Wednesday, December 28, 2011

Night 136 - Long Silence As Ennui Sets In + The Side Effects Added To Warning Label Of Peg Interferon - Depression and Suicidal Ideation

I know I have been silent for almost ten days which is the longest gap since I started treatment. It is strange because you would think I would have been silent during he nightmare and living hell of the constant itch and pain of the rash and staph infection. But the blog was my life preserver during that six weeks of hell, and it provided me with a sense of value and faith. Now things have shifted as I slowly recover from the trauma while remaining on the Interferon and the Ribavirin. 
Although I See The Way Out, I Remain In The Dark Tunnel At Essence

Although I see the light at the end of the tunnel I am still in the tunnel, still nursing my wounds, and, in the stillness of the cold night, facing the weight of the consequences. I have shifted into the doldrums of ennui as my burned-out body sags to the floor, and I fall on the couch and surrender to the banality of just being uncomfortable. Mind you, being consistently uncomfortable 24-7 is so much better than being in the thick of hell on earth. I am grateful, but being out of the flames and the fire, you begin to register the price and the traumatic effects of the wounds and damage. It is a bit overwhelming as I give in to being a couchaholic once again and find refuge in the arms of my old brown leather couch.

At the same time, I am writing beautiful poetry, and I shall publish a few newly rewritten and completely revised poems in the next blog. Right now, I am healing from the most extreme trauma of my life, and I must be gentle with myself. It is hard and brutal at times, and I must realize the toll taken in terms of the extremity of my survival. Yes, I survived and even did well in the face of a such a living nightmare, but there was damage and there was a lasting price. Although the long-term consequences have turned out to be both negative and positive, I must recognize that the negative cannot be ignored and must be treated with the respect of the price and the necessity of healing and recovering slowly.

Finally, I am still on the Ribavirin and Peg Interferon for another 2.5 months. The traditional side effects of these two drugs is what you always heard about when people mentioned how awful and difficult the process of going through Hepatitis C treatment. The worst side effects I experienced was due to the new Protease Inhibitor, but I am in a clinical trial, the drug is completely new, and my side effects won the gold medal for the worst in the entire country, if not, the entire world of clinical trials. Nevertheless, the side effects of the other two drugs continues to be a challenge.
The Ribavirin and Peg Inteferon Side Effects Continue To Be A Challenge

Here is a recent article about side effects officially added to the Interferon warning label:


FDA Hepatitis Update - Important Updates to PegIntron Warning Labeling


On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the warning and precaution sections of the product labeling.

Warning and Precaution section was revised as follows:

Neuropsychiatric Events

Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.
PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.

Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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