Ospreys - Loch Of The Lowes, Scotland.
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Obtaining information on Medicines
15 Answers
I hope someone may be able to help.
Where can I find information as to the side effects of separate ingredients that a pharmaceutical company uses in a particular medicinal product when they claim that due to the Code of Practice they are under it isn't permitted. I mean more than one finds in a patient leaflet. Bearing in mind that until I asked "awkward" questions they were very helpful and forthcoming and now have clammed up (think I touched a nerve...)! If they still refuse is there any authority I can contact to help me further with my quest do you know?
Many thanks in advance for any help you are able to give.
Where can I find information as to the side effects of separate ingredients that a pharmaceutical company uses in a particular medicinal product when they claim that due to the Code of Practice they are under it isn't permitted. I mean more than one finds in a patient leaflet. Bearing in mind that until I asked "awkward" questions they were very helpful and forthcoming and now have clammed up (think I touched a nerve...)! If they still refuse is there any authority I can contact to help me further with my quest do you know?
Many thanks in advance for any help you are able to give.
Answers
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In answer to your original question, you may contact the MHRA who may be able to give you more specific information. They can be contacted here: http://
15:47 Fri 27th Jul 2012
http://www.medicines.org.uk/EMC/default.aspx have a look here
Thanks Hollie but I've already been there (kind of you to supply the link). I've found out the ingredients of the medicine but only the manufacturers/licence holder can give me the information I require as it is specific. They said they can't help further which I find disconcerting because it's their product we are talking about and surely they have a "care of duty" to supply information that will be helpful to a patient if there is an issue with their product....
I have never been issued a P I leaflet with this medicine but the company who manufacture it gave me a link to one on line which I have looked at. Boxy I haven't looked at the BNF but will do now you've mentioned it. I have emailed the manufacturer again to ask if they would give me the further information but was again told by the person responding ... "Unfortunately, you are protected by the ABPI Code of Practice and I am unable to enter into further discussion regarding this matter".
I am enquiring regarding one of the chemicals used in their medicine as to if in the process they use it in it can cause some or any of the side effects it is documented for in other forms. It's complicated because the chemical itself isn't listed, it's a process they use it for within the medicine itself. Also the colouring they use for their medicine can aggravate existing asthma problems and may cause problems for people allergic to aspirin but there is nothing mentioned of this in their leaflet. I'm trying to establish whether these two substances could have side effects that they don't list in their patients leaflet. As far as I'm concerned the only people who can answer this is the manufacturers and now they have clammed up and quoted the Code of Practice! I just wondered if there was an authority/body who I could appeal to to obtain this information. I'm concerned because this medicine can be taken by children and if it can exacerbate asthma etc then there should be a warning on their leaflet IMO.
I am enquiring regarding one of the chemicals used in their medicine as to if in the process they use it in it can cause some or any of the side effects it is documented for in other forms. It's complicated because the chemical itself isn't listed, it's a process they use it for within the medicine itself. Also the colouring they use for their medicine can aggravate existing asthma problems and may cause problems for people allergic to aspirin but there is nothing mentioned of this in their leaflet. I'm trying to establish whether these two substances could have side effects that they don't list in their patients leaflet. As far as I'm concerned the only people who can answer this is the manufacturers and now they have clammed up and quoted the Code of Practice! I just wondered if there was an authority/body who I could appeal to to obtain this information. I'm concerned because this medicine can be taken by children and if it can exacerbate asthma etc then there should be a warning on their leaflet IMO.
Hi sq... the chemical is EDTA which is used to form a chelate I don't know if that will make any sense. I am not sure if used like that it can have adverse effects on the lungs as it is a given as a lung irritant but I'm not sure in what form ...only someone in the know would be able to say methinks. As for the colour that is Ponceau 4R (E124) which is as far as I can establish banned in the USA and Norway but not here.
In answer to your original question, you may contact the MHRA who may be able to give you more specific information. They can be contacted here: http://www.mhra.gov.uk/Contactus/index.htm
The MHRA oversee the licensing of all products in the UK and will only allow a product to be classed as a medicine and allow it to be administered after proven clinical trials have taken place. They may be able to give you specific information about the use of E124 and EDTA as pharmaceutical ingredients.
I suspect though as the product you are alluding to does have a product license, they will refer you back to the manufacturer.
All medicines contain ingredients called exipients in addition to the active drug. They are usually necessary to mask the taste or colour. Some exipients are neccesary to ensure that the drug is absorbed in the body correctly - this is the case for the EDTA in your preparation. Unfortunately, there is a risk that some people can be allergic to these. These risks would have been scrutinised during the trial phase before the medcine was put forward for a license.
There are many products that contain exipients - as an example some shampoos and bubble baths contain EDTA. The colour E124 can be found in many products available without prescription - such as Germolene cream. They can also be found in foods such as Jelly Tots.
If you are suspicious that somebody has had a reaction to a prescrobed product it is essential that it is reported to either your GP or pharmacist who can raise the problem with the manufacturer.
The MHRA oversee the licensing of all products in the UK and will only allow a product to be classed as a medicine and allow it to be administered after proven clinical trials have taken place. They may be able to give you specific information about the use of E124 and EDTA as pharmaceutical ingredients.
I suspect though as the product you are alluding to does have a product license, they will refer you back to the manufacturer.
All medicines contain ingredients called exipients in addition to the active drug. They are usually necessary to mask the taste or colour. Some exipients are neccesary to ensure that the drug is absorbed in the body correctly - this is the case for the EDTA in your preparation. Unfortunately, there is a risk that some people can be allergic to these. These risks would have been scrutinised during the trial phase before the medcine was put forward for a license.
There are many products that contain exipients - as an example some shampoos and bubble baths contain EDTA. The colour E124 can be found in many products available without prescription - such as Germolene cream. They can also be found in foods such as Jelly Tots.
If you are suspicious that somebody has had a reaction to a prescrobed product it is essential that it is reported to either your GP or pharmacist who can raise the problem with the manufacturer.
Hi sq. Thank you so much for your help with the info you've given me. I will write to the MHRA to see what technical details they can give. I just want to know if those two items could give the side effects experienced but as said previously, the manufacturer/licence holder have now declined to deal with me. I personally cannot see why they can't be open about what their product may do to some people, after all if they use these things in the preparation they should IMO know possible side effects especially as it is given elsewhere regarding them. I appreciate your help, thank you.
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