Additionally, serious injuries were reported after the drug spread to vital organs. Believing that patients should be better informed of the possible risks associated with this treatment, Public Citizen, a health advocacy group, filed a petition with the Food and Drug Administration this past Thursday requesting that Botox come with a much stronger warning label for consumers.

In response to these allegations, executives at Allergan, the maker of Botox, claim that such reactions are rare and, that many patients who receive this drug are seriously ill, thus making it difficult to prove that Botox injections alone caused these negative reactions.

In addition to its function as a wrinkle reducer, Botox is also used to treat a painful condition of the neck muscles called cervical dystonia. When injected into the neck, Botox can relieve sufferers of disabling pain for weeks or even months. The problem is that when the injection sites are located too closely to the esophagus, partial paralysis can lead to swallowing problems and aspiration pneumonia, a condition caused by breathing in food or liquids, Public Citizen explains.

Only one of the 16 deaths occurred in a patient utilizing Botox as a treatment for wrinkles. Most of the complications occurred in patients who suffered from muscle problems or other conditions. However, Public Citizen reports that 658 cases of Botox-related problems have been reported to the F.D.A.

In contrast, health authorities in Europe go to great lengths to highlight the possible dangers of these drugs. A petition published by the Danish Medicines Agency found 600 problems associated with Botox type drugs. Half of these problems occurred from a spreading of the toxin to other areas of the body, which is why in Europe, labeling on these drugs contains a section called "special warnings and precautions" which details specific dangers regarding this potential complication. Danish authorities also warn that muscle weakness which occurs as a result of using Botox or similar drugs can be long lasting, especially in children, the elderly or those with neurological problems.

Authorities in both Britain and Germany require drug manufacturers to send warning letters to doctors detailing the specific dangers of these drugs. In Europe, patients who are prescribed Botox receive a leaflet with medical advice regarding breathing abnormalities, dry mouth or swallowing difficulties.

Dr. Sidney M. Wolfe, director of the Public Citizen's health research group, believes that if patients were better informed of the dangers of Botox and similar drugs, these deaths in the United States would never have occurred. "Nobody should die from the medical use of Botox. The fact that they are shows that patients don't have a clue about these problems," he states.