Suicide rating for new drugs?
Every new drug licensed in Britain will be given a 'suicide
rating' under proposals for a big shake-up in the rules
governing pharmaceutical development. European regulators are
also to require pharmaceutical companies to include a
comprehensive suicide assessment into trials of new
medicines.
The reform, based on a system adopted recently in the United
States, has been fuelled by a growing body of evidence that
drugs that affect the brain can heavily influence behaviour
through seemingly innocuous changes in body chemistry.
Medicines to treat acne, swelling, heartburn, pain, obesity,
high blood pressure and cholesterol, bacterial infections,
smoking and insomnia have all been associated recently with
psychiatric problems. There have been warnings about the
potential side-effects of Acomplia, an antiobesity drug,
Roaccutane, an acne treatment, and Champix, an antismoking
medication, which together have been prescribed to more than
60,000 patients in Britain.
Acomplia, also known as rimonabant, is designed to suppress
the appetite but has been reported to more than double the
rate of suicidal symptoms. Champix (varenicline), a drug that
negates the pleasurable effects of smoking, has also received
1,513 reports of adverse reactions, including 62 reports of
suicidal feelings.
David Roberts is one of 26 people said to have killed
themselves while taking Roaccutane. The 'cheerful'
20-year-old was found hanged near his Liverpool home three
months after he began taking the drug.
The European Medicines Agency (EMEA), which regulates all
drugs, has sent letters to an undisclosed number of drug
companies requiring them to analyse their data again, using
the system approved by the US Food and Drug Administration
(FDA).
Discussions have also taken place between Kelly Posner, the
designer of a suicide risk-assessment system, the EMEA and
the pharmaceutical giants. They are due to meet in April to
discuss how to introduce a suicide risk questionnaire, which
has already been translated into 80 languages, into future
drug trials. "All the players, the FDA, EMEA, representatives from the drug companies, will be at the meeting to discuss how to move
forward," Dr Posner, a research scientist based at Columbia University, New York, told The Times. "I’ve been getting
requests from clinics and authorities in Europe asking how to
implement the study. It’s really moved the field in that way.
Hopefully this will be the first step to broadening the study
across Europe."
Dr Posner and her team spent months creating a comprehensive
questionnaire known as the Columbia Suicide Severity Rating,
in which patients’ actions can be classified as either
suicidal or nonsuicidal. The questionnaire takes less than
five minutes to administer and looks for four different types
of suicidal behaviours. Each behaviour is rated for its
severity and the drug is given an overall 'suicide rating'
out of 23.
The system could also vindicate the reputation of the class
of antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs), which are no longer prescribed to people
under 18 because of fears that they encourage suicidal
thoughts in this age group. "All the previous studies that
these risks were based on were not set up to assess suicide
risk," Dr Posner said. "What we can learn from them is very
limited. After the warnings [about SSRIs] were issued there
was a 22 per cent decline in prescriptions in the US and in
parts of Europe. There is a concerning correlation between
reduced prescriptions and increased suicide."
The Medicines and Healthcare Products Regulatory Authority,
the British watchdog, said yesterday that it would follow the EMEA if the Columbia test became more widely used. "The EMEA
would probably implement the change through a directive, which we would be bound to follow," a spokeswoman said.
Drugs with known links to depression
Acomplia, an antiobesity drug
Dianette, a treatment for severe acne
Strattera, a medicine used to treat attention deficit
hyperactivity disorder
Interferon alfa, used to treat certain cancers and hepatitis B
Roaccutane, an acne treatment
Zarontin, drug used to control epileptic seizures.
Source:
British National Formulary