So I've found lately that the FDA updates haven't had a lot of interesting material in them lately, but I do get interesting updates all week about all kinds of things, so I'm going to start including some of that in here. The end result (I hope) is that there will be more diversity, interesting and relevant material in the Sunday updates.
New Continuing Education
Treatment Options in Managing Chronic Low Back Pain
Written by Amy P. Witte, PharmD and published by PharmQD. Cost is $6.50 to get credit, but the course is available for free if you're just interested in the material. Includes pathology, diagnosis and treatment options, including pharmacologic and nonpharmacologic.
Drug Recalls
Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet
Endo pharmaceuticals is recalling two lots of Endocet 10/325mg tablets due to higher strength tablets being found in a bottle. The two lots we found to contain some of the 10/650mg tablets, which are larger and have different markings.
Qualitest Pharmaceuticals Issues Recall of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets
Qualitest, which is owned by Endo Pharmaceuticals, is recalling 4 lots each of Butalbital, APAP and Caffiene and Hydrocodone Bitartrate with Acetaminophen due to a labeling mixup which resulting in some bottles of butalbital, APAP and caffeine being incorrectly labeled as hydrocodone and acetaminophen. For more information, click the link above.
Ortho-McNeil issues recall of Tylenol Extra Strength Caplets
The single-lot recall was issued due to an uncharacteristic odor, thought to be the result of 2,4,6-tribromoanisole (TBA) contamination. If you'll remember correctly, there was a recall last week of OMJ's Risperidone and Risperidal for the same reason.
New Drug Approvals
None outstanding
Recent Generic Releases
None outstanding
Other Notices
There is No Legal Substitute for Bromday
Ista Pharmaceuticals would like to remind pharmacy staff that there is no legal substitution for their product, Bromday. Xibrom, which has been approved generically, is not AB rated as a substitute for Bromday and therefore the two cannot be interchanged without physician approval.
Intensive-Dose Statin Therapy Associated With Increased Risk of Diabetes
From ScienceDaily, a new report shows that high doses of HMG-CoA Reductase Inhibitors decreases the risk of cardiovascular side effects, but increases the risk of diabetes, especially in those with multiple risk factors.
Acetaminophen Concentration Change for Infants
The concentrated (80mg/0.8mL) infant's acetaminophen drops are being discontinued and being changed to the 160mg/5mL, typically called "children's strength" liquid to avoid dosing errors and misconceptions about concentration. The following dosing chart may be helpful to patients and in pharmacies to clear up confusion about the change:
Infant's Acetaminophen Dosage Change Chart
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