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I have emphysema and was prescribed Symbicort 100/6 which I ...

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I have emphysema and was prescribed Symbicort 100/6 which I took for 8 months. I felt no better, in fact I was considerably worse during one of my regular check ups. I checked the leaflet which comes with the medication and found that Symbicort 100/6 should not be taken by COPD patients. I have been on oxygen since, I think, about February ''08. I have asked my consultant if he thinks being on the wrong dose for 8 months could have done any harm, he didn''t seem to think so. The drug company won''t tell me what symptoms would occur and will only deal with my GP. He being the one who made the mistake of the 100/6 dose when I should have been given 200/6. I would like to know if I have any rights to know what I health problems I may or maynot have with regard to the wrong dosage being given for so long.
Submitted: 6 years ago.
Category: Health
Expert:  Dr. Mark replied 6 years ago.
The botXXXXX XXXXXne is that these are essentially the same medications: both have budesonide, which is a steroid medication that reduces inflammation in the airways, and formoterol, which relaxes the airways to make it easier to breathe.

The 200/6 dosing just has twice as much steroid than the 100/6 dose, but it is the same medication.

Here is the quoted information about COPD an Symbicort 200/6:

"In two 12-month studies, the effects on lung function and the rate of exacerbation (defined as courses of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with severe COPD was evaluated. Median FEV1 at inclusion in the trials was 36% of predicted normal. The mean number of exacerbations per year (as defined above) was significantly reduced with Symbicort as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group). The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the Symbicort group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol groups, respectively). For changes in lung-function parameters, such as FEV1, Symbicort was not superior to treatment with formoterol alone."

http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=4821

Essentially what this is saying is that the steroid part of the medication made a difference in the number of COPD exacerbations, more so than the formoterol alone. The steroid part of the medication was not shown to change the course of the disease though (as evidenced by the lung-function FEV1, the last sentence).

So essentially, by receiving the other medication (the one with 50% of the intended steroid dose) may have made you more susceptible to COPD exacerbations (compared to a full 100% dose) but has no effect on the disease progression itself. In other words, your COPD should not have been affected by the differences in medication. Remember you were taking the same ingredients; just not as much.
Customer: replied 6 years ago.
Thanks alot for your reply, it's just that from information I've been able to find on the net I'm led to believe that the ratios of budesonide to formoterol has to be right or the blood gas exchange can go wrong and lead to hypoxemia which can lead to hypoxia which in turn can damage internal organs through lack of oxygen.

Some information I found on "sciencedirect.com/science, "effect of formoterol/budesonide combination...   I must admit that I didn't understand completely about b-agonists an ug's. Could you have a quick look at this site and see what you think.

8months is a long time to be on the wrong dose of any medicine don't you think.

many thanks

lindaej
Expert:  Dr. Mark replied 6 years ago.
Do you have the exact web link to the information that you have found?

I can't seem to find where specific "ratios" of medications would be detrimental, while other "ratios" would be beneficial. I can't make sense of it...e.g. If such a ratio were possibly detrimental for oxygen delivery, why would they give it to asthmatic patients?
Customer: replied 6 years ago.
yes the web link is http:www.sciencedirect.com/science.

On the information leaflet I have with symbicort it says that symbicort 100/6 must not be given to patients with COPD. COPD patients should only be given 200/6.

Sorry but it's very confusing. Customer
Expert:  Dr. Mark replied 6 years ago.
Yes, unfortunately that link just gets to the front page of the site, and not anything specific.

I believe that formulation 100/6 was not supposed to be given to patients with COPD since it was not studied at that dose in COPD patients. The dose of 200/6 appears to have been studied with COPD patients.

So your governmental agency has "licenced" the use of the 200/6 in COPD patients only. This was because the dose studied in COPD patients was the larger dose. It was approved by the Mutual Recognition Procedure of the European Union for COPD in 2003.

http://www.astrazeneca.com/pressrelease/472.aspx

I do not believe there is a medical reason for this, it is just regulatory.
Dr. Mark, Doctor (MD)
Category: Health
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Experience: U.S. Physician/Surgeon in Neurosurgery
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