What is an Adverse Drug Reaction (ADR) ?
The definition of an ADR or AE is:
"unwanted or unintended effects of a medicine which occurs during proper use."
Defined by the British Medical Association.in a policy document titled "Reporting adverse drug reactions" published by the BMA Board of Science and Education.
List of some medicines that may cause psychiatric adverse effects
Pharmaceutical manufacture's data sheets may be accessed here: www.medicines.org.uk
This is the Association of British Pharmaceutical Industry Electronic Medicines Compendium (eMC) and they state on their web site:
"When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, they show the dates it was published on the eMC and the reasons for change."
Where else can we obtain updated information from the medicines regulators?
Click here for access to the USA Medwatch Safety Information Alerts
Click here for sign up details for UK MHRA medicines safety alerts
Everyday drugs commonly used for indigestion, acne, inflammation, pain, infections, cholesterol, malaria prevention and other conditions, as well as those prescribed for depression and anxiety, can cause serious psychiatric side effects or withdrawal reactions.
Long term treatment for perceived mental illness may be prevented if the psychiatric adverse effects are recognised in time.
The medicines used to treat psychiatric symptoms are known as psychotropic, anti-psychotic or neuroleptic and can lead to unwanted side effects. For severe psychiatric illness, these medicines may be required. Unfortunately they are often prescribed in higher and higher doses when side effects are not recognised as such and diagnosed as a new or deteriorating illness.
To ensure that the new symptoms are not a possible adverse side effect due to a change of dosage, or withdrawal reaction caused by your medication. Check the side effects listed on the Patient Information Leaflet. oR look at the data sheet on www.medicines.org.uk put the name of the drug in the top box and look at the SPC data which is the Summary of Product Characteristics.
Prescription drugs with reported psychiatric reactions include:
- Steroids
- Sulphonamides and other Anti-bacterials
- Hormonal drugs
- Acne drugs
- ADHD drugs
- Antidepressants
- Anti-Parkinsonian
- Anti-convulsants
- Anti-malarials
- Beta-blockers and other cardiovascular drugs
- Anti-biotics
- Anti- histamines
- Anti-hypersensitives
- Tranquillisers
- Statins
- anti-smoking
- anti-viral Tamiflu
Drugs which cause dependency and consequent difficulties during and after withdrawal for some people include Benzodiazepines, (tranquillisers and sleeping pills), some antidepressants, pain killers, inhaled and oral steroids.
POSSIBLE EARLY WARNING SIGNS OF DRUG INTOLERANCE or WITHDRAWAL SYNDROME
- INSOMNIA
- ANXIETY
- MOOD CHANGES
- FEELING LOW
- CONFUSION
- HEADACHES
- DISTURBED SLEEP
- BAD DREAMS
- HALLUCINATIONS
- DEPRESSION
- THOUGHTS OF SUICIDE
- EUPHORIA
- MALAISE
- AMNESIA
- LOSS OF LIBIDO
A decline into mental illness and more serious states of:
- MANIA
- PSYCHOSIS
- AGGRESSIVE BEHAVIOUR
- SUICIDAL THOUGHTS.....
......may be prevented if prompt action is taken at the first sign of what MAY be an ADVERSE DRUG REACTION.
IF YOU ARE WORRIED THAT THE MEDICATION IS HAVING AN ADVERSE EFFECT SEEK PROFESSIONAL MEDICAL HELP. Under medical supervision a change of medication may be possible.
ADVERSE PSYCHIATRIC REACTIONS TO PRESCRIBED DRUGS from the Textbook of Adverse Drug Reactions - Davies 1991 Oxford University Press (OUP) Psychiatric disorders section by K. Davison and F. Hassanyeh
"Adverse drug reactions account for a substantial amount of psychiatric morbidity (illness) which is increasing as new and ever more potent drugs are introduced. A survey of adverse drug reactions in general practice revealed that neuropsychiatric reactions accounted for 30 per cent of cases, second only to gastrointestinal reactions (Martys 1979) The Boston Collaborative Drug Surveillance Program (BCDSP 1971) recorded adverse psychiatric reactions in 2.7 per cent of 9000 hospital patients receiving non- psychiatric drugs.
The difficulties attaching to establishing the validity of any alleged drug reaction are greatly magnified for psychiatric reactions. The latter may be delayed in onset, and some reactions may persist for weeks or months after drug withdrawal.
The chapter continues after elaborating on the difficulties.
"Many reports emanate from non-psychiatrists, who tend to equate hallucinations and delusions with ' psychosis' or even 'schizoprenia' and apathy with ' depression' when the correct diagnosis is 'delirium'.
Application of a recognized diagnostic system, such as the International Classification of Diseases (ICD-9) (WHO 1977) or that of the American Psychiatric Association (DSM-111-R) (APA 1987) would help to obviate this difficulty. These problems emphasize importance of national systems of reporting adverse drug reactions.
Predisposing factors to adverse psychiatric reactions
An important variable in the production of adverse psychiatric reactions is personal predisposition. The risk of increased in those with pre-existing impairment of brain function, such as the elderly or brain-damaged, or with past or present psychiatric illness, or a history of alcohol or drug abuse, but those with unblemished psychiatric records are by no means immune. Although a family history of affective disorder (depression or mania) predisposes to the drug precipitation of the same conditions. (Whitlock and Evans 1978), the relationship is less clear - cut for paranoid or schizophreniform psychoses (Davison 1976). These disorders can also appear in those without such predisposition.
Other predisposing factors include extreme youth (Prescott 1979), concurrent physical disease (James 1975), and stressful environments, such as intensive treatment units (Tomlin 1977; Davison 1989a)
Types of Reaction
The vast majority of adverse psychiatric drug reactions are of Type A in that they are dose-dependent or recognizably related to the known pharmacological properties of the drug. Even when a reaction occurs at therapeutic plasma drug levels there is often an interaction of an identifiable drug effect with individual predisposition." END OF QUOTE
The following is quoted from 'Iatrogenic Diseases by D'Arcy and Griffin 1986 (OUP)
If an unexpected psychiatric disturbance arises suddenly in a person of good previous personality, shortly after a drug of any sort has been taken, no matter how harmless it usually is, it is clearly wise to suspect a drug-induced reaction and, if possible, to discontinue or reduce the dose of the suspected medication. It is also good practice to avoid unnecessary polypharmacy, to attempt to treat one psychiatric condition with one drug if possible, and to remember that the use of two drugs from the same group (antidepressant, neuroleptic, minor tranqullizer, etc.) can rarely, if ever, be justified.
Delirium
A very wide range of drugs have been associated with toxic confusional reactions (acute brain syndrome) which are characterized by a fluctuating clouding of consciousness, restlessness, emotional changes (usually fear and perplexity, and paranoid delusions and/ or visual hallucinations in severe cases.)
Detailed descriptions of delirious states were given in the classic paper by Wolfe and Curran (1935) who reviewed 106 cases associated with 27 different precipitating noxious agents. The only drugs involved in these cases were alcohol, barbiturates, bromide, lead and copper. Wider range of drugs can be associated with such reactions, either during administration or in withdrawal." END OF QUOTE