An article by Gardiner Harris in the New York Times today, as well as other articles issued by various leading news media, reported that the group ‘Public Citizen’ wants more health warnings about the drug Botox as well as similar drugs, after it was established that at least 16 persons, among them 4 children, died using these drugs. Only one of those patients used the drug for cosmetic reasons - others used it for medical reasons to relieve pain associated with muscle knotting and other unknown complications.
The drug, a neurotoxin that is used to relax muscles and to remove wrinkles, was known to spread to vital organs, Public Citizen says and insists that the drug should come with a far stronger warning label and that patients should be given a letter detailing its risks. Public Citizen filed a petition this Thursday with the Food and Drug Administration (FDA) of the USA. Julie Zawisza, a spokeswoman for the FDA, said she could not comment while the petition was under review.
Allergan, the maker of Botox, issued a statement via their Executives saying that adverse reactions were rare because many patients who get the drug are seriously ill, it is not proven that Botox causes the reactions. Solstice Neurosciences, the maker of a similar drug, Myobloc, did not return a message for comment.
Botox is approved to treat cervical dystonia, a painful knotting of neck muscles and the procedure requires that doctors inject it into multiple spots on the neck, sometimes relieving disabling pain for weeks or months. However, it is reported that the locations of the injection sites sometimes come dangerously close to the esophagus, causing partial paralysis that can lead patients to have difficulty swallowing and to suffer aspiration pneumonia, caused by breathing in food or liquids.
The director of Public Citizen, which is a health research and advocacy group, Dr. Sidney M. Wolf, states that these deaths might have been prevented had patients been adequately warned of the possible dangers. Presently, labels for Botox and Myobloc mention the issue but not prominently enough, Dr. Wolfe said. According to Dr. Wolfe, patients don’t have a clue about these problems and he insists that “Nobody should die from the medical use of Botox”. Dr. Wolfe gave Britain and Germany as good examples of countries that require drug manufacturers to send letters to doctors warning of the dangers. The European drug labels also have a prominent section titled “special warnings and precautions for use” that warns of the dangers of the spread of the toxin and patients in Europe are also advised and warned to seek medical help if they have trouble breathing, experience dry mouth or have trouble swallowing by receiving a leaflet.
Public Citizen also illustrated the procedures of the Danish Medicines Agency (DMA), which published an analysis of adverse events associated with the products on August 9th 2007. Public Citizen’s petition states that the DMA’s analysis found 600 problems associated with the drugs, and that half of the serious problems associated with the drugs occurred after the toxin spread. The DMA also warned that muscle weakness associated with Botox may be long-lasting, especially among children, the elderly and those suffering serious neurological problems.
According to Public Citizen, the drugs’ manufacturers and others in th USA have reported 658 cases of problems associated with Botox and Myobloc to the FDA.