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Injured by Elidel?
Elidel, manufactured by Novartis, was approved by the FDA in December 2001. Elidel is prescribed to treat Eczema and is also commonly prescribed off-label for psoriasis and dermatitis seborrhea.On March 10, 2005, the FDA stated that Elidel should carry a strong advisory about cancer risks. Research shows that the cream is absorbed into the body and may have the potential to cause cancer. The FDA is working on a ″black box″ warning for Elidel. The data collected by the FDA showed that the risk of cancer increased as the amount of the drug given increased. This data also included a small number of reports of cancers in children and adults treated with Elidel. Elidel and similar medications suppress the immune system, which may be a precipitating factor in the development of cancer. Elidel has become widely prescribed as an alternative to steroid creams, which also have long-term side effects.
On January 20, 2005, the FDA declared that Elidel must bear "black box" warnings of possible cancer risks. The new labeling will also recommend that the drug be prescribed for use only after other prescription topical medicines have been tried by patients. The FDA is also issuing a guide updating patients of its concerns. A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk. As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Elidel or Protopic, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division.
If you or a loved one took Elidel and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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FDA Orders 'Black Box' Warning for Eczema Drugs, Elidel and Protopic
Jan 21, 2006 | www.Newsinferno.com
In an important notification, the Federal Drug Administration (FDA) has announced the approval of updated labeling for two topical eczema drugs, Protopic Ointment (tacrolimus) and Elidel Cream (pimecrolimus).The new labeling will add a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established.A Medication Guide (FDA-approved patient labeling) will also be included with the medications in...
FDA to Require Warnings on 2 Eczema Drugs
Jan 20, 2006 | AP
The labels on two prescription creams to treat eczema will have to bear "black box" warnings of possible cancer risks.The Food and Drug Administration action Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings.The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said. The agency is also...
Health Alert for Eczema Patients
May 3, 2005 | www.cfcn.ca
Health Canada and the U-S Food and Drug Administration have issued health alerts on two Eczema skin creams.But Canadian dermatologists say the warnings are overkill.Health Canada has linked Elidel and Protopic ointment to a potential cancer risk.The agency is worried about a connection to lymphoma.The advisories don't advise patients to stop using the treatment but do warn that they should be used only as directed.The drug companies have also been asked to update safety information on the...
FDA Panel Urges Warnings on 2 Eczema Drugs
Feb 16, 2005 | Washington Post
A prescription cream and an ointment that millions of Americans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especially among children, a federal panel concluded yesterday.Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs' safety, including adding a...
FDA Considers Warnings for Eczema Creams
Feb 12, 2005 | Washington Post
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...
Elidel
Elidel FDA Information
FDA Drug Information Facts
ELIDEL (Pimecrolimus) FDA INFORMATION
The FDA issued several warnings concerning Elidel related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Elidel Reference Guide
Generic Name
Pimecrolimus
Date Approved
December 13, 2001
Manufacturer
Novartis
Status
On the market
1/20/05 Black box warning
3/10/05 FDA warning
Approved Uses
Eczema
Off Label Uses
Psoriasis
Dermatitis Seborrhea
Serious Side Effects
Skin cancer
Non-hodgkin's lymphoma
Related Topics
Protopic
Defective Drugs
Pimecrolimus
Date Approved
December 13, 2001
Manufacturer
Novartis
Status
On the market
1/20/05 Black box warning
3/10/05 FDA warning
Approved Uses
Eczema
Off Label Uses
Psoriasis
Dermatitis Seborrhea
Serious Side Effects
Skin cancer
Non-hodgkin's lymphoma
Related Topics
Protopic
Defective Drugs
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