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FDA Reviewing Safety of Botox

February 8, 2008

The Food and Drug Administration has begun a safety review of Allergan Inc’s Botox, as well as Myobloc, a competing product, after several deaths and respiratory issues were linked to the products.

These adverse reactions are likely linked to overdosing, and there have been no reported adult deaths, according to the FDA. The affects have been reported in both FDA approved and non-approved cases.

Most of the deaths occurred in children with cerebral palsy outside the U.S. who had been injected with the products for treatment of limb spasticity. This procedure is not FDA approved and is not promoted by Allergan or Solstice Neurosciences, the creators of Myobloc; however it is approved for use in nearly 60 other countries. The dose of Botox used in this treatment is much larger than the dose used for cosmetic purposes.

In some of these cases the toxins from the product spread to other parts of the body, impacting respiratory muscles. The symptoms are similar to those of botulism and may include breathing problems, weakness and difficulty swallowing, or dysphagia. The products already contain warnings to consumers and doctors regarding dysphagia.

Thus far 16 deaths have been recorded from November 1997 through 2006.

Allergan shares fell $3.61 or 5.4% Friday afternoon to $63.70 on the New York Stock Exchange. This occurred despite the fact that the FDA claims that there is no evidence that the reactions were caused by a product defect. The decline was seemingly unwarranted, especially considering the company’s strong track record. Allergan has supported the safety review according to spokeswoman Caroline Van Howve.

The FDA is not instructing health care professionals to discontinue use of these products; however they are recommending tighter regulations regarding their use. They have also advised doctors and patients to be aware of symptoms of botulism.

Peter Bye, an analyst for Jefferies & Co said that the FDA is likely to require a black box warning discouraging prescription for unapproved uses and drawing attention to the recent events. Bye said that a similar warning was given in Europe and it had little to no effect of the European growth of the product.

It is possible that this review might work in the favor of Allergan. A new competitor, Reloxin, will probably have a much longer review period than previously planned, buying Allergan some time.

On the Net:

www.fda.gov




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