Washington, DCThe potential relationship—however slight —between Protopic and cancer may not be resonating with the masses, in spite of the fact that the US Food and Drug Administration (FDA) issued a boxed warning in 2006 with regard to the cancer risk.
Here's an excerpt from the Protopic official website:
"The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However, a link with Protopic has not been shown. Patients should avoid using Protopic continuously for a long time and apply Protopic only to areas with eczema. If the eczema does not improve within 6 weeks, patients should talk to their doctor."
Information for health car professionals is a little more specific:
"Protopic Ointment, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy (emphasis from source) for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis or when those treatments are not advisable. Protopic is not indicated for children younger than 2 years of age" (original emphasis).
The message here is that Protopic cream is not meant for continued, regular maintenance of a skin condition. However, as evidenced by an entry authored by Kim, a mother of a teen who posted on the talkeczema.com website, the message may not be getting through.
"My daughter who is 16 years old has had eczema for 14 years. The past four years she has been using Protopic and it works wonders. She had severe eczema and allergies and asthma. I am wondering if there is a connection between her always getting boils, infected hair follicles and staph infections related to Protopic. She has also had had herpes virus. I think the side effects of Protopic are like a double-edged sword. She cannot live without the cream and she uses it everyday…"
The entry was posted a month after the FDA issued the black box warning. What's worrisome in this case is the perceived regular use of Protopic skin ointment that is meant to be a second-line defense against atopic dermatitis, and only for a short period of time. That, in comparison to the "everyday" use of the product for four years, according to the girl's mother.
There was no indication from Kim in her posting as to what her doctor thinks of such continued use. However, according to postings on various sites, it appears that Protopic works extremely well for the treatment of eczema. Little wonder that eczema patients would be reluctant to stop using such an effective product.
In reporting its Q1 earnings for 2010, there was no reference from Astellas Pharmaceutical Inc., the manufacturer of Protopic, as to any plans for stepping up public awareness with regard to potential cancer risk, various other side effects and / or the importance of not using Protopic for continued, long-term use. The company did indicate in its Q1 reporting that the market for Protopic is growing, with steadily increasing sales.
In 2001 the FDA issued a warning letter to Fujisawa Pharmaceutical Co. with regard to allegedly misleading advertisements and marketing materials that depicted Protopic as working a little too well.
In 2005 Fujisawa merged with Yamanouchi Pharmaceutical Co. Ltd. to form Astellas Pharma Inc.
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