Drug trial in UK puts 6 in ICU
2006-03-15 09:54
London - Six men were seriously ill in a London hospital on Tuesday after taking a new drug during a clinical trial, health officials said.
The volunteers fell ill after taking a drug being developed to treat chronic inflammatory conditions and leukemia, a British medicines watchdog said in a statement.
The Medicines and Healthcare products Regulatory Agency (MHRA) said eight men took part in the trial, two of whom were given a placebo. The six who took it became ill.
US drug research company Parexel International Corp said it had set up the trial for German pharmaceutical company TeGenero AG.
"It is assumed that the adverse affects were based on a drug reaction," Professor Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a statement.
"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation."
Parexel said those who fell ill were taking part in the first human tests of an experimental drug called TGN 1412. It is being developed by TeGenero to treat diseases such as cancer and rheumatoid arthritis.
All regulatory, clinical and medical guidelines had been followed during the trial, Parexel said.
Exhaustive investigation to determine cause
The MHRA watchdog said it had suspended the trial and notified other European regulatory bodies about the incident.
"Our immediate priority has been to ensure that no further patients are harmed," Kent Woods, MHRA's chief executive officer, said in a statement.
"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken," said Woods.
The unnamed patients were moved to a critical care unit at Northwick Park Hospital in north London on Monday from a research centre on the same site.
"They are in a serious condition," said Ganesh Suntharalingam, the hospital's Clinical Director of Intensive Care. "Their families are very concerned, and we are keeping them closely informed about their relatives' progress."