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December 23rd 2004

Lilly Announces Important Liver Safety Update to Strattera® Label

No cause for immediate alarm

We have been made aware of a FDA Safety Warning Strattera. This is from the USA but is still worth mentioning here for UK visitors as well.

Label change discusses 2 reported cases of severe Liver Injury out of more than 2 million patients who had taken Strattera.

It appears that earlier in the year Lilly were made aware that there was one case of a person developing liver problems while taking Strattera - Lilly therefore immediately contacted the FDA to make them aware of the problem and Lilly conducted a full investigation.

The person was taken off of Strattera and the problem resolved itself and their liver function returned to normal.

However later in the year the FDA were made aware of another case of liver problems with one other individual

The FDA therefore advised Lilly to place a Bolded Warning on the packaging and information sheet for Strattera to warn of a possible liver function problem - a Bolded Warning is about a level 3 warning out of 5 levels so it is considered as a possible problem rather than a likely problem.

In the 6,000 people who took part in the trials for Strattera none had any problems with liver function so it would appear that these are isolated cases and therefore it looks like very rare idiosyncratic cases

However in the USA Ely Lilly have issued statements to Health Professionals to give them this information and to advise patient that if any of the following symptoms start to occur that they need to seek medical attention immediately to ensure of no ill effects from the medication.

The symptoms being advised to look out for include:

Pruritus (Itchy skin)
Jaundice
Dark urine
Upper right-sided abdominal tenderness
Or unexplained "flu-like" symptoms

There is the full FDA report on the Strattera USA website at www.strattera.com

Direct link: http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=150719

Here in the UK Lilly are in discussions with the Medicine and Health Care Product Regulatory Agency concerning the need for similar changes to prescribing advice to UK doctors

16th February 2005 Update

We have just been given an update on this and can let you know that the UK license for Strattera has now been amended to include reference to possible liver damage. A new patient information leaflet is going into packs of Strattera now. A copy of this can be found at: http://emc.medicines.org.uk

The MHRA have assessed the risk of liver damage as rare and said that it is about 1 in 50,000.

There have so far been only 2 cases of severe liver damage in 2 million worldwide and both have made full recoveries.

It is worth noting here that there are other medications which have similar risks of liver damage and these include some over the counter medications as well.

MHRA have not recommended routine monitoring of liver function and MHRA and Lilly have written to health care professionals to advise them of this change to the license.

For a copy of the Question and Answer Sheet produced by MHRA click here

With regard to the recent media coverage of this has been based on the MHRA press release which is common practice for all safety warnings.

Maybe it was picked up more because of what this is and what this medication is used for - ADHD is a bit of a hot media topic isn't it? Ed

At the same time as the updated safety warning Strattera's license for Adults has been changed - this is due to the regulatory process for licensing of Strattera in Europe. All European countries must have the same license agreement and as a consequence of this procedure initiation of Strattera in Adults is not considered appropriate. However Strattera may be appropriate to continue from Adolescence into Adulthood.

It must be noted that this last comment of license change is NOT safety related



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