Elidel and Protopic Unsafe for children
So much for elidel being safe to use on children...
Eczema drugs linked to cancer risk, says FDA
Elidel and Protopic creams to carry 'black box' warnings
Updated: 3:07 p.m. ET March 10, 2005
WASHINGTON - Two eczema creams — Novartis AG’s Elidel and Fujisawa Healthcare, Inc.’s Protopic, must carry a strong warning of cancer risk, the Food and Drug Administration said Thursday.
Research shows the creams are absorbed into the body and can cause cancer, the FDA said. The creams will carry a “black box” warning — the strongest warning carried on medicines.
And babies should not be treated with the creams at all, the FDA said.Entire article
Elidel & Protopic Cancer Warnings
So they say that these creams are to be used when steroids fail but too frequently, I have dermatologists who prescribe steroidal creams and Elidel or Protopic IN CONJUNCTION. I am gaining a distrust for mainstream medical doctors and am willing to turn to alternative therapy for help. I have severe eczema and I'm desperate!!!
Yay for doctors and pharmaceutical companies who don't know crap!
Fox News
reported:
Cancer Warning Suggested for Eczema CreamsThursday, February 17, 2005
By Colette BouchezTwo relatively new and very popular prescription creams used to treat eczema in children and adults may soon carry a "black box" warning — indicating the drugs represent a cancer risk for some.
In an FDA meeting, a distinguished nationwide panel of experts reviewed medical data that linked Elidel and Protopic with an increased risk of skin cancer and lymphoma.
Their recommendation: That both medications carry a warning that the drugs may increase the risk of cancer. They continue to back the original FDA ruling that the drugs should not be used in children under the age of two.
"We made our recommendation based on animal data and biologic plausibility combined with the fact that the use of these products is increasing tremendously," says Dianne Murphy, MD, committee member and FDA director of the Office of Pediatric Therapeutics.
Both drugs are currently approved for the treatment of eczema, an inflammatory condition of the skin which affects some 15 million Americans, 20 percent of whom are children. The condition causes dry, red, itchy skin that can blister or develop scaly patches.
The majority of patients develop their first bout of eczema before they are 12 months old. Both Elidel and Protopic are currently approved for use in children aged two and up.
While the FDA committee recommends a stern warning for all those who use the drug, Murphy stresses that there were no human clinical trials that indicated cancer was a risk.
However, she tells WebMD that the committee reviewed numerous animal studies that did indicate a risk, including one monkey study that showed an increasing risk of developing tumors as doses increased.
"The greater the dose the greater the number of tumors — and with the highest dose we saw seven out of eight monkeys develop tumors," says Murphy.
Equally important was the "biologic plausibility of the drugs” — meaning, the way in which the medications work. These medications suppress the immune system, which may be a precipitating factor in the development of cancer.
"It depends greatly on what other precipitating factors may be present in an individual patient's profile, but this could certainly be a contributing factor under certain circumstances," says Murphy.
Adding more fuel to the fire was a series of isolated adverse events voluntarily reported by consumers and their doctors to the FDA.
Since Protopic was approved in 2000, the FDA has received 10 reports of serious adverse events in children under age 2, and 17 cancers in all age groups. These included non-Hodgkin's lymphoma and skin cancer. Published reports say three of these cancer patients have died.
Elidel, which was approved in 2001, appears to have a similar profile. According to FDA records, from approval in December 2001 through September 2004, there were 54 serious adverse events reported in children under the age of 2, and eight cancers in all age groups, including four in children over the age of 2. The majority of the noncancer events were skin related, and resulted in hospitalization for 15 children.
Creams Used When Steroids FailWhile the number of tumors detected is significant, experts point out it is still small compared with the millions of people using these medications. According to the FDA, nearly 9 million prescriptions were written for Elidel since its approval, with 12.7 percent prescribed for children between 1 and 2 years old. Although Protopic was on the market sooner, prescriptions for this drug climbed to just 3.5 million, with about 8 percent given to younger patients, says the FDA.
Other drugs used to treat eczema include steroid medications (search), which are normally the initial treatment. Experts say both Elidel and Protopic are considered second-string drugs, recommended only when steroid medications fail.
If you are currently using either Protopic or Elidel, Murphy says be certain you are using them only for the conditions for which they have been approved, and only if there are no other treatment options. Experts also say you should talk to your doctor about whether or not you are at increased risk for cancer due to other precipitating factors, including personal and family history of disease.
The FDA is expected to rule on the "black box" warning soon, though it is likely they will take the committee’s recommendation.
Published reports indicate both drug manufacturers say there is no clinical evidence of increased cancer risk in humans with either medication. Both companies agree monitoring should continue. Published reports say the companies also plan to review safety data and are planning to continue studies on their own.
