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Medications
Medicines and drugs prescribed by your GP are gluten-free.
Normally GPs will prescribe medicines that are licensed and listed in prescribing guides such as the BNF and MIMS. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines are acceptably safe.
They have informed Coeliac UK that all medications listed in the prescribing guidelines are gluten-free.
If a medicine contains wheat starch this will be indicated on the label and the accompanying patient information leaflet.
Wheat starch of pharmaceutical quality is highly processed and considered gluten-free and therefore any licensed medications that contain wheat starch are suitable for people with coeliac disease.
If buying a medicine, which has not been prescribed by your GP, Coeliac UK has been advised that if there is a Product Licence (PL) number on the packet then this would also be gluten-free. This can usually be found either on the packaging or on the patient information leaflet.
Sometimes medications can cause side effects that are similar to symptoms that occur after accidentally eating gluten. If you have any unexpected side effects when taking medications we would advise you to speak to your GP.
Prescribed medications should only be taken or stopped under medical advice. Do not stop taking any medication without consulting your GP. For further information about medications you can also speak to your Pharmacist.
Medicines and drugs prescribed by your GP are gluten-free
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Medicines and drugs prescribed by your GP are gluten-free
by Lyn G » Sun Jul 04, 2010 9:55 am
- Lyn G
- Site Admin
- Posts: 4764
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What is the gluten content of oral prescription medicines?
by Lyn G » Wed Jul 28, 2010 9:51 am
What is the gluten content of oral prescription medicines?
Publisher: Wessex Drug and Medicines Information Centre
...
...
Summary
by: Sandra Hicks
Any oral prescription medicine must state if it contains wheat starch as an excipient according to European labelling guidelines.
The total amount of protein permitted in wheat starch as an excipient is less than 0.3%.
As the gluten component will be much less than this it is considered to be below the threshold of clinical relevance for patients with coeliac disease and therefore suitable for these people.
http://www.nelm.nhs.uk/en/NeLM-Area/Evi ... medicines/
*********************************
Publisher: Wessex Drug and Medicines Information Centre
...
...
Summary
by: Sandra Hicks
Any oral prescription medicine must state if it contains wheat starch as an excipient according to European labelling guidelines.
The total amount of protein permitted in wheat starch as an excipient is less than 0.3%.
As the gluten component will be much less than this it is considered to be below the threshold of clinical relevance for patients with coeliac disease and therefore suitable for these people.
http://www.nelm.nhs.uk/en/NeLM-Area/Evi ... medicines/
*********************************
- Lyn G
- Site Admin
- Posts: 4764
- Joined: Thu Jul 04, 2002 5:33 pm
- Location: Dorset
Re: Medicines and drugs prescribed by your GP are gluten-free
by Lyn G » Sun Aug 01, 2010 11:13 am
NHS
UKMI
Q&A 81.1
What is the gluten content of oral prescription medicines?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals.
Expiry: 31st March 2011
Background
Gluten is the collective name for a type of protein found in the cereals wheat, rye and barley. Patients with coeliac disease need to avoid gluten in their diet, as it causes their immune system to damage the lining of their bowel (1,2).
Wheat products can be used in the manufacturing of prescription medicines in the form of wheat starch, for example, as a tablet binding agent (3).
An ingredient which has no therapeutic action of its own, such as a binding agent is known as an excipient; however not all of these are completely inactive (3). Where a medicine contains an excipient of known effect in its own right, this particular ingredient has to appear prominently on the labelling and contain an additional warning in the patient information leaflet which accompanies the medicine. By law, all excipients must appear in the patient information leaflet supplied with a prescription medicine (4).
Answer
Any oral prescription medicine must state if it contains wheat starch according to European labelling guidelines on excipients. These were issued in 2003 by the European Medicines Agency (EMEA) (5). The Medicines and Healthcare products Regulatory Agency (MHRA) also adhere to these EMEA guidelines (4).
Wheat starch used in the manufacturing process of prescription medicines must be of pharmaceutical grade, which means that it is highly refined, containing only ‘trace amounts’ of gluten (4,5).
The EMEA confirm that the ‘total amount of protein’ in wheat starch (of pharmaceutical grade) used in prescription medicines must be less than 0.3% (6), which is from the European Pharmacopoeia standard for wheat starch (7). As the gluten component will be much less than 0.3% it is considered to be below the threshold of clinical relevance for patients with coeliac disease (6). Consequently pharmaceutical grade wheat starch is deemed to be gluten-free (4).
