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WASHINGTON -- 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's 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's a relative handful," said Dr. Russell Katz, FDA's 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."
Friday's
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 drugs' 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's
what's different about these latest cases, said FDA's Katz: The
botulism toxin seems to be harming people who don't 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's probe but stressed that the agency hasn't 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
Citizen's Dr. Sidney Wolfe criticized FDA's warning as falling short.
He asked that the agency order a black-box warning, the FDA's strongest
type, be put on the drugs' 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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CHICAGO -- Baby shampoos, lotions and powders
may expose infants to chemicals that have been linked with possible
reproductive problems, a small study suggests.
The chemicals, called phthalates, are found in many ordinary
products including cosmetics, toys, vinyl flooring and medical
supplies. They are used to stabilize fragrances and make plastics
flexible.
In the study, they were found in elevated levels in the urine of
babies who'd been recently shampooed, powdered or lotioned with baby
products.
Phthalates (pronounced thowl-ates) are under attack by some
environmental advocacy groups, but experts are uncertain what dangers,
if any, they might pose. The federal government doesn't limit their
use, although California and some countries have restricted their use.
Animal studies have suggested that phthalates can cause reproductive
birth defects and some activists believe they may cause reproductive
problems in boys and early puberty in girls.
Rigorous scientific evidence in human studies is lacking. The
current study offers no direct evidence that products the infants used
contained phthalates, and no evidence that the chemicals in the babies'
urine caused any harm. Still, the results worried environmental groups
that support restrictions on these chemicals.
"There is an obvious need for laws that force the beauty industry to
clean up its act," said Stacy Malkan of Health Care Without Harm.
The study's lead author, Dr. Sheela Sathyanarayana, a University of
Washington pediatrician, said, "The bottom line is that these chemicals
likely do exist in products that we're commonly using on our children
and they potentially could cause health effects."
Babies don't usually need special lotions and powders, and water
alone or shampoo in very small amounts is generally enough to clean
infant hair, Sathyanarayana said.
Concerned parents can seek products labeled "phthalate-free," or check labels for common phthalates, including DEP and DEHP.
But the chemicals often don't appear on product labels. That's
because retail products aren't required to list individual ingredients
of fragrances, which are a common phthalate source.
The Food and Drug Administration "has no compelling evidence that
phthalates pose a safety risk when used in cosmetics," spokeswoman
Stephanie Kwisnek said. "Should new data emerge, we will inform the
public as well as the industry."
The federal Centers for Disease Control and Prevention says the health effects in humans are uncertain.
"Although several studies in people have explored possible
associations with developmental and reproductive outcomes (semen
quality, genital development in boys, shortened pregnancy, and
premature breast development in young girls), more research is needed,"
a 2005 CDC report said.
The new study, which appears in February's issue of the journal
Pediatrics, involved 163 babies. Most were white, ages 2 to 28 months
and living in California, Minnesota and Missouri.
The researchers measured levels of several phthalates in urine from
diapers. They also asked the mothers about use in the previous 24 hours
of baby products including lotions, powders, diaper creams and baby
wipes.
All urine samples had detectable levels of at least one phthalate,
and most had levels of several more. The highest levels were linked
with shampoos, lotions and powders, and were most prevalent in babies
younger than 8 months.
John Bailey, chief scientist at the Personal Care Products Council,
questioned the methods and said the phthalates could have come from
diapers, lab materials or other sources.
"Unfortunately, the researchers of this study did not test baby care
products for the presence of phthalates or control for other possible
routes of exposure," Bailey said.
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Women’s Shampoos and Body Wash also Contaminated
WASHINGTON — A hidden cancer-causing petrochemical has been found in
dozens of children’s bath products and adults’ personal care products,
in some cases at levels that are more than twice the U.S. Food and Drug
Administration’s lenient recommended maximum.
Laboratory tests released today revealed the presence of 1,4-Dioxane in
products such as Hello Kitty Bubble Bath, Huggies Baby Wash, Johnson’s
Baby Wash, Scooby-Doo Bubble Bath and Sesame Street Bubble Bath. The
tests also found the carcinogen in Clairol Herbal Essences shampoo,
Olay Complete Body Wash and many other personal care products.
