Botox And Myobloc Should Carry Stricter Warnings Consumer Group Petitions FDA

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 25 Jan 2008 - 12:00 PDT

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Citing deaths linked to the use of the drugs, Public Citizen, an American consumer advocacy group has petitioned the US Food and Drug Administration (FDA) to increase its warnings and directly advise patients and doctors about the dangers of botulinum toxin, available commercially as Botox and Myobloc.

The group filed a petition yesterday, Thursday 25h January, urging the federal agency to bring in "black box" labels and issue stricter patient and health professional warnings because of serious adverse reactions, including deaths, linked to the use of Botox and Myobloc.

Unlike patients and doctors in Europe, where drug regulation agencies have issued warnings, Americans have no idea about the dangers of using the toxin, because the FDA has issued no warnings.

Director of Public Citizen's Health Research Group, Dr Sidney Wolfe, said that if the FDA were to issue doctors and patients with the significantly improved warnings requested in the petition, it would:

"Increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear and could prevent more serious complications, including death."

Botulinum toxin is commonly used in therapeutic and cosmetic procedures, where it blocks nerve impulses in selected muscles, which makes them relax.

But if it spreads to other parts of the body, as has happened in some reported cases, the toxin causes paralysis of respiratory muscles and difficulty swallowing (dysphagia), which can lead to food or drink getting into the windpipe and lungs which causes aspiration pneumonia.

Public Citizen said it had analyzed data sent by the drug makers to the FDA, and found 180 cases of Americans suffering this kind of life-threatening condition after being injected with the toxin. This included 16 deaths, four of them in children under 18.

They said because this data came from reports volunteered by the drug companies, these cases could be just ten per cent of the real figures.

The rest of the data showed that between the beginning of November 1997 and the end of December 2006, there were 658 cases reported of people having adverse side effects from botulinum toxin injections in the US. 180 of these cases had fluid in the lungs, dysphagia, and/or pneumonia.

Botulinum toxin is approved by the FDA to treat certain conditions such as uncontrollable neck and shoulder muscle contractions, spasmodic blinking of the eyes, crossed eyes, and excessive underarm sweating. As a cosmetic treatment it is only approved for the removal or temporary smoothing of wrinkles between the eyebrows.

However, most cosmetic applications of botulinum toxin are "off-label", that is they are used in treatments that are not approved by the FDA. This is not illegal, as doctors have the right to use drugs in unapproved ways if they believe they benefit the patient.

The Public Citizen petition said the FDA should issue a warning letter and send it directly to doctors, telling them about the potential adverse side effects, including the number of cases that have ended up being treated in hospital, and the deaths.

The petition also asked the FDA to issue a "black box" level of warning to accompany the drug. This is the strongest level of warning that the FDA issues with a drug, and it requires that doctors give patients the accompanying patient information so they are appropriately warned of potential side effects.

As Wolfe explained:

"Nobody should be dying from injected botulinum toxin. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives."

Patients and doctors should be advised to look out for the following early symptoms of adverse reactions, said the petition: dry mouth, difficulty swallowing or breathing, slurred speech, drooping eyelids and muscle weakness.

Wolfe said the FDA should follow Europe's lead. Last year, the European Union cautioned doctors about the dangers of using botulinum toxin, by posting warnings on its Web site, and German and British authorities have also sent letters to doctors.

According to a report in the New York Times, a spokesperson for the FDA said the agency was not in a position to comment while it reviewed the petition, and the makers of Botox, Allergan, issued a statement saying that adverse reactions were rare, and in the cases reported to the FDA it is not possible to rule out existing serious illnesses as the cause.

Sources: Public Citizen press statement, New York Times.

Written by: Catharine Paddock


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