Email from John Perrott to Dr June Raine, Director, Vigilance, Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (04 December 2011)

Dear Dr Raine,

I noted from your last communication that you will no longer answer questions explaining why you will not investigate Wyeth withholding safety data from the UK Ativan data sheet or explain why it took a further 18 years for warnings to start being listed by the regulatory authority, but that you are willing to answer questions on other benzodiazepines.

Would you please explain why the warnings for the benzodiazepine Clorazepate (Tranxene) listed below from the US data sheet in 1973 did not appear on the UK data sheet and why it took over a decade following this before any warning of dependence risk was listed on the UK data sheet?

Clorazepate (Tranxene) – US data sheet – “Physical and psychological dependence: Withdrawal symptoms (similar in character to those noted with barbiturates and alcohol) have occurred following abrupt discontinuation of clorazepate. Symptoms of nervousness, insomnia, irritability, diarrhea, muscle aches and memory impairment have followed withdrawal after long-term use of high dosage…. Evidence of drug dependence has been observed in dogs and rabbits which was characterized by convulsive seizures when the drug was abruptly withdrawn or the dose was reduced…”

Would you also please explain why Wyeth was not investigated for withholding safety data regarding the withdrawal effects of its drug Venlafaxine (Effexor) which Wyeth only gradually disclosed some 8 years after this drug was first licensed?

Yours sincerely,

John Perrott

This entry was posted in benzo, Benzodiazepines, PERROTT. Bookmark the permalink.

Comments are closed.