Adverse drug reactions - Drug Addict et al

[coquina]

Given the recent removal of Vioxx from the market, I was wondering if any of you have ever had serious adverse reactions to a newly prescribed medication. I'm also hoping for some comments from Drug Addict.

 

Several years ago, I got thrombocytopenia as an adverse reaction to Pravochol. It was an enlightening and frightening experience, to put it mildly.

 

Rather than give me a prescription, the doc gave me a couple weeks worth of samples, but he didn't warn me to watch of for any specific adverse reactions. After I had taken it for a few days, I noticed a few bruises I didn't remember acquiring, but I didn't think much about them, because I work in a machine shop and I am a klutz, so it is not unusual for me to bash myself and not remember it.

 

We went away for the weekend and on a Saturday morning I saw big purple streaks across my stomach. I had been bitten by a gnat and had scratched the itch in the middle of the night - not hard, either.

 

At that point I realized I was probably having a drug reaction, but didn't know how serious it was, so I figured I'd just stop taking the pills and call the doc on Monday.

 

Several new bruises appeared, but when I woke up on Monday morning, my arms and legs were covered with small red dots - a petechial rash. I called my doc and he had me come in immediately. He took blood samples and told me to come in for the results the next day. I was awakened the next morning by the ringing of the phone - it was my doc and he wanted me in his office immediately.

 

He showed me the results of the platelet count test - 6,000, with the word PANIC!!! written in red by the lab tech. Normal ranges are from 150,000 to 400,000 per cubic mililiter.

 

It took me over six months to recover from that escapade. I had to take massive doses of prednisone, every time they started to taper it off, the thrombocyte count would drop like a rock.

 

It's my understanding that thrombocytopenia can occur from many different kinds of drugs. I really think patients should be made more aware of the seriousness of it and advised to call their physician or go to the ER at the first inkling of problems.

[Drug addict]

In the UK the British National Formulary (http:///www.bnf.org) is a twice yearly publication from the Royal Pharmaceutical Society and the British Medical Association (as well as some more frequent publications such as Monthly Index of Medical Specialities [MIMS]).

 

A scheme for reporting adverse drug reactions (ADRs) has been in place for sometime in the UK and is known as the yelllow card scheme, basically because you fill out a yellow piece of paper to tell the Medicines and Healthcare products Regulatory Agency (UK equivalent of the FDA) of ADRs. Forms are available in both theh BNF and MIMS. The scheme is open to both doctors and pharmacists (not sure about nurses.)

 

The yellow card scheme works slightly differently for new and old drugs. With old drugs, only serious ADRs should be reported (i.e. such as thrombocytopenia), whereas for new drugs (= black triangle drugs) all ADRs should be reported, not matter how trivial so that a reasonable picture of ADRs can be built up.

 

I assume that by 'pavochol' you are talking about pravastatin. The BNF notes that thrombocytopenia is reported rarely. A more common side effect of the statins is myopathy (muscle damage) and whenever I dispense a statin I speak to the patient about this, even though the probability of it occuring is small.

 

Talking to people about side effects of medication can be difficult; if you look at patient information leaflets the list of side effects can be huge. Where potential side effects are serious, such as myopathy with statins or agranulocytosis with clozapine, patients should be told about the possibilty of these side effects and what to do if they occur, while reassuring patients that the risk of these side effects is small.

 

Where you taking the pravochol as part of a trial? (you said that your doctor gave you some samples.) Pravastatin is the only statin that can cause thrombocytopenia, and so if you were part of a trial, it is possible that this side effect wasn't encountered in earlier trials with less patients, though your doctor should have warned you about the risk of myopathy and told you to report and unexplained muscle pains.

 

When a new drug comes onto the market, it is possible that rare side effects are discovered, purely because it is being given to far more people than it was in the trials. This is why it is essential to have a robust system in place for monitoring ADRs to new drugs.l

[coquina]

Where you taking the pravochol as part of a trial? (you said that your doctor gave you some samples.) Pravastatin is the only statin that can cause thrombocytopenia, and so if you were part of a trial, it is possible that this side effect wasn't encountered in earlier trials with less patients, though your doctor should have warned you about the risk of myopathy and told you to report and unexplained muscle pains.

 

No, this happened several years ago, about 1996.

 

Background - I hadn't been having yearly checkups for a while - got a nasty bronchial pneumonia and had to be seen. Didn't see the doc in the group who had followed me for years. This guy was fresh out of med school. When he reviewed my file he noticed I hadn't had a physical in a while. He suggested doing a blood work up because insurance would pay since I was sick. I agreed. He called me a couple of days later and told me my cholesterol was high and that he'd like me to try a new medication. He said he could leave some samples at the front desk for me to pick up and I could come back in for followup bloodwork. If it was having the desired effect, he'd write a script. He didn't mention any possible side effects - just told me to pick up the samples at the front desk. That's what I did, and I didn't read the fine print flyer that was put in with it. After the problem occurred - I went on line and read possible side effects. At that time, low platelet count wasn't mentioned. I also googled "adverse reactions - bruising" and learned about thrombocytopenia, and that another med. I was taking - accupril, mentioned it as a side effect.

 

When I called I talked to my regular doc instead of the newbie and told him I thought I was having a reaction to Accupril. The first day I went in and old doc saw me, and I told him about the Pravochol, he told me it was probably the new drug, not the old one. He called new doc in to show him what had happened.

 

After months of treatment - old doc told me he thought I had ITP - only thing, in the meantime I had done research and there was no way my problem was "idiopathic". There is a support group on the internet for ITP and 90% of them told me there problem arose as a result of a medication.

 

I was sent to a hemotologist, and was told I might have to have my spleen removed and would probably be on high doses of steroids for the remainder of my life. At that point, I took myself off all my meds - no more BP med - I didn't even take an aspirin or tylenol for about 2 years. I decided I'd rather take my chances with hypertension than long term steroids or bleeding to death.

 

Fortunately - it now seems to have sorted itself out. I am now seeing an endocrinologist who is managing my medications with a great deal of care.

His motto is "manage your health as much as possible with diet and exercise - take medications as a last resort". Until I had my little problem, I was more than willing to have a pill solve my problems for me. It is working quite well - over the course of 2 years I have lost 110 pounds strictly by increasing exercise and decreasing food intake.

 

At this time I take Zetia for cholesterol - are you familiar with that medication?

[Auburngirl05]

This isn't nearly as serious as Coquina's, but I thought it might be noteworthy. When I had my wisdom teeth out they prescribed me hydrocodone for the pain, but I broke out in severe hives and kept passing out, so I stopped using it after two days and was fine...(the passing out could have been due to not eating, though, but there wasn't anything else I could identify to cause the hives, and they went away when I stopped taking it.) I know several people who've been on hydrocodone after surgeries, though, and none had that reaction.