December 1, 2004
Cause of Post-Botox Illnesses a Mystery
Four patients being treated for botulism after receiving Botox injections at an Oakland Park clinic last week continue to pose a medical mystery for state and federal investigators.
While all four patients are hospitalized in critical condition, even their diagnoses remained in doubt Monday, with health officials saying they are awaiting test results they do not expect until Thursday.
Two patients were breathing through ventilators and receiving intravenous feeding, said Dr. Charles Schallop, a neurologist treating them at Palm Beach Gardens Medical Center. Health officials are not identifying the patients, who are in their 50s.
Schallop said the couple told him that a doctor at the clinic and his girlfriend got the same treatment last week and had fallen ill. The couple are hospitalized in New Jersey.
Palm Beach Gardens Medical Center released a statement saying the two patients there had been "promptly" diagnosed with the paralyzing disease, usually caused by food contaminated with the same bacteria used for wrinkle-smoothing injections.
Botulism, if it is suspected in a patient, is one of 65 diseases that must be reported to federal officials.
The couple were admitted to the hospital late Friday, and doctors reported their conditions to the national Centers for Disease Control and Prevention on Saturday night.
By then, the couple were unable to talk to the state investigator who interviewed family members and attending physicians.
Officials spread the word that night to emergency departments at the county's 13 other hospitals to look for symptoms of the disease and consider the diagnosis when examining patients with muscle weakness descending through the body, as well as other symptoms.
Schallop said he suspects both couples might have fallen ill either from contaminated doses of Botox or some other drug in their treatment.
In the meantime, state and county health investigators are tracing the movements of the four patients in the days preceding their illness, testing samples from the clinic and awaiting other test results, a state health spokeswoman said.
Advanced Integrated Medical Center, where the four received Botox on Wednesday, was closed on Monday, with its telephone-message service full. Thomas Toia, a Palm Beach Gardens chiropractor listed on state records as the company's director, could not be reached for comment.
Allergan, the company that produces the cosmetic wrinkle treatment, posted a message on its Web site saying it is working with public health authorities.
The company supplied the clinic with Botox, company spokeswoman Caroline Van Hove said, adding that "there has never been a case where a patient suffered from botulism following treatment with Botox."
To cause botulism, a dose much larger than the usual would have to be injected, she said. She could not specify how large a dose.
Charles Inlander of the medical watchdog group Peoples Medical Society said the incident highlights the dangers of patients being inadequately warned of the risks associated with elective treatments.
"This is boutique medicine," he said.
The Food and Drug Administration, which approved cosmetic use of Botox in 2002 and also is investigating the incident, lists among side effects of the drug headache, nausea, flu symptoms, respiratory infection and muscle weakness.
Patients are cautioned not to rub the injection site after treatment and to limit treatments to no more frequently than once every three months.
Approved for use under medical supervision, the age-defying treatment has grown in popularity and is sometimes administered at parties in hotels and living rooms.
A 43-year-old woman in Gainesville died last year after having an allergic reaction to Botox, according to autopsy results. The woman went into cardiac arrest and could not be revived.
The Associated Press contributed to this story.
Botox and wrinkles
Injecting Botox, a muscle paralyzer produced by the same toxin that causes food poisoning, has become a popular way to temporarily smooth facial wrinkles.
Doctor injects Botox into face muscle with small needles; lasts about four months.
HOW BOTOX WORKS
Brain sends signal for face muscle to contract
Signal triggers release of neurotransmitter
Botox blocks release of neurotransmitter
Muscle can't contract; skin smooths as muscle weakens
The U.S. Food and Drug Administration approved the use of Botox to treat eye muscle disorders in 1989, and in 2002 approved cosmetic use to temporarily treat unwanted facial lines. It is recommended that Botox be injected not more than once every three months.
Side effects have included headache, respiratory infection, flu- like symptoms, droopy eyelids and nausea. Fewer than 3 percent of patients experienced facial pain, redness at the site of the injection and muscle weakness.
Sources: U.S. Food and Drug Administration and American Society for Dermatologic Surgery
Information on botulism: causes, symptoms and treatment.