Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.
While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.
Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.
It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distributio...
Definition Ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen overdose occurs when someone accidentally or intentionally takes more than the normal or recommended amount of this medication. See also: Pain medicine This is for information only and not for use in the treatment or management of an actual poison exposure. If you have an exposure, you should call your local emergency number (such as 911) or the National Poison Control Center at 1-800-222-1222. Alternative Names Advil overdose; Nuprin overdose; PediaProfen overdose; Rufen overdose; Motrin overdose Poisonous Ingredient Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that is sold over-the-counter and by prescription. Where Found Advil Medipren Midol Motrin Nuprin Pamprin IB PediaProfen Rufen Note: This list may not be all-inclusive.
I generally don't make a practice of reporting on new drugs that are still in the clinical trial phases of development because it takes so many years to bring a new drug to market and you never know what might happen to them along the way. But there are two new drugs in the final phase of clinical trials that I find particularly interesting and promising. Although it will still be at least three to five years before they might be approved, I thought you might like to know about them. Controlled-Release Hydrocodone The first is a controlled-release hydrocodone being developed by Zogenix, Inc. Hydrocodone is the most widely prescribed drug in the U.S., but there are two things that make this new drug unique:
It is just hydrocodone, with nothing added. Currently you can only get hydrocodone combined with either acetaminophen or ibuprofen.
It is a controlled-release formulation for people who require round-the-clock pain relief. Right now, h...
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