Keeping you Informed: Updates from the FDA on Opana ER and Ambien

There have been two recent drug announcements by the FDA affecting Opana ER and Ambien, both of which are commonly prescribed in workers’ compensation claims.

On May 10, 2013, the FDA announced that generic versions of non-crush resistant Opana ER (indicated for treatment of moderate to severe pain in patients requiring around-the clock analgesia) could continue to be submitted for approval by the FDA and marketed. 

Last year, the manufacturer of the new reformulated crush resistant Opana ER, Endo, requested that the FDA consider the withdrawal of generic non-crush resistant formulations (7.5mg & 15mg approved in 2011, all strengths approved in 2013) due to safety issues.  The FDA (unlike in the case of crush resistant brand Oxycontin) found, after reviewing available data, that even though newly formulated brand Opana ER was more difficult to misuse, it could still be manipulated by grinding or cutting for snorting and injection.  Therefore, non-crush resistant formulations would still be considered for approval. 

As indicated in PMSI’s 2013 Drug Trend Report, Oxymorphone (Opana & Opana ER) ranked number 10 out of the top 20 medications prescribed in workers’ compensation. Additionally, the cost of generic Opana ER (non-crush resistant) is noted to be 24% lower in cost than the brand crush resistant product. 

In January of 2013, the FDA announced new guidelines for the recommended dosing of Ambien (immediate release zolpidem) and Ambien CR (extended release zolpidem), in women to be reduced to 5mg and 6.25mg respectively at bedtime due to reports of next day sedation as well as impaired driving ability. Both of these medications are utilized to treat insomnia.  The FDA noted this was more likely to occur with the extended release formulation; therefore, on May 14, 2013, the FDA announced they had not only approved labeling changes for zolpidem products concerning the new dose limitations, but also added a recommendation to be placed under the “Warnings and Precautions” section of the extended release zolpidem products that patients refrain from driving or participating in activities that require complete mental alertness the day following its use. 

The new dosing guidelines and warnings for zolpidem should lead to physicians prescribing zolpidem products at the recommended lower dose in female claimants.  This would result in a lower cost to payers, as well as a possible overall reduction in the number of prescriptions for zolpidem written. PMSI’s 2013 Drug Trend Report noted that out of the top 20 medications prescribed in workers’ compensation, zolpidem (Ambien, Ambien CR) ranked #9 in total transactions and #13 in total spend.

These updates from the FDA not only create greater safety for those that are prescribed these drugs, but also will likely result in the long-term effect of reduced costs for claims. PMSI applauds these decisions from the FDA and will continue to update its subscribers on any other changes to commonly prescribed drugs in workers’ compensation.

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