The drug used for cosmetic purposes and some muscle spasms known as Botox has received criticism for inadequate warnings about off-label uses.

The FDA-approved drug uses a toxin known as botulinium toxin type-A to remove facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms. The toxin paralyzes the targeted muscles or nerves for an average three to four months.

If improperly used, the toxin (which is essentially the same bacterium that causes botulism) can spread throughout the body, causing muscle weakness, difficulty breathing, blurry vision, bladder control, and even death.

Another concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose; several injuries have been reported as a result of this off-label use.

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.

Botox and Botox Cosmetics have been given a new warning label in Canada that indicates that the anti-wrinkle drug can spread to other parts of the body. This potential side effect can be fatal. The new label also states that the drug can cause muscle weakness, difficulties in swallowing, pneumonia, and speech disorders.

The muscle relaxant has been licensed in Canada to treat facial nerve disorders and cerebral palsy, but it is much more commonly used to eliminate wrinkles and other facial age lines. Last February, the FDA linked the spread of Botox in the body to both FDA-approved and non-approved applications of the drug.

The new label stems from an investigation performed by Health Canada last October. Five patients died following Botox injections, and more than eight patients experienced severe side effects. The condition was deemed “distant toxin spread” by Health Canada.

The investigation also determined that doctors downplay the risks involved with Botox injections.