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...
Generic Name: HYDROCODONE/IBUPROFEN - ORAL Pronounced: (HYE-droe-KOE-done/EYE-bue-proe-fen) Hydrocodone-Ibuprofen Oral Precautions
Before taking this medication, tell your doctor or
pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or
other NSAIDs (such as naproxen, celecoxib); or to narcotic pain medications
(such as codeine, morphine); or if you have any other allergies. This product
may contain inactive ingredients, which can cause allergic reactions or other
problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or
pharmacist your medical history, especially of:
aspirin-sensitive asthma (a history of worsening breathing
with runny/stuffy nose after taking aspirin or other NSAIDs)
low red blood cell count (anemia)
bleeding or clotting problem
brain disorders (such as head injury, tumor, seizures,
breathing problems (such as asthma, sleep apnea, ...
I have had severe migraines for over 25 years and have gone to the same doctor for 35. After years of medications not working and taking over 1,600 MG of Advil a day, nothing worked until she gave me hydrocodone 10/325. My migraines the week before my period will be daily for 4-5 days and then I usually have a migraine 1 - 2 days every week. She has given me 30 pills a months for 4 years, with the notes to take 1-2 pills every 4 hours as needed. Well when I have the 4-5 days I will take approx. in those days 20-25 pills depending on when they hit. If it is closer to the weekend I can knock it out in 2 days. During the week I try to manage only taking meds at night. So over the last 25 years I now find that I need to take 2 pills at a time. I have asked that she increase me meds to 45 pills per month. She has refused and now wants me to sign a controlled substance agreement. She says she is concerned amount her medical license. Obviously not my pain or her patient. She ...
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