Must-Read: FDA approves long-acting hydrocodone despite warning from its own advisory panel (Weekly Web Review in Toxicology)

This study design allows researchers to enroll only subjects who have already been shown to tolerate and respond to the drug. Critics of this method argue that it stacks the deck in favor of good results, and in no way simulates real-world conditions or predicts after-market experience. Last December, an FDA panel voted against approving the drug. One panel member, medical toxicologist Jeanmarie Perrone, said she was “surprised” when the drug was approved. In a related story, the Journal Sentinal previously reported that the enhanced enrollment design was worked out at annual private meetings between drug companies and federal regulators, held at expensive hotels and paid for by the companies. (HT @DavidJuurlink) PMA sold as ecstasy killing users in Britain: The BBC News (U.K.) reports that deaths from the hallucinogenic amphetamine PMA are rising dramatically in the UK, from 1 fatality in 2011 to 23 so far this year. The drug is often sold on the street as MDMA (ecstasy). In the story, Professor David Nutt, a former government advisor, notes that PMA is much more potent than MDMA. In addition, its prolonged onset time predisposes to overdose: “If you’re used to having a sort of hit from ecstasy within 20 minutes or half an hour and you don’t get this from PMA, then you think, ‘Well obviously it was a bum lot – I’d better take some more.’” Toddler dies after ingesting battery: When 1-year old Julian Wilson died a...
Source: The Poison Review - Category: Toxicology Authors: Tags: Medical battery ingestion central park ecstasy FDA federal drug administration hydrocodone mdma pma toxic plant zohydroer Source Type: news