Элидел
AD
22 ноя 2005, 20:39
У ребенка атопический дерматит. Аллерголог посоветовала нам мазать высыпания Элиделом вместо Пимафукорта.
Вот я и нтересуюсь у местных знатоков, что говорит мировая наука об Элиделе?
Не будет ли это заменой шила на мыло?
Вот я и нтересуюсь у местных знатоков, что говорит мировая наука об Элиделе?
Не будет ли это заменой шила на мыло?
22 ноя 2005, 23:14
Мы пользовались Элиделом. При первом применении краснота проходила, а потом опять все заново началось. Попробуйте может он Вам поможет.Мы снего ушли.
23 ноя 2005, 10:05
а на какой крем Вы перешли?
26 ноя 2005, 01:58
Нашла в нете статью что он провоцирует развитие раковых клеток
22 ноя 2005, 23:38
на мыло не будет, поскольку гормональный советуют сменить на НЕгормональный.
Прошу вас не счесть за труд, а внимательно просмотреть вот этот наш топик:
http://www.eva.ru/forum/show?idPost=15395094 :)
(не пугайтесь названия)
Прошу вас не счесть за труд, а внимательно просмотреть вот этот наш топик:
http://www.eva.ru/forum/show?idPost=15395094 :)
(не пугайтесь названия)
23 ноя 2005, 00:16
Нам помог, мы остались довольны. Опять же если мазать постоянно. Но поверте, это лучше чем гормональная мазь!
23 ноя 2005, 09:50
А после прочтения топа про Адвантан изучить инфу по элиделу:
Автор: Полосатый Кать (???)
Управлениe по контролю за пищевыми продуктами и лекарственными средствами США (Food and Drug Administration, FDA) выпустило официальное предупреждение о потенциальной опасности дерматологических препаратов Elidel (pimecrolimus) и Protopic (tacrolimus), применяющихся в том числе и на территории России.
Согласно последним исследованиям, проведенным фирмами-производителями указанных препаратов, их применение повышает риск развития злокачественных образований. Эффект связан с основным действием Elidel и Protopic - подавлением иммунитета, которое и используют врачи при лечении экземы.
На упаковках данных препаратов появится специальное предупреждение, кроме того, FDA рекомендует применять Elidel и Protopic только тогда, когда все другие методы лечения экземы опробованы и оказались неэффективными.
Применение указанных препаратов запрещено у детей младше двух лет и у пациентов любых возрастов, страдающих иммунодефицитами. Курс лечения должны быть кратковременным, либо - если требуется длительное лечение - с обязательными перерывами. В любом случае рекомендовано использовать минимальную дозу Elidel и Protopic, обеспечивающую терапевтический эффект.
источник: Медицинское информационное агентство Mednovosti.ru
__________________________________
Eczema creams should have cancer warning-US FDA
11 Mar 2005 02:46:30 GMT
Source: Reuters
(Adds Fujisawa, American Academy of Dermatology comment)
By Maggie Fox, Health and Science Correspondent
WASHINGTON, March 10 (Reuters) - Two eczema creams, Elidel and Protopic, should carry a strong advisory about a cancer risk, the U.S. Food and Drug Administration said on Thursday in a warning strongly disputed by the manufacturers.
Research shows the creams are absorbed into the body and may have the potential to cause cancer, the FDA said. It was working on a "black box" warning for the salves -- the strongest warning carried on medicines.
And babies should not be treated with the creams at all, the FDA said.
But Novartis AG <NOVN.VX> <NVS.N>, which makes Elidel, disputed the FDA's call for a black box warning and said there would be no change in its label for the time being. Fujisawa Healthcare Inc. <4511.T>, which makes Protopic, also said its product is safe.
"FDA has informed Novartis that we will begin discussions about the type of label and the exact wording contained in the label within the next few weeks. There is no change in the label at this time," Novartis said in a statement
And the American Academy of Dermatology, which represents skin specialists, also questioned the move.