By Colette Bouchez, reviewed by Michael W. Smith, MD
SOURCES: Diane Murphy, MD, director, Office of Pediatric Therapeutics, FDA. FDA advisory committee briefing, Feb. 15, 2005. Questions and Answers on Atopic Dermatitis, American Academy of Dermatology.
FDA Considers Warnings for Eczema Creams
washingtonpost.com
FDA Considers Warnings for Eczema Creams
By Rob Stein
Washington Post Staff Writer
Saturday, February 12, 2005; Page A09
Government scientists, concerned that two prescription creams used widely for a common skin condition may increase the risk of certain cancers, especially among children, will propose adding strong new warnings to the product labels.
A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a new Food and Drug Administration analysis.
"The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents," wrote Jean Temeck of the FDA's division of pediatric drug development in a recommendation posted late yesterday on the agency's Web site.
The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend what action the agency should take.
Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.
The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written for the creams.
The creams were approved for short-term or intermittent use by adults and children age 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively, and both creams are believed to be widely used for longer periods and among babies.
"These products are being widely used to treat . . . a non-life-threatening disease, and heavily advertised for use in young children without appreciation . . . regarding the potential for carcinogenic risk," Temeck wrote.
Both Novartis and Fujisawa Healthcare Inc., which makes Protopic, defended the safety of their products to the FDA.
"Elidel is an effective, steroid-free treatment for mild to moderate eczema and has a well-established safety profile," Novartis spokesman Tom Jones added in an e-mail.
Because the drugs work by suppressing the immune system, scientists had been concerned that they could increase the risk of cancer. As a result, when the FDA approved the creams the agency required both companies to monitor whether any cancers were reported among users.
In 2003, the agency convened an expert panel to examine the evidence to date, but at that time only seven possible cases had been reported, so the agency decided to continue to monitor the situation.
Since then, however, a study involving monkeys has suggested the creams might cause lymphoma, a cancer of the immune system, and reports of a variety of cancers in humans using the creams have continued to rise.
At least seven cases of lymphoma have been reported, as well as at least seven cases of skin cancer and a handful of others, Temeck wrote. Several children reported infections, including an 8-month-old boy whose infection was so severe he suffered a heart attack after Protopic was applied "over his entire body for six months," she wrote.
While it remains far from proven that the creams are causing the complications, "there is a need for a stronger approach to the communication and minimization of the potential risk of cancer," Dianne Murphy, director of the FDA's office of pediatric therapeutics, wrote in another document.
"We believe regulatory action is needed at this time since a definitive answer to the carcinogenic risk of these products will not be known for years," Temeck wrote.
The addition of a possible "black box" warning to the label is one of several recommendations that the committee will consider, an agency spokesman said.
The concern comes as the FDA has come under intense criticism for failing to protect the public from potentially dangerous drugs. The blockbuster painkiller Vioxx was recently pulled from the market because of concerns that it and similar agents may increase the risk of heart attacks and strokes.
The advisory committee will focus on children because exposure to a potential cancer-causing agent poses a greater risk to the young, but its recommendations would apply to adults as well, the spokesman said.
Although the FDA is not bound to follow the recommendations of its advisory panels, it usually does.
© 2005 The Washington Post Company
Eczema Links - Helpful or not?
I've come across some eczema links through the new MSN search and if you have any suggestions or input as to whether or not these products or advice are helpful, I'm sure I (and others) would appreciate it.
ZENMED™ DermCare
Brief description:
ZENMED™ DermCare is the natural alternative for fast, long-term relief from eczema, or atopic dermatitis.
Millions of people of all age groups suffer from eczema and though many find topical steroids to be highly effective for them, they are definitely not for everyone.
Topical steroids like hydrocortisone are not recommended for long-term use or for use on the face. Extended use can cause thinning and premature wrinkling of the skin.
ZENMED™ has taken these and other concerns of eczema sufferers in full view and created a multi-faceted relief treatment gentle and safe enough to use in delicate areas like the face and neck and still provide 24 hours worth of relief.
Biolanyn®
Brief description:
Discover Biolanyn®, a powerful, natural and safe (no steroids/cortisone) skin treatment, proven very effective against eczema. It has been in production for over 10 years. Biolanyn will deliver healthier skin for you in just 21 days! Read the 29 life-changing testimonials from people just like you who have treated eczema on every part of their body! We promise that if you faithfully follow our easy usage instructions, Attogram Corp., a trusted company in business since 1978, will back your purchase with a no risk, money-back guarantee.
Chinese Herbal Treatment for Eczema
Self-Help Care of Your Eczema: Over-the-counter: A good resource that provides links to different aids in controlling eczema
Living With Itch site provides anecdotes and stories in addition with advice to aid those who live with constant, unbearable itching.
