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August 14th, 2008

140,000+ ER Visits Due to Antibiotic Side Effects

Overuse of antibiotics is sending thousands of people to the emergency room every year, according to a newly released Centers for Disease Control (CDC) study. Around 78 percent of the adverse events in the study were allergic reactions, ranging from rash to a serious reaction known as anaphylaxis, and the remaining 22 percent were caused by errors and overdoses.

While penicillin and related antibiotics such as amoxicillin accounted for half the emergency visits, other classes of antibiotics such fluoroquinolones - the class that includes Cipro - and newer antibiotics accounted for the rest.

This was the first time a large scale study looked at antibiotic side effects in the U.S. To reach their conclusions, the authors of the study 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.

“This number is an important reminder for physicians and patients that antibiotics can have serious side effects and should only be taken when necessary,” said the CDC’s Dr. Daniel Budnitz, who led the study.

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August 8th, 2008

Cipro Use During Anthrax Attacks Left One Man Disabled

John Angell, who was working on Capitol Hill as staff director for Senator Max Baucus (D-Mont.) when the 2001 anthrax attacks occurred, recently talked about his Cipro injuries with The Wall Street Journal.

Like hundreds of other people, Angell took a course of Cipro to prevent infection. A few days later, he felt pain in both his Achilles tendons. A week after that, the pain had grown so bad that he talked to a doctor, who switched him to another antibiotic. Unfortunately, the drug switch came too late.

Angell’s Cipro injury was so bad, that he became all but immobile for a time. He had to undergo rehab, and missed a great deal of work. He had to give up his staff director position, and now holds a much less senior job. Even today, Angell still walks with a cane and can’t hike or play tennis the way he used to.

Many patient advocates have argued that Cipro was overused during the anthrax scare in people like Angell, who did not actually develop an infection.

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July 15th, 2008

Cipro Tendon Rupture Risk Known for Years

Cipro’s association with tendon ruptures was recognized long before the Food & Drug Administration (FDA) asked for a black box warning on the risk. In fact, several victims of the 2001 anthrax attack filed lawsuits claiming Cipro caused a variety of ills, including tendon damage. What’s more, a prominent consumer group first warned about the tendon risk associated with drugs in the same class as Cipro well over 10 years ago.

In 2002, four US postal workers from New Jersey - all of whom were exposed to anthrax - sued Bayer Corp. claiming the company failed to disclose data that Cipro could damage nerves and tendons. One of the plaintiffs, mail handler James Sherman said he developed pain in his elbows, knees and groin shortly after taking Cipro. “I later complained to the hospital,” Sherman told The Star-Ledger of Newark. “But now, I walk like I’m crippled all the time. I never had these aches and pain before.”

It was only last week that the FDA asked the makers of Cipro and similar antibiotics to add a black box warning about the risk of tendon ruptures to their labels. But the advocacy group Public Citizen raised the alarm about tendon damage more than a decade ago. In 1996, the group first petitioned the FDA for a tendon damage warning. The FDA that year granted the petition, but the warning was buried in the list of possible adverse reactions and proved inadequate.

In 2006, as reports of tendon damage linked to Cipro and its related antibiotics continued to grow, Public Citizen petitioned the FDA for a stronger black box warning. But the FDA never responded to that petition. This past January, Public Citizen sued the FDA to compel it to take action. With the lawsuit looming, the FDA finally took appropriate action to warn consumers of this dangerous Cipro side effect.

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July 15th, 2008

Canada Asks for Cipro Tendon Rupture Warning

Just days after federal regulators in the US announced that Cipro and similar antibiotics would bear black box warnings about their risk of tendon damage, Health Canada is asking manufacturers to add the same type of warning to the drugs sold in that country.

Last Tuesday, the US Food & Drug Administration (FDA) asked the makers of fluoroquinolone antibiotics to add the agency’s strictest safety warning to the product labels about their link to tendon damage. The FDA said that patients with the highest risk of problems included people over 60, those with kidney, heart and lung transplants, and those also taking steroids. Most of the tendon ruptures reported to the FDA involved the Achilles tendon. Ruptures of tendons in the rotator cuff, hand, biceps and thumb were also reported.

According to an article by the Associated Press, Health Canada said it will ask manufacturers of fluoroquinolones to include a “box warning” on the product monographs alerting people who take the drugs of the fact they may be at higher risk of tendon ruptures. In an email to the Associated Press spokesperson Alastair Sinclair, said that “tendonitis, tendon disorder, and tendon rupture are known adverse reactions for quinolones.”

In addition to Cipro, the drugs levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), gemifloxacin (Factive) and moxifloxacin (Avelox) will be subject to the new Canadian warning.

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July 14th, 2008

Cipro Finally Gets Black Box on Tendon Ruptures

Cipro and other similar antibiotics will finally bear black box warnings about their association for tendon damage. The Food & Drug Administration (FDA) said last week it decision to ask for the black boxes was made because reports of tendonitis and tendon rupture associated with Cipro use are on the rise.

According to the FDA, tendon ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The risk of tendonitis and tendon rupture linked to drugs such as Cipro is “especially increased” in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.

The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.”

Other antibiotics that will now bear a similar black box warning include gemifloxacin, marketed as Factive; levofloxacin, marketed as Levaquin; moxifloxacin, marketed as Avelox; norfloxacin, marketed as Noroxin; and ofloxacin, marketed as Floxin and generic ofloxacin.

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