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A new wrinkle for Botox users: Stronger warnings

May 6, 2009 |

Allergan Inc. was ordered by U.S. regulators to strengthen precautions on its wrinkle smoother Botox, hours after the first major competition to the treatment, Dysport, was approved for sale.  Botulinum toxins used to relax forehead lines and treat neurological disorders may cause muscle weakness or breathing difficulties if the poison spreads beyond the site of injection, the Food and Drug Administration said.

All manufacturers were ordered to add a boxed warning to their prescribing information and implement programs to minimize the risks.

The new safety programs may benefit Dysport, whose approval was announced last week by its makers, Ipsen SA and Medicis Pharmaceutical Corp. The product will compete with Botox in treating a neck twisting disorder called cervical dystonia, and in cosmetics, where the American Society for Aesthetic Plastic Surgery estimates that almost 2.5 million Americans got Botox injections last year.

“On the competitive side, it puts the two on much more of an equal playing field,” said Corey Davis, an analyst at Natixis Bleichroeder in New York. “Because Botox was already on the market, nobody thought something like this could be forced on the company.”

Botox controls about 83 percent of the global market for neurotoxins that relax muscles or nerves, according to Allergan. The drug accounted for almost a third of the Irvine, California- based company’s revenue last year with $1.3 billion in sales, split between cosmetic and therapeutic uses.

The FDA reviewed reports of children and adults who died or were hospitalized after getting botulinum toxins. Most serious side effects occurred with higher doses to treat arm and leg spasms, a use not approved by the agency, and cervical dystonia.

“They’re commonly used and we don’t mean in any way to discourage that use,” said Ellis Unger, acting deputy director of the FDA’s Office of Drug Evaluation “People just need to understand the risks that are involved so they can make informed risk-benefit decisions.”

Botox was approved almost 20 years ago for medical uses. The FDA cleared it for smoothing wrinkles in 2002, which quickly became fashionable among aging celebrities as a nonsurgical way to appear younger. Its only competition in the U.S. before now has been Myobloc, a toxin sold by closely held Solstice Neurosciences Inc., of Malvern, Penn. for cervical dystonia.

Unger declined to say how many cases of illnesses were reported, noting deaths were “very, very rare.” Public Citizen, a consumer advocacy group in Washington, filed a petition with regulators last year calling for stricter warnings on Botox and Myobloc. The group said 180 reports of harmful side effects, including deaths of 12 adults and four children, were reported to the FDA from November 1997 to December 2006.

Source:  Chicago Daily Herald, May 4, 2009

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