What is the FDA thinking? If the Crohn’s does not kill us, the treatments will.

by Brandee

What the hell is a person suppose to do? I’ve been here before; wondering what the 6MP would do to me over time, as over time the dosage has risen from 50mg to 100mg. I’ve seen what medications can do to people over time. I have a couple of family members who are suffering the effects of long term medications they took 20 years ago. Now, with the FDA forcing stronger cancer warnings on drugs like Remicade and Humira, it’s back on my mind again. Not that it was ever that far.

The big picture about the FDA is that until their death/injury quota is satisfied, they sit still. Once the quota has been met or someone screams loud enough, it still takes months, even years, for these drugs to be pulled or have more strict labeling instituted. Since Remicade and like drugs are given intravenously, where does the patient or guardian get the information leaflet in the package? Personally, I have never had anyone give me one for anything I’ve had done at the hospital, nor inform me of risks. Then again, I have never had a Remicade treatment.

I have found that Remicade was initially approved in 1998 to treat Crohn’s disease in adults. And they knew as early as 1998 about the cancer risks, yet  Remicade (infliximab) was approved to treat children with active Crohn’s disease on May 19th 2006. What?

Furthermore, evidence published in May 2006 in the Journal of the American Medical Association, suggests that Remicade can TRIPLE the risk of skin cancer . While previous studies indicated the increased risk of infection and lymphoma, a blood cancer, this is the first study to show that Remicade can cause skin cancer. Remicade treatment has been previously linked to serious side effects, including fatal reactions such as heart failure and infections including tuberculosis, histoplasmosis, listeriosis, and pneumocystosis. The FDA issued a series of warnings and now requires the drug to carry a special “black box warning” on its label, a heightened warning for potentially dangerous drugs.

On September 4, 2008, the FDA ordered a stronger warning for Remicade and for three other drugs used to treat rheumatoid arthritis. The FDA is warning users that they are at risk of developing potentially fatal fungal infections. In its announcement the agency reports that 240 users of the drugs have contracted a fungal infection called histoplasmosis. 45 of the reported cases have resulted in death.

And then today, 11 years, 2 months and 4 days after it first approved the drug for Crohn’s Disease treatment- we are supposed to feel safe because ANOTHER black box warning was issued. According to the news release, the FDA is investigating approximately 30 reports submitted to its Adverse Event Reporting System over a ten-year interval, beginning in 1998 and extending through April 29, 2008. These reports described cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less.

The same news release also informed the public that it had received rare post-marketing reports of an aggressive and often fatal type of T-cell lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with Crohn’s disease. In most cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-mercaptopurine) in combination with Remicade. The FDA also stated that these risks were already included in the labels for all approved TNF-alpha blocking agents, including Remicade, and it was working with the manufacturer to address this risk by updating the Warnings sections of the Remicade label.

The FDA also stated that it still believes that the potential benefits of the use of TNF blockers outweigh the potential risks. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, health care providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

I seriously doubt that FDA Gods or any of their family members on on the drugs that we are on. If they were, the FDA would not be issuing horrendous statements like,”…use of TNF blockers outweigh the potential risks.” Thank you for looking out for us, FDA.

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