Strattera Adverse Events: Deaths Mount - Will EU Health Authorities Intervene?
Will European Health Authorities act on reports of serious side effects and deaths connected with the ADHD drug Strattera? Are 95 deaths, 965 reports of suicidal behavior and some 60,000 reported adverse events enough to take action, asks Swedish researcher Janne Larsson in a letter to the UK's Medicines Agency.
Eli Lilly's ADHD drug Strattera (atomoxetine HCl), is promoted as the first non-stimulant medication that's FDA-approved to treat ADHD in Children, adolescents, and adults. Side effects are downplayed. Tiredness and nausea are listed as common but rarely, the company says, are there suicidal thoughts in children (not adults), or liver damage.
Janne Larsen, a Swedish investigator, charges that these official pronouncements of Eli Lilly are in sharp contrast with real world deaths and frequently observed suicidal tendencies as well as episodes of psychosis, mania and aggression that keep being reported to Adverse Drug Reactions databases. A clinical trial in Sweden in 2005 turned out disastrous for the drug.
While the FDA has reviewed the drug and required warning labels for sale in the US, a European review is drawing on without much movement. Apparently, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) is leading efforts to review Strattera's safety for the European Health Authorities, but - says Larsen - they are dragging their feet.
Instead of installing an independent panel for the review of the drug, the MHRA has asked Eli Lilly to do the review themselves. Predictably, the company that makes the drug has found that there aren't so many adverse effects, and that with so many confounding factors to consider, it isn't sure whether the drug was responsible for any of them.
Now Janne Larsson has sent a third letter to Kent Woods, the chief executive of the MHRA, pointing out inconsistencies in Lilly's review of Strattera side effects and he is asking whether the agency has plans to question Lilly's data or whether it is going to continue to rely on their faulty analysis. Larsson also wants to know:
"Will the agency, considering the harm caused to children, start an investigation of all the reported cases of death in connection with Strattera 'treatment'?"
- - -
In a letter to Kent Woods of the MHRA, Larsson charges that Eli Lilly gave false information about Strattera related deaths and asks for a full investigation:
- - -
To: Professor Kent Woods
Medicines and Healthcare products Regulatory Agency – MHRA
Copy: All European Medical Agencies (concerned member states for Strattera)
May 15, 2008
Strattera: Eli Lilly gave false information about deaths from Strattera “treatment” – a request for full investigation
In April I gave data to the MHRA about reported instances of deaths in connection with Strattera treatment. The agency has still not answered and no investigation has been announced about the fatal cases reported.
The following updated report – a compilation of confirmed fatal cases in connection with Strattera treatment, is sent to assist the agency in its investigation.
This report also contains proof that Eli Lilly in January gave false and misleading information to the MHRA about deaths from Strattera treatment.
The children and teenagers getting Strattera “for ADHD” can be expected to be healthy normal children and in this group of “patients” there should be extremely low morbidity and mortality. This report tells another story.
In November 2007 I made an FOIA-request to the MHRA about the number of persons who have died while under Strattera treatment. The agency didn’t know and asked the manufacturer, Eli Lilly.
Eli Lilly noted, that the company up to November 30, 2007 “has identified 41 fatal cases in our safety database”. But as the company only accepts deaths reported by a “health care professional (HCP) or regulatory authority”, 17 of these cases were right away deducted. In Lilly’s words: “Of the 41, only 24 were Adverse Drug Reactions (ADR) with fatal outcomes.” 
The MHRA did not get further data about these fatal cases from Lilly, only the numbers.
A new investigation of cases, with death as outcome, reported to the FDA (2004-2007), and a review of Periodic Safety Update Reports (PSURs) for Strattera, have shown the following:
Children and teenagers:
31 children and teenagers have died while under Strattera treatment, with Strattera reported as the Primary Suspect Drug (PS). 19 of these young persons committed suicide.
In addition to the FDA reports, data in different PSURs in Europe show that an additional 6 children and teenagers have died while under Strattera treatment.
33 adults have died while under Strattera treatment, with Strattera reported as the Primary Suspect Drug (PS). 17 of these adults committed suicide.
In addition to the FDA reports, data in different PSURs in Europe show that an additional 4 adults have died while under Strattera treatment (cardiac death).
In the reports to the FDA there are also 7 cases of stillbirth/abortion spontaneaus reported with Strattera noted to be the Primary Suspect Drug.
Summary of fatal cases from FDA 2004-2007 and PSURs:
37 children and adolescents + 37 adults + 7 stillbirth/abortion sponteneous = 81 deaths.
Of these 81 fatal cases at least 47 were reported by health care professionals (HCPs).
