Antibiotic Side Effects Responsible for 140,000+ ER Visits Every Year

Overuse of antibiotics like Cipro and amoxicillan result in serious reactions that send  more than 140,000 people to emergency rooms every year.   Those starting statistics provide yet another reason for doctors to limit their use of the drugs.

The findings are part of a new study on antibiotic reactions in the U.S. - the first of its kind -conducted by the Centers or Disease Control (CDC).  The researchers used the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, a sample of 63 U.S. hospitals, between 2004 and 2006.  According to their survey, the hospitals recorded more than 6,600 emergency visits that were due to an adverse reaction to an antibiotics.  They were able to extrapolate this to the whole country and estimated that 142,000 such emergency visits are made every year. (more…)

Cipro Tendon Injury Still Plagues Anthrax Attack Victim

Victims of the 2001 anthrax attacks are still dealing with some difficult health issues.   Surprisingly, their difficulties have nothing to do with the deadly virus itself, but rather were caused by Cipro, the medicine that was supposed to make them well.

Cipro  belongs to the antibiotic group known as fluoroquinolones.  Fluoroquinolones are known to carry a number of risks.  These include liver problems and tendon damage.  The first fluoroquinolone was introduced in 1986, but they are really modified quinolones, a class of antibiotics discovered in the early 1960s.  Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers. (more…)

FDA To Seek Black-Box Warning On Cipro and Levaquin

The U.S. Food and Drug Administration (FDA) has announced that it will seek to add black box warnings about the risk of tendon rupture associated with Cipro and Levaquin. The drugs are in a class of antibiotics used to treat bacterial infections and black box warnings are the strongest warning the FDA issues. Cipro is made by Bayer AG and Johnson & Johnson makes Levaquin. Six months ago, the consumer group Public Citizen sued the FDA to require it to add black-box warnings to the drugs.

Cipro and Levaquin belong to the antibiotic group known as fluoroquinolones, which are sold by several drug makers under a variety of brand and generic names. Although the drug labels warn of the risk of tendon ruptures, none include black-box warnings. A black-box warning is in bold type, surrounded by a black box to make it stand out. Such warnings usually appear at the top of drug labels. Any advertising of products that carry black box labels must also include the black box warning information as part of the advertisement. The FDA also announced it will ask the drug companies to create a Medication Guide to be provided to patients to alert them about possible side effects. (more…)

Antibiotic Lawsuit Seeks Stronger Warnings on Cipro, Levaquin and Others for Tendon Damage

Cipro, Levaquin and other antibiotics known as fluoroquinolones have long been known to cause serious side effect, including tendon damage. Yet despite massive amounts of evidence, the Food & Drug Administration (FDA) has not required the makers of Cipro, Levaquin and other fluoroquinolone antibiotics to add warning labels about their links to ruptured tendons and other tendon problems. Now, the consumer advocacy group Public Citizen is trying to force the FDA to act, and has taken it to court in attempt to compel the agency to add black box warnings about tendon problems to the labels of these antibiotics.

Fluoroquinolones are used to treat bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth. From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. But Public Citizen contends that only a small fraction of cases are typically reported to the FDA, so the actual number of ruptures and other tendon injuries attributable to the antibiotic is probably much higher.

(more…)

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