"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, a 41-year-old stay-at-home mom, 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, in 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.
Reilly took the drugs for about a year, until late 2003, when she was diagnosed with breast cancer. She didn't find out about the FDA warnings until after her mastectomy and agonizing chemotherapy treatment. That's when she received a letter from her doctor about the cancer risk - about two years after she had stopped taking the drug.
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.
He also said 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.
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."
"We can't panic at this time," said Dr. Anthony Mancini, head of pediatric dermatology at Children's Memorial Hospital in Chicago. "These drugs still should be included as part of our toolbox 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.
For Dawn Grish, of Lockport, an eczema sufferer, the benefits she's experienced from using both drugs encourage her to continue the treatments. She said 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."
But Aarah Logan, whose 9-year-old son, Karl Wymbs, died after using Protopic to treat eczema, said, "If I would have been warned of the risks, I would have said, 'Never mind. It's not worth losing one of my children.'"
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.
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.
Source: www.nbc5.com
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