Botox and two other injections have been linked to rare botulism symptoms according to the Food and Drug Administration (FDA).  Botox and other drugs have been approved to treat certain types of muscle spasms, but health officials have warned doctors and patients about potentially deadly risks of using Botox and other drugs.

Although Botox is usually known for clearing the body of wrinkles by paralyzing facial muscles, it is also widely used for muscle-spasm conditions.  But in some cases, the drug can spread to areas outside of the target site and paralyze or weaken the muscles used for breathing and swallowing thus causing death.

Signs of botulism can appear just several hours after injection and include difficulty swallowing or breathing, slurred speech, and muscle weakness.

The FDA stated that it received reports of children being hospitalized and even dying after they were injected with the drugs to treat cerebral palsy.  Most adult cases came when they were treated for muscle spasms and neck contractions.  Some were hospitalized and had to be put on mechanical ventilation to breathe.

The FDA is now requiring manufacturers such as Allergan, Solstice Neurosciences, and Medicis to put additional warnings on their products and conduct safety studies.  The warnings urge physicians to tell their patients about the risks of the drugs and to seek medical help if they show any signs of botulism.  They also have to create pamphlets that tell the risks to patients.

Allergan said that they would cooperate but also stated that the cases of botulism are very rare.  “Botox has been marketed in the United States for nearly 20 years, its safety and efficacy profile are well understood, and reports of suspected distant spread have been rare,” the company said.

This entry was posted on Monday, May 11th, 2009 at 2:40 pm and is filed under Safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.