Skin Drugs Used By Millions Could Pose Cancer Risk

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protopic(CBS) CHICAGO Drugs used to treat skin conditions were prescribed to millions of users for years before federal authorities warned that the medicines might cause cancer. CBS station WBBM-TV In Chicago's Dave Savini reports on the risks that some say should have been made known from the start.

“I would never have put this in my body had I known how toxic and potent this drug was,” says Traci Reilly of Naperville, who believes two widely prescribed medications may be responsible for her breast cancer. “I noticed a lump in my right breast which is the exact area where I was using the drug.”

Reilly, 41, developed breast cancer after using a topical ointment called Protopic and a similar drug named Elidel. Both are commonly prescribed for skin disorders like eczema or, in Reilly’s case, a condition called vitiligo that caused small patches of discolored skin on her body.

Protopic and Elidel have been on the market for the last five years and, combined, have been prescribed to 7.5 million people, including children.

It wasn’t until last year, January 2006, that the U.S. Food and Drug Administration, warned of a cancer risk. It added a black box warning to both drugs and requested that long-term cancer studies be conducted by the drug makers.

Warning too late

Reilly didn’t find out about the warning until after her mastectomy and agonizing chemotherapy cancer treatment. That’s when she received a letter from her doctor about the cancer risk.

“I had no idea (about the warning), and when I opened (the letter) up I was totally freaking out. I was so angry that this had happened,” Reilly said.

Reilly’s story is one example of many cancer cases that may be connected to the two drugs.

“There should have been warnings from the start,” says Tom Moore, an author of several books involving the pharmaceutical industry.

Moore studied about 1,200 cases of suspected drug injuries pertaining to Protopic and Elidel reported to the FDA through 2005. He found more than 100 potential cancer cases in children and adults and says most involve lymphoma or skin cancer. However, these cancers may not all be linked to the drugs.

Moore said these numbers may also be low. Most adverse drug reactions are never reported to the agency. “Neither the drug companies nor the FDA really have the slightest idea how many cancer cases might have been reported,” Moore says.

He also says the FDA made a mistake by ignoring earlier warning signs associated with the oral form of Protopic, called Prograf (Tacrimilus). Prograf is used to prevent transplant patients from rejecting new organs.

According to the FDA, Prograf is “known to cause both skin cancers and lymphoma in humans by suppressing the body’s normal immune defenses against cancer.”

A 2005 FDA report involving animals given high doses of protopic concluded there are “serious safety concerns regarding the potential for carcinogenicity of these agents in humans.” In one study, monkeys developed cancer after receiving the oral form of the drug. That study, in conjunction with the drug injuries reported to the FDA, led to the black box warning. As a result, long-term cancer studies involving the topical form of both drugs are now being conducted.

“The weight of the evidence suggests that these drugs have some cancer risk,” Moore says.

Companies tout safety

Representatives from Astellas Pharma U.S., Inc. and Novartis Pharmaceuticals Corporation, the companies that manufacture Protopic and Elidel, respectively, say the drugs are safe based on clinical trials in humans, and can be valuable treatments in managing skin diseases.

A written statement from Novartis says, “Novartis is committed to patient safety and Elidel is one of the most thoroughly researched dermatology products in the world.”

“A causal relationship has not been established between Protopic and the rare cases of malignancies that have been reported in patients,” said a written statement issued by Astellas. “Protopic remains safe and effective when used in a manner consistent with its label and is an important treatment option for children aged 2 and older and adults with moderate to severe eczema.”

Many physicians agree.

“We can’t panic at this time,” says Dr. Anthony Mancini, head of pediatric dermatology at Children’s Memorial Hospital in Chicago. “These drugs still should be included as part of our tool box for treatment of inflammatory skin conditions.”

Mancini tells all patients about the black box warning, but he believes the drugs are safe and are needed to treat people with severe skin disorders. He even prescribes them for his own children to treat flares of eczema.

“My heart goes out to patients who have developed a malignancy,” Mancini says, although he has seen no conclusive evidence linking the topical drugs to cancer in humans.

“We all eagerly anticipate results of long-term studies that are underway,” he says. “We should not be close-minded to the fact that every drug has a potential risk and every drug has a potential benefit, and it all comes down to a balance of the two.”

Studies continue

For Dawn Grish of Lockport, an eczema sufferer, the benefits she’s experienced from using both drugs encourage her to continue the treatments. She says she believes the drugs are safe but, “I do think the investigations by the appropriate agencies should continue so that the health of everyone is a consideration.”

“If I would have been warned of the risks, I would have said, ‘Never mind. It’s not worth losing one of my children,’” said Aarah Logan whose 9-year-old son, Karl Wymbs, died after using Protopic to treat eczema.

The black box warning had not been issued when their doctor prescribed the drug for Karl. He developed an application site lymphoma after using Protopic for about a year.

“On his last day he asked me, ‘Why is this happening to me?’ I didn’t have an answer for him,” said a tearful Logan, who is suing Astellas, the maker of Protopic.

Several wrongful death and injury lawsuits involving these drugs have recently been filed across the United States. Tom Moore is a drug-safety consultant hired by some of the lawyers. Neither company will comment about pending litigation.

Reilly, who is planning to file a lawsuit, spent the last year researching the drugs and trying to warn others about what she considers the potential dangers.

“I was young. I was healthy and all of a sudden I use one drug on one part of my body and that’s the part I get cancer in. It just doesn’t add up,” Reilly says.

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