WASHINGTON IN BRIEF

FDA Issues Warning on Use of Botox, Myobloc

The popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children have died, the government warned yesterday.

The Food and Drug Administration's warning includes Botox, a wrinkle-specific version called Botox Cosmetic and Myobloc. The products contain drugs that use botulinum toxin to block nerve impulses, causing muscles to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

Botox is best known for minimizing wrinkles by paralyzing facial muscles, but botulinum toxin is also widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has not formally approved the use of the drugs for such treatment, but some other countries have.

The FDA warned that it is also examining reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

EPA Subpoenaed Over Calif. Emissions Law

A House committee chairman subpoenaed the Environmental Protection Agency, seeking documents reviewed by the agency's administrator before he blocked a California tailpipe-emissions law.

There have been indications that EPA Administrator Stephen L. Johnson overruled agency staff members who recommended allowing California to implement its first-in-the-nation greenhouse-gas emissions controls. Congressional investigators have released excerpts of an internal presentation, made to Johnson, that said California has a compelling need for a waiver from the EPA and that the agency is likely to lose a court battle over it.

The subpoena by Rep. Henry A. Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee, seeks an unredacted version of the presentation.

EPA spokesman Jonathan Shradar contended that congressional investigators have already seen the documents in question and said the agency has concerns about releasing them publicly because of ongoing litigation.

-- From News Services