"Because these medications are applied to the skin, virtually none of it gets inside the body," dermatologist Dr. Clay Cockerell, president of the academy, said in a statement.
"These are valuable medications, and if used properly, they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."
The FDA usually negotiates changes in drug labeling with the makers. But the agency has been under fire from consumer groups and Congress, which question whether the agency does enough to monitor the side-effects of medications after they are approved for the market
COMPANY SAYS CREAM SAFE
"Novartis agrees that patients suffering from mild-to-moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide," the company said.
The FDA said animal studies showed a link with cancer. Tests of whether an agent can cause cancer are done on animals, because it would be unethical to experiment on humans.
"The data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic," the FDA said in a statement.
These included seven cases of lymphoma and six skin cancer cases.
In February, members of an FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.
Elidel, known generically as pimecrolimus, and Protopic, known generically as tacrolimus, should be used only as directed and only after other eczema treatments have failed to work because of the risk, the FDA said.
"Both products are applied to the skin to control eczema by suppressing the immune system." the agency added. Suppressing the immune system is known to potentially contribute to cancer.
Doctors who prescribe the drugs should remember they should be used only for the shortest time possible, the FDA said.
"Elidel and Protopic are not approved for use in children younger than 2 years old," the FDA added.
Novartis stock closed down 12 cents at $48.70 on the New York Stock Exchange on Thursday. (Additional reporting by Lisa Richwine)
AlertNet news is provided by REUTERS
__
Patient Information Sheet for Elidel Cream (pimecrolimus)
This is a summary of the most important information about Elidel. For details, talk to your health care professional.
FDA ALERT: [ 03/2005]
The FDA has issued a public health advisory to inform healthcare professionals and patients about a potential cancer risk from use of Elidel (pimecrolimus). This concern is based on information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work. It may take human studies of ten years or longer to determine if use of Elidel is linked to cancer. In the meantime, this risk is uncertain, and FDA advises Elidel should be used only for patients after other treatments have failed to work.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
--------------------------------------------------------------------------------
What is Elidel?
Elidel is a cream used to treat mild to moderate atopic dermatitis, a form of eczema. It should be used only for short stretches of time or periodically for longer stretches of time. It is not for constant long-term use.
Elidel should not be the first treatment that you try to treat your eczema. Use Elidel only after other treatments did not work or you had too many side effects, or when other therapies cannot be used because of potential risks.
Elidel is approved for adults and children 2 years and older with normal immune systems (not weakened or compromised).
Who Should Not Use Elidel?
Do not use on children younger than 2 years.
Do not use if
Your eczema is infected
You have Netherton’s Syndrome. This is an inherited condition where the skin is red, itchy, and covered with large coarse scales.
You are pregnant or breastfeeding, unless directed by your doctor.
You are allergic to Elidel or any of its ingredients
What are The Risks?
Do not use Elidel as the first treatment for your eczema since there are risks of some serious side effects. The following are major side effects seen with Elidel therapy. However, this list is not complete.
Lymph node cancer: See FDA Alert above.
Skin cancer: See FDA Alert above. Animal studies have showed that skin tumors formed faster in animals treated with Elidel and exposed to light. Because of this, you should limit exposure to natural or artificial sunlight, such as sunlamps or tanning beds.
Viral infections: Elidel may increase the chance of getting chicken pox, shingles, skin warts, or other viral infections.
Skin irritation: Elidel’s most common side effect is a sensation of warmth or burning where you apply the cream. See your doctor if your reaction is severe, or you have it for more than 1 week.
Other side effects may include headache, throat or nose redness and soreness, flu symptoms, fever, and cough.
What Should I Tell My Health Care Professional?