1,4-Dioxane is a petroleum-derived contaminant considered a probable
human carcinogen by the U.S. Environmental Protection Agency and a
clear-cut animal carcinogen by the National Toxicology Program. It is
also on California’s Proposition 65 list of chemicals known or
suspected by the state to cause cancer or birth defects. Because it is
a contaminant produced during manufacturing, the FDA does not require
it to be listed as an ingredient on product labels.
The problem of 1,4-Dioxane contamination in personal care products is
highlighted in a new book, “Safe Trip to Eden: Ten Steps to Save the
Planet Earth from the Global Warming Meltdown,” by David Steinman. The
laboratory results were released jointly today at the National Press
Club by Steinman and the Campaign for Safe Cosmetics, a coalition of
U.S.-based health and environmental groups working to protect cosmetics
consumers from toxic chemicals and hold companies accountable for the
safety of their products.
“Regrettably, 1,4-Dioxane contamination is just the tip of the
iceberg,” said Jeanne Rizzo, R.N., executive director of the Breast
Cancer Fund, a founding member of the Campaign for Safe Cosmetics.
“Because the FDA does not require cosmetics products to be approved as
safe before they are sold, companies can put unlimited amounts of toxic
chemicals in cosmetics.”
Steinman said parents should be outraged that companies are willing to
spend a significant amount of money on entertainment licensing
agreements that entice children but won’t spend pennies to remove
contaminants such as 1,4-Dioxane.
“Consumers who have young children, as I do, have the right to expect the highest purity
in children’s products,” Steinman said. “I call on American consumers
to say no to dangerous petrochemicals in their children’s cosmetic and
personal care products.”
Contrary to what many consumers may believe, the FDA does not review or
regulate cosmetics products or ingredients for safety before they are
sold to the public and has no legal authority to require safety
assessments of cosmetics.
Devra Lee Davis, professor of epidemiology and director of the Center
for Environmental Oncology at the University of Pittsburgh Cancer
Institute, said that the usual regulatory approach of assessing risk
one chemical at a time does not account for the combined effects of
very low levels of hidden contaminants in personal care products and
from other sources. “We must lower exposures to controllable agents
that we know or suspect cause cancer,” she said.
The FDA has been measuring 1,4-Dioxane levels since 1979, but because
the agency has little authority or enforcement capacity over the
cosmetics industry, it has worked with manufacturers to reduce levels
on a voluntary basis only. In 2000, the FDA recommended that cosmetic
products should not contain 1,4-Dioxane at concentrations greater than
10 ppm (parts per million); yet some 15 percent of products tested
exceeded even these lenient guidelines. This limit, however, also does
not take into account that babies exposed to 1,4-Dioxane from baby
shampoo may be exposed at the same time to 1,4-Dioxane from bubble
bath, body wash and many other products.
More than two dozen products were tested at Steinman’s request by West
Coast Analytical Service, an independent testing laboratory
specializing in trace chemical analysis. Among the products tested: continue reading this article here.
Founding members of The Campaign for Safe Cosmetics include: Alliance
for a Healthy Tomorrow, The Breast Cancer Fund, Commonweal, Friends of
the Earth, Women's Voices for the Earth, Environmental Working Group,
National Black Environmental Justice Network and National Environmental
Trust. For more information and background on the campaign, see www.SafeCosmetics.org.
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Kids And Health: Steer clear of these 3 substances
By DR.ROBERT NOHLE, SPECIAL TO THE SEATTLE POST INTELLIGENCER.
With all the toy recalls this past year, it
seemed that perhaps the safest thing to play with was the box the toy
came in. In fact, the U.S. Consumer Product Safety Commission recalled
20 million toys in 2007. Many of these recalls involved toys with
unsafe lead levels that had been imported from China.
