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Big Issues Management Moment: 130 Reports Of Suicidality In A Single Month For Eli Lilly's Strattera
Janne Larsson, a writer from Sweden, is reporting that the British received some disturbing news about Eli Lilly's ADHD medication Strattera recently.  She says that 130 individuals either attempted suicide or tried to hurt themselves over a one month period in 2005 while taking Strattera.  Larsson claims that the information was "revealed in a not released discussion paper from 9 December 2005, written by the British MHRA and sent to the Swedish MPA." She said "the information [was obtained] as a result of [Freedom of Information Act] FOIA-requests, and released by court order."

I'm not sure what to make of this report because -- based the tone of her news release -- Larsson clearly has something against Eli Lilly's Strattera.  However, because she cites the British Medicines and Healthcare Products Regulatory Agency (MHRA) as the source of the information, her assertions must be taken seriously.

Despite Larsson's claims, the MHRA does not appear to share her concerns about Strattera's safety.  According to a statement issued on on February 17, the agency believes Strattera's benefits outweigh its risks.  However, the MHRA warned that physicians should closely monitor patients taking Strattera due to an increased risk of seizures and abnormal heart rhythm. 

Clearly there are serious and persistent questions about Strattera's safety profile that Eli Lilly will have to aggressively address.  However, the company is going to have a  difficult time of it.  A FDA panel recently recommended that the agency warn physicians and patients about the safety profile of stimulant ADHD medications like Ritalin.  While Strattera is not a stimulant people will certainly wonder whether the medication has safety problems of its own.  Larsson's report may confirm their fears.  (See this post on my other blog, Envisioning 2.0, about this issue.)

This new information about Strattera's safety profile is a big issues management moment for Eli Lilly.  I expect (and hope) the company will speak out about this issue over the coming days and months.

Kudos: Thanks to John M. Grohol, Psy.D. for highlighting this report on his blog, Psych Central.

1 Comments/Trackbacks

MHRA - In whose Interests?

The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.

News this week that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.

The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?

For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.

A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?

The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’

Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)

Birmingham, UK

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