See specifics about all fatal cases reported to the FDA 2004-2007 in the table
Strattera Deaths with Strattera as Primary Suspect Drug , and for ALL reported fatal cases in the attached (and linked) document StratteraDeath 
In addition, the following fatal cases in connection with Strattera treatment – with Strattera as Secondary Suspect Drug (SS) or with Concomitant drugs (C) – are reported to FDA 2004-2007: 4 children and teenagers and 10 adults [see also 3]
In total: From FDA 2004-2007 and PSURs including Strattera in all Role Codes (PS, SS, C):
22 (suicides) + 19 = 41 children and adolescents;
22 (suicides) + 25 = 47 adults
+ 7 stillbirth/abortion sponteneous
= 95 cases of death
Lilly gave the figure 41 deaths - but right away excluded 17 case reports, and said the figure to be used was 24. 
I have now given specifics about confirmed cases of death in connection with Strattera treatment. And the number is much higher than in the Lilly report.
I refer to the promise by the agency: to “take any necessary action to protect the public promptly if there is a problem” .
The above information does definitely tell there is a problem: As said, the children and teenagers getting Strattera “for ADHD” can be expected to be healthy normal children and in this group of “patients” there should be extremely low morbidity and mortality.
But the above data say that 41 children and teenagers have died in the last 5 years while under Strattera “treatment” – with 22 of them committing suicide.
Add to this the staggering number of adverse events reported internationally for Strattera (the majority for children) – Lilly has told the MHRA: “During this reporting period, a total of 23,132 spontaneous adverse event reports of atomoxetine [Strattera], representing 58,048 adverse events, were collected by the MAH [Market Authorization Holder; Eli Lilly].”  This covered the period from November 2002 to March 2006. The number of persons who have experienced suicidality in connection with Strattera treatment has now reached 965 (PSUR 9, p. 106). Up to November 2007 (PSUR 9, Annex 16) there were also 513 case reports about mania, psychosis or hallucinations in connection with Strattera treatment.
The MHRA has not taken any visible actions to protect children from all these harmful effects – not even answering on earlier reports about deaths from Strattera treatment.
I would like to get a swift answer to these two questions:
1. Is the agency going to call in question the data given by Eli Lilly (41 deaths, 24 confirmed by HCPs) in light of the now presented evidence (81 deaths in FDA 2004-2007 with Strattera as Primary Suspect Drug and in PSURs, with at least 47 of these 81 confirmed by HCPs; and in total 95 cases of death)?
2. Will the agency, considering the harm caused to children, start an investigation of all the reported cases of death in connection with Strattera “treatment”?
Reporter – investigating psychiatry
129 45 Hägersten
 Eli Lilly, Letter to the MHRA, January 2, 2008, (see last 3 pages)
 Psychdrugdangers - (www.psychdrugdangers.com/stratteradeath-new.html - link no longer active) Strattera Deaths with Strattera as Primary Suspect Drug, (visited May 15, 2008)
 StratteraDeath, May 15, 2008
 MHRA, About us, (visited May 15, 2008)
 Eli Lilly, Main Report, for Periodic Safety Update Report (PSUR) 6, page 105, period November 27, 2005 through May 28, 2006
- - -
An earlier letter, sent on 9 March 2008 to Kent Woods of the MHRA which outlines adverse event reports showing Strattera-induced mania, psychosis and hallucinations, has not been answered to date. The letter is available here:
An even earlier letter, sent in January 2008, asking that action be taken by the MHRA is available here:
An FDA review of several ADHD drugs discusses prevalence of psychosis, mania, violent behavior and suicidality. It shows that Strattera is by a large margin associated with the most reports of such adverse events:
Children's suicide attempts raise concerns about ADHD medication
New questions are being raised about the safety of a drug used to treat attention-deficit hyperactivity disorder amid reports that more than 40 Canadian children have attempted suicide after taking it.
Health Canada said it received 189 reports of adverse reactions associated with atomoxetine, sold under the name Strattera, from the time it was put on the market in February, 2005, to the end of last year.
The reports included 55 suicide attempts - 41 of which were among children aged 6 to 17, and 12 that were adults between 18 and 45.
Given drug companies' readiness to produce evidence that puts their products in a good light, it seems curious our drug watchdog should be willing to rely so heavily on them. And yet it continued to do so.
Take the case of Strattera, the drug used to treat hyperactivity in children.
There have been concerns it could cause psychosis — hallucinations, delusional thinking, or mania — in some children. Three years ago, the American drug watchdog, the Food and Drug Administration, highlighted the risks and, as a result, the warnings on the
label were changed. Instead of issuing a similar warning, the UK drug watchdog contacted Eli Lilly and asked them to review the evidence.
The drug firm came to a rather different conclusion, including doubting whether the reports of hallucinations in children were genuine.
'Asking a drug company to review its own product is crazy, but it goes on quite a lot,' says Andrew Herxheimer, editor of the Drug And Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre (the organisation which gathers and assesses information about drug effectiveness and safety)
December 2008: ADHD drug causes psychosis, hallucinations, mania
The manufacturer, Eli Lilly, has now changed the label for Strattera in Europe to include warnings that Strattera CAUSES "hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania … at usual doses".
posted by Sepp Hasslberger on Wednesday May 21 2008
updated on Friday November 19 2010
URL of this article:
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