- Home
- Medical Conditions
- Arthritis
- RA Drugs Have New Warnings, But Will the Doctors Listen?
- Home
- Pharmer's Market
- RA Drugs Have New Warnings, But Will the Doctors Listen?
RA Drugs Have New Warnings, But Will the Doctors Listen?
- By Joseph Mercola, DO
- Published 08/29/2001
- Arthritis , Pharmer's Market
- Unrated
Johnson & Johnson's labeling for its drug Remicade will be updated with a boxed warning stressing that the drug can increase the risk of infections.
The company's statement comes just 2 days before an advisory committee to the US Food and Drug Administration (FDA) is scheduled to discuss whether stronger warnings are needed for Remicade and Enbrel.
The drugs are tumor necrosis factor (TNF) blocking agents. In excessive amounts, TNF is believed to trigger joint inflammation -- but it also helps combat infections.
As a result, TNF inhibitors may increase the risk of infection, especially in elderly patients taking immune-system-suppressing treatments for other conditions. Remicade has been associated with 84 cases of tuberculosis worldwide, including 14 fatal cases.
Along with strengthening the basic warning, the new label -- which was devised in cooperation with the FDA -- will instruct physicians to screen patients for tuberculosis and treat any such infections before Remicade is prescribed.
The labeling revision also highlights the risk of various other opportunistic infections, such as the serious lung infection pneumocystis.
Centocor plans to send letters to healthcare professionals and create a patient leaflet to help reinforce the new information. The company said it would also continue to collect safety data on about 15,000 patients to ensure that the labeling changes are sufficient.
Remicade has been prescribed to more than 170,000 patients since its launch.
Immunex spokesperson Robin Shapiro said the company does not expect its rheumatoid arthritis drug Enbrel to need a similarly strengthened warning.
Last year, Enbrel's labeling was updated to include warnings about the possibility of central nervous system disorders and pancytopenia, a drop in the body's number of red and white blood cells.
Reuters August 15, 2001
Dr. Mercola's Comments:
In light of last week's JAMA study which documented very clearly that doctor's do NOT listen to these warnings for the most part, what difference do they make?
Well, they do at least give one a fighting chance. If you are diligent, you can look them up on the Net or in this newsletter and find out what the dangers are.
They, of course, give the pharamaceutical companies an out and they can say they warned doctors about this but they did not listen, knowing full well they will not listen and all the while they will continue to collect their profits for selling many of these deadly poisons.
Tragic? You bet.
Especially when there are such effective solutions for RA. I have treated over 2,000 patients with RA successfully with my revision of Dr. Brown's work with mycoplamsa. The eating plan is especially useful and more recently NST has been a major benefit for most of the RA patients that we care for.
Be on the watch also for future RA drug, s as an advisory panel to the US Food and Drug Administration (FDA) on August 16 recommended that the FDA approve Amgen Inc.'s Kineret (anakinra), an intravenous drug for RA. The FDA is not bound by advisory panel recommendations, but it usually follows them.
Similarly, Kineret works by inhibiting other immune substances believed to be involved in the inflammation that marks RA.
The FDA panel's decision was based upon three clinical studies, in which it was demonstrated that Kineret had a 20% greater effect than a sugar pill in alleviating patients' symptoms. RA symptoms include joint pain, swelling and stiffness.
In all the clinical trials, a majority of patients had injection site reactions and about 12% suffered from low white blood cell counts. In one small trial conducted in combination with Enbrel, about 7% of the patients suffered from infections with flu-like symptoms.
So what about the risk-benefit ratio?
Obviously not very good here.
© Copyright 2008 Dr. Joseph Mercola. All Rights Reserved.
The company's statement comes just 2 days before an advisory committee to the US Food and Drug Administration (FDA) is scheduled to discuss whether stronger warnings are needed for Remicade and Enbrel.
The drugs are tumor necrosis factor (TNF) blocking agents. In excessive amounts, TNF is believed to trigger joint inflammation -- but it also helps combat infections.
As a result, TNF inhibitors may increase the risk of infection, especially in elderly patients taking immune-system-suppressing treatments for other conditions. Remicade has been associated with 84 cases of tuberculosis worldwide, including 14 fatal cases.
Along with strengthening the basic warning, the new label -- which was devised in cooperation with the FDA -- will instruct physicians to screen patients for tuberculosis and treat any such infections before Remicade is prescribed.
The labeling revision also highlights the risk of various other opportunistic infections, such as the serious lung infection pneumocystis.
Centocor plans to send letters to healthcare professionals and create a patient leaflet to help reinforce the new information. The company said it would also continue to collect safety data on about 15,000 patients to ensure that the labeling changes are sufficient.
Remicade has been prescribed to more than 170,000 patients since its launch.
Immunex spokesperson Robin Shapiro said the company does not expect its rheumatoid arthritis drug Enbrel to need a similarly strengthened warning.
Last year, Enbrel's labeling was updated to include warnings about the possibility of central nervous system disorders and pancytopenia, a drop in the body's number of red and white blood cells.
Reuters August 15, 2001
Dr. Mercola's Comments:
In light of last week's JAMA study which documented very clearly that doctor's do NOT listen to these warnings for the most part, what difference do they make?
Well, they do at least give one a fighting chance. If you are diligent, you can look them up on the Net or in this newsletter and find out what the dangers are.
They, of course, give the pharamaceutical companies an out and they can say they warned doctors about this but they did not listen, knowing full well they will not listen and all the while they will continue to collect their profits for selling many of these deadly poisons.
Tragic? You bet.
Especially when there are such effective solutions for RA. I have treated over 2,000 patients with RA successfully with my revision of Dr. Brown's work with mycoplamsa. The eating plan is especially useful and more recently NST has been a major benefit for most of the RA patients that we care for.
Be on the watch also for future RA drug, s as an advisory panel to the US Food and Drug Administration (FDA) on August 16 recommended that the FDA approve Amgen Inc.'s Kineret (anakinra), an intravenous drug for RA. The FDA is not bound by advisory panel recommendations, but it usually follows them.
Similarly, Kineret works by inhibiting other immune substances believed to be involved in the inflammation that marks RA.
The FDA panel's decision was based upon three clinical studies, in which it was demonstrated that Kineret had a 20% greater effect than a sugar pill in alleviating patients' symptoms. RA symptoms include joint pain, swelling and stiffness.
In all the clinical trials, a majority of patients had injection site reactions and about 12% suffered from low white blood cell counts. In one small trial conducted in combination with Enbrel, about 7% of the patients suffered from infections with flu-like symptoms.
So what about the risk-benefit ratio?
Obviously not very good here.
© Copyright 2008 Dr. Joseph Mercola. All Rights Reserved.
