any evidence that eczema skin cream causes cancer?

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FDA Public Health Advisory
Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment

The FDA is issuing a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.

The FDA recommends that healthcare providers, patients and caregivers consider the following:

Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.

Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.

Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.

Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.

Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.

Elidel cream and Protopic ointment are topical immunosuppressant calcineurin inhibitors that are applied to the skin and are the only approved drug products in this class.

Animal studies have shown that three different species of animals developed cancer following exposure to these drugs applied topically or given by mouth, including mice, rats and a recent study of monkeys. These studies were conducted at doses higher than generally used by patients and the risk of cancer increased with increasing drug dose and duration.

In addition to an ointment, tacrolimus, also comes as a pill or by injection, this form is known as (Prograf). Prograf is approved to prevent liver or kidney transplant rejection. It is known to cause both skin cancers and lymphoma in humans by suppressing the body’s normal immune defenses against cancer. The cancer risk increases with higher doses and longer treatment courses of Prograf. Both Elidel and Protopic are sometimes absorbed through the skin, though usually at very low amounts. Occasionally, children who have been treated with Elidel or Protopic have had high blood levels of these drugs.

Protopic was approved in December 2000 and Elidel in December 2001. Since their approval, FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic; whether the reported cancers are associated with these products has not been clearly established.

Based on the advice of the FDA Pediatric Advisory Committee, which met on February 15, 2005, to review these findings, FDA will require labeling changes for Elidel and Protopic, including the placement of a boxed warning about the potential cancer risk. In addition, FDA will work with the commercial sponsors of the drugs to develop and implement a Medication Guide (MedGuide) to provide this information and instructions about appropriate use of Elidel and Protopic to patients, their families, and caregivers. MedGuides are intended to be distributed by pharmacists with each prescription or refill of a medication.

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© 2004 What Doctors Don't Tell You (Volume 16, Issue 3)

Studies have revealed that three different species of animals developed cancer (including skin cancer and lymphomas) after topical applications of Elidel (pimecrolimus) and Protopic (tacrolimus) eczema creams.
The effects of Elidel and Protopic on the developing immune system in children is not known. In clinical studies with Elidel, children under two had a higher rate of upper respiratory infections than those treated with a placebo cream.

As the long-term safety of the creams remains questionable, the FDA advises that they should be used for just short periods of time and only by patients who don’t respond with or are intolerant of other treatments. Children and adults with compromised immune function should also avoid these creams, says the American regulatory body.

As well as a cream, tacrolimus can also be taken in a pill or by injection to prevent liver or kidney transplant rejection. Marketed as Prograf, it can cause skin cancer and lymphomas in people by suppressing normal immune defences. The higher the dose and longer the treatment, the higher the cancer risk (

What Doctors Don't Tell You (Volume 16, Issue 3)

Could a skin cream be giving you cancer?

04:15 PM MST on Friday, April 27, 2007

By Jeremy Rogalski /KHOU-TV

In a word, faith is what pulls the Rev. Johnny Henderson through this time of his life.

Henderson fans picture after picture of himself across the table. And they are of Henderson, but you might not realize it.

“This is when it was at its worst,” he said, looking down.

In each picture, his face and body is covered with discolorations and what appear to be growths.

He said his doctor called it cancer. Henderson just calls it a living hell.

“That’s that monster,” Henderson said.

He has since had months of cancer treatment.

“Nah, that’s not me,” he said.

But Henderson said he’s angry. Why? Because he claims his cancer appeared after using a prescription cream called Elidel for several months.

“My understanding was that the Elidel was supposed to help,” he said. The medication is used for eczema, a dry, itchy skin condition. In fact, Elidel did help.

But then Henderson said he noticed the problem.

“Everywhere that I applied it on my body, that’s where the rashes came,” he said.

And what’s worse, he said there was never any warning of such a potentially serious side effect.

Instead, Henderson claims the drug manufacturer was “promoting it like it was all this and all that.”

But Henderson isn’t alone.

“If I was warned about it, I would have never used it,” Dale Nalley said about Protopic, a similar product also used for eczema.

But Nalley said he thinks he developed a side effect from that Protopic: “Turns out, I developed Hodgkin’s lymphoma. It hit me like a ton of bricks.”

He said it took him several rounds of chemotherapy to battle the disease.

Now Nalley worries.

“I mean people need to know about this,” he said, “If it’s causing these things, it’s just scary.”

But did someone already know? 11 News Investigates has discovered both the Food and Drug Administration and the drug makers were aware there might be a cancer risk early on before the products ever hit the market, yet they wound up in the hands of millions.

