Covance iPledge loophole ‘must be closed’

Covance’s iPledge programme must be reviewed to ensure fewer pregnant women are exposed to acne treatment Accutane, it has been warned.

The programme operates in the US in order to prevent the drug – which contains isotretinoin, known to cause birth defects – being administered to pregnant women.

But new figures published by health campaign group March of Dimes show 122 women received the drug during the first year of the programme.

The association notes that a loophole whereby internet sales were not monitored was recently targeted by the US Food and Drug Authority.

Dr Michael Katz, senior vice-president for research and global programmes at March of Dimes, said: "Although no human system will ever be perfect, the goal is to prevent birth defects to the fullest extent possible.

"No woman should ever take isotretinoin while pregnant and no woman should get pregnant while taking isotretinoin."

Under the specifications of the iPledge programme, women must receive two negative pregnancy tests before they can start a course of treatment containing isotretinoin.