Disclaimer

*Results may vary. The information in this site is NOT to be construed as medical advice. Cirrhosis of the liver is a serious condition and if you have it, you should see a doctor. I am not a doctor and am not able to dispense medical advice. My husband saw a doctor (many of them) and they were able to do things for him that I could not. However, they were unable to recommend alternative treatments, and in MY OPINION they were VERY beneficial to my husband, so I am providing some of that information here. My husband and I tried all of these alternative therapies at our own risk, and if you try them you will be doing the same. At your own risk. No promises are made in this blog. I am not saying there is a cure for cirrhosis or any other condition. However, I believe most people can get well, like my husband did. My husband is alive, happy, productive, functional and has his energy back. He no longer worries about having to go on disability or getting a $577,000 liver transplant. Cirrhosis is a serious condition. He is currently in the fibrosis stage (Stage 2 liver disease), which is still serious. I cannot guarantee you will have the same results. I just want you to know about what worked well for my husband. I hope you will share what you learned with others, and share your story with us as well. This blog was made for YOU! Thanks for visiting!

Sunday, May 20, 2018

The Black Box Warning and Prescription Meds like Antibiotics - What you Need to Know

I never knew what a "black box warning" was, until a few years ago. I discovered that many of my husband's medications, which I assumed were relatively safe, had some SERIOUS side effects, that in my opinion, made his condition worse. 

Here's the quick google-search-definition of a black box warning:

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug.

Black Box Warnings|Compliance and SafetyAsk a Pharmacist | Health ...

https://www.walgreens.com/topic/faq/questionandanswer.jsp?questionTierId=900002...


A few years ago I was in my car, talking to a guy who's pharmacist (who was also a family friend), told him that the antibiotic he was just prescribed could kill him. The friend (who'd been the family's pharmacist for a long time) said, "I could lose my job over this, but I have to tell you this."

I asked the guy what antibiotic he was prescribed, but he couldn't remember. So I finally just got around to googling antibiotics that have black box warnings, and you can see the list further down the page. I was surprised to see Cippro is on that list.... I took that stuff MANY times, for bladder infections, in my 20s and 30s. 

Rifaximin is the antibiotic that seems to be most commonly prescribed for people with hepatic encephalopathy. You can read more about that drug HERE. Rifaximin doesn't have a black box warning, but if you scroll down that page, you'll this part, which does make me feel somewhat uneasy:


What should I discuss with my healthcare provider before taking rifaximin (Xifaxan)?

You should not use take this medication if you are allergic to rifaximin or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).

If you have any of these other conditions, you may need a rifaximin dose adjustment or special tests:
  • severe liver disease;
  • diarrhea with a fever; or
  • watery or bloody diarrhea.

Spironolactone (not an antibiotic but a common diuretic given to just about everyone with cirrhosis) also has a black box warning, and you can read about that by clicking HERE.  You can also read about the serious side effects of Furosemide (another common diuretic that's typically given with Spironolactone) by clicking HERE.  And PLEASE be sure to read THIS PAGE, as well.


FDA orders 'black box' label on some antibiotics

Decrease font
Enlarge font
(CNN) -- 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 tendonitis.
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.
Public Citizen said Tuesday it was "pleased" with the FDA's order but added "there is still more that the FDA must do."
"The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture," the group said. "We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures."
When asked about the lawsuit and why it didn't order the "black box" label warning until now, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year. Video Dr. Gupta explains more on antibiotic risks »
"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.

Don't Miss

Bayer HealthCare Pharmaceuticals Inc., which holds licenses for Cipro and Avelox, said it would make the changes requested by the FDA but defended the drugs as "well-tolerated and effective in all approved indications." Schering-Plough markets Cipro and Avelox in the United States under agreement with Bayer.
Ortho-McNeil-Janssen Pharmaceuticals, which markets Levaquin in the United States, also said it would abide by the FDA's request.
Merck & Co., the maker of Noroxin, said it, too, would update the drug's label. But Merck noted it has stopped promotion of Noroxin because of the widespread availability of its generic form.
Oscient Pharmaceuticals (Factive), Daiichi Sankyo (Floxin) and Dipomed (Proquin) did not immediately respond to CNN's requests for comment.
The fluoroquinolones drugs can increase the risk of tendonitis 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.

Health Library

  • MayoClinic.com: Achilles tendon rupture
  • MayoClinic.com: Tendonitis
Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."
Public Citizen, founded in 1971 by consumer activist Ralph Nader, said more than 400 cases of tendon rupture and more than 300 cases of tendonitis in patients using fluoroquinolones were reported between November 1997 and December 2007.
"Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher," the group said.
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.
advertisement
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 [Risk Evaluation and Mitigation Strategy] to ask for a letter [to doctors]," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."
Had to share!
Ellie
 

No comments:

Post a Comment