Jonathan Radzik was only 13 when he died from a very aggressive T-cell lymphoma.

Certainly, the death of a child is tragic under any circumstances.

But in Jonathan’s case, his parents — and now a jury — blame the Remicade he received to treat his Crohn’s disease for his death.

And they also blame the doctor who gave the Connecticut boy 16 Remicade infusions over the course of two-and-a-half years without so much as breathing a word to his parents about the risk of Jonathan coming down with a deadly cancer.

Despite this verdict for the Radzik family, however, children are still receiving Remicade infusions all the time.

Children as young as six years old.

Addressing ‘the risk’

When does a drug become just too dangerous to prescribe — especially for kids?

When it can lower your immune function enough so you’re “more likely” to come down with “serious infections,” even TB? When it can trigger “very aggressive” cancers and rare lymphomas?

Or how about when it can cause blood disorders, central nervous system disorders, “lupus-like syndrome,” and a whole host of other persistent and sometimes fatal conditions?

Those side effects are just some of the ones listed on the book-length label of Remicade — a med that somehow has been able to wrangle over a dozen approved uses out of the FDA for conditions ranging from Crohn’s disease to plaque psoriasis.

But despite the lawsuits, despite the added black-box warnings, and despite nine mentions of “death” on the Remicade label, the drug just seems to march on like an Energizer Bunny.

Around the same time (over a decade ago) that the FDA approved the med for kids, who, like Jonathan, had Crohn’s disease, it also knew that deadly T-cell lymphomas were showing up in some who received the drug. And here’s how the agency leaped into action to “address this risk”:

It worked with the manufacturer to update the warnings on the Remicade label!

Well, that certainly makes the drug safer now, doesn’t it?

But wait, you didn’t think that was all the FDA had in mind to protect kids, now, did you?

The agency also has required the drugmaker to conduct postmarketing research on Remicade and other TNF blockers (which includes Humira and Enbrel).

Janssen (which makes Remicade) actually has eight of these currently going on with the drug. One, just for children, will tally up the reports that come in as to how many kids on it develop cancer. That will finish up in 2020.

Another one has been designed to keep tabs on kids with Crohn’s disease given the drug so Janssen can establish “long-term… safety information.” That one is due 2027. No, I’m not kidding.

It’s hard to believe that innocent little children as young as six (maybe even younger if used off-label) are being used as guinea pigs to find out in ten years how “safe” this drug really is.

I think we know enough already to say that if your child is suffering from Crohn’s disease, ulcerative colitis or any other inflammatory condition, biologics such as Remicade shouldn’t even be discussed, let alone used.

Following an anti-inflammatory diet is a must in such cases. And so is finding a doctor for your child or grandchild who believes that giving drugs to children that can leave them vulnerable to possibly fatal infections and “a rare type of T-cell lymphoma” isn’t even an option.

And if your child’s doctor thinks otherwise, just give him five minutes with Jonathan Radzik’s parents.

“Doctor faces $6.8 million verdict after boy dies of cancer” Robert Storace, February 27, 2017, Connecticut Law Tribune, ctlawtribune.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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