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50 Side Effects posted for dr edward

July 8th
2008
5:57 PM

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

******

FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

-- By lukela | Reply | Private Message me

April 6th
2007
4:45 PM

I'm sorry so many of you have bad experiences with Adderall. My side effects went away in about two weeks.

The amphetamines in Adderall have been used for 70 years, so if they were that dangerous, they would not be around today and one of the top 10 most prescribed pediatric drugs in America.

To Spoiled Rotten,
Apparently you can't read all that well or don't know how to do research, maybe you should have been on Adderall as a kid. RITALIN, CONCERTA, FOCALIN, DAYTRANA are all Methylphenidate, which IS NOT AN AMPHETAMINE.

Be a Big BOY/GIRL and do your own research about these drugs. Real research, not a side-effects website where people who know nothing about the drugs themselves hear something from someone, who knows someone's sisters friend who ABUSED their medication.

ALL DRUGS can be bad. You can die of an aspirin overdose. It's how they are used. Adderall and Ritalin are "very safe" when used properly" (Driven To Distraction).

I'm sure 99 percent of you don't even know what ADDICTION really is. This is a huge health problem in America. Yes, the addictions, but MORE so the ignorance and stereotypes of people with them.

African American 47,
You DON'T just get addicted to a drug. You can BE DEPENDENT on a drug, and not an addict. Cancer patients take very large amounts of NARCOTIC pain killers and THEY ARE DEPENDENT on them. For pain relief and physical dependence. They DON'T crave the drugs though.

So with SPOILED rotten's philosophy, the 20,000,000 people on Adderall or Ritalin (NOT AN AMPHETAMINE, similar, but not the same thing) who's quality of life has been improved 100 fold just like mine. I would have benefited GREATLY from medication but did not get diagnosed until 3 months ago at the age of 24.

Medication IS NOT for everyone, as "it doesn't work very well for about 80% of people who take it." (Driven To Distraction, Dr Edward Hallowell).

IF anyone has questions about ADD read "Driven To Distraction". The Author(s) both have ADD themselves and are psychiatrists.

Too many people with ADD refuse medication because they think "oh no, I will get addicted", which is 99 percent of the time not the case for ADD. They miss out on at least an option that could help them immensely.

I am so irritated with the ignorance and lack of knowledge from people who bad mouth things they know really nothing about. It didn't work for me so I am going to demonize the drugs and spread lies that they turn kids into zombies and cause them to shoot up schools..........C'mon, you're how old? I'm probably 1/2 your age and I have twice the common sense.
I'm not saying your a bad parent Spoiled, but your NAME IS Spoiled....you seem to be on a high and mighty chair, and you seemingly have a very self centered mind. Doesn't work for you then it must be the work of the devil.

Learn how to do research, form educated opinions, maybe read a book. Use your rights as a patient to see a different doctor if you don't agree with one. Do something productive.

-- By alemberger24 | Reply | (4) replies | Private Message me


 

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