Healthy Skepticism Library item: 12785

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lamotta L.
FDA Gives Allergan Frown Lines
Forbes.com 2008 Feb 8
http://www.forbes.com/2008/02/08/allergan-botox-fda-markets-equity-cx_lal_0208markets18_print.html

Full text:

Allergan shareholders would grimace at Friday’s falling stock prices if their Botox-injected faces would let them.

Allergan shares were down 5.6%, or $3.78, to $63.53 in the afternoon on Friday after the U.S. Food and Drug Administration announced that it would be looking into the safety of the pharmaceutical company’s most high-profile product, Botox Cosmetic, as well as Botox itself. The agency is also investigating Solstice Neurosciences’ Myobloc. All of these drugs are botulinum toxins.

Botox Cosmetic is most widely known as a dermal filler that smooths wrinkles, but the three drugs have a variety of approved uses and are often used for unapproved uses.

The FDA is looking into several reports of respiratory impairment and an unspecified number of deaths that occurred mostly in children treated for limb spasticity that was associated with cerebral palsy, a treatment use that is not approved by the FDA. Symptoms included weakness, breathing problems, and trouble swallowing. The problems were brought to the FDA’s attention by a consumer group, Public Citizen, toward the end of January.

“It’s not enough that the FDA publicly acknowledges the risks of using botulinum toxin; in fact, the agency did this much in a published article three years ago. The FDA must immediately force the drug makers to send out warning letters to doctors, similar to what drug regulatory agencies in Europe already require,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, after the FDA’s announcement on Friday.

The group is also calling for the FDA to give the drugs a black box label, the strongest warning the agency issues.

The FDA added in its statement that it does not recommend that physicians stop prescribing the product or that anything might be wrong with the products if used in the correct doses for approved uses.

“It seems that the FDA has a pretty limited scope interest in this,” said Sanford C. Bernstein analyst Aaron Gal. “They are not looking for additional significant warnings around the use of Botox. I told shareholders that I know the drug is safe and that they should not worry if the FDA is not.”