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Allergan Trial Will Focus on Botox’s Safety in Cerebral Palsy Treatments

The family of Kristen Spears alleges an overdose of the drug manufactured by Irvine-based Allergan Inc. killed her at age 7.

Spears started getting Botox injections at the age of 6 — not to smooth furrows in her brow, but to calm spasms in her legs.

The girl was born with severe cerebral palsy, and Botox, best known as a face-lift-in-a-syringe, can relax contorted muscles and sometimes help young patients walk without surgery.

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Instead, Kristen’s mother alleges, an overdose of the drug killed her.

At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.

The trial comes less than a year after federal authorities mandated “black box” labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker’s own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

The drug uses botulinum toxin, a powerful poison, to block neural communications, allowing muscles that produce worry lines or gnarled limbs to relax. A few injections smooth wrinkles, while larger doses are required to relax arms and legs.

Kristen died in November 2007 of respiratory failure and pneumonia, according to her death certificate. Experts hired by Dee Spears say Botox weakened muscles that controlled her breathing and swallowing, leading to respiratory failure and pneumonia.

Kristen’s death came more than a year before the U.S. Food and Drug Administration ordered the labels warning of the drug’s potential to cause botulism symptoms, including “potentially life-threatening swallowing and breathing difficulties and even death.”

In preparation for the trial, Allergan was required to produce safety assessments of Botox and other confidential internal reports. Portions of some documents were obtained by The Times after Orange County Superior Court Judge Ronald L. Bauer unsealed them.

The documents include a 2005 letter sent by a European health official that alerted Allergan of reports that botulinum toxin had spread beyond the injection site among patients who sought cosmetic treatment.

Trouble with swallowing and “aspiration have been reported to occur secondary to muscle weakness in the muscle in the neck region,” the letter says. “Fatal cases of aspiration have been reported.”

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 888-210-9693 or Contact Me Online.

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