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Old 02-01-2006, 12:49 PM   #1 (permalink)
 
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It's still Black Magic

For those of you that have clients that ARE being treated by a Dermatologist for Skin Issues..... please read the following.....

This reminds me of the Sunscreens of yesteryear that contained carcinogens..... they told people they were 'allergic' to the lotions


Anyhooooooo..... just because something or some drug has FDA 'approval' does not mean it's 'good for ya'....







Medscape Alert
Elidel, Protopic May Increase Cancer Risk

Yael Waknine

Jan. 19, 2006 — The US Food and Drug Administration (FDA) has approved revisions to the safety labeling for 1% pimecrolimus cream (Elidel, made by Novartis Pharmaceuticals Corporation) and tacrolimus 0.03% and 0.1% ointment (Protopic, made by Astellas Pharma, Inc), advising of the potential risk for cancer associated with their use.

The revisions will include a new boxed warning and a medication guide for patients that emphasize appropriate use of these drugs to minimize this risk, according to a news release sent today from the FDA.

The agency has received postmarketing reports of lymphomas and skin malignancies (basal cell and squamous cell carcinoma, and malignant melanoma) in patients using topical calcineurin inhibitors such as pimecrolimus and tacrolimus.

Although a causal relationship has not been established and studies are being conducted by the manufacturers of both drugs to address this potential risk, the FDA notes that it may be many years before conclusive data is obtained regarding their long-term safety.

In the interim, continuous long-term use of these drugs should be avoided in all age groups and their application limited to areas affected by atopic dermatitis.

The FDA also emphasized that topical tacrolimus and pimecrolimus should not be used in children younger than 2 years, and that only 0.03% tacrolimus ointment is indicated for use in children aged 2 to 15 years.

Pimecrolimus cream 1% is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children aged 2 years and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are contraindicated.

Tacrolimus ointment (0.03% and 0.1% for adults; 0.03% for children aged 2 to 15 years) is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

Healthcare professionals are encouraged to report adverse events related to use of pimecrolimus or tacrolimus to the FDA's MedWatch safety information and adverse event reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD
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Old 02-01-2006, 01:04 PM   #2 (permalink)
 
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Re: It's still Black Magic

It's sad since these type of stories like the above never end. If Mother Nature didn't make it, it's probably bad for yah.
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Old 02-01-2006, 01:15 PM   #3 (permalink)
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Re: It's still Black Magic

Isn't that the truth? ^
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Old 02-02-2006, 01:01 PM   #4 (permalink)
 
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Re: It's still Black Magic

American Academy of Dermatology Responds to FDA Decision on Eczema Medications
SCHAUMBURG, ILL., (January 19, 2006) – The American Academy of Dermatology (Academy) today issued a statement in response to the U.S. Food and Drug Administration’s (FDA) announcement that a black box warning will be added to the labeling and a medication guide will be distributed for the topical calcineurin inhibitors (TCIs), pimecrolimus and tacrolimus. These topical medications effectively reduce the inflammation and other symptoms associated with the skin disease eczema.

“The American Academy of Dermatology disagrees with this action taken by the FDA. We believe that the data does not prove that the proper topical use of pimecrolimus and tacrolimus is dangerous,” said dermatologist Clay J. Cockerell, M.D., president of the American Academy of Dermatology. “Because these medications are applied to the skin, virtually none of it gets inside the body. It’s not the same as taking a pill. These are valuable medications, and if used properly, they allow millions of our patients with eczema to live normal lives.”

This past summer, the Academy held a conference to discuss the scientific, regulatory, clinical, and public concerns raised by this potential FDA action. The dermatologists, patients, pharmacists and immunologists participating in the conference reviewed the current literature and safety data for these medications. It was determined that the addition of a black box warning and medication guide was unwarranted and could limit access to TCIs, or limit treatment options if qualified patients decide not to use these medications based on fear of a malignancy risk.

“The health, safety and welfare of our patients being treated with these topical medications are of paramount importance to dermatologists,” said Dr. Cockerell. “We are concerned that this warning will confuse and unnecessarily worry our patients. We urge patients to get the facts on how to appropriately manage their eczema from their dermatologist.”

The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 14,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.



Funny how this:
Quote:
The agency has received postmarketing reports of lymphomas and skin malignancies (basal cell and squamous cell carcinoma, and malignant melanoma) in patients using topical calcineurin inhibitors such as pimecrolimus and tacrolimus.


could be reasoned with this:
Quote:
“The health, safety and welfare of our patients being treated with these topical medications are of paramount importance to dermatologists,” said Dr. Cockerell.



It's ALL ABOUT 'show me da money'.......


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Old 02-05-2006, 03:34 PM   #5 (permalink)
 
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Re: It's still Black Magic

dermatologists??....like the ones slamming OUR industy as bad for ya!
Sure, sure....its all about whats best for patients....like zero sun, right?
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Old 02-05-2006, 03:36 PM   #6 (permalink)
 
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Re: It's still Black Magic

"“We are concerned that this warning will confuse and unnecessarily worry our patients. We urge patients to get the facts on how to appropriately manage their eczema from their dermatologist.”
Get the facts, huh? As long as they are the Derms facts.....
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