Before you start using Elidel, tell your healthcare professional if:
You are getting light therapy for your skin (phototherapy, UVA or UVB)
You are taking any prescription or nonprescription (over-the-counter) medicine or supplements
You are using any other skin product
You are pregnant or planning to get pregnant
After you start using Elidel, tell your healthcare professional if:
Your eczema does not get better after 6 weeks of use
Your eczema gets worse
How Do I Use Elidel?
Wash your hands before using Elidel.
Put a thin layer of Elidel cream on the affected skin twice a day, unless otherwise directed by your doctor. Rub in completely.
Wash your hands after applying Elidel unless you are treating your hands.
Do not use Elidel under a bandage or wrap that keeps out air.
Stop using Elidel once your symptoms go away, but start again if they reappear, as directed by your healthcare professional.
Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Elidel.
Elidel FDA Approved 2001
Patient Information Sheet Revised 3/10/2005
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Автор: Полосатый Кать (???)
Управлениe по контролю за пищевыми продуктами и лекарственными средствами США (Food and Drug Administration, FDA) выпустило официальное предупреждение о потенциальной опасности дерматологических препаратов Elidel (pimecrolimus) и Protopic (tacrolimus), применяющихся в том числе и на территории России.
Согласно последним исследованиям, проведенным фирмами-производителями указанных препаратов, их применение повышает риск развития злокачественных образований. Эффект связан с основным действием Elidel и Protopic - подавлением иммунитета, которое и используют врачи при лечении экземы.
На упаковках данных препаратов появится специальное предупреждение, кроме того, FDA рекомендует применять Elidel и Protopic только тогда, когда все другие методы лечения экземы опробованы и оказались неэффективными.
Применение указанных препаратов запрещено у детей младше двух лет и у пациентов любых возрастов, страдающих иммунодефицитами. Курс лечения должны быть кратковременным, либо - если требуется длительное лечение - с обязательными перерывами. В любом случае рекомендовано использовать минимальную дозу Elidel и Protopic, обеспечивающую терапевтический эффект.
источник: Медицинское информационное агентство Mednovosti.ru
__________________________________
Eczema creams should have cancer warning-US FDA
11 Mar 2005 02:46:30 GMT
Source: Reuters
(Adds Fujisawa, American Academy of Dermatology comment)
By Maggie Fox, Health and Science Correspondent
WASHINGTON, March 10 (Reuters) - Two eczema creams, Elidel and Protopic, should carry a strong advisory about a cancer risk, the U.S. Food and Drug Administration said on Thursday in a warning strongly disputed by the manufacturers.
Research shows the creams are absorbed into the body and may have the potential to cause cancer, the FDA said. It was working on a "black box" warning for the salves -- the strongest warning carried on medicines.
And babies should not be treated with the creams at all, the FDA said.
But Novartis AG <NOVN.VX> <NVS.N>, which makes Elidel, disputed the FDA's call for a black box warning and said there would be no change in its label for the time being. Fujisawa Healthcare Inc. <4511.T>, which makes Protopic, also said its product is safe.
"FDA has informed Novartis that we will begin discussions about the type of label and the exact wording contained in the label within the next few weeks. There is no change in the label at this time," Novartis said in a statement
And the American Academy of Dermatology, which represents skin specialists, also questioned the move.
"Because these medications are applied to the skin, virtually none of it gets inside the body," dermatologist Dr. Clay Cockerell, president of the academy, said in a statement.
"These are valuable medications, and if used properly, they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."
The FDA usually negotiates changes in drug labeling with the makers. But the agency has been under fire from consumer groups and Congress, which question whether the agency does enough to monitor the side-effects of medications after they are approved for the market
COMPANY SAYS CREAM SAFE
"Novartis agrees that patients suffering from mild-to-moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide," the company said.
The FDA said animal studies showed a link with cancer. Tests of whether an agent can cause cancer are done on animals, because it would be unethical to experiment on humans.
"The data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic," the FDA said in a statement.
These included seven cases of lymphoma and six skin cancer cases.
In February, members of an FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.
