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Adverse
Psychiatric Reactions Information Link |
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InformationANTACID MEDICATIONZOTON also known as LANSOPRAZOLE Prevacid in USA and Canada is one of a group of drugs called PROTON - PUMP INHIBITORS If you have suffered a psychiatric adverse reaction
to this drug please email us at reactions@april.org.uk
The UK Patient Information Leaflet which is found neatly tucked inside the box of tablets states under the heading 'After Taking your medicine’ Written in very small grey type, on pale yellow paper, it states: "Occasionally ZOTON may cause side effects. Such side-effects do not usually last for long, However, please see your doctor if any of the following become severe to troublesome. Headache, diarrhoea, stomach pain, feeling of sickness, vomiting, taste disturbances, dizziness, vertigo, confusion, blurred vision, hallucinations, feeling unwell, constipation, wind, dry or sore mouth or throat, tiredness, burning or prickling feeling, itching, hair thinning, muscle or joint pains, fluid retention, swelling, depression. As with other acid reducing drugs, men taking lansoprazole may occasionally experience temporary breast swelling or impotence. You should contact your doctor if you develop a rash. The majority of rashes are mild and self-limiting but sensitivity to sunlight and more severe blistering rashes have occurred rarely, which may require medical treatment. You should see your doctor at once if you get a fever, any unexplained bruising or bleeding, extreme fatigue, difficulty in urinating, if your skin or whites of your eyes become more yellow than usual or if you experience symptoms of an allergic reaction such as shortness of breath or face swelling. As natural acid in the stomach helps to kill bacteria, the lowering of acid by acid-reducing drugs such as ZOTON may make some people more liable to suffer from certain stomach infections. If you suffer from severe persistent diarrhoea and/ or vomiting whilst taking ZOTON you should consult your doctor. Other side effects include kidney problems, inflammation of the liver or changes in kidney or liver function. Please tell your doctor if you have any unwanted event not listed above." In the DATA SHEET produced by the manufacturer Wyeth Laboratories found in the ABPI COMPENDIUM OF DATA SHEETS, it includes among the most commonly reported adverse events, headache, dizziness, fatigue and malaise. After listing gastrointestinal side effects is states "Other reactions include arthralgia, (pain in the joints) myalgia, (pain in the muscles) depression, peripheral oedema and, rarely, paraesthesia or blurred vision." THE DANGER OF REPEAT PRESCRIPTIONS Proton-pump-inhibitors are often obtained by patients on repeat prescriptions and to quote from the British Journal of General Practice Nov 1996 'Repeat prescribing has long been seen as a potential cause of poor clinical care’ THE drug information manual of the USPDI United States Pharmacopeial Convention Inc 1998, contains the following information regarding oral antacid medication. For patients taking this medicine for increased stomach acid: "Do not take it for more than 2 weeks unless otherwise directed by your doctor. ANTACIDS SHOULD BE USED ONLY FOR OCCASIONAL RELIEF" USPDI - PRECAUTIONS WHILE TAKING THIS MEDICINE: "If this medicine has been ordered by your doctor and you will be taking it in large doses or for a long time, your doctor should check your progress at regular visits. This is to make sure the medicine does not cause unwanted effects." It goes on to state: Under side effects the book states ‘Along with its needed effects, a medicine may cause some unwanted effects. Although the following side effects occur very rarely when this medicine is taken as recommended, they may be more likely to occur if: medicine is taken in too large doses or is taken for a long time, or taken by patients with kidney disease, it includes in the list: Mood or mental changes, muscle weakness, nervousness, restlessness, unusual tiredness or weakness. THE BMJ BRITISH MEDICAL JOURNAL August 1998 contained an item titled ‘Choice GP’ ‘Between the idea and the reality falls the shadow’ In which the comment is included: "Plenty of guidelines cover the management of dyspepsia in general practice, but few seem to be used. A paper on page 452 show that it is another area where the shadow falls between what should be done and what is done. The prescription of proton pump inhibitors is going up rapidly, but many are being used for the unlicensed indications on non-ulcer dyspepsia and non- specific abdominal pain. In the BNF British National Formulary of Sept 1997 Under side effects for lansoprazole (ZOTON) it includes among others: liver enzyme changes and liver disfunction, nausea, abdominal pain, malaise and depression. In International controlled trials the following adverse reactions were included as occurring during treatment with lansoprazole Nervous System: agitation, amnesia, anxiety, depression libido decreased, thinking abnormality. ALCOHOL DANGER! Under precautions in the drugs information provided on the internet it advises that alcohol increases the risk of side effects. In THE LANCET Volume 349, Number 9066 7th June 1997 An article entitled "Proton-pump inhibitors: three of a kind?" States: "If the benefit of a pharmacological treatment was judged on its sales, then therapies for peptic ulcers would rate highly." the article goes on to discuss side effects and lists further references. For this article click here: http://www.thelancet.com/newlancet/reg/issues/vol349no9066/body.commentary1637.html NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (NICE) GUIDANCE ON PROTON PUMP INHIBITORS FOR DYSPEPSIA "The Institute’s guidance has been circulated to all GPs and Consultant gastroenterologists in England and Wales. The guidance describes some of the causes of dyspepsia and provides advice as to where a Proton-pump-inhibitor should be used in each case. All doctors prescribing PPIs have been asked to review their use of PPIs against the guidance with the aim of reducing the dose or even stopping the medicine where appropriate." The full guidance and patient notes are available on the web site at www.nice.org.uk Or from NICE, PO Box 777, London SE1 6XH Fax: 01623 724 524 Telephone 0541 555 455 or email doh@prologistcs.co.uk This information and much more can be seen at; http://www.nice.org.uk/nice-web/Article.asp?a=3541&ss=Proton%20pump%20inhibitors Information compiled by the charity ‘APRIL’ Adverse Psychiatric Reactions Information Link, May 2000 If you have suffered a psychiatric adverse reaction to this drug please email us at reactions@april.org.uk |
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