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Author Topic: Videx warning issued  (Read 1550 times)

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Offline aztecan

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  • 28 years positive, 56 years a pain in the butt
Videx warning issued
« on: January 31, 2010, 04:11:50 PM »
Here is a recent warning and label revision for Videx (DDI).  While not as common in the U.S. and Europe, Videx is used in other areas.

  
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Audience - HIV/AIDS, Infectious Disease healthcare professionals 
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.

Read the complete MedWatch 2010 Safety summary including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm
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"May your life preach more loudly than your lips."
~ William Ellery Channing (Unitarian Minister)

Offline leatherman

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Re: Videx warning issued
« Reply #1 on: January 31, 2010, 04:27:13 PM »
thanks for posting that warning. ;)
I've been taking ddI ever since it was those big chalky tablets back in the late 90s. Knock on wood, I've been lucky to escape any of the truly bad side effects from the videx ec (in capsule form) or the Reyetaz that I've been taking for 6 or 7 yrs.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

Offline aztecan

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  • Posts: 5,358
  • 28 years positive, 56 years a pain in the butt
Re: Videx warning issued
« Reply #2 on: January 31, 2010, 06:19:07 PM »
I've been taking ddI ever since it was those big chalky tablets back in the late 90s.

Eww! I remember those big tablets. I didn't take them, I opted for Crixivan instead. :P

That is a whole 'nuther topic!  ;)

HUGS,

Mark
"May your life preach more loudly than your lips."
~ William Ellery Channing (Unitarian Minister)

Offline leatherman

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Re: Videx warning issued
« Reply #3 on: January 31, 2010, 06:32:03 PM »
Eww! I remember those big tablets.
Somewhere in a box of memorabilia (from when Randy was alive, so early 90s) is the glass pestle that I used to crunch them up - supposedly to mix them into drinks. ::) Eventually, it was like eating chalk no matter what you did, so I just chewed and crunched them up like the big ol' antacid tablets that they were. :P (I took Crixivan a few yrs later)

Since I don't eat breakfast, I take my videx ec first thing in the mornings since it has a 2hr eating restriction before and away. First thing in the am, I haven't eaten for 2 hours (cause I was asleep) and if I'm terribly hunger in the morning I only have to wait two hrs to get something into my belly. It's still the antacid in the formula that is the need for the eating restriction. The antacid gets rid of some of the stomach acid so that more of the med is absorbed rather that digested.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

Offline Inchlingblue

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Re: Videx warning issued
« Reply #4 on: February 02, 2010, 11:02:33 AM »
How can the FDA conclude that "the benefits of the drug outweigh the risk"? I can understand them concluding that if there were no other good HIV drugs available but that's obviously not the case.

Old HIV drug found to produce rare liver problem, FDA says
February 1, 2010 | 11:13 am

Didanosine, the second drug approved for the treatment of HIV infections and one of the oldest weapons in the AIDS armamentarium, has been found to produce rare cases of potentially fatal liver disease in patients taking it for long periods, the Food and Drug Administration announced Monday. Didanosine, marketed by Bristol-Myers Squibb under the brand names Videx and Videx EC (an extended release version), was approved by the FDA in 1991, joining AZT as the only drugs then approved to treat HIV.  It is a reverse transcriptase inhibitor, blocking the action of the key enzyme used by HIV in replicating. It has limited value when used alone because the virus rapidly mutates to overcome it, and is thus generally used in drug cocktails.

In the 18 years since the drug has been on the market, the FDA has received 42 reports of a rare disorder called non-cirrhotic portal hypertension. It results when high blood pressure occurs in the portal vein--a major vein of the liver--causing the vein to enlarge and weaken. Once the vein wall is weakened, it can split open, leading to fatal bleeding. Non-cirrhotic means that the condition is not caused by cirrhosis of the liver, a consequence of alcohol abuse.

Of the 42 cases, 26 were males, 14 were females and no gender was reported for two. Their ages ranged from 10 to 66 years. All had been taking the drug for months or years before the condition developed. Four of the patients died from bleeding or organ failure. Eight patients were treated by surgical techniques to reinforce the vein or by a liver transplant. Only the three patients who had transplants fully recovered.

The FDA concluded that the benefits of the drug outweigh the risk, but is increasing the package warning to alert physicians and patients to the possibility that the problem will develop. The drug already has a box warning of an increased risk of lactic acidosis and hepatomegaly with steatosis, caused by damage to mitochondria in liver cells.

