FDA orders stronger warnings for 4 arthritis drugs

This is an article I read in my local paper. This is the whole story word for word. But, there are MANY MANY other things posted on the net about these sort of things. If you'd like to read more, let me know and I will post them for you! Thanks for reading, this is VERY important!! Here it goes:

The Food and Drug Administration ordered stronger warnings Thursday (August 4, 2008) 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 joints, but it's a \"double-edged sword\", siad the FDA's Dr. Jeffrey Siegel. That's because the drugs also lower the body's defenses to various kinds of infections.
Siegel, who heads the office that oversees arthritis drugs, said the FDA became concerned after discovering that doctors seemed to be overlooking a particular kind of fungal infection called histoplasmosis. Of 240 cases reported to the FDA in which patients taking one of the four drugs developed this infection, a total of 45 died ---about 20 percent.
The infection, which mimics the flu, is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body.
Siegel said the investigation began with a single case of a woman taking one of the drugs who died of histoplasmosis. Delving into the case, doctors at the FDA found that the woman had been sick with the fungal infection for a long time. \"This case led us to be concerned that there may be other situations in which physicians may not recognize histoplasmosis,\" said Siegel.
FDA officials searched the agency's database and found the 240 cases of patients taking the medications who had also developed the fungal infection. Of those, at least 21 appeared to involve a late diagnosis, and 12 of them -- more than half --- ultimately died.
Siegel said the FDA order Thursday means that the risk of histoplasmosis will be flagged in a \"black box,\" the strongest warning information in a drug's prescribing literature. The four medications already have black box warnings about the risk of infections, but the language varies from drug to drug.
Patients should call their doctor if they develope persistent fever, cough, shortness of breath or fatigue, which can be signs of the fungal infection.
The FDA is also urging doctors to consider aggressive use of antifungal drugs in patients who develop such symptoms, even if the infection has not been confirmed by a laboratory test. Siegel said such a decison should not be taken lightly, since antifungal drugs can also have dangerous side effects. Doctors should consider stopping treatment with the immune-suppressing drugs if patients develope infections.
The four drugs belong to a class known as TNF-alpha blockers, and are considered a mainstay for treating rheumatoid arthritis, a disabling disease in which the immune system attacks the joints. They are also used to treat Crohn's Disease, juvenile arthritis, certain types of psoriasis, and other immune system disorders. All are taken by injection.
Seperately, the FDA is investigating a possible link between the four medications and cancer in young patients. They agency said earlier this year it has received 30 reports of cancer, mainly lymphomas, in patients who began taking the medications when they were 18 or younger. That investigation is expected to take the rest of the year.
Three of the drugs, Enbrel, Humira and Remicade, are considered blockbusters, with sales of over $1 billion annually for each. Cimzia is newer and less widely used.

This photo is something I posted and (of course) was NOT in the paper.

<br><br>Post edited by: BrokenSoul85, at: 2008/09/10 22:37

I like the ink there! Thanks for posting this keisha. It,s very interesting. My concerns this week are also on the news. Apparently regular use of a particular type of indegestion meds has been linked to brittle bones!! Im always using these along with omeprazole for recuring gastritis. Does anyone know anything about this as well? Im not great at pc,s at all but im trying to find out what/which tablets they said is linked. This is a really good way of keeping ourselves informed and up to date on issues like medication and such like so wicked idea and thanks keisha! Cat

For saome of us over here in the UK, Remicade is better known as it's generic name of Infliximab, and is widely used - i had it years ago, it got stopped and I went onto MST instead.
Enbrel is known as Etanercept, and is not widely used now, as it's so hard to get hold of, and NICE have withdrawn it from their list.
Humira is known over here as Adalimumab, and is the most common in use for not just Still's, RA etc, but a multitude of other illnesses. With none of them has it been 100% proven that they cause cancer, but so I understand trials are continuing with Embrel.

Great article, (welcome by the way), thanks for posting it.

the unpacking continues....

Well...I for one am greatful...Im taking Embril for several years..and after an infection over Christmas,have had resperatory problems....
I hadnt considered this ...many thanks xxx;)

Hmmm....Cat, I think I had heard something about that. I will run a search for you and post what is found. And to all of you...thanks for your responses! Also, the pic I posted was an injection site reaction from Enbrel that I thought should be shared with you all. There were many other bad side effects that, lucky me, got to suffer from.lol. I'm happy for those of you it's helped, but for the rest of us...just wanted to share the possible type of injection site reaction you may get. Believe me...the little boogers hurt and itch! lol.<br><br>Post edited by: BrokenSoul85, at: 2008/09/26 12:43

tonypark wrote:

Well...I for one am greatful...Im taking Embril for several years..and after an infection over Christmas,have had resperatory problems....
I hadnt considered this ...many thanks xxx;)

Tony,
I had taken Enbrel for about a year (even though I didn't want to), but anyway..after about a month or two on it I was diagnosed with Pleurisy. Pleurisy is an inflammation of the lining of the chest wall and lungs. It can cause coughing, some types of chest and lung pain...especially when taking a deep breath in and sometimes just when u breathe in, period. Hope this helps! Good luck!