Clearly children are exposed to a variety of substances, and the
long-term effects are not always known. Children are particularly
susceptible to toxins. Their lungs, organ systems and immune systems
are not fully developed and absorb higher concentrations of pesticides
and poisons. Luckily, most exposures are not great enough to cause
problems. Here are some of the more common substances and their effects:
Lead: Too much lead in the body can cause irreversible
problems in growth and development in children, including behavior,
hearing and learning problems and delayed growth. If you owned a toy
that had lead, chances are that this one product had no effect on your
child. My daughter had one of the "Thomas" toys that was recalled due
to lead paint. We decided to simply remove the toy from the house. If
you are concerned about your child's lead exposure, your physician can
do a simple blood test to check. Home kits are available, but their
effectiveness has been questioned. I would recommend talking with your
pediatrician if you are concerned.
Plastic bottles: Also in the news a lot lately is the
question of whether hard plastic bottles, such as baby bottles and
sippy cups, contain a chemical that mimics estrogen and thus could
induce hormonal responses. The compound in question is Bisphenol A,
also known as BPA. There's little consensus right now. The FDA says
products with BPA pose no health risks, while scientists feel there is
a concern and cite that Americans have levels of BPA higher than those
found to cause harm in lab animals. Some manufacturers are volunteering
to stop producing products with BPA so if you are concerned look for
products touting themselves as "BPA free."
Magnets and batteries: Not truly a toxin, the magnets found
in many toys still can pose a real threat to kids when swallowed.
Because magnets stick together, if more than one magnet is swallowed,
they could stack together or magnetically join across loops of the
intestines and cause serious problems. Swallowing magnets may cause
symptoms of feeling sick to the stomach (nausea), vomiting, abdominal
pain and distention, or diarrhea. Along these lines are the hazards of
swallowing a button or disc battery. These batteries, which contain
corrosive fluids, can come apart when swallowed and quickly damage
tissue. Some batteries contain potentially life-threatening amounts of
mercury. A disc battery can cause burning, corrosion or complete
perforation of the intestines when swallowed. Damage can occur rapidly
so immediate medical attention is important.
So what is a parent to do?
Common sense has to prevail. Even if a product is on the market, you
can't assume it's safe. Just a few months ago, my wife came home with a
popular new baby seat which we quickly decided was not safe to put our
infant in and returned it. Interestingly, it was recalled a few weeks
later because of it being associated with serious head injuries.
There is no specific product testing board for toys at this time, so
you need to be smart. Additionally, even a "Made in U.S.A." label is no
guarantee of safety; the item can comprise parts from another country
or simply be unsafe. Until we decide if the U.S. will have a regulatory
agency for toys, parents will have to be extra-cautious consumers.
Check toys for loose parts and caution your child -- even older
children -- against chewing or swallowing small pieces. Also regularly
check recall lists, such as recalls.gov,
to ensure you don't have, accept or give away a recalled product. If
you ever have concerns about your child's exposure to a potential
toxin, you can always ask for a reality check from your child's
pediatrician.
COMMON HOUSEHOLD HAZARDS
The Consumer Protection Agency says these are the top five hidden household hazards:
Magnets: Small powerful magnets, if swallowed, can attract
inside the body and block, twist or tear the intestines. If you think
your child has swallowed a magnet, seek medical attention immediately.
Recalled products: Be aware of the latest safety recalls and get dangerous products out of the home. Sign up for recall notices now at cpsc.gov.
Windows: To prevent strangulation use cordless blinds or
install safety devices on blind cords; and install window guards or
stops to prevent falls. Never rely on window screens to prevent falls.
Tipover: Kids will climb. Top-heavy furniture, TVs and stoves
can tip over and crush young children. Make them all more stable by
installing anchors and brackets.
Pools and spa drains: Suction from a pool or spa drain can be
powerful enough to trap a child or adult underwater. Inspect pools and
spas for missing or broken drain covers.
Dr. Robert Nohle is chief of pediatrics for
Seattle-based Group Health Cooperative. His column runs the first
Monday of every month. Have a question or comment for Dr. Nohle?
Contact him at health@seattlepi.com.
