urging doctors and their patients to watch for signs of botulism poisoning.

The agency said it is reviewing the safety data from clinical trials submitted by the makers of the drugs. In addition, the FDA is looking at "post-marketing adverse event reports" and any published studies.

"We don't think the current labeling is as clear about the distant effects in children and in patients without underlying neuromuscular disorders," Katz said.

In a statement released Friday afternoon, Solstice Neurosciences Inc. said "safety of patients treated with Myobloc (botulinum toxin type B) Injectable Solution has always been of primary importance" for the company. "We support education and training of physicians in a number of ways regarding the proper use of this product as outlined in the prescribing information."

Public Citizen said the FDA should follow the lead of European drug regulators who have issued warnings about the dangers of using botulinum toxin.

"Nobody should be dying from injected botulinum toxin. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.

More information

For more on Botox, visit the FDA.



SOURCES: Feb. 8, 2008, teleconference with Russell Katz, M.D., director, Division of Neurology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Public Citizen, petition and statement; Feb. 8, 2008, news release, Solstice Neurosciences Inc., South San Francisco, Calif.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Warns of Codeine Risk for Some Nursing Mothers
2. PA Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Perry County Dairy
3. Research warns that human papillomavirus might cause bladder cancer
4. New research warns of the lack of specialization when judging individuals with mental disorders
5. Coalition of Caregivers Warns Congress of Danger to Oldest U.S. Seniors if Medicare Slashed
6. Health Department Warns Consumers of Home-Canned Soup Linked to Potter County Restaurant
7. FDA Warns Against Bio-Identical Hormone Therapy
8. Cold Meds Not Safe for Kids Under 2, FDA Warns
9. FDA Warns Clot Risk Higher in Birth Control Patch Than Pill
10. Renaissance Health Publishing, LLC Warns the Public that ConsumerLab.com is Not Independent and Labels the CL Seal of Approval a Worthless, Paid-For Advertising Gimmick
11. Health Capital Group Warns of Fallout to Hospitals From the Subprime Mortgage Crisis and Urges Hospitals to Immediately Reassess Existing Debt Structures and Capital Financing Plans
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Warns of Children's Deaths Linked to Botox
(Date:7/24/2017)... ... July 24, 2017 , ... ... that already work hand-in-hand on an Innovation Collaboration program, have signed a five-year ... experience and cost of the care members and patients receive. The agreement also ...
(Date:7/24/2017)... California (PRWEB) , ... July 24, 2017 , ... ... of autologous fat (adipose) transfer systems announces the issuance of United States Patent ... patent) for its adipose filtration technology. The '398 and '324 patents cover ...
(Date:7/24/2017)... (PRWEB) , ... July 24, 2017 , ... ... August 13-17 in National Harbor, MD. This year's theme focuses on the new ... principal benchmarks for quality and integrity in testing and calibration will be changed. ...
(Date:7/24/2017)... (PRWEB) , ... July 24, 2017 , ... ... sleep management solution focused on delivering end-to-end sleep health care at ... , Recent literature shows that adherence rates for positive airway pressure (PAP) therapy, ...
(Date:7/24/2017)... ... July 24, 2017 , ... A Southern California-based author has ... sexual abuse, and how she has overcome them. “Forbidden Memories: A Memoir,” by author ... and how she has risen above. , In “Memories,” readers get a firsthand look ...
Breaking Medicine News(10 mins):
(Date:7/11/2017)...  The global market for liquid biopsy diagnostic and ... in 2016.  Although in early stages, the global market ... as a result of the gradual shift towards personalized ... of a significant number of new liquid biopsy tests ... biomarkers to guide treatment decisions. ...
(Date:7/10/2017)... CLEVELAND , July 10, 2017  US medical ... billion in 2021, according to Medical Equipment ... released by Freedonia Focus Reports. Continued increases in demand ... the aging of the population and supported by gains ... associated equipment and supplies. New product introductions will also ...
(Date:7/10/2017)... PARK, N.C. , July 10, 2017 ... $5m Convertible Note to support the development of CRISPR-Cas3 ... Tencent Holdings Limited, a leading Chinese Internet services provider, ... funding will advance multiple infectious disease product programs targeting ... Founded by Dr. Rodolphe ...
Breaking Medicine Technology: