Max
06-27-2003, 03:22 PM
Botox ads frowned on by regulator
FDA says claims false, misleading
'Risk of harmful effects minimized'
HELEN HENDERSON
LIFE WRITER
The company that rocketed to fame and fortune with a wrinkle reducer coveted by the stars says it has not misled consumers about the safety of its product.
U.S. regulators this week issued a formal warning to California-based Allergan Inc., saying some advertisements for Botox Cosmetic are "false and/or misleading" because, among other things, they minimize the risk of potentially harmful side effects.
The Food and Drug Administration, which monitors the safety and effectiveness of products sold in the U.S., said three Botox Cosmetic ads, including one with the catch phrase "We promised to grow old together, not look old together," misrepresented the product as a cosmetic treatment and failed to reveal possible adverse effects.
Health Canada - which has approved Botox both as a cosmetic treatment and as a muscle-relaxer - said consumer advertisements in this country are not permitted to link a product directly to a treating a particular condition.
Health Canada spokesperson Ryan Baker said Allergan contravened those rules in a spring advertising campaign last year. Since then, he said, the company has had to submit its ads for preclearance to the Pharmaceutical Advisory Board or the Advertising Standards Association, depending on the product.
In product information, Allergan says the most frequently reported side effects in clinical trials of Botox Cosmetic injections were headache, nausea, respiratory infection and drooping eyelids.
A spokesperson for the company said it has already taken steps to rectify its advertising and stands by the safety of Botox Cosmetic.
The product, which is also used to relax stiffened muscles in children with cerebral palsy and adults who have had strokes, is essentially a vastly diluted formulation of botulinum toxin, a poisonous bacterium that immobilizes. The effects of the diluted form are not permanent and treatment must be repeated at regular intervals.
Botox has also proved effective against back spasms, migraines, excessive sweating and some forms of incontinence.
In the U.S. Botox has not been approved by the FDA for cosmetic use but is widely and legally prescribed, in an "off-label" derivative use, to smooth out forehead lines and other signs of aging.
What it has been FDA-approved for is "the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ...."
Translation: It can be used to treat severe vertical lines above the bridge of the nose, which are considered a medical condition.
The ads in question say: "FDA-approved for the temporary treatment of frown lines in people aged 18 to 65."
Allergan spokesperson Christine Cassiano said that is intended to refer to the vertical glabeller lines. The FDA disagrees.
Cassiano said the company will add the words "between the brows" to its U.S. ads and is confident this will satisfy FDA concerns about its print campaign
Regarding safety, she said it is misleading to represent the side effects as anything other than mild and infrequent.
The warning letter from the FDA refers to adverse events occurring in almost 44 per cent of subjects in clinical trials. Of those subjects, 177 were injected with Botox Cosmetic and 54 were injected with a placebo.
Cassiano says 3.5 per cent of those receiving Botox and 3.8 per cent of those receiving the placebo experienced mild respiratory infections; 13.3 per cent receiving Botox and 17.7 per cent getting the placebo experienced headaches.
Overall, 43.7 per cent getting Botox and 41.5 per cent getting the placebo reported some kind of "adverse effect," including "accidental injury": 0.7 per cent on Botox, 0.8 per cent on the placebo.
"We report everything in detail," she said.
While the Ontario Health Insurance Plan (OHIP) does not cover Botox for cosmetic procedures, it does cover it for treating the spasticity associated with "upper motor neuron disorders," such as cerebral palsy, multiple sclerosis, stroke, and spinal cord or traumatic brain injury.
In Toronto, Botox has helped many children with cerebral palsy to take their first steps.
At the Bloorview MacMillan Children's Centre, developmental paediatrician Dr. Darcy Fehlings, who runs a busy Botox clinic, says she has seen only minimal side effects.
"Botox is very well tolerated," says Fehlings. "If the appropriate dosage is given at the appropriate frequency, we don't see any significant side effects."
A recent study published in Developmental Medicine and Child Neurology reported some transient general fatigue and urinary incontinence in 1 per cent of children treated.
"Out of the many thousands of injections I've done, I've only had one child experience urinary incontinence and two that have had generalized fatigue," says Fehlings.
Allergan Inc. was an unremarkable maker of eye treatment products until it bought the rights to Botox in 1987. Today, the company has more than 5,000 employees worldwide, including a division in Markham.
Additional articles by Helen Henderson
http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1056665411796&call_pageid=968867505381&col=969048872038
FDA says claims false, misleading
'Risk of harmful effects minimized'
HELEN HENDERSON
LIFE WRITER
The company that rocketed to fame and fortune with a wrinkle reducer coveted by the stars says it has not misled consumers about the safety of its product.
U.S. regulators this week issued a formal warning to California-based Allergan Inc., saying some advertisements for Botox Cosmetic are "false and/or misleading" because, among other things, they minimize the risk of potentially harmful side effects.
The Food and Drug Administration, which monitors the safety and effectiveness of products sold in the U.S., said three Botox Cosmetic ads, including one with the catch phrase "We promised to grow old together, not look old together," misrepresented the product as a cosmetic treatment and failed to reveal possible adverse effects.
Health Canada - which has approved Botox both as a cosmetic treatment and as a muscle-relaxer - said consumer advertisements in this country are not permitted to link a product directly to a treating a particular condition.
Health Canada spokesperson Ryan Baker said Allergan contravened those rules in a spring advertising campaign last year. Since then, he said, the company has had to submit its ads for preclearance to the Pharmaceutical Advisory Board or the Advertising Standards Association, depending on the product.
In product information, Allergan says the most frequently reported side effects in clinical trials of Botox Cosmetic injections were headache, nausea, respiratory infection and drooping eyelids.
A spokesperson for the company said it has already taken steps to rectify its advertising and stands by the safety of Botox Cosmetic.
The product, which is also used to relax stiffened muscles in children with cerebral palsy and adults who have had strokes, is essentially a vastly diluted formulation of botulinum toxin, a poisonous bacterium that immobilizes. The effects of the diluted form are not permanent and treatment must be repeated at regular intervals.
Botox has also proved effective against back spasms, migraines, excessive sweating and some forms of incontinence.
In the U.S. Botox has not been approved by the FDA for cosmetic use but is widely and legally prescribed, in an "off-label" derivative use, to smooth out forehead lines and other signs of aging.
What it has been FDA-approved for is "the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ...."
Translation: It can be used to treat severe vertical lines above the bridge of the nose, which are considered a medical condition.
The ads in question say: "FDA-approved for the temporary treatment of frown lines in people aged 18 to 65."
Allergan spokesperson Christine Cassiano said that is intended to refer to the vertical glabeller lines. The FDA disagrees.
Cassiano said the company will add the words "between the brows" to its U.S. ads and is confident this will satisfy FDA concerns about its print campaign
Regarding safety, she said it is misleading to represent the side effects as anything other than mild and infrequent.
The warning letter from the FDA refers to adverse events occurring in almost 44 per cent of subjects in clinical trials. Of those subjects, 177 were injected with Botox Cosmetic and 54 were injected with a placebo.
Cassiano says 3.5 per cent of those receiving Botox and 3.8 per cent of those receiving the placebo experienced mild respiratory infections; 13.3 per cent receiving Botox and 17.7 per cent getting the placebo experienced headaches.
Overall, 43.7 per cent getting Botox and 41.5 per cent getting the placebo reported some kind of "adverse effect," including "accidental injury": 0.7 per cent on Botox, 0.8 per cent on the placebo.
"We report everything in detail," she said.
While the Ontario Health Insurance Plan (OHIP) does not cover Botox for cosmetic procedures, it does cover it for treating the spasticity associated with "upper motor neuron disorders," such as cerebral palsy, multiple sclerosis, stroke, and spinal cord or traumatic brain injury.
In Toronto, Botox has helped many children with cerebral palsy to take their first steps.
At the Bloorview MacMillan Children's Centre, developmental paediatrician Dr. Darcy Fehlings, who runs a busy Botox clinic, says she has seen only minimal side effects.
"Botox is very well tolerated," says Fehlings. "If the appropriate dosage is given at the appropriate frequency, we don't see any significant side effects."
A recent study published in Developmental Medicine and Child Neurology reported some transient general fatigue and urinary incontinence in 1 per cent of children treated.
"Out of the many thousands of injections I've done, I've only had one child experience urinary incontinence and two that have had generalized fatigue," says Fehlings.
Allergan Inc. was an unremarkable maker of eye treatment products until it bought the rights to Botox in 1987. Today, the company has more than 5,000 employees worldwide, including a division in Markham.
Additional articles by Helen Henderson
http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1056665411796&call_pageid=968867505381&col=969048872038