British Health Regulatory Agency Fails to Reveal Strattera Harmful Side Effects

British Health Regulatory Agency Fails to Reveal Strattera Harmful Side Effects

In its new report about the ADHD drug Strattera, expected to be published by the end of November 2006, the British Medicines and Healthcare products Regulatory Agency (MHRA) which is the equivalent to the FDA will issue new warnings about the harmful effects of the drug. These warnings are about the risk for sudden cardiac death in connection with Strattera.

But the report will not take up all the psychiatric reactions known by the agency for almost a year. The reason is the MHRA didn't care to investigate them.

In January the agency wrote in its Risk: Benefit Assessment about, what it called, the large number of psychiatric reactions from Strattera. The assessment had requested Eli Lilly to perform a cumulative review of all psychiatric disorders reported from Strattera.

Yet by August there was still no evaluation while more than 12,000 psychiatric reactions were reported. Eli Lilly had submitted no review. As a consequence, in the beginning of September the MHRA announced there would be no review. When Eli Lilly didn't submit any documents to the MHRA by August 9, the agency dropped the request.

Instead the MHRA started to refer to the analysis done by the FDA, considered by the FDA Pediatric Advisory Committee at its meeting on 22 March 2006. However the FDA review covered parts of all these reactions and was completed already in September 2005 as the MHRA knew all about it a long time ago.

This means that the British MHRA, leading the current "safety review" of Strattera in Europe, didn't care to investigate what the agency itself called a large number of psychiatric reactions. It didn't even report any biased data about these harmful effects from the manufacturer Eli Lilly.

Warnings that Strattera increase the risk of suicide were issued internationally in September 2005 after Eli Lilly announced a "new analysis" of its clinical trials of the drug.

The number of reports of suicide and self-injurious behaviour in connection with Strattera had as of May 2006 reached - 600! The number has doubled since September 2005.

Despite the fact that reported cases of suicide are now over 600, the MHRA has failed to set up an independent investigation of these horrendous harmful effects. (Eli Lillty Strattera Analysis News)