Therefore all oral prescription medicines in the UK are considered to be gluten-free by the MHRA (4). The EMEA labelling guidelines on excipients state that wheat starch may contain gluten, but only in trace amounts and is therefore considered safe for people with coeliac disease (5).
Summary
¨ Any oral prescription medicine must state if it contains wheat starch as an excipient according to European labelling guidelines (5).
¨ Wheat starch used in prescription medicines is of pharmaceutical grade and therefore highly refined and deemed to be gluten-free (4).
¨ The total amount of protein permitted in wheat starch as an excipient is less than 0.3%. As the gluten component will be much less than this it is considered to be below the threshold of clinical relevance for patients with coeliac disease and therefore suitable for these people (6).
Limitations
· In certain cases the prescription medicine may have been manufactured in a country other than the UK or the European Union. If there is any concern about the country of origin, then the appropriate manufacturer should be contacted with product name, batch number and expiry date to confirm the gluten content of that particular prescription medicine.
· This Medicines Q&A does not cover patients who have a wheat allergy. These patients should not take any medicines containing wheat starch (5,6).
Disclaimer
· Medicines Q&As are intended for healthcare professionals and reflect UK practice.
· Each Q&A relates only to the clinical scenario described.
· Q&As are believed to accurately reflect the medical literature at the time of writing.
· See NeLM for full disclaimer.
References
(1) Coeliac Disease - What is it? Accessed via http://www.coeliac.org.uk/.on 4th February 2009.
(2) Coeliac Disease (coeliac sprue or gluten allergy). Accessed via http://www.netdoctor.co.uk/digestivehea ... llergy.htm on #4th February 2009.
(3) Sweetman SC, editor. Martindale: The Complete Drug Reference. Electronic edition. London: Pharmaceutical Press. Starch Monograph. Accessed via http://www.medicinescomplete.com/ 5th March 2009.
(4) Personal communication with the Medicines and Healthcare products Regulatory (MHRA) via email February 2009.
(5) Medicinal products for human use. Safety, environment and information. Excipients in the label and package leaflet of medicinal products for human use Volume 3B Guidelines July 2003 p16-17. Accessed via http://www.emea.europa.eu/pdfs/human/pr ... 0307en.pdf on 4th February 2009.
(6) Personal communication with the European Medicines Agency (EMEA) via email February 2009 and March 2009.
(7) European Pharmacopoeia 2009, Suppl 6.3: 4346 (Wheat Starch).
Quality Assurance
Prepared by
Sandra Hicks, Medicines Q&A Pharmacist, Wessex Drug & Medicines Information Centre, Southampton University Hospitals Trust.
Date Prepared
18th March 2009
Checked by
Kate Pickett, Medicines Q&A Pharmacist, Wessex Drug and Medicines Information Centre, Southampton University Hospitals Trust
Date of check
19th March 2009
Search strategy
· Coeliac UK website http://www.coeliac.org.uk/.
· MHRA website http://www.mhra.gov.uk/
· Department of Health website http://www.dh.gov.uk/
· EMEA website http://www.emea.europa.eu/
· Personal communication with Coeliac UK (dietician) via email on 5th February 2009
· Personal communication with MHRA (central enquiry point) on 11th & 19th February 2009 via email info@mhra.gsi.gov.uk
· Personal communication with EMEA (medical information sector) on 24th February and 3rd March 2009 via email info@emea.europa.eu
· RPSGB library contacted by phone on 25th February 2009 for copy of Test for Total Protein from European Pharmacopoeia monograph and on 12th March 2009 for Wheat Starch monograph.
**********************
UKMI
Q&A 81.1
What is the gluten content of oral prescription medicines?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals.
Expiry: 31st March 2011
Background
Gluten is the collective name for a type of protein found in the cereals wheat, rye and barley. Patients with coeliac disease need to avoid gluten in their diet, as it causes their immune system to damage the lining of their bowel (1,2).
Wheat products can be used in the manufacturing of prescription medicines in the form of wheat starch, for example, as a tablet binding agent (3).
An ingredient which has no therapeutic action of its own, such as a binding agent is known as an excipient; however not all of these are completely inactive (3). Where a medicine contains an excipient of known effect in its own right, this particular ingredient has to appear prominently on the labelling and contain an additional warning in the patient information leaflet which accompanies the medicine. By law, all excipients must appear in the patient information leaflet supplied with a prescription medicine (4).
