Re: FDA issues Cipro and Levaquin warnings

[Guest guest]

hi all,

after carefully reading this great information that was found by robin, my

husband and i started talking. there are only 3 or 4 antibiotics that i can take

cipro and levaquin  are two to them.  one has to weigh out the options as to

whether the risks outweigh the beneifits of teh drug, cipro and levaquin are

both used commonly for UTI " S, i have had them both RX''d by both Vanderbilt

Medicla Center and Univ of Florida/Shands. it seems that the article mostly

states that athletic people are most apt to be affected.  it is scary that every

drug and alot of foods are now being classified as somehow with something

dangerous or cuasing ill sideeffects.   we must weigh out the pros/cons of each

drug for our own use and that of our loved ones. if dad were still alive i would

still give him those two medicines as i think as little as he used his hands he

would not be at high risk, but if your loved one knits or crochets than i would

definietly consider it

very carefully thanks for the info robin. hugs to all sharon

Subject: FDA issues Cipro and Levaquin warnings

To: rriddle@...

Date: Tuesday, July 8, 2008, 10:17 PM

According to this news article, " Cipro is often

used to treat urinary tract infections. Levaquin

is generally used to treat respiratory

infections. " Here's an AP news story from today

on the FDA black-box warning (which is a big

deal) ordered for Cipro and Levaquin (but not for

fluoroquinolone drops used to treat eye infections):

July 8, 2008

FDA calls for urgent warning on tendon risks

By RICARDO ALONSO-ZALDIVAR

Associated Press Writer

Drug safety officials Tuesday imposed the

government's most urgent safety warning on Cipro

and similar antibiotics, citing evidence that

they may lead to tendon ruptures, a serious

injury that can leave patients incapacitated and needing extensive surgery.

The Food and Drug Administration ordered makers

of flouroquinolone drugs — a potent class of

antibacterials — to add a prominent " black box "

warning to their products and develop new

literature for patients emphasizing the risks.

Tendon ruptures are normally thought of as sports

injuries, generally occurring among men in their

mid-30s. The link to treatment with the

antibiotics is highly unusual, and scientists

still don't fully understand why it happens.

However, FDA officials stressed that many of the

serious injuries appear to be preventable if

patients stop taking the drug at the first sign

of pain or swelling in a tendon, call their

doctor, and switch to another antibiotic.

The two leading drugs covered by the warning are

Cipro, made by Bayer, and Levaquin, which is made

by Ortho-McNeil. Cipro became a household name

during the anthrax attacks of 2001. It is

effective against that deadly bacteria, and is

among the drugs stockpiled by the government in

case of a bio-terror attack. In everyday

medicine, Cipro is often used to treat urinary

tract infections. Levaquin is generally used to

treat respiratory infections. The FDA warnings do

not apply to fluoroquinolone drops used to treat eye infections.

The FDA's action came after the consumer group

Public Citizen petitioned — and later sued — the

agency for such warnings. Regulators took too

long to act, complained Sidney Wolfe, head of the

consumer group's health section. Many injuries

" would have been prevented if patients and

doctors had known a pain in the tendon is an

early sign that leads to rupture, " Wolfe said.

Public Citizen's original petition was filed nearly two years ago.

FDA officials pointed out that prescribing

literature for the drug class already carried

clear warnings of the risk of tendon rupture.

They said the agency acted to emphasize the

warnings because continued reports of injuries

indicated that the message may not have gotten through to doctors and patients.

" The continued reports demonstrate additional

steps are warranted to better manage the risk of

tendon rupture, " said Renata Albrecht, director

of an FDA office that focuses on unusual microbes.

FDA officials said they had received several

hundred reports of tendon ruptures, but would not

cite a specific number. Wolfe, of Public Citizen,

said the number was 407 at the end of 2007, with

another 341 reports of tendinitis. He continued

to criticize the agency, saying it should also

require drug makers to send individual letters to

doctors about the risks. FDA officials said

manufacturers could choose to send such letters on their own.

Tendons are cords of tissue that join muscles and

bones, and are essential in movement. The most

common kind of rupture reported to the FDA

involved the Achilles tendon in the heel, but

some also involved the rotator cuff in the

shoulder, and tendons in the hands, biceps, and even the thumb.

Some of the ruptures reported to the FDA occurred

without warning — the patient felt a snap or pop

soon after starting treatment. That suggests

flouroquinolone antibiotics may be toxic to some people, the FDA said.

But typically, patients felt some kind of pain or

inflammation for a week or two before they

suffered a tendon rupture. That suggests that

many of the most serious problems can be avoided

if patients stop the drug, officials said.

The FDA's analysis found that patients with the

highest risk of problems include people over 60,

those with kidney, heart and lung transplants, and those also taking steroids.

Manufacturers called the tendon ruptures a rare

side effect. They said are complying with the FDA

order and remain confident that the drugs' benefits outweigh their risks.

__

FDA site on drug warnings —

http://www.fda. gov/cder/ index.html [http://www.fda. gov/cder/ index.html]

(This version CORRECTS spelling of fluoroquinolone in paragraph 4.)

Here's the related FDA news release from today:

http://www.fda. gov/bbs/topics/ NEWS/2008/ NEW01858. html