Back in September I wrote to the British drug regulator, the MHRA, under the terms of the Freedom of information act.
The question I put to them was in regard to reported suicides associated with Lariam (mefloquine) reported on their database. Their Drug Analysis Print (DAP) had shown that there were 9 completed suicides associated with the drug.
For those that don't know, Lariam, marketed and manufactured by Roche, is a drug used to treat the prevention of malaria and I wrote about it here back in August. It's used a lot by the military to treat soldiers who visit and train in countries that have a high risk of malaria.
Worryingly, it wasn't just the completed suicides that concerned me. There were a number of other psychiatric events associated with this drug, namely;
- 18 reports of Abnormal behaviour.
- 24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
- 61 reports of Agitation
- 304 reports of Anxiety
- 38 reports of Aggression
- 82 reports of Paranoia
- 11 reports of Personality change
- 67 reports of Confusional state
- 61 reports of Disorientation
- 19 reports of Delusion
- 341 reports of Depression
- 10 reports of Depersonalisation
- 14 reports of Dissociation
- 28 reports of Irritability
- 59 reports of Mood swings
- 15 reports of Mental disorder
- 11 reports of Mania
- 162 reports of Panic attack
- 119 reports of Abnormal dreams
- 146 reports of Nightmares
- 113 reports of Hallucinations
- 19 reports of Acute psychosis*
- 76 reports of Psychotic disorder
- 9 reports of Completed suicide
- 33 reports of Suicidal ideation
- 12 reports of Thinking abnormal
* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" category - unless, of course, the person died naturally?
The MHRA took approx one month to answer my question. Their full response is below.
They told me...
"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."
Hopefully, this somewhat blasé response from the MHRA will help those campaigning, or, as I strongly suggest, get those campaigning to write to the MHRA to ask them why the follow-up rate has been so poor regarding the reported suicides and other psychiatric adverse events associated with this drug.
The MHRA can be contacted via email here.
Bob Fiddaman.
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