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.

A North Carolina syringe factory that has been linked to the heparin scandal operated for almost two years without an inspection by the FDA. In a story published by the Associated Press the FDA failed to inspect the company even after complaints were filed about the syringes being dirty or filled with colored particles.

In 2007, before the heparin outbreak, the FDA received more than a dozen reports of problems with the AM2PAT’s syringes. Some reported “orange specks” floating inside the unopened syringes, and others reported “yellow sediment” or “muddy brown” syringes with floating white specks.

The FDA says they first received complaints of particles in the heparin syringes in November 2005. An FDA spokeswoman said the company was inspected in January 2006, but wasn’t checked again until December 2007—22 months later.

While the FDA declined to release its inspection reports from the January 2006 and December 2007 visits to the syringe plant, the reports could be released through a Freedom of Information act request.