History
Ofloxacin was developed as a broader-spectrum analog of norfloxacin, the first fluoroquinolone antibiotic, Ofloxacin was first patented in 1982 (European Patent Daiichi) and received U.S. Food and Drug Administration (FDA) approval December 28, 1990. One of the first major adverse reactions noted with Ofloxacin were psychiatric in nature. Ofloxacin can cause serious psychiatric side effects with up to 25% of such patients suffering such reactions. This reaction was detailed within Stephen Fried’s 1999 book: “Bitter Pills”
In the United States name branded ofloxacin is rarely used anymore, having been discontinued by the manufacturer, Ortho McNeil Janssen, a subsidiary of Johnson & Johnson. Johnson and Johnson's annual sales of Floxin in 2003 was approximately $30 million, whereas their combined sales of Levaquin/Floxin exceeded $ 1.15 billion in the same year. However generic use continues. The FDA website lists Floxin (Ortho McNeil Jannsen) as being discontinued, with just a few generic equivalents still in use. The otic solution continues to be listed as being available both as an original drug as well as a generic equivalent.
During the 2008 Johnson & Johnson shareholder’s meetings, the safety of both ofloxacin and levofloxacin were called into question. Paul Cahan, a shareholder who had suffered severe and continuing adverse reactions to ofloxacin, publicly challenged Johnson and Johnson’s CEO, William Weldon, to adhere to the company’s credo. This credo states in part “to put the needs and well-being of the people we serve first”. Mr. Cahan requested additional warnings be added to the package inserts for both ofloxacin and levofloxacin.
During the 2009 meeting, yet another shareholder who alleges to have been crippled by these drugs, raised these same issues having seen no significant changes in the warnings (regarding the issues raised during the 2008 meeting). Once again a public request for stronger warnings for both ofloxacin and levofloxacin was made. Though the FDA requested additional Black Box Warnings concerning the tendon issues in 2008, these warnings were still not present in the inserts for ofloxacin or levofloxacin that are being dispensed by pharmacists in 2009, prompting this second request by a shareholder for stronger warnings and Dear Doctor Letters
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