Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets , USP 10 mg/500 mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.
The problem with getting too much acetaminophen is that it could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.
The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. For a list of the lot numbers, see Qualitest's press release .
If you have hydrocodone/acetaminophen tablets from the affected lots, contact Qualitest at 1-800-444-4011. If you are unsure if you have the affected ...
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...
Full Question: I take hydrocodone for stress/migraine headaches. I am currently breastfeeding my 6 week old son. My doctor told me to go ahead and breastfeed, and then take one or two tablets depending on how bad the pain is. I am wondering how long the medicine stays in my system? I don’t want my baby to get any of it but I know that whatever I eat or drink goes through my breast milk. They reassure me that it is safe to take these but does my baby also get it? Courtney. Answer: Dear Courtney; You didn't mention how often your headaches come; assuming they are only once a week or so hydrocodone with acetaminophen might be all right since they both have short half lives, which means that they leave the body pretty quickly. Therefore, if you just breast-fed (at least four to six hours after the last dose), that would mean there was very little medication left in your milk. The same would be true for migraine specific medications like triptans, especially...
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