Read this article written by a New Zealand woman, and the experiences she is facing after her sons suicide.
Here is an excerpt:
A couple of days ago, after two years of fighting, I received Mylan Pharmaceuticals assessment of the causal link between their drug Fluox and my son’s suicide. Their conclusion is identical to that of the New Zealand drug regulator Medsafe, that the SSRI antidepressant Fluoxetine is the probable cause of Toran’s death. The rating of ‘probable’ includes an assessment that Toran’s suicide was ‘unlikely to be attributed to disease or other drugs.’
I recieved two documents from Mylan. The first was a record of the adverse reaction report I made to them. It is full of errors. Critically, my son is recorded as having been 19 years old. In fact he never got to be 19, or even 18. He was 17 when he died. He was a pediatric prescription drug user, not an adult as Mylan has recorded.
The second major error is that the person who received the information I reported, recorded that Toran had been diagnosed with depression. Toran did not ever have a diagnosis of depression or any other mental disorder. At the time of his death, his medical records showed ‘diagnosis deferred.’
There are lots of other errors – the dates on which his dose was titrated, the date on which he took three times the prescribed dose and ended up in the emergency room having self harmed, the levels of glucose in his blood prior to starting Fluoxetine, while on the drug and after withdrawal.
The most shocking thing about the form though, is that despite my providing my contact phone numbers, despite my offering to provide Torans medical file and the transcripts of his inquest (in which his clinicians, teachers and others gave evidence on his adverse reactions to the drug), the recorder has finished the report by ticking the box ‘unassessible’ under the heading ‘Causality of Reaction (In the Opinion of the Reporter) which provides the options ‘possible’, ‘unlikely’, ‘unassessible’ and ‘not related’. The definition of unassessable is a report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified.
This makes me unspeakably angry. It takes no small emotional toll to call a drug company and recount the events leading to your child’s suicide. For my report to be dismissed so easily is insulting to me and to Toran.
Perhaps the Regulatory Affairs Team Leader mistook the word causal for the word casual.
This report was sent to Mylan’s UK office for assessment where despite the errors, notably the incorrect record of Toran having depression, the assessment was that the drug was the probable cause of his death.
The Mylan NZ report is here Mylan NZ Causality Assessment
The Mylan UK report is here Mylan UK Causality Assessment
I have written to Mylan correcting the errors in their reports and asking for an amended report to be sent to me along with an explanation of the ‘unassessible’ rating in the face of my clear offers to provide any information necessary for the assessment.
More info on the website as link above,