Medicines

Please refer to information below. A few medicines linked to psychiatric adverse effects are listed down the left side of this page. Please also refer to the topics listed under the headings above.

We hope you will find information that is of help to you

All medicines have effects but some are unwanted and can be harmful. Adverse Drug Reactions (ADRs) or Adverse Effects (AEs) may occur after a drug is licensed. If they occur during a clinical trial they should be recorded as a Serious Adverse Event (SAE)

What is an Adverse Drug Reaction (ADR) ?

The definition of an ADR or AE is defined by the British Medical Association (BMA) as:

"unwanted or unintended effects of a medicine which occurs during proper use."

The British Medical Association policy document titled "Reporting adverse drug reactions". was published by the BMA Board of Science and Education. 

In the conclusions section of the BMA document mentionded above, is stated "The subject of adverse drug reaction reporting should be included in both undergraduate and continuing medical education provision for general practitioners and hospital doctors."

However the above recommendation was not heeded. The General Medical Council's (GMC) guidelines on medical education publication, "Tomorrow's Doctors", contained no reference to adverse drug reactions or withdrawal effects for many years. Clinical Pharmacology and Therapeutics was not a required subject for medical students, according to the GMC under their policy of "integrated medicine".

 

Could my symptoms be an adverse reaction?

If medication is involved and you are concerned about yourself or another person, due to an unusual change in mood, a rash, or any other sudden or gradual difference in mental or physical condition

  • Read the Patient Information Leaflet (PIL) carefully
  • For more details about the medication find the Summary of Product Characteristics on the Pharmaceutical manufacurer's data sheet (SmPC or SPC) on www.medicines.org.uk
  • Speak to your local pharmacist or call the pharmacy in your local hospital with a list of other medicines, drugs or herbal products that may possibly be interacting with the new medication.

The focus of APRIL is mainly on drugs prescribed for physical conditions and drugs used around surgical procedures. Information about a few of the specific drugs or drug groups with known psychiatric ADRs , are listed in the left hand menu.

 

Could adverse reactions occur following surgery or anaesthetics used for local anaesthesia?"

Incidents of psychosis or depression or sucidal thoughts have been reported following surgery, either immediately or several days following the procedure. This may be due to the anaesthetics or drugs used pre and post surgery or a combination.

The important message is to stay with a person who is having unusual mood swings or seems not to be their usual self. Do not leave them alone.

The list on the left side contains some of the medicines we know can cause psychiatric side effects. However, there are many more drugs implicated in the onset of mental distress.

 

Useful web sites to find more information about drug side-effects

Rxisk is an independent data base set up by doctors. They provide information and welcome your reports of ADRs  www.rxisk.org

The Association of British Pharmaceutical Industry (ABPI) electronic medicines compendium (emc), contains pharmaceutical data sheets known as Summary of product characteristics (SPCs or SmPCs) www.medicines.org.uk  on this site will be the latest  Patient Information Leaflet (PIL) too.

The data from the pharmaceutical manufacturer may also have information that your doctor would find helpful in helping to discern if a particular drug is implicated in mental changes. However if one finds discussion in forums that relate to your suspicion being correct, then remember the patient's voice should be heard. Most drugs have not been monitored for psychiatric ADRs prior to being licensed. 

Many adverse side effects are only recognised officially after many years of the drug has been licensed

Just because the particular condition is not listed does not mean it has not been caused by the drug.

An example known to Millie Kieve the founder of APRIL is a drug in a group called sulphonamides. The drug Sulfasalazine or Sulphasalasine, if not tolerated, can lead to a sudden onset of psychosis. The MHRA have reports of this very serious recognised psychiatric adverse drug reaction (ADR) yet have not insisted the manufacturer places this condition on the data sheet (SPC) or the PIL.

 

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

Be aware of interactions with other medicines

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)

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 Report to the MHRA using this link above or call the MHRA 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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