Answer
Any oral prescription medicine must state if it contains wheat starch according to European labelling guidelines on excipients. These were issued in 2003 by the European Medicines Agency (EMEA) (5). The Medicines and Healthcare products Regulatory Agency (MHRA) also adhere to these EMEA guidelines (4).
Wheat starch used in the manufacturing process of prescription medicines must be of pharmaceutical grade, which means that it is highly refined, containing only ‘trace amounts’ of gluten (4,5).
The EMEA confirm that the ‘total amount of protein’ in wheat starch (of pharmaceutical grade) used in prescription medicines must be less than 0.3% (6), which is from the European Pharmacopoeia standard for wheat starch (7). As the gluten component will be much less than 0.3% it is considered to be below the threshold of clinical relevance for patients with coeliac disease (6). Consequently pharmaceutical grade wheat starch is deemed to be gluten-free (4).
Therefore all oral prescription medicines in the UK are considered to be gluten-free by the MHRA (4). The EMEA labelling guidelines on excipients state that wheat starch may contain gluten, but only in trace amounts and is therefore considered safe for people with coeliac disease (5).
Summary
¨ Any oral prescription medicine must state if it contains wheat starch as an excipient according to European labelling guidelines (5).
¨ Wheat starch used in prescription medicines is of pharmaceutical grade and therefore highly refined and deemed to be gluten-free (4).
¨ The total amount of protein permitted in wheat starch as an excipient is less than 0.3%. As the gluten component will be much less than this it is considered to be below the threshold of clinical relevance for patients with coeliac disease and therefore suitable for these people (6).
Limitations
· In certain cases the prescription medicine may have been manufactured in a country other than the UK or the European Union. If there is any concern about the country of origin, then the appropriate manufacturer should be contacted with product name, batch number and expiry date to confirm the gluten content of that particular prescription medicine.
· This Medicines Q&A does not cover patients who have a wheat allergy. These patients should not take any medicines containing wheat starch (5,6).
Disclaimer
· Medicines Q&As are intended for healthcare professionals and reflect UK practice.
· Each Q&A relates only to the clinical scenario described.
· Q&As are believed to accurately reflect the medical literature at the time of writing.
· See NeLM for full disclaimer.
References
(1) Coeliac Disease - What is it? Accessed via http://www.coeliac.org.uk/.on 4th February 2009.
(2) Coeliac Disease (coeliac sprue or gluten allergy). Accessed via http://www.netdoctor.co.uk/digestivehea ... llergy.htm on #4th February 2009.
(3) Sweetman SC, editor. Martindale: The Complete Drug Reference. Electronic edition. London: Pharmaceutical Press. Starch Monograph. Accessed via http://www.medicinescomplete.com/ 5th March 2009.
(4) Personal communication with the Medicines and Healthcare products Regulatory (MHRA) via email February 2009.
(5) Medicinal products for human use. Safety, environment and information. Excipients in the label and package leaflet of medicinal products for human use Volume 3B Guidelines July 2003 p16-17. Accessed via http://www.emea.europa.eu/pdfs/human/pr ... 0307en.pdf on 4th February 2009.
(6) Personal communication with the European Medicines Agency (EMEA) via email February 2009 and March 2009.
(7) European Pharmacopoeia 2009, Suppl 6.3: 4346 (Wheat Starch).
Quality Assurance
Prepared by
Sandra Hicks, Medicines Q&A Pharmacist, Wessex Drug & Medicines Information Centre, Southampton University Hospitals Trust.
Date Prepared
18th March 2009
Checked by
Kate Pickett, Medicines Q&A Pharmacist, Wessex Drug and Medicines Information Centre, Southampton University Hospitals Trust
Date of check
19th March 2009
Search strategy
· Coeliac UK website http://www.coeliac.org.uk/.
· MHRA website http://www.mhra.gov.uk/
· Department of Health website http://www.dh.gov.uk/
· EMEA website http://www.emea.europa.eu/
· Personal communication with Coeliac UK (dietician) via email on 5th February 2009
· Personal communication with MHRA (central enquiry point) on 11th & 19th February 2009 via email info@mhra.gsi.gov.uk
· Personal communication with EMEA (medical information sector) on 24th February and 3rd March 2009 via email info@emea.europa.eu
· RPSGB library contacted by phone on 25th February 2009 for copy of Test for Total Protein from European Pharmacopoeia monograph and on 12th March 2009 for Wheat Starch monograph.
**********************
- Lyn G
- Site Admin
- Posts: 4764
- Joined: Thu Jul 04, 2002 5:33 pm
- Location: Dorset
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