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May 2024
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“Off-Label” Prescribing Responsible for Two Patient Deaths…

New Years Day is supposed to be a time of celebration. To celebrate what’s to come, to celebrate what has happened. Well on New Year’s Day 2007, the U.S. Food and Drug Administration (FDA) announced that two patients suffering from lupus passed away from of a rare brain infection after medical doctors prescribed the Genentech and Biogen drug Rituxan, which was never approved to treat lupus.
The FDA posted a notice on it’s website stating Rituxan was approved to treat lymphoma (cancer of the lymph nodes) and rheumatoid arthritis, but not lupus. In some cases however, medical doctors prescribe the drug to treat lupus. They do this through a practice known as “off-label” prescribing where doctors prescribe a medication (as long as the medicine was approved by the FDA to treat some condition) to treat a condition it was not approved for.
This is an issue that I have found to be ludicrous since day one. In a nutshell, as long as the FDA approves a drug, no matter what it’s for, it can be prescribed for anything. So in reality, if he or she really wanted to, a doctor could prescribe anti-depressant medication such as Prozac for a stomach condition. What a joke!

Think about it. You have stomach problems. You’re always running to the bathroom. Perhaps you have Irritable Bowel Syndrome. You go to the doctor and he/she prescribes a medication for something completely different, which is “justified” by the fact that the drug is FDA “approved”.
Well, here’s a harsh dose of reality. After taking Rituxanm, two patients contracted a rare brain infection known as progressive multifocal leukoencephalopathy (PML) and died. Not only is the drug associated with (PML) but it also includes warning information on viral infections. By the way, after taking the drug, cancer patients reported worsening of existing viral infections or reactivation of old infections.
Here’s the bottom line folks. The FDA says there is no known treatment for PML, and doctors should discuss the risk of taking Rituxan with patients. They claim to be working to gather more information about Rituxan and PML and to strengthen the warnings about PML in the Rituxan product label. But the fact is, they should just simply not allow anyone to prescribe it, period.
The whole thing is a joke which just yet again corresponds to the fact that an alliance between the FDA and the Big Pharmaceutical companies exists.
While in the mind of the unaware public, the FDA “watches over and regulates” the prescription drug market, in reality, anything goes. Unfortunately this time, the proof lies within the death of two human beings.

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Comment from Medic
Time January 24, 2007 at 12:47 pm

The pharmaceutical companies every year increase sales volumes who it supervises? WBR LeoP

Comment from Sandra Bowman
Time February 1, 2007 at 7:34 pm

A related problem can occur with a drug that IS approved for a specific disease if the doctor tells you to take 4 times as much as should normally be taken. I had that happen. Luckily, my pharmacist caught it and I refused to take it as prescribed. My doctor said he didn’t see any harm in it even if it was ‘off label’. He’s no longer my doctor.

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