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Injured by Protopic?
Protopic (Generic:Tacrolimus) is a cream approved for the treatment of eczema and is commonly prescribed off-label for psoriasis and dermatitis seborrhea. Protopic is manufactured by Astellas Pharmaceuticals, formerly Fujisawa Healthcare, and was approved by the FDA in 2000.The FDA required a warning for Protopic and Elidel after reviewing numerous animal studies that did indicate a risk, including one monkey study that showed an increasing risk of developing tumors as doses increased. The FDA added that the cancer risks of Elidel and Protopic are biologically plausible. Protopic and Elidel are medications that suppress the immune system, and this may be a precipitating factor in the development of cancer. Research has also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs. Protopic and Elidel have become widely prescribed as an alternative to steroid creams, which have long term side effects.
On January 20, 2005 the FDA declared that Protopic will have to bear a "black box" warning indicating possible cancer risks. The new labeling also will clarify that the drug be recommended for use only after other prescription topical medicines have been tried by patients. The agency is also issuing a guide updating patients about these risks and 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 2004, the FDA had received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Protopic or Elidel, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division.
If you or a loved one took Protopic and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
ProtopicRSS Feed
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...
Protopic
Protopic FDA Information
FDA Drug Information Facts
PROPTIC (Tacrolimus) FDA INFORMATION
The FDA issued several warnings concerning Protopic related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Protopic Reference Guide
Generic Name
Tacrolimus
Date Approved
December 8, 2000
Manufacturer
Fujisawa Healthcare
Status
On the market Approved Uses
Eczema
Off Label Uses
Dermatitis Seborrhea
Psoriasis
Serious Side Effects
Non-Hodgkin's Lymphoma
Skin Cancer
Related Topics
Elidel
Defective Drugs
Tacrolimus
Date Approved
December 8, 2000
Manufacturer
Fujisawa Healthcare
Status
On the market Approved Uses
Eczema
Off Label Uses
Dermatitis Seborrhea
Psoriasis
Serious Side Effects
Non-Hodgkin's Lymphoma
Skin Cancer
Related Topics
Elidel
Defective Drugs
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