Botox safety to be investigated after 16 deaths among patients

Robin Pagnamenta
February 9, 2008

The use of Botox in cosmetic and medical procedures is under investigation by US federal regulators after it was linked with 16 deaths and a series of cases needing hospital treatment.

America’s Food and Drug Administration (FDA) said yesterday that it was investigating “systemic adverse reactions including respiratory compromise and death” associated with the medical use of the drug.

Botox is made from botulinum toxin, a poison produced by the bacteria that cause botulism, a severe form of food poisoning. In small quantities, it is used to reduce wrinkles by interrupting nerve impulses to muscles in the face. In a more potent formulation, it treats muscular conditions such as spasms of the neck and eyelids.

The FDA said that the most serious cases, including the reported deaths, had been during the treatment of children with cerebral palsy suffering from arm and leg muscle spasms — an unregistered use of the drug. It said that they had developed symptoms of botulism, including breathing difficulties, numbness and difficulty swallowing. Some of the children required feeding tubes and artificial breathing support, and several subsequently died.

There were also reports of botulism spreading out from the point of injection among adult patients who were being treated for muscular problems — a licensed use of the drug. These had also led to some people being admitted to hospital, although there were no reported deaths.

The FDA alert comes two weeks after Public Citizen, the consumer advocacy group, petitioned it to strengthen warnings to users of Botox and Myobloc, a similar product made by Solstice Neurosciences. Public Citizen cited 180 reports of US patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

“FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature,” a spokesman for the administration said. The FDA said it was not restricting the use of Botox but urged doctors who administered the drug to be aware of the risks and to be alert to warning signs.

A spokesman for the Medicines and Healthcare products Regulatory Agency said that health professionals in Britain had been made aware of the risks last year. Reports of deaths were very rare, he added.

One in 400 children in Britain has cerebral palsy. Richard Parnell, of the disability support group SCOPE, said that thousands of patients in Britain had been treated with Botox. He was not aware of any deaths but said that SCOPE would be examining the claims closely.

The FDA said that its review applied to Allergan’s Botox, Botox Cosmetic and Myobloc. Shares in Allergan, which had no comment, dropped 4 per cent on the announcement.

Smooth operator

— Botox was developed in the 1980s to treat muscle disorders Cosmetic treatments were introduced from 1987 and the drug has become hugely popular, especially among women

— In small doses, it works by paralysing face muscles. When they relax, the fine lines and wrinkles go

— Botox can also be injected into the armpits to paralyse the glands and prevent excessive sweating

Source: Times database
The Times, UK.