"Doug" is a healthy 31-year-old man with no pressing health problems—until, it seems, he was prescribed Levaquin to combat a bad case of bronchitis. His doctor prescribed a 10-day regimen of Levaquin, 500 mg once per day. While his bronchitis appeared to be on the mend, Doug began noticing pain in his left knee after taking the Levaquin for only two days. Doug describes it as a dull ache that was almost a constant, regardless of whether he was walking, standing or sitting—however the pain would escalate sharply whenever he moved.
It wasn't long before the pain had spread to his right knee, ankles, and hipbones—and upon the conclusion of his 10 days on Levaquin the pain had spread throughout his entire body. Moving through the day was becoming a constant source of pain, but Doug also reports that it even hurt to sleep, and he turned to over-the-counter painkillers in an attempt to ease the pain.
A trip to his doctor resulted in a battery of tests, but nothing out of the ordinary was found. "We talked about the Levaquin," Doug reports, but his doctor dismissed the Levaquin as a potential suspect.
Doug was eventually referred to a Rheumatologist, but once again nothing out of the ordinary was found. A check for arthritis was done, but again with negative results.
At the end of the day, it was determined that Levaquin was at the root of Doug's problem after all, and he expects to continue to have discomfort until the medication has been completely eradicated from his system.
Doug is lucky, in that he managed to avoid tendonitis or ruptured tendon as the result of taking Levaquin, which is the overriding concern with this antibiotic. That's why the FDA is mandating the black box warning. Still, for a hale and healthy 31-year-old male to be suddenly wracked with pain without any prior history of such discomfort, it serves as yet another bellwether example of Levaquin side effects.
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The FDA also wants to develop a medication guide for patients, in an effort to mitigate the very real risks for tendonitis and tendon rupture.
As with other drugs, the FDA and drug manufacturers can make the case for a drug to remain on the market, even in the midst of concern, if the benefit / risk profile can be supported. In other words, if a drug's overall benefits outweigh individual risk, then it can stay—albeit with the proper caveats.
To that end, Levaquin medicine will remain on the market with a black box warning.