Patients taking an “important” antipsychotic treatment for schizophrenia and bipolar disorder should be warned of the risk of developing gambling addictions, the Medicines and Healthcare products Regulatory Agency (MHRA) "reminded" healthcare professionals yesterday (December 18).
The medicines watchdog said that aripiprazole was “suspected to be the cause” of 32 reports of “gambling disorder and pathological gambling” received by the MHRA’s Yellow Card scheme between January 1 and the end of August this year.
In total, the MHRA said that aripiprazole had been linked to a total of 69 such reports “in the last 14 years”.
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According to the MHRA’s drug safety update, also published on December 18, “in many cases” people reporting the development of gambling disorders had “no previous history of gambling behaviour”.
Eight Yellow Card reports were submitted about patients who had suffered the loss of “significant sums of money” or who had “accrued considerable debts” due to their gambling, according to the update.
Most of the patients “resolved” their urges when they reduced their dose or stopped using aripiprazole, it said.
Few reports compared to prescribing frequency
Alison Cave, the MHRA’s chief safety officer, said that the agency had received a “small” number of reports about suspected aripiprazole-linked gambling and impulse disorders “in comparison to the frequency with which it is prescribed”.
Aripiprazole, an “effective and acceptably safe” treatment of adult schizophrenia, manic episodes in adults with bipolar disorder and for the prevention of manic episodes, was prescribed “over 1.5 million times” between October 2022 and end-September 2023, the MHRA said.
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Nevertheless, Ms Cave noted that “the consequences for any patient developing these conditions can be significant”, with the MHRA’s drug safety update noting that gambling is “a common risk factor linked to suicide”.
The MHRA said that “stakeholders” had told it that there was “a lack of awareness” that the drug was linked to people developing or worsening gambling disorders.
Patients “unaware of the risks”
Professor Henrietta Bowden-Jones, the director of the National Problem Gambling Clinic, said that the clinic had seen a “significant number” of people that had been prescribed aripiprazole and who were “unaware of the risks” presented by the drug.
She said that these patients had not been properly informed by their mental health teams and “many” had not had “periodic reviews” to assess whether new symptoms had emerged after treatment began.
The MHRA said that it had approached gambling clinics in March this year to “report any suspected cases that may account for some of the rise”.
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Professor Bowden-Jones said that patients should be “consistently” alerted to the risks “both during the initial prescription and follow-up reviews”.
The MHRA advised healthcare professionals to warn patients using the drug to monitor whether they developed “new or increased urges to gamble” or any other “impulse control symptoms”.
It said that these could include developing an “abnormally high sex drive”, eating to excess or spending money to excess.
The MHRA called for patients to talk with their pharmacist, doctor or nurse if they experienced side effects from aripiprazole.
MHRA news
Yesterday (December 18), C+D reported that a coroner had demanded that the medicines regulator “take action” following the death of a 35-year-old woman after taking the anti-nausea drug cyclizine, which she had purchased from a community pharmacy.
And at an event earlier this month, MHRA chief executive Dame June Raine said that a relaunched working group of government, regulation and business would “open doors” for manufacturers contemplating medicine reclassifications.
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