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Washington – After reports of death and serious reactions, the U.S. Food and Drug Administration (FDA) said on Friday they were reviewing the safety of Allergan Inc’s Botox and a competing product.

The FDA said that an unspecified number of deaths and hospitalizations occured. most of the reported deaths were in children who were being treated for cerebral palsy-associated limb spasticity with botox, a use which is not approved in the U.S.

Botox is currently approved for the treatment of wrinkes as well as sweating and certain neurological conditions, WebMD reported.

The FDA said its review applied to Allergan’s Botox and Botox Cosmetic, and Solstice Neurosciences Inc’s Myobloc.

The reactions reported are suggestive of botulism. The Center For Disease Control (CDC) describes botulism as a “rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum.”

In the reported cases, patients were using the treatment for approved as well as unapproved uses and at various doses, the FDA added.

“FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature,” the agency said in a notice posted on its Web site.

During the review, patients are encouraged to watch for signs of botulism. Signs include weakness, respiratory distress and trouble swallowing.

A spokesman for Allergan told Reuters that the company will comply with the FDA during the investigation.