Prozac one of 30 antidepressants probed by UK watchdog over links to suicide

More than 30 of the most common antidepressants used in the UK are to be reviewed by the UK’s medicines regulator, as figures point to hundreds of deaths linked to suicide and self-harm among people prescribed these drugs.

The medicines, which include Prozac and are prescribed to millions of patients, will all be looked at by the Medicines and Healthcare products Regulatory Agency (MHRA).

It follows concerns raised by families in Britain over the adequacy of safety measures in place to protect those taking the drugs, such as warnings about potential side effects.

The regulator will look into the effectiveness of the current warnings, according to a letter from mental health minister Maria Caulfield, which has been seen by The Independent.

There has been a huge rise in the use of antidepressants in England, with 85 million prescriptions issued in 2022-23, up from 58 million in 2015-16, according to NHS figures.

Nigel Crisp, a crossbench peer and chair of the Beyond Pills all-party parliamentary group, told The Independent: “Overprescribing of antidepressants has an enormous cost in terms of human suffering, because so many people become dependent and then struggle to get off them – and it wastes vital NHS resources.”

The review comes as it emerged that:

Side effects of many antidepressants can include suicidal thoughts and anxiety, according to the National Institute for Health and Care Excellence (NICE), though this is considered uncommon.

One mother, Lyn Richardson, called on the regulator via The Independent to review safety measures around the drug mirtazapine after her daughter took her own life two weeks after being prescribed it.

The regulator confirmed to The Independent that the expert working group will look at 30 different medications, including fluoxetine – the generic name of the drug sold under the brand name Prozac – as well as lithium and citalopram.

According to MHRA data, fluoxetine has prompted 9,237 serious and fatal alerts relating to adverse reactions since the year 2000. Of these, 438 were related to “suicidal and self-injurious behaviours” and 286 were linked to anxiety symptoms.

Data suggests that there have been 73 fatalities linked to suicidal and self-injurious behaviours in patients taking fluoxetine in the last two decades. The data does not confirm that the drug was the direct cause of death.

Last week, The Independent reported Ms Richardson’s call for the regulator to review safety measures around mirtazapine after her daughter Rebecca Kruza took her own life two weeks after being prescribed the medication.

Mirtazapine, which was given a “black box” alert in the USA due to its possible side effects, has been the subject of 59 alerts linked to suicidal and self-injurious behaviours. This led to the US regulator placing clearer warnings on the packaging.

It will be included in the MHRA’s wider review.

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In a letter to Ms Richardson, Ms Caulfield said the MHRA’s review will look into the effectiveness of the warnings provided to patients who are prescribed antidepressants.

As the use of antidepressants soars, the most recent NHS data from March 2023 to December 2023 shows that 331,000 patients between the ages of 10 and 19 were prescribed an antidepressant during that time – up from 240,000 during the same period in 2015-16.

Last year, the Beyond Pills APPG called for government action to reverse the increase in prescriptions of these drugs.

James Davies, associate professor of psychology at the University of Roehampton and a member of the Beyond Pills APPG, warned that the provision of social and psychological alternatives to medication is “insufficient”.

While 8.5 million people were prescribed antidepressants in 2022-23, only 1.2 million people commenced so-called “talking” therapies.

“We have over 85 million prescriptions of these drugs each year in England, and that figure grows yearly,” said Professor Davies. “Another concern is that not only are we seeing vaulted rates of prescribing to the general population, we’re seeing the average duration of time a given person spends on these drugs increasing as well.

“One of the reasons for this is that there’s still insufficient provision for social and psychological alternatives in the NHS.”

Prof Davies warned that patients are not being adequately followed up once they have been prescribed these medications.

He added: “We should not be prescribing these psychotropics to young people. We should be providing young people with the psychological and social support necessary to enable them to overcome the difficulties that they’re encountering.”

The MHRA said it could not confirm the scope of the review or what actions could be taken as a result, as it was still convening its panel of experts.

It told The Independent: “We are currently finalising the core membership of the expert working group considering risk minimisation measures for antidepressants, and anticipate that their first meeting will take place in July. The group will be considering all antidepressants on the UK market.”

Professor Davies highlighted concerns over the regulator’s ability to conduct the review. He said: “The MHRA is far too close with the industry to be objective for this review, in my view. It is 100 per cent funded by the pharmaceutical industry. There are serious concerns about what we call regulatory capture, which is when it is far too close to the industry it is purporting to independently regulate.”

An MHRA spokesperson said the agency has “robust conflict-of-interest mechanisms covering MHRA staff, board members and those who give independent, expert advice on MHRA committees”, adding: “These mitigate any potential conflicts of interest effectively.”

Dr Amit Aggarwal, of the Association of the British Pharmaceutical Industry (ABPI), said that companies support “ethical and evidence-based prescribing” and want to help healthcare professionals and patients to reach sensible decisions on the best treatment.

A Department of Health and Social Care spokesperson said that talking therapies constitute the recommended first-line treatment for depression, and that the programme to improve access to these treatments will be expanded to treat 384,000 more people over the next five years.

It added: “The decision to prescribe a particular product is a clinical one and should be based on the patient’s medical need, taking into account NICE guidelines, which recommend not routinely offering antidepressant medication as a first-line treatment for less severe depression.”

Eli Lilly, which manufactures Prozac, told The Independent: “There is nothing more important to Lilly than the safety of our medicines. For decades, Lilly has been submitting fluoxetine safety data to regulatory authorities around the world, including the MHRA and FDA.

“Fluoxetine is approved by the MHRA and FDA and continues to be considered to have a positive benefit-risk profile by regulatory authorities, physicians and patients around the world.”