Anti-wrinkle - Warning about the risks associated with the use of Botox

In a public statement dated February 8, 2008, the FDA (U.S. Food and Drug Administration), sent a warning about the risks associated with the use of Botox and said that she is currently reviewing the safety of Botox, Cosmetic Botox (botulinum toxin type A), and Myobloc (botulinum toxin type B). This follows reports describing side effects, such as respiratory failure and death after administration of a Botox treatment.

Botox works by using botulinum toxin, which blocks the nerve impulses of muscles, which results in a release. It was approved by the FDA in 2002 for its use in improving the appearance of wrinkles front of moderate to severe. The agency has also approved the use of Botox in the treatment of cervical dystonia (stiffness of the neck muscles). The drug is also used off-label to treat excessive sweating, known as primary axillary hyperhidrosis, and pain. Myobloc has also been approved only for use on the neck region.

The FDA said side effects may be the consequence of an overdose and that nothing is allowed to certify that they are linked to defects own product. The side effects similar to characterizing the botulism symptoms: difficulty swallowing, weakness and respiratory problems. Dr. Russell Katz, director of the division of neurological products of the Centre for Research and Evaluation of Medicinal Products of the FDA said: "We have taken note of a number of reports of serious adverse reactions associated with 'use of botulinum toxin. These reactions occur on areas of the body that are physically remote from the injection site. "

The most serious adverse reactions were found among children treated for their members spasticity caused by cerebral palsy, which explains the FDA has not approved the use of botulinum toxin in either adults or children.

Katz said it is unlikely that responsibility could be attributed to these drugs in connection with serious illnesses developed in some patients, and that in most cases, injections have been used for non-neuromuscular diseases, which is the cause can trigger side effects.

If Dr. Katz has refrained from disclosing the number of deaths or adverse events related to products, a petition filed by the Public Citizen Health Research Group has not hesitated to report such data. During a recent statement, Sidney Wolfe, director of the organization, states that: "Our analysis of data from the FDA revealed that between 1 November 1997 and December 31, 2006, manufacturers of this medicine in the USA had reported 180 cases of people who have developed serious illnesses after receiving injections of Botox. "Of the 180 listed reactions, 16 patients died, including four children were aged less than 18 years."

The Public Citizen Health Research Group asked the FDA to open an investigation and requested the establishment of a warning, the strictest warning on the Botox and Myobloc. Currently, the goal of the FDA does not invite health professionals to stop prescribing these products, but to urge doctors and patients as to monitor signs of botulism poisoning.

The FDA says it is currently reviewing the safety data from clinical studies presented by the manufacturers of medicines, as well as "adverse event reports" and all the studies published in this case. The FDA says that after completing this analysis, the findings will be communicated to the general public, as well as the recommendations arising therefrom and that all regulatory measures attaching thereto.

The Public Citizen's Health Research Group said the FDA should follow the example of''the European Directorate of Quality Medicines''(EDQM), which has already issued warnings about the dangers of using botulinum toxin. "Nobody should die as a result of an injection of botulinum toxin. Educating doctors and patients about the search for negative symptoms and encourage them to seek immediate professional help save lives, "said Director Wolfe.

In a recent statement, Myobloc manufacturers have claimed that "the safety of patients treated with injectable solution Myobloc has always been of paramount importance" for the company. "We encourage the training of doctors through various means about the proper use of this product as specified in the dosage."

Botox and Botox cosmetics are manufactured by Allergan Inc., Myobloc by Solstice Neurosciences Inc.