Originally the drug was sold as Prograf, a pill that helped patients not reject organ transplants. But it was only to be used in life-threatening cases because studies showed it created a risk for cancer in patients.

In fact, by 1994 the FDA required Prograf carry a warning label alerting the public of possible cancer dangers.

But then in 2000 and 2001 came new topical forms of the drugs: Protopic, manufactured by the Astellas Corporation came first, then Elidel made by Novartis. Again, both drugs were to be used to treat the non-life threatening condition, eczema.

And so despite past cancer concerns with the pill or oral form of Prograf, both Protopic and Elidel were approved for use in the United States by the FDA.

"It is extremely worrisome,” said Dr. Sidney Wolfe about the FDA’s approval of these drugs. Dr. Wolfe is with the watchdog group Public Citizen.

“It’s especially worrisome when the disease being treated is not that serious,” Dr. Wolfe said.

Wolfe also said despite the cancer warnings of the pill form he said, the two creams had no thorough cancer testing before getting that FDA approval.

“Once you approve a drug for anything,” Dr. Wolfe said, “the industry gets a running head start and tries to promote it.”

It turns out in this case, both drugs were heavily promoted for use on children.

Brandon Butzberger’s parents used Elidel on him. They said by age 4 he was frail and weak from liver cancer.

“It was our worst nightmare,” his mother Cecilia said.

She said, “on TV, they had commercials,” calling it a safe, new treatment. So his parents used it on Brandon for a year.

Then they said their boy’s health went straight downhill.

His father David said doctors eventually told them, “chances are he has about a 10 percent chance to live.”

But Brandon eventually beat the odds and is recovering.

But other children were not so lucky.

Aarah Logan’s son Karl used Protopic for his Eczema, and mom said after a year came the diagnosis: stage three cancer.

Karl Logan died before his 10th birthday.

“He asked me, ‘why is this happening to me?’” she said. “And I just, you know, I didn’t have an answer for him.”

So you might be asking where was the FDA?

11 News Investigates read and listened to records of a 2003 FDA Advisory panel where several doctors discussed the possible cancer dangers.

“How much stronger does the signal have to be before the drug is considered inappropriate for a non-life threatening condition?” asked one.

Part of their concerns included “animal studies that showed increases in malignancies,” other data indicating “a small number of human malignancies,” and “no long-term safety data” to evaluate the potential cancer risk of the two products.

“I think people should be aware,” one panel member said.

But the public didn’t become aware for another two-and-a-half years.

“But meanwhile, the drug is out there, exposing huge numbers of people,” Dr. Wolfe said.

Finally in January 2006, the FDA issued a so-called black box warning informing the public of the potential risk to cancer from both Protopic and Elidel.

But there are also strong supporters of both drugs.

“I think they are very safe,” Dr. Madeleine Duvic said. “I think every drug has side effects.”

Dr. Duvic is a board member of the American Academy of Dermatology.

“There are millions of people who use these drugs, without a problem,” she said. “And there’s a handful of anecdotal cases where something has gone awry.”

Dr. Duvic said those cases “could be chance or it doesn’t prove causality” or a connection between any cases of cancer and the two skin products.

However, you should also know that Elidel’s manufacturer is currently paying Dr. Duvic to study their drug.

But she said, “I’m not getting enough money that that would cloud my judgment.”

And what do both manufacturers have to say?

The Astellas company claims: “Protopic remains safe and effective when used in a manner consistent with its label,” and that clinical studies of more than 20,000 patients and data on 2.1 million patients do not show an increased cancer risk “compared with rates in the general population.”

The Novartis company told 11 News that Elidel is a “safe and valuable treatment” for short-term use against Eczema. It also says that clinical trials in 21,000 patients, and experience with 6 million patients worldwide show Elidel is not associated with an increase cancer risk.

Both companies emphasized no causal link has been established between their products and the “rare” reports of cancer.

But that does little for Johnny Henderson and other former users who think they should have been given a warning

“It did mess with my life,” Henderson said. “The old saying is you’re a guinea pig; that’s what it made me.”

11 News requested for on-camera interviews with both drug companies and the FDA but all declined.

But the FDA did say that it appropriately balanced the risks with the benefits when originally approving the two creams but added that long-term cancer risk studies are needed regarding these medicines

However, Dr. Wolfe said the FDA has gone from a watchdog to a lapdog in terms of protecting the public. Among other factors, Dr. Wolfe blames the nearly $400 million-a-year he said the agency gets from drug companies as part of a government program.

One final note: Some of the cancer victims in this story either plan or have filed a lawsuit against the Novartis or Astellas companies.

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