Cosmetic Procedures May Have Deadly Side Effects

The popularity of plastic surgery and other cosmetic procedures has exploded in the last few years. The number of these procedures being performed worldwide has increased over 4300% since 1997, and almost 25% of these involve Botox injections as an anti-wrinkle treatment. Botox and other similar drugs contain the botulinum toxin, which has been identified as one of the most lethal substances known to man. How dangerous is this stuff? Even the makers of Botox admit that the drug has been associated with spontaneous reports of death. As the article below reports, last Friday the FDA issued a warning about the hazards of such drugs, but only after a consumer group had first sounded the alarm about the deaths of 16 persons (including several children) who were given botulinum drugs.

Even when it is administered properly, Botox is hazardous. In addition, injections must be repeated multiple times. To make matters even worse, a trend has developed that seeks to beat the high cost of the treatments by having Botox parties whereby individuals get together and give each other injections. This is a very foolish choice, as the botulinum can easily be introduced to unintended muscles and can result in paralysis of them, including muscles associated with swallowing and breathing. This has even happened in the hands of a professional who may not have had the necessary experience to give proper treatments.

There are much safer, more effective, and more natural ways to fight wrinkles. Many natural skin care companies using organic botanicals have excellent lines of products specifically designed to diminish the appearance wrinkles without exposing you to poisons or caustic chemicals. And, of course, putting healthy foods in your body and keeping it well-hydrated with filtered water will certainly have a positive effect on the outward appearance of your skin as well.


FDA Links Anti-Wrinkle Drugs to Deaths
By LAURAN NEERGAARD - 1 day ago

WASHINGTON (AP) - The popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warned Friday.

The Food and Drug Administration warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

Botox is best known for minimizing wrinkles by paralyzing facial muscles - but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

The FDA wouldn't say exactly how many reports it is probing.

"We're not talking hundreds. It is a relative handful," said Dr. Russell Katz, FDA neurology chief.

But the agency warned that patients receiving a botulinum toxin injection for any reason - cosmetic or medical - should be told to seek immediate care if they suffer symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head.

"I think people should be aware there's a potential for this to happen," Katz said. "People should be on the lookout for it."

Fridays warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc - citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Nor is it the first warning. The drug labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with certain neuromuscular diseases, such as myasthenia gravis.

That is what is different about these latest cases, said FDAs Katz: The botulism toxin seems to be harming people who do not have that particular risk factor. (Cerebral palsy involves a brain injury, not a disease.)

Still, the FDA cautioned that its investigation is in the early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.

Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults seeking wrinkle care.

In a statement, Solstice said it supports FDA probe but stressed that the agency has not concluded the drug poses any new risk.

While the FDA said the problems may be related to overdoses, it also has reports of side effects with a variety of doses.

Public Citizens Dr. Sidney Wolfe criticized FDAs warning as falling short. He asked that the agency order a black-box warning, the FDAs strongest type, be put on the drug labels and require that every patient receive a pamphlet outlining the risk before each injection.

"Every doctor needs to notified about this, every patient needs to be notified," Wolfe said. "Children are showing the way, unfortunately some dead children."

He said drug regulators in Britain and Germany last year required that sterner warnings be sent to every doctor in those countries.

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