These anti-wrinkle drugs, when given to children for muscle spasms, have been also linked to deaths, the government warned Friday.
The FDA had already approved the drug Botox to treat children with cerebral palsy for limb spasms. However, the recent warnings now mean the federal government will now review the Botox use in children.
The federal warning includes both Botox, a wrinkle-specific version called Botox Cosmetic. The drug uses a botulinum toxin which basically blocks nerve impulses to muscles allowing them to relax for the anti-wrinkle effect to take place. The same botulinum toxin is also widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.
However, the drug can easily spread beyond the injected site into the body thus leading to certain respiratory muscles to become paralyzed.
The FDA is currently investigating deaths in children, mostly cerebral palsy patients that were treated for spasticity in their legs. Additionally, the federal agency is also looking into reports of illnesses in people of all ages who used the drugs for a variety of conditions. It included hospitalization of one woman given Botox for forehead wrinkles.
The FDA has warned that patients receiving the Botox treatment to seek immediate care if they suffer symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head. This is irrespective of the fact whether the botulinum toxin injection was used for cosmetic or medical reason.
Two weeks earlier, the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc. It cited 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia after the use of Botox. It also included 16 deaths.
