Generic Cipro Antibiotic Under Fire, Guliani Steps Up

Washington, DCIt's bad enough when a popular medication begins rearing its dark side—the Cipro antibiotic, manufactured by Bayer A.G., has the potential for ruptured tendon and other side effects. But a generic version of the Cipro drug, manufactured in India, is also under scrutiny for reasons of quality control, which could further compound Cipro side effects.

Ciprofloxacin is a synthetic antibiotic belonging to the fluoroquinolone family used to treat lower respiratory tract, and urinary tract infections, among other indications. However, Cipro antibiotic has also been known to unleash a host of side effects in some patients. Various manufacturer-funded studies reveal that approximately 9 percent of patients taking the Cipro drug experience side effects relating to metabolic-nutritional problems and the central nervous system.

The most highly publicized adverse reaction, however, pertains to increasing reports of swelling to the joints and cartilage, leading in many cases to tendon rupture and chronic pain. In 2005 the US Food and Drug Administration (FDA) mandated a change to the product labeling for Cipro, acknowledging the risk for tendon rupture together with the development of irreversible neurological conditions.

And yet, there were those who thought the FDA response in 2005 was lacking. Public Citizen, the high-profile consumer advocacy group founded by Ralph Nader, filed a lawsuit against the FDA in an effort to force the agency to mandate a black box warning for Cipro. On July 8th of this year the FDA complied, mandating a black box warning for all medicines in the fluoroquinolone drug family, including ciprofloxacin.

According to Wikipedia, a majority of physicians are inclined to believe that Cipro is generally safe, and that the incidence of side effects is considered acceptable. However, that position is being challenged, given the increasing reports of debilitating side effects, tendon rupture among them. The latter can have serious ramifications to an individual's mobility, and the symptoms and pain can last for months, or longer. Such impairment can affect an individual's livelihood, and capacity to earn a living.

And now there's another kink in the Cipro cog. It seems that a generic version of Cipro manufactured by Ranbaxy Laboratories Ltd.—India's largest pharmaceutical manufacturer—is among 30 drugs that have been barred from import into the United States by the FDA due to what the agency refers to as various violations of good manufacturing practices at two of its facilities there. While specific violations were not reported, there was concern expressed with regard to quality.

For the patient, it only compounds the adverse reaction profile for Cipro, given the possibility that generic Cipro manufactured by Ranbaxy and already in hand, could further compound the existing adverse reaction profile for Cipro.

For its part, Ranbaxy is not taking this sitting down. It was announced this week that it has retained former New York mayor and Presidential hopeful Rudi Giuliani to help protect its turf. According to a statement from Ranbaxy, Giuliani Partners, a consulting and investment firm, will provide advice and review compliance issues.

Ranbaxy has much at stake, with 23 percent of its total revenue derived from US sales of generics.

What's at stake for the patient? The potential for debilitating adverse affects from Cipro, including the possibility of ruptured tendon, compounded by the possibility of poor quality if the Cipro in your cupboard is a generic manufactured by Ranbaxy.

All the more reason to consult a Cipro lawyer if you have experienced pain and suffering from Cipro side effects—generic, or otherwise.