Los Angeles, CAAn antibiotic produced by Bayer AG is plagued with a reputation for attacking tendons, and nobody knows why. The fact remains, however, that the tendency for Cipro to evoke tendonitis and tendon ruptures has earned the drug a black box warning from the US Food and Drug Administration (FDA).
The irony is that it appears to have taken the threat of a lawsuit to do it. And no, not against Bayer AG, but against the FDA.
Drug companies have to deal with lawsuits all the time. Critics, in fact, accuse the drug manufacturers of building lawsuits and litigation into their business plans. While morally reprehensible, the reality of a drug earning a manufacturer billions of dollars in revenue, but costing millions of dollars in litigation and settlement fees, is simply good business.
However Public Citizen, a consumer advocacy group originally founded by Ralph Nader, had a problem with Cipro's relationship with a patient's tendons. Cipro is the commercial handle for fluoroquinolone, a class of drug that is associated with tendon problems, and not just with jocks, either. One would expect a demographic group hell-bent on running, cycling, tennis and squash to experience tendon problems.
What alarmed Public Citizen were the number of Cipro patients over 60 who experienced tendon problems, or those patients who had undergone heart, kidney or lung transplants.
The numbers speak for themselves: 407 ruptures by the end of last year, together with 341 cases of tendonitis in a population that was not largely active, at least not in the sense that tendons would be unduly stressed. Critics also made the point that adverse reactions to drugs are only reported about 10 percent of the time, and when a drug doesn't appear to be the natural culprit, the reporting rate could be even lower.
Unless otherwise informed, how could a 60-year-old conclude that his, or her ruptured Achilles tendon—the most common rupture—may have been a Cipro side effect? Instead, they would be forgiven for assuming that the injury was caused by moving the wrong way.
And so two years ago Public Citizen petitioned the FDA to step up the warnings for fluoroquinolones, including the addition of a black box warning, the requirement of professional medical guides that would highlight the risk for consumers, as well as the provision for so-called 'Dear Doctor' letters.
When the FDA had failed to respond by January of this year, Public Citizen launched a lawsuit. That seemed to get the FDA's attention, and last month it added the black box warning to Cipro with regard to the relationship between tendon issues, and fluoroquinolones. The agency is said to have made no mention of the Public Citizen lawsuit, but made the point that Cipro warning labels have been updated between 2001 and 2004. The FDA resisted the addition of a black box warning, given the assumption that doctors would discuss any, and all risks with their patients. However, a continual flow of adverse reaction reports appeared to suggest that those warnings were either not provided, or not heeded.
Thus, the FDA decided to go the black box route with Cipro, and also ordered medication guides to inform patients about the new warning. While it stopped short of ordering the 'Dear Doctor' letters, the FDA did authorize the distribution of medication alerts to more than 100,000 physicians and 170 medical organizations.
It should be noted that while tendon ruptures could occur quite suddenly, more often than not they are preceded by a week or two of discomfort. The latter, those in the medical community say, can be useful in switching from a medication such as Cipro that could be the ultimate cause of the discomfort, thereby mitigating the potential for a tendon issue before it happens. But the consumer needs to know that Cipro might just be the culprit, in the first place.
Public Citizen thinks the Dear Doctor letters would have been helpful.
In the meantime, should such recent efforts help to mitigate, and even prevent serious tendon injury, then terrific. However, anyone who has suffered a major tendon injury knows all too well the debilitating effect it has, and the impact on an individual's life and livelihood.
And if that injury happened in relation to the ingestion of Cipro prior to the addition of the black box warning, during a time when the FDA appeared to be stalling while Public Citizen formally petitioned the agency to step up warnings in an effort to protect people…
Perhaps a call to a Cipro legal professional would be in order. You may have lost income, and racked up medical bills you can't pay for. You may not have even recovered. If it can be proven that Cipro caused your injury, and no one made you aware of the risk, you could be in for some compensation.