SULPHASALAZINE (sulphonamide)
also known as salazopyrin, sulfasalazine and azulfidine Drugs with sulfa / sulpha in are liable to cause life threatening allergic reactions including serious psychiatric or rash related mental & physical Adverse Drug Reactions (ADRs)
Drugs with sulfur may cause a bad reaction for people who cannot tolerate this component. Antibiotics and the above drug prescribed for Inflamatory Bowel Disease and arthritis
Bactrim also known as C0-Trimoxazole or Trimethoprim -sulfamethoxazole or TMP-SMX has been linked to severe life threatening ADRs and it should be realised some people cannot tolerate drugs with a sulfur content.
Sulfasalazine-Induced Major Depressive Disorder with Psychotic Features My personal experience of the devastating effect ignorance of a Consultant caused our family.
I was and still am so disappointed in the reaction of a consultant gastroenterologist (now deceased). When in 1985 my daughter Karen suffered a sudden onset of psychosis, following terrifying nightmares.
He assured us the bad dreams were not an adverse drug reaction (ADR) caused by sulphasalazine he had prescribed at 3 grams a day, for a 20 year old girl weighing only seven stone. He went out of his way to prevent the manufacturer Pharmacia (now allied with Pfizer) from reporting to the medicines' regulator.
This doctor's atttempts to prevent a report of the nightmares and psychotic episode shocked me. A later serious skin rash adverse reaction was reported by a dermatologist.
My request for the gastroenterologist to report was ten years later, so he knew he was safe from litigation. My daughter had just died, aged only 30 and I had started to research at the British Library Medical deprartment for reports of such ADRs. We patients still had no patient information in 1995 as the EU Directive for this to be mandatory was not until 1997.
For more detailed information about this please click here.- You can read an 8 page account of Karen's shocking experience due to sulfasalazine adverse drug reactions and how it affected my family. This is to be the first part of a book, available free on this web site in sections to be written over time, in relation to prescribed medicines and anaethetics.
The Medicines Regulator, the the Medicines Control Agency and now the MHRA had records of eight reports of psychosis yet when I asked Dr June Raine then the Chief person in the area of Pharmacovigilance, to ensure this was listed on patient information, I was told they would not do this until " They received enought reports". I asked "how many reports to you need?" the response from Dr Raine was " There is no set number" . This was in a public meeting, launch of so called 'improved patient information leafltets (PILS) there were many representative from the Pharmaceutical Industry present.
Karen had no history of psychiatric illness until this sudden onset of psychosis due to sulphasalazine.
I found a case report of
Sulfasalazine - Induced Major Depressive Disorder with Psychotic Features,
Kindly made by members of the department of Psychiatry Selcuk Univeristy, Turkey...I say a hearfelt 'thank you' to them.
I recently met a health professional who on hearing my story, confided in me their experience with the same drug which induced a brain heamorrhage.
You can be sure this 'rare' ADR will not appear on any data, just as the risk of psychosis wont, unless we all pressure the regulators and make sure to report the ADRs.
Can you imagine my feelings on hearing this informative talk by Professor John Abrahams at the CEP conference organised by Luke Montagu & Lord Sandwich in Roehampton university. The conference talks are on YouTube and hopefully will remain accessible
Read the article in the New York Times about this drug Sulfasalazine, published April 2019
regarding how serious a rash can be
Now see response by Millie Kieve published 2019 in the New York Times
The comment by Millie Kieve for APRIL wa the final comment to be published in the NY Times as the comments section on this subject closed. However you can submit a letter to the editor. - letters@nytimes.com together with your name, city and telephone number.
Adverse Drug Reaction (ADR) reports for Sulfasalazine include insomnia, mental depression, hallucinations and psychosis and severe skin erruptions / blisters / rash - WARNING at the first sign of a rash or nightmares STOP taling the drug.
There have been reports of terrifying nightmares in medical publications
Psychosis is a known and recorded side effect of sulphonamide drugs yet the term does not appear in the patient information.
It is vital not to become dehydrated when taking sulfasalazine.
The Pharmacia and Upjohn data sheet states:
Sulphasalazine (salazopyrine) is prescribed for maintaining remission in ulcerative colitis for the treatment of active Crohn's disease.
On the manufacturers data sheet is a statement "A PATIENT INFORMATION LEAFLET SHOULD BE SUPPLIED SPECIFICALLY ADVISING PATIENTS ON BLOOD DYSCRASIAS" It recommends blood tests and "the patient should also be counselled to report immediately with any sore throat, fever, malaise or unexpected non specific illness."
In medical literature it has been stressed that patients should be instructed regarding the importance of adequate fluid intake"
Reporting Adverse Drug Reactions (ADRs)
It is well known that serious side effects of medicines are under reported and the UK regulatory body the Medicines and Healthcare Regulatory Agency (MHRA) estimate less than 10% of serious ADRs are reported.
If you are, for no apparent reason, feeling mentally distressed, it may be caused by starting or stopping medication, due to a changed dose, withdrawal effects, interactions with other drugs, or following surgery. You can request a list of drugs used pre surgery and during surgery and those for pain or infection to be taken later.
Some drugs must not be stopped suddenly
If you have suffered psychiatric, neurological or physical adverse drug reactions (ADRs) please report them. There may be adverse effects not mentioned on the patient leaflets (PILs) or data sheets. (SPCs) The link takes you to the web containing the Data for all licensed medicines. Just put the drug name in the search box.
You should be given a patient information leaflet (PIL) for all drugs prescribed, either as you are discharged from hospital, or if the pharmacy supplies you from a bulk supply of pills. (EU Directive 1997)
Please report Adverse Drug Reactions (ADRs) to:
UK - Yellow Card Reporting for Patient and Health Professional reports of Adverse Drug Reactions you can report to the MHRA using the link above or call them 0808 100 3352 10am - 2pm Monday to Friday
USA and worldwide - to the Food and Drug Administration for Patients and Healthcare Professionals
Universal free, independent drug safety website - Rxisk
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