Elidel, known generically as pimecrolimus, and Protopic, known generically as tacrolimus, should be used only as directed and only after other eczema treatments have failed to work because of the risk, the FDA said.
"Both products are applied to the skin to control eczema by suppressing the immune system." the agency added. Suppressing the immune system is known to potentially contribute to cancer.
Doctors who prescribe the drugs should remember they should be used only for the shortest time possible, the FDA said.
"Elidel and Protopic are not approved for use in children younger than 2 years old," the FDA added.
Novartis stock closed down 12 cents at $48.70 on the New York Stock Exchange on Thursday. (Additional reporting by Lisa Richwine)
AlertNet news is provided by REUTERS
__
Patient Information Sheet for Elidel Cream (pimecrolimus)
This is a summary of the most important information about Elidel. For details, talk to your health care professional.
FDA ALERT: [ 03/2005]
The FDA has issued a public health advisory to inform healthcare professionals and patients about a potential cancer risk from use of Elidel (pimecrolimus). This concern is based on information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work. It may take human studies of ten years or longer to determine if use of Elidel is linked to cancer. In the meantime, this risk is uncertain, and FDA advises Elidel should be used only for patients after other treatments have failed to work.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
--------------------------------------------------------------------------------
What is Elidel?
Elidel is a cream used to treat mild to moderate atopic dermatitis, a form of eczema. It should be used only for short stretches of time or periodically for longer stretches of time. It is not for constant long-term use.
Elidel should not be the first treatment that you try to treat your eczema. Use Elidel only after other treatments did not work or you had too many side effects, or when other therapies cannot be used because of potential risks.
Elidel is approved for adults and children 2 years and older with normal immune systems (not weakened or compromised).
Who Should Not Use Elidel?
Do not use on children younger than 2 years.
Do not use if
Your eczema is infected
You have Netherton’s Syndrome. This is an inherited condition where the skin is red, itchy, and covered with large coarse scales.
You are pregnant or breastfeeding, unless directed by your doctor.
You are allergic to Elidel or any of its ingredients
What are The Risks?
Do not use Elidel as the first treatment for your eczema since there are risks of some serious side effects. The following are major side effects seen with Elidel therapy. However, this list is not complete.
Lymph node cancer: See FDA Alert above.
Skin cancer: See FDA Alert above. Animal studies have showed that skin tumors formed faster in animals treated with Elidel and exposed to light. Because of this, you should limit exposure to natural or artificial sunlight, such as sunlamps or tanning beds.
Viral infections: Elidel may increase the chance of getting chicken pox, shingles, skin warts, or other viral infections.
Skin irritation: Elidel’s most common side effect is a sensation of warmth or burning where you apply the cream. See your doctor if your reaction is severe, or you have it for more than 1 week.
Other side effects may include headache, throat or nose redness and soreness, flu symptoms, fever, and cough.
What Should I Tell My Health Care Professional?
Before you start using Elidel, tell your healthcare professional if:
You are getting light therapy for your skin (phototherapy, UVA or UVB)
You are taking any prescription or nonprescription (over-the-counter) medicine or supplements
You are using any other skin product
You are pregnant or planning to get pregnant
After you start using Elidel, tell your healthcare professional if:
Your eczema does not get better after 6 weeks of use
Your eczema gets worse
How Do I Use Elidel?
Wash your hands before using Elidel.
Put a thin layer of Elidel cream on the affected skin twice a day, unless otherwise directed by your doctor. Rub in completely.
Wash your hands after applying Elidel unless you are treating your hands.
Do not use Elidel under a bandage or wrap that keeps out air.
Stop using Elidel once your symptoms go away, but start again if they reappear, as directed by your healthcare professional.
Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Elidel.
Elidel FDA Approved 2001
Patient Information Sheet Revised 3/10/2005
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
23 ноя 2005, 10:04
спасибо за информацию. :-)
я здесь крайне редко бываю, поэтому и не знаю, какие топики заводят...
