On January 24th, a group called Public Citizen filed a petition with the Food and Drug Administration to request that the makers of Botox be required to include a much stronger warning on the label. They cite 16 deaths, four of them in children, and a total 658 cases of adverse reactions from 1997-2006, including many serious injuries related to difficulty breathing and/or swallowing, as well as the drug spreading to internal organs.  One death was related to a cosmetic treatment. In addition to these adverse reactions in the US, Public Citizen’s petition mentions 693 reports of “adverse events” in Europe.

While the FDA has not yet commented on the petition, the main issue seems to be due to the fact that once Botox enters the body, it can spread to areas and organs where its paralyzing action can cause serious damage. A Danish report confirms that the spreading of the drug inside the body is a major concern.

Public Citizen would like to see a black-box warning on the packaging insert. This type of warning means that the drug carries a significant risk of serious or life-threatening adverse effects. Drugs that currently carry black box warnings include the diabetes medication Avandia, due to a heart attack risk, and Depo-Provera contraceptive injections, due to a significant loss of bone density with long-term use, among others.

Allergan, the manufacturer of Botox, has been quick to respond to the petition. "Our first priority is the safety and well being of the patients who use our products," said spokesperson Dr. Kurstjens. "In the last 18 years since Botox was first approved by the FDA to treat rare eye disorders, Allergan has vigilantly monitored the use of the product and worked closely with the FDA to ensure that all appropriate warnings and guidance are in the product labels. We also work closely with the medical community to educate them on the safe administration of the product.”

This may be or may not be an accurate assessment: Public Citizen points out some significant discrepancies between “warnings and guidance” provided to US doctors and consumers and those provided in Europe.

In Europe, Botox comes with warnings that include letters sent to doctors, far more strongly worded cautions on labels, and leaflets sent home with patients to warn them to seek immediate assistance if they have trouble breathing, experience dry mouth, or have trouble swallowing. Injections near the neck seem to be particularly problematic because they can paralyze the esophagus.

At this point, it’s unclear if the United States will follow Europe’s lead in requiring stronger warnings. However, the FDA has previously warned consumers that risks of cosmetic Botox include droopy eyelids (ptosis) that can last for weeks, a problem that was seen in the drug’s pre-approval clinical trials. Other common side effects noted by the FDA are headache, respiratory infection, flu syndrome, and nausea. Less frequent adverse reactions included pain in the face, redness at the injection site, and muscle weakness. These reactions were generally temporary, but could last several months. The FDA recommends that Botox Cosmetic be injected no more frequently than once every three months.

The majority of serious problems have been related to therapeutic rather than cosmetic uses of Botox. This may be due to the fact that cosmetic uses typically use less of the drug. It may also be due to the fact that the therapeutic uses often involve people who are sick to begin with. It is certain to be partially due to the fact that Botox was approved for cosmetic use in 2002, near the end of the time period covered by the FDA report.

In any case, Botox has a far from clean record when it comes to cosmetic applications. During 1989-2003 (which includes less than a year of approved cosmetic use), there were 36 serious FDA reports related to cosmetic use, including two reports of dysphagia. There were, in addition, 995 non-serious reports for cosmetic use. The agency also noted that “numerous departures from FDA-approved recommendations for drug use, dilution, handling, site of injection, and storage were noted in these AE [adverse event] reports.”

The Public Citizen petition isn’t the first time that the dangers of Botox have made the news. In addition to the dangers inherent in the drug, the issue of black-market versions surface every once in awhile. In 2005, ABC News reported the case of chiropractor and healthy living book author, Eric Kaplan. He and his wife had been treated, unknowingly, with a bootlegged batch of botulism. Both suffered paralysis resulting in an inability to swallow or speak, and had to be hospitalized and tube-fed. The doctor who injected them also injected himself and his girlfriend; both were also paralyzed.

In 2002, the FDA reported in its own magazine that the federal agency had concerns about the potential for Botox being abused. Shortly after FDA approval, the American Society for Aesthetic Plastic Surgeons also reported its concerns related to unqualified people dispensing Botox in salons, gyms, hotel rooms, home-based offices, and other retail venues. They make the point that, in such cases, people run the risks of improper technique, inappropriate dosages, and unsanitary conditions, and that Botox should always be administered by a licensed medical practitioner.