Ofloxacin (generic Floxin and Ocuflox) is a common antibiotic used to treat ear and eye infections, among other common bacterial infections. In the past, there have been both ear (otic) and eye (ophthalmic) drops available, along with an oral tablet—but now, you and your doctor may need to find an alternative antibiotic, at least when it comes to the ear drops.
Last year, in 2015, two pharmaceutical companies (Apotex and Sandoz) discontinued their ofloxacin 0.3% otic solutions (ear drops). This created a backorder situation at the start, but eventually lead to all bottle sizes being discontinued—with the manufacturers unable to provide a reason.
Until recently, Valeant Pharmaceuticals was the last manufacturer with ofloxacin ear drops still available, but they have now announced a temporary discontinuation of both their 5 mL and 10 mL bottles. Valeant is also unable to provide an estimated date when ofloxacin will be back on pharmacy shelves.
Are there any manufacturers that aren’t affected and are still making ofloxacin ear drops?
No. At this time all manufacturers have discontinued both the 5 mL and 10 mL bottles of ofloxacin 0.3% otic solution.
What was the reason for the backorder?
None of the manufacturers involved could provide a reason for the shortages and discontinuations.
In general, medications can be withdrawn or discontinued for a variety of reasons, including:
- Directions from a regulatory authority (like the FDA) due to health or safety concerns
- Changes in pricing that mean producing the medication is no longer cost-effective
- Inability to get the raw materials needed to make the medication
- Lack of demand due to readily available or newer alternatives
What can you do if you’re affected by the ofloxacin discontinuation?
If your pharmacy no longer has ofloxacin ear drops in stock, you may have a couple of options.
First, if you can locate another pharmacy that still has ofloxacin ear drops, your pharmacist can transfer your prescription for you. Transferring will mean you’ll have a bit more of a wait before you can fill, so make sure you take the extra time into account.
Your pharmacist can also call your doctor to get approval to switch you to a different medication. Believe it or not, the ofloxacin 0.3% eye drops are a great alternative.
Be aware though—eye drops are safe to use in the ear but ear drops should never be used in the eye. Your pharmacist should also make sure you know this.
Want more information, and updates on the shortage?
See this announcement from the American Society of Health-System Pharmacists (ASHP).