FDA panel recommends dangerous drug for psoriasis in kids

Dazed and Concerned

Here’s how a Reuters Health headline put it: “Amgen’s Enbrel in Kids ‘Concerning,’ FDA Staff Says.”

Concerning. How touching! Someone at the FDA is concerned.

What in the world could move FDA staff members to work themselves up into a case of actual concern? Well, how about the deaths of a few kids for starters?

Plenty of good reasons

In May, an “FDA Talk Paper” offered this note about Enbrel, a rheumatoid arthritis drug: “New postmarketing reports indicate that certain patients receiving Enbrel have developed serious infections, including sepsis, and that several of these patients have died from their infections.”

But that wasn’t May 2008. It was May 1999. And in the ten years since the FDA approved Enbrel, this has been the trend: more and more reports of serious side effects.

Now Amgen wants the FDA to approve Enbrel as a treatment for psoriasis in children. But according to Reuters, in nearly 950 cases where Enbrel was used to treat children for either arthritis or psoriasis, reports of “serious complications in children ages 4 to 17,” reveal “14 deaths and 76 other life-threatening complications” including sepsis infections, anemia, and seizures.

But wait – it gets worse.

Kids in jeopardy

In an FDA report last month, officials announced an investigation into 30 cases of cancer in children and young adults who were taking “TNF blocker” drugs. Enbrel is in this class of drugs.

Okay – let’s review. We’ve got potential cancer risk, serious infections, seizures, and other life-threatening complications in the mix here. So here’s an idea: How about saying no to Enbrel use in kids until we’re absolutely sure the drug won’t put children at serious risk?

But in FDA World, that’s just crazy talk.

Last month, an FDA advisory panel recommended that Enbrel be approved for use in children who have moderate-to-severe psoriasis. The panel also recommended that Enbrel’s label be “strengthened” to inform parents that side effects could lead to hospitalizations and deaths.

A strengthened label? Oh yeah, it’s on! Sepsis, seizures, and cancer don’t stand a chance against a strongly worded label.

Sources:
“Amgen’s Enbrel in Kids ‘Concerning,’ FDA Staff Says” Susan Heavey, Reuters, 6/16/08, reuters.com
“New Warning for Arthritis Drug, Enbrel” FDA Talk Paper, 5/12/99, fda.gov
“Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade Enbrel, Humira, and Cimzia)” FDA, 6/4/08, fda.gov
“FDA Panel Recommends Enbrel for Pediatric Patients” HealthDay, 6/18/08, nlm.nih.gov