The Hamilton family is now questioning Health Canada’s approval of Botox after their daughter became so ill that she nearly died after being given Botox to treat cerebral palsy.

Francine Giacomelli is having trouble eating and speaking since she had the Botox treatment last May to relieve muscle pains and improve muscle function in her thighs, hips, and lower back.

The 25-year-old has drooping eyelids and she even has trouble swallowing her own saliva. As of press time, she is in St. Joseph Hospital to ensure that her lungs are not affected by Botox, which spread throughout her tissue.

Botox is approved for cerebral palsy treatment in Canada, but not in the United States.

“I’m so floored because Canada is usually so strict,” Karen Giacomelli, Francine’s mother. “Why do they allow it when the U.S. doesn’t?”

Health Canada did not provide comments yesterday regarding the approval of the cosmetic drug to treat cerebral palsy.

However, the regulator did announce a safety review of Botox last February. Health Canada found that Botox has the tendency to spread beyond the target muscles, causing serious health risks to the patient.

Last April, the US Food and Drug Administration put stricter warning labels on Botox, because of similar health risks.

However, the Giacomellis say that they never saw this labels, because physicians at the hospital never showed them the boxes before injecting the drug.  

“If there is some kind of warning, it’s not working,” Fab Giacomelli, father of Francine. “If we were told it could lead to this, we would have said, ‘No, it’s not worth it.’”

The case of Francine has already been reported to Allergan, the manufacturer of Botox.

“We are investigating,” said Amanda Mills Sirois, a spokesperson for Allergan.

She said that adverse effects of the drug are rarely reported. And when they do happen, they happen in patients that have medical conditions, not cosmetic use.

“In such cases, they’re often treated with very high doses of Botox in large muscles sometimes in doses above what are recommended in our guidelines” to achieve a more positive result, Sirois said.

St. Joseph Hospital is now reviewing its policies on Botox—from how it is stored to how it is administered.

According to Dr. Hugh Filler from St. Joseph, about twelve people a year get Botox to treat cerebral palsy and it rarely leads to this type of reaction [referring to Francine’s case].

Dr. Filler hopes that Health Canada will continue to approve this application of Botox because “the benefits are significant” said Filler.

However, the Giacomellis disagree. They say the risk is too dangerous and they will never allow Botox on any of their family member again.

Source: TheSpec.com