Two of the painkilling drugs used by orthopedic patients are being recalled.
Hydrocodone Bitartrate and APAP Tablets Recalled
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Two lots of Hydrocodone Bitartrate and APAP Tablets, USP mg/500 mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide), have been voluntarily recalled by Watson Laboratories.
The FDA made the announcement on September 24, 2012.
A complaint had been received for tablets that were “thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen, ” stated the announcement.
Kidney and Liver
Taking too much acetaminophen may “potentially result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.”
Taking too much hydrocodone may “result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, such as sedating medications or certain antidepressants.”
What to Do
Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A segregate any material from the lots, and to contact GENCO Pharmaceutical Services at 1-800-950-5479 for instructions on product return.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
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Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release here.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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