Адвантаном мы как-то не пользовались, а Элидел посоветовала врач-аллерголог...
я здесь крайне редко бываю, поэтому и не знаю, какие топики заводят...
Адвантаном мы как-то не пользовались, а Элидел посоветовала врач-аллерголог...
23 ноя 2005, 12:18
В топе, который Вам посоветовали, вообще много про АД и про применение мазей\кремов. Я могу сказать на примере моего ребенка: когда мы начали лечение у гомеопата, после первого же шарика начался кашель и полились прозрачные сопли. Это "выходила" аллергия, загнанная кремами\мазями внутрь :-(
23 ноя 2005, 12:26
я вот именно поэтому против этих мазей, что они только загоняют внутрь болезнь, а не лечат ее.
23 ноя 2005, 17:08
тогда зачем же вы спрашиваете, стоит ли заменить пимафукорт на элидел????:-0:-0:-0
(был и у нас пимафукорт :-| :-| :-| , да только в районе складочек. На большее нам даже врач не рекомендовал замахиваться....)
К слову, какой врач, не скажете(в каком центре)
(был и у нас пимафукорт :-| :-| :-| , да только в районе складочек. На большее нам даже врач не рекомендовал замахиваться....)
К слову, какой врач, не скажете(в каком центре)
23 ноя 2005, 17:47
мужу покажу ваши аргументы, он настаивает на этих мазях...
24 ноя 2005, 02:21
спасибо за честь :) но лавры нужно отдать другим - в частности, Куруш и КАтю в полосУ :Р
А мужу скажите, чтоб не маялся... Мой так же вёл себя с этим атопическим ДЕРЬМОтитом, пока не дошёл до неизлечимой нервно-кожной болячки :(
Когда недавно "залетели" под козье молоко, тоже рвался, да спустя неделю как рукой сняло "настаивания". Спрашиваю - вот это пятнышко маленькое никак не сойдёт, давай только его мазнём элиделиком? - Ты что? НеТ!!!! Никаких эликов-деликов :Р:Р:Р
И чего, спрашивается, нужно было так семью подводить? Заболевать неизлечимыми заболеваниями? :(
А мужу скажите, чтоб не маялся... Мой так же вёл себя с этим атопическим ДЕРЬМОтитом, пока не дошёл до неизлечимой нервно-кожной болячки :(
Когда недавно "залетели" под козье молоко, тоже рвался, да спустя неделю как рукой сняло "настаивания". Спрашиваю - вот это пятнышко маленькое никак не сойдёт, давай только его мазнём элиделиком? - Ты что? НеТ!!!! Никаких эликов-деликов :Р:Р:Р
И чего, спрашивается, нужно было так семью подводить? Заболевать неизлечимыми заболеваниями? :(
23 ноя 2005, 17:33
А не посоветуете врача-гомеопата? ;)Вылечили вы аллергию в результате?
24 ноя 2005, 02:23
ещё у Кариши загляните в паЧпырт ;)
24 ноя 2005, 13:19
Мартюшев Александр Васильевич. Запись по тел. 675-7170 Лечим. Пока недолго - меньше месяца. Но кажется нам с мужем, что улучшения наблюдаются
24 ноя 2005, 18:05
Год назад Элидел активно рекламировали и рекомендовали. Сейчас в Европе его продажа прекращена, т.к. в долгосрочном периоде приемнения выявлен риск появления плохих последствий. Наш врач его уже не рекомендует:)
24 ноя 2005, 19:07
а производство не запретили? это было бы логично.
25 ноя 2005, 18:11
У нас не запрещен, я живу в Австрии. Я у врача спрашивала про вредность Элидела, он сказал, что своим детям он бы его прописал, если надо было бы.
24 ноя 2005, 19:31
вот по Элиделу...
http://www.rxlist.com/cgi/generic/elidel_ad.html
http://www.rxlist.com/cgi/generic/elidel_ad.html