Adverse Events in Treatment: If it’s you, it’s minor. If it’s me, it’s major

Adverse Events and Reactions

There are conflicting definitions here because there are conflicting definitions in science and medicine.

A Side Effect (SE) is when a drug does something besides what you are treating. Rogaine was initially a drug for hypertension that had a side effect (SE) causing hair to grow on your head.  It was predictable.  Talk about a marketing turn-around. That  pharmaceutical guy is probably still hailed as a hero. What? Me judge? 

Minoxidil is an antihypertensive vasodilator medication which also slows or stops hair loss and promotes hair regrowth.

Ooh ah, chemistry structure. 

Why is it that I can understand how this crosses the epidermis but I cannot understand how house plans will look as a house?

An Adverse Drug Event (ADE) is something that is dose independent and causes harm.  Wow, the definitions are wide open.

I went to the Veterans Administration (VA) website:   No clear definition  from their panel of experts

I went to the NIH:  The National Institutes of Health (NIH) Blah Blah Blah ”  WTF? I stopped there.  These people had no intention of helping me get  a clear definition. 

 Wikipedia, that bastion of scientific rigor says:

http://en.wikipedia.org/wiki/Adverse_drug_reactions

An adverse drug reaction (abbreviated ADR) is an expression that describes harm associated with the use of given medications at a normal dosage during normal use. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this expression differs from the meaning of “side effect“, as this last expression might also imply that the effects can be beneficial.[1] The study of ADRs is the concern of the field known as pharmacovigilanceNo shit.  Just what we need, splitting more ill-defined hairs.

An adverse drug event (abbreviated ADE) refers to any injury caused by the drug (at normal dosage and/or due to overdose) and any harm associated with the use of drug (e.g. discontinuation of drug therapy).[2] ADRs are a special type of ADEs.

  • Type A: Augmented pharmacologic effects – dose dependent and predictable
    • Intolerance: Severe decrease in red blood cells (RBCs) with ribavirin.  Decrease dose of ribavirin.
    • Side Effects. Immobilizing depression .  Anti-depression agents can help.

     My question to you and your doctor is “Why not start antidepressants in advance of hepatitis C therapy?”  I did the 2nd time around and I wasn’t on another planet every day.  Only sometimes.

  • Type B: Bizarre effects (or idiosyncratic) – dose independent and unpredictable.

Congratulations!  You are 1 in 100,000 whose teeth fall out.  It is a rare occurrence, 1 in 100,000.  But if you are the one, it is 1 in 1 (100%).  I apologize, I do not remember where I got this mask rendering.  Please don’t sue me.

  • Type C: Chronic effects: You keep taking that boy ,and you will go blind.
  • Type D: Delayed effects:  We didn’t realize that three weeks into treatment your butt hole would fail to shut.  Awkward!
  • Type E: End-of-treatment effects: Seriously, , Ribavirin stays in red blood cells (RBCs) for 6 months after treatment causing teratogenic effects (birth defects)  in non mammals.  Even if only the sire is taking the drug.
  • Type F: Failure of therapy The operation was a success but the patient died.
  • Type G: Genetic reactions OOPs,  you went deaf because you don’t have the enzyme to pee out that drug. Are your parents from Lapland?

My two favorite terms are Bizarre and Idiosyncratic. Bizarre we recognize. Sort of. Idiosyncratic means we have no effing clue. Idiosyncratic is more palatable than ” no effing clue”. 

The Food and Drug Administration (FDA to their friends) says An ADR should not be labeled as ‘certain’ unless the ADR abates with a challenge-dechallenge-rechallenge protocol (stopping and starting the drug). Now, I don’t know about you, but I am probably not going to volunteer to restart a drug that I had to stop because of  a bad experience.  At least not any more.

Both Interferon and Ribavirin warn about severe depression, suicide, homicide, and  crazy thinking.  I got the D and CT.  These are predictable SEs

  From the Interferon (Pegasys) package Insert

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm#cont

BOXED WARNING 

 Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see WARNINGS and ADVERSE REACTIONS).

Neuropsychiatric

Life-threatening neuropsychiatric reactions may manifest in patients receiving therapy with PEGASYS. Depression, suicidal ideation, and suicidal attempt may occur in patients with and without previous psychiatric illness.

PEGASYS should be used with extreme caution in patients who report a history of depression. Neuropsychiatric adverse events observed with alpha interferon treatment include relapse of drug addiction, drug overdose, aggressive behavior, psychoses, hallucinations, bipolar disorders and mania.   Almost all patients with hepatitis c have a history of depression.  It goes with the territory. 

ADVERSE REACTIONS

Nearly all patients in clinical trials experienced one or more adverse events. The most commonly reported adverse reactions were psychiatric reactions, including depression, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. The most common reason for dose modification or withdrawal from studies was hematologic abnormalities.

Ribavirin  http://en.wikipedia.org/wiki/Ribavirin  It is more difficult to get a straight package insert regarding Ribavirin as there are multiple manufacturers.  Of note, Ribavirin has shown teratogenicity in non mammals.  You will have to sign many forms to document that you grasp this.

 I am not the suicide type.  As a kid, I stumbled on my mom trying to kill herself.  Pills, cut wrists, head in gaseous oven.  I would call an ambulance then my Aunt Sudie.   Aunt Sudie kept  my brother and me during hospital stays.  I packed our school stuff in a  cardboard box and waited for her.  We stayed there till Mom promised the psych doctors that she’s better and wouldn’t try suicide again.  Back then you would whisper “She’s had a nervous breakdown”.  You don’t hear that anymore.

It was weird at Aunt Sudie’s house.  It was quiet , clean and ran on a schedule.  They had ice cream all the time  and a freezer that kept it frozen.   My cousins  Gary and Randy would have to room together so my brother  and I could have a bed.  I put every effort into making sure Tim and I were no trouble. Little Orphan Annie has come to our house to stay.  To wash the cups and saucers up and brush the crumbs away…  J W Riley.  This thinking came from me.  Aunt Sudie didn’t expect me to work for my keep.

 When my period  started, Randy’s dog , Lady, shredded my Kotex all over the dining room floor and they saw it.   I died quietly.  At home no one shredded my Kotex stuff.   No matter how bad it is at home, there are some plusses.

Back then there was no Valium or Prozac.  Only Thorazine.  Which Mom used to for suicide attempts. See a pattern?    Mom later found an alternative.  She began drinking with my dad.  I became grown up on duty (GOD) when I was about eleven.

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