Eucerin Dry Skin Therapy For Itching
In the April 2004 issue of Real Simple Magazine, Eucerin took out a full-page ad for their DRY SKIN THERAPY campaign. The products unveiled:
* Itch-Relief Moisturizing Spray
* Calming Creme (NEW)
Helpful eczema links from Eucerin and the Mayo Clinic:
Eucerin: Eczema Information
Mayo Clinic: Eczema Information
Note: I have personally tried the Itch-relief moisturizing spray and found that it did absolutely nothing for me. I find that Aveeno's Anti-Itch Creme with Calamine lotion is much more helpful.
African Caribbean Skin and Eczema
A look at the management of eczema in black skin
• A study in London schools in 1995 found that eczema was twice as common in children of African - Caribbean descent than in white children. The study concluded that London-born African Caribbean children appear to be almost twice as likely to have atopic eczema than white children.
• The management of eczema in black and white people is generally the same, but differences in skin structure can lead to some specific problems.
• Black skin contains more melanin, which is brown pigment. This pigment provides three to four times more protection from the sun through burning and reddening.
• Black skin absorbs about one third more energy than white skin does and, to combat this, black skin has more sweat glands to help with the control of temperature.
• The outer layer of skin is the same thickness in black and white skin. However, black skin is tougher and stronger than white skin due to the cells that make up black skin being more linked together.
• Black skin contains more sebaceous glands, which produce oil and this increased moisture helps against wrinkling and ageing. However, the skin can still be prone to drying out very quickly, especially during winter, after washing, and with over use with cleansers and detergents.
• Excessively dry skin is common in people of African Caribbean descent, especially in the UK where the humdity is lower than in other parts of the world.
Skin disorders
• Pigmentation can sometimes occur when the skin colour is damaged in some way. This can vary from fading of the skin to loss of colour altogether.
• People with atopic eczema are more likely to develop lichenification (thickening) from scratching. This can lead to disturbance of the pigment layer, which may therefore lead to changes in colour.
• Changes in pigmentation happen alongside atopic skin disease when inflammation of the skin can disturb the pigment layer. The colour of the skin usually returns to normal once the inflammation goes down, but can take several months to do so.
Diagnosis
• Diagnosis can be difficult in black skin because the features vary – scaling, crusting or hyperkeratosis (build-up of skin cells) could be due to psoriasis, eczema, fungal infection, or ichthyosis. Rashes on black skin can appear more purple brown and this can also make diagnosis difficult.
• Eczema in black babies can at times be more focused around the hair follicles and can blister more than the skin in white babies.
Treatments
• Treatments for eczema in black and white people are generally the same – emollients and steroids.
• A main feature of eczema is the itching, but scratching can have a different effect on black skin.
• Inflammation in black skin can lead to other complications such as change in colour and the skin is more prone to being raised and spotty around the hair follicles and hardened. This also increases the risk of scarring.
• Skin care is essential to maintain well moisturised skin in order to combat itching and scratching.
• When choosing a cream, use what you are happy with and what suits you or your child’s skin.
General points to consider
• Almost all black babies are born with bluish-black patches that usually appear on the calves, thighs and buttocks. This is called dermal melanocytosis and it gradually disappears by the time your child is a year old.
• A condition called pityriasis alba is sometimes seen with (or without) atopic eczema and is more obvious in black children. This can appear as faint pale dry areas, sometimes scaly, on the cheeks of children. This condition eventually resolves without treatment.
• Keloids are quite common in black people as black skin scars more easily. Keloids are overgrowths of scar tissue from wounding, injury, operation or ear piecing etc. Common inflammatory conditions such as acne or eczema can lead to keloid scarring. Keloids can be treated surgically and have sometimes been prevented by treating the scar with hydrocortisone or high doses of vitamin E.
• Black babies who have had seborrhoeic eczema can become very pale.
About the National Eczema Society
• The National Eczema Society is the only charity in the UK dedicated to providing support and information for people with eczema and their carers – including health professionals - and depends entirely on voluntary income for its work. It has approximately 12,000 members
• The Society runs the only telephone helpline dedicated to providing information to people affected by eczema and deals with over 20,000 enquiries a year
• The National Eczema Society is committed to educating health professionals about the physical and psychological aspects of eczema, through a professional membership scheme, training programmes, open days and workshops.
• The Society’s objectives include finding a cure for eczema. To that end it also funds research into eczema and its causes.
• It was formed in 1975 to provide support and information to anyone whose life is affected by eczema. Membership costs £20 a year and members receive a comprehensive age related members pack, quarterly magazine along with up to date news and support through a network of local support groups and experienced key volunteers
• Each year the Society runs a National awareness week (third week in September) to promote awareness and understanding of the condition
1 Williams H C et al (1995) London born black caribbean children are at increased risk of atopicdermatitis. Journal of the American Academy of Dermatology, 32,212-17
By the
NEASE Patient Conference
According to http://www.nationaleczema.org, the National Eczema Association for Science and Education will be holding a Patient Conference in San Jose, California from Friday, Aug. 5 - Sunday, Aug. 7, 2005. Check the website again in February 2005 for more details.
