** Originally posted by ScottinFL **
I just searched enbrel on Yahoo and Google. This is a very scary drug!!
It seems that the FDA ordered the company to go back and revise their warning label after several deaths and many serious infections, siezures and more.
Other Dangerous Treatments Enbrel
Many other patients with autoimmune diseases such as rheumatoid arthritis have used Enbrel (etanercept). This drug was approved by the U.S. Food and Drug Administration in 1998. Like Remicade, Enbrel was widely promoted its maker as a wonder drug, however it also has potent and dangerous side effects. The adverse effects that are known are often serious and can be fatal. Attorneys believe that many patients have not been fully warned of the risks of using enbrel and many have suffered serious long term injury.
Enbrel is a genetically engineered antibody, that works by inhibiting the natural actions of the body's inflammatory and immune systems. Enbrel works by inhibiting part of the body's natural defenses against serious infection called the tumor necrosis factor (TNF). The suppression of this chemical can lead to serious problems however.
Although many sufferers of rheumatoid arthritis prescribed Enbrel have had positive responses, the drug has a dark side. In subsequent studies Enbrel is reportedly linked to serious infections and sepsis, nervous system disorders such as multiple sclerosis, seizures, blood disorders, tuberculosis, SLA, inflammation of the nerves of the eyes, and death. Other researchers are concerned about the long-term effects of Enbrel and TNF antagonists in general both in the dangers of infection, and autoimmune disease.
Within months of approval, reports about Enbrel noted nearly thirty serious infections and six fatalities. This prompted a warning letter to be send out to prescribing doctors and added to the drug label warnings section. The new warnings discussed infections and sepsis and advised doctors not to use Enbrel to use caution in patients with a history of recurring infections, and to stop Enbrel if serious infection arises.
In October 2000, a second warning letter was sent out to doctors stating that "Rare cases of central nervous system disorders, including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis; have been reported in patients with rheumatoid arthritis who have received Enbrel therapy [and that] rare cases of pancytopenia, including aplastic anemia, some with a fatal outcome, have been reported in patients with rheumatoid arthritis who have received Enbrel therapy."
In January 2002, the FDA warned about serious nervous system problems related to Enbrel, involving demyelination, producing MS and other conditions; patients were also warned to watch for vision changes.
Remicade has also been linked to the deaths of congestive heart failure patients. On October 18, 2001, Centocor, Inc. issued an "Important Drug Warning" which announced that seven of one hundred one patients treated with Remicade had died during ongoing testing, compared to zero deaths among 49 test patients not using Remicade. The following day, the Food and Drug Administration revealed Remicade's potentially negative effects on patients with congestive heart failure. Subsequently, a detailed statement was issued to physicians describing the reasons for the warning and recommended treatment changes for patients with congestive heart failure taking the drug. According to the Centocor, Inc. it was determined that patients with moderate to severe congestive heart failure were at higher risk of death or worsening of their condition while taking Remicade. For congestive heart failure patients with Crohn's disease or rheumatoid arthritis, Centocor, Inc. advised against initiating any Remicade therapy.