-- Thomas H. Maugh II

LINK:

http://latimesblogs.latimes.com/booster_shots/2010/02/old-hiv-drug-found-to-produce-rare-liver-problem-fda-says.html

Offline leatherman

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Re: Videx warning issued
« Reply #5 on: February 02, 2010, 11:46:01 AM »
How can the FDA conclude that "the benefits of the drug outweigh the risk"? I can understand them concluding that if there were no other good HIV drugs available but that's obviously not the case.
don't you mean that the other way around? If there were no other good drugs available then they would not say the benefits outweigh the risk. In the early days of treatment, I took a lot of meds that weren't so great but the benefits outweighted the risk of death without the meds. Since there are other meds on the market now, then they could possibly conclude that Videx is not worth using anymore.

However, I do agree that this seems to be some sort of arbitrary conclusion possibly based on the same faulty lines of reasoning as they have used with other meds. For example, the anti-smoking drug Chantix. Although over 4 million people have used that medication, the number of FDA complaints over the last few yrs total less than 5000. That means the FDA has issued 3 or 4 "alerts" because less than 1% of the users have lodged complaints. (about .125% from data from 5/08) Forty-two reports against Videx over 18 yrs doesn't seem like a large issue, though I don't know the number of Videx users to make a full assessment.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

Offline Inchlingblue

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Re: Videx warning issued
« Reply #6 on: February 02, 2010, 11:52:17 AM »
don't you mean that the other way around? If there were no other good drugs available then they would not say the benefits outweigh the risk. In the early days of treatment, I took a lot of meds that weren't so great but the benefits outweighted the risk of death without the meds. Since there are other meds on the market now, then they could possibly conclude that Videx is not worth using anymore.

 

We're saying the same thing! LOL

If there were no other drugs available then yes, the benefits of Videx might outweigh the risk. But with so many other ARVs to choose from, there doesn't appear to be any real benefit in keeping Videx on the market at all.

Offline leatherman

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Re: Videx warning issued
« Reply #7 on: February 02, 2010, 11:59:25 AM »
But with so many other ARVs to choose from, there doesn't appear to be any real benefit in keeping Videx on the market at all.
except for people, like me, that have been using the drug satisfactorily for years. ;) Just like I hate updating software that is working just fine for me, I hate changing meds when I don't need to. I subscribe to the "if it ain't broke, don't fix it" school of thought.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

Offline Inchlingblue

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Re: Videx warning issued
« Reply #8 on: February 02, 2010, 12:18:55 PM »
except for people, like me, that have been using the drug satisfactorily for years. ;) Just like I hate updating software that is working just fine for me, I hate changing meds when I don't need to. I subscribe to the "if it ain't broke, don't fix it" school of thought.

I had forgotten that you are still on Videx?!

This is of course a personal choice but if I were you I'd replace it with something better. In my humble opinion it is "broken" to be taking something so toxic that it's potentially fatal especially if there are other options available that are not nearly as toxic.

I'll bet that if you ask Dr. Gallant or the doctors on thebody.com they'd agree.

Just my 2 because I care.

 
« Last Edit: February 02, 2010, 12:30:10 PM by Inchlingblue »

Offline leatherman

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Re: Videx warning issued
« Reply #9 on: February 02, 2010, 01:19:19 PM »
In my humble opinion it is "broken" to be taking something so toxic that it's potentially fatal especially if there are other options available that are not nearly as toxic.
without knowing the number of patients taking videx, we can't really say just how toxic videx is vs. some other med. Wonder how many 1000s of people still take Videx without having any issues?

In reality, though aren't many/most meds toxic?

Though reyataz (a med I take) might destroy your liver and has caused death, I'm not hearing an outcry against it. Same goes for viread (another med I take) - 1% death side effect but no extra fda warning. AZT mono-therapy likely killed people, yet it's still included in in several meds. Sustiva (which I did take but with many side effects) may have actually caused several suicides, yet as a component of Atripla (which has also had deaths as a side effect) it's a front-line med.

Of course, the all time fav drug I use as an illustration is aspirin. Aspirin (which I am highly allergic to and therefore do not take anymore) cannot be taken by everyone and causes 100's of deaths per year. No medicine is 100% perfect, because everyone's body is a little different.

http://www.annals.org/content/127/6/429.full
Quote
70 million prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs) are dispensed in the United States... Studies done in Canada, the United States, Australia, and Great Britain have shown that NSAID use increases the risk for hospitalization and death from gastrointestinal bleeding and perforation. Each year, use of NSAIDs accounts for an estimated 7600 deaths and 76 000 hospitalizations in the United States

of course, in full disclosure, I am very prejudiced for videx. After taking nearly a dozen meds for a dozen years, it wasn't until my current regimen - with videx - that I finally reached undetectable. ;)
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

 


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