Concerns raised about Botox safety
February 9, 2008
Concerns about the widely used anti-wrinkle treatment Botox and a similar drug arose Friday as federal regulators said they were reviewing reports of at least one death and other serious reactions among some patients.
Food and Drug Administration officials said they were not aware of any deaths among cosmetic users of Botox, the trade name for the blockbuster wrinkle buster made by Irvine’s Allergan Inc.
The FDA said it had reports of at least one death among patients who received a botulinum-based drug and what one official described as a “a relative handful” of serious side effects in which the toxin spread beyond the injection site.
The most serious of the reported problems occurred in children who had cerebral palsy and who were treated for arm and leg spasms with doses many times those used for cosmetic treatments — and in some cases at levels higher than recommended guidelines. The agency did not identify which drugs were involved in any of the problems.
Still, the development raised eyebrows among at least some of the millions of people who have made Botox a huge beauty treatment.
[...]The FDA said that no product defect had been identified and suggested that the problems might have been related to overdosing.
Russell Katz, director of the FDA’s division of neurology drugs, told reporters in a conference call that the agency’s focus was on those larger doses, where the risk appears higher than in the quantities used to smooth facial wrinkles.
- Source: Death, drug reactions spur concern about Botox safety, Los Angeles Times, Feb.
The popular injectable drug Botox smooths wrinkles for up to six months by paralyzing nerve endings around muscles.
The drug, which is made from a form of botulism, is available by prescription and also treats a wide variety of other ailments including crossed eyes, sweaty palms, headaches and juvenile cerebral palsy.
- Source: Los Angeles Times, Feb. 9, 2008
• 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: The Times, Feb. 9, 2008
Why not turn that frown upside down — with a shot of Botox?
By preventing the physical act of frowning, the muscle-paralyzing toxin just might ease depression.
A small-scale pilot trial, published in the May 15 journal Dermatologic Surgery, found that Botox injected into frown lines around the mouth or in forehead furrows of 10 women eliminated depression symptoms in nine of them and reduced symptoms in the 10th.
It’s nowhere near proof that Botox can treat depression, but experts, including the study’s authors, say it should be studied further in larger trials that can control for a placebo effect.
After all, clinical depression will, according to the American Psychiatric Assn., affect 10% to 25% of women and 5% to 10% of men at some time in their lives.
- Source: Botox: A lift for faces — and moods?
FRIDAY, Feb. 8 (HealthDay News) — U.S. health officials are investigating reports of children’s deaths and severe side effects for others treated for a variety of conditions with the wrinkle-erasing drug Botox and related products.
Most of the children were being treated with botulinum toxin products to control limb spasms caused by cerebral palsy, the U.S. Food and Drug Administration said Friday. The agency hasn’t approved the use of the drugs for such treatment, officials added.
The FDA said it was reviewing the safety of Allergan Inc.’s Botox and Botox Cosmetic (botulinum toxin type A) and Solstice Neurosciences Inc.’s Myobloc (botulinum toxin type B) after reports of the adverse reactions, which included respiratory failure.
The FDA said that the adverse reactions may be due to overdosing and there was no indication they were related to defects in the products.
The reactions appeared to be related to the spread of the botulinum toxin to areas away from the site of injection, and mimic symptoms of botulism poisoning, which can include difficulty swallowing, weakness and breathing problems.
- Source: FDA Warns of Children’s Deaths Linked to Botox, HealthDay, via US News & World Report, Feb. 8, 2008
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.
- Source: The Times, Feb. 9, 2008
