With the rapid rise in deaths related to narcotic painkillers.
In 2009 February, the FDA released notices to 16 producers of narcotic painkillers to build up so-called Risk Evaluation and Mitigation Strategies to reduce the number of accidental overdoses. As the FDA mulls over the new rules, doctors remain concerned these regulations can make it harder to take care of patients fighting chronic pain. Last week Just, at the annual conference of the American Academy of Pain Medicine, doctors urged the FDA to consider instead state-run drug monitoring programs. So whatever type the FDA rules take, they’ll not necessarily win over everyone.Among other things, Wellness Canada has requested additional information on polyglucose sorbitol carboxymethylether , a material found in the produce of Feraheme, including details related to pre-clinical safety of PSC and the making controls and processes linked to the incorporation of PSC. ‘We are working diligently with Takeda Canada to make sure that every concern raised in the NON is definitely addressed,’ stated Lee F. Allen, MD, PhD, Chief Medical Officer of AMAG Pharmaceuticals, Inc.