Sunday, 5 December 2010

MP's concern over Benzodiazepine use - vital data lost

Check on benzodiazepine-use must be done, say MPs
By Nina Lakhani

The safety of tranquillising drugs prescribed to millions of people over the past 50 years must be urgently investigated, MPs and peers will demand this week.

A group of cross-party parliamentarians want publicly funded health bodies to be forced to carry out research into the dangers of benzodiazepines which they say have destroyed the lives of hundreds of thousands of people.

Their demand comes as the Medicines and Healthcare products Regulatory Agency (MHRA), the drug safety watchdog, admitted issuing 26 new licences for a powerful tranquilliser, Lorazepam, despite the fact it no longer holds any safety information about the drug.

Lorazepam, manufactured under the name Ativan by John Wyeth since 1972, is 10 times stronger than Valium, the most common tranquilliser drug, and many patients find it extremely hard to withdraw from it.

The MHRA has issued generic licences for the manufacture and distribution of the drug under a European directive which allows it to "bridge back" to the safety dossier and clinical trial evidence provided by the original manufacturers in their original licence application. John Wyeth voluntarily cancelled its licence for "commercial reasons" in 2008.

However, it has now admitted that it "no longer holds" the safety information because, after 15 years, "files are destroyed unless there is a legal, regulatory or business need to keep them, or they are considered to be of lasting historic interest". No one knows when or who reviewed the safety information last.

Click on title to access full article

No comments: