FDA Urges Stronger Warnings For TNF Blockers

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Don’t mean to scare anyone, but we all know the TNF inhibitors do come with some potentially worrisome side effects. Just wanted to put the news out there so you are informed.

From the NY Times:

WASHINGTON (AP) — The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections.

The drugs — Enbrel, Remicade , Humira and Cimzia — work by suppressing the immune system to keep it from attacking the body. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it is “a double-edged sword,” said Dr. Jeffrey Siegel of the drug agency. That is because the drugs also lower the body’s defenses to infections.

Dr. Siegel, who heads the office that oversees arthritis drugs, said the agency became concerned after discovering that doctors seemed to be overlooking a kind of fungal infection called histoplasmosis . Of 240 cases reported to the agency in which patients taking one of the four drugs developed this infection, 45 died. That is about 20 percent.

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UK Is Not NICE To Arthritis Patients

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The National Institute for Health and Clinical Excellence (NICE) had decided that NHS (National Health Service) arthritis patients in England and Wales can only try one anti-TNF drug. Yes, you read that correctly. Doctors will only get one shot at prescribing the “right” anti-TNF therapy for each of their patients. No pressure there.

Say that one drug is Remicade. If Remicade does not work for a patient or loses its effectiveness over time, people in the UK will not be allowed to try a second TNF inhibitor therapy, such as Enbrel or Humira. Knowing how Enbrel and other anti-TNFs have been life-changing drugs for me and my arthritis friends, this information in this news article really disturbs me.

NICE said that giving patients two, or even three, anti-TNFs is not cost-effective and that doctors should offer patients the next drug in line – rituximab – which costs about £3,000 less per year than the cheapest anti-TNF.

However, around a quarter of patients do not gain any benefit from rituximab.

WTF?

Charities and patient groups are planning to appeal the ruling before the draft guidance is approved in the fall.

I have a lot of complaints about the U.S. health care system, but this definitely makes me appreciate our system a lot more. What do you think of this ruling?

Plan to Curb Arthritis Drug Use