Lovenox Safety Warning

[Blanche]

My husband was hospitalized for internal bleeding two weeks ago. He was taken off coumadin and given vitamin K. When all testing was finished, he was put on coumadin and Lovenox. I thought I had heard something about problems with Lovenox on this board, but could not find anything. However, when I searched the web, I found a FDA MedWatch 2002 Safety Alert-Lovenox (hhtp://www.fda.gov/medwatch/SAFETY/2002/lovenox.htm) that stated "Prosthetic Heart Valves: The use of Lovenox Injection is not recommended for thrombophylaxis in patients with prosthetic valves who have received enoxaparin for thrombprophlaxis. Some of these cases were pregnant women in whom thrombosis led to maternal deaths and fetal deaths."

When I took the FDA Alert and new prescribing instructions found on the Adventis web site to the hospital, hubby was taken off Lovenox. According to our doctor, although the majority of the problems were with pregnant women, it has now been decided that the warning applies to all patients with prosthetic heart valves. The doctor checked with other docs and hospitals in out area and found that they were not using Lovenox anymore with prosthetic heart valve patients. The drug manufacturer, Adventis, has included this warning on the new packaging of the drug.

I believe this warning has been in effect since March 2002. Obviously, the dr who ordered Lovenox for my hubby had not read the alert. Anyone have any thoughts on this?

 

[Gisele]

Thanks for the info........

Thanks for the info........

I was unaware of the lovenox warning. I keep a supply here on hand as I have very erratic INR's. My cardiologist is normally very up to date on all of this, so I will go to the site you posted and read the contents of the warning to see if it would apply to me. Out of curiosity, if Lovenox is not recommended, what would be used to substitute it? Heparin? Lovenox is a very convenient way of handling low INR's until the Coumadin kicks in.
Also Blanche you mentioned you were searching the site regarding problems with Lovenox. Back in March I had posted problems I was having with bleeding in my joint from the Lovenox. Could that be what you were referring to?
Thanks so much for the FDA warning.
Gisele

 

[Christina]

Thanks!

Thanks!

Hi Blanche,

Thanks for giving us the link to the Lovenox warning. I was unaware of it.
I had an appoinment with my cardiologist yesterday and had printed an extra copy for him. He was unaware of it. I am not sure if he liked that I gave it to him. He thanked me but gave no response other than the thank you. He was in a hurry and was way behind on his schedule, so anxious to get to the next patient. It was near the end of the day as well.
I also gave him the valvereplacement website and told him all about it and asked him to make his valve patients aware that support and lots of other information is available.

Christina
Congenital Aortic Stenosis
AVR's 8/7/00 & 8/18/00
St. Jude's Mechanical

 

[ALCapshaw]

SO, are there any alternatives to Coumadin?

Has anyone experienced problems adjusting to Coumadin?

If so, what kinds of problerms? Any allergies or other reactions?
How long did it take to resolve those problems?

'AL'

 

[Christina]

Hi Al,

The only thing I noticed after I started taking Coumadin that some of my hair fell out. It lasted a few months and than it subsided. I still have plenty left...LOL! But that was the only thing I noticed, and for the rest no side effects that I can remember.

Christina
Congenital Aortic Stenosis
AVR's 8/7/00 & 8/18/00
St,Jude's Mechanical

 

[Johnny Stephens]

Hi Al, the only effect I've seen from Coumadin is constipation..and some minor bleeding during the same process

Went away after about a week. NO other problems..I can't even tell I'm taking it.

 

[Blanche]

Lovenox continued

Lovenox continued

Hello Gisele and Christina:

Gisele, I do believe that it was your post that I remembered.
Christina, now that I think of it, I seem to remember that you too had some difficulty while on Lovenox. In any event, I appear to have opened a can of worms. Husband's cardiologist's office called yesterday and cancelled him post-hospital office visit. They said "it wasn't necessary" and said that his internist would handle the post-hospital follow-up. I'm telling my self to take it on face value, but I can't help but wonder if this has anything to do with the questions I brought up. In any event, when Lovenox came out there was no statement that it was not recommended for those with prosthetic heart valves. That warning now exists. While I confess that I don't fully know what that means and will not even attempt to interpret that message, I know enough to say, "Not on my husband and not on my watch." I have so many frustrations with this last hospitalization. One nurse tried to give hubby a second l0mg dose of coumadin four hours after he had a 10mg dose, and the next day a nurse gave him 6-1/2 when he was supposed to get 10mg. I'm not going to lose my sense of humor....and I am adding a can opener to my tool belt. I'm begining to wonder how anyone gets out of the hospital alive.
Kind regards,
Blanche

 

[Gisele]

We'll see......

We'll see......

I just sent away last week for my Rx of Lovenox 30mg to Express Scripts. That way I can have 30mg and 60mg available on hand for my low INR's. I will let you all know if there is any type of warning on my supply. Now, the problem will be whether or not I will even be able to use it. One of the employees in the office of my cardiologist office is printing up the warning and bringing it to work. I will find out what his reaction is. (I used to work in that office). One thing I thought of but never asked was when a patient is on heperin the doc can monitor the level with a PTT, and if the patient is on coumadin, it is monitored with a PT/INR. So how does the MD check the level when on Lovenox. Is there no test available? I realize the dose is dispensed on the patients weight. But I know first hand that this method is not foolproof for maintaining a theuraputic level.
Don't loose your sense of humor Blanche, I think you will need it again!
Gisele

 

[Gisele]

Lovenox supply arrived today

Lovenox supply arrived today

and I searched through all the fine print and I couldn't find a warning regarding patients with mechanical valves. Go figure. I am not sure how long it takes to update the insert, but I would think the mfg would add a suplement to update it. I guess they aren't worried about it.
Gisele

 

[Christina]

The problem I was having......

The problem I was having......

This is to Blanche...


The problem I was having was I missed three Lovenox injections. If they had told us in the hospital HOW IMPORTANT
THE INJECTIONS WERE WE WOULD HAVE GONE TO WALGREENS AND BOUGHT THEM OURSELVES and my second surgery would never have happened. We were so new at this that we didn't realize the importance of all this.
This is what happened:

After 4 days out of surgery my INR just wouldn't come up. They had already been injecting me with the Lovenox but without the necessary results. They didn't want to keep me longer in the hospital so they taught my daughter how to inject the Lovenox. We were told to call when we were running low on the Lovenox. Well, when we ran low we called and left 5 different messages at the cardiologist office without anyone getting back with us. All we got was a voice mail to leave our messages. No one returned our calls.
When someone finally got back with us I had missed 3 injections. The following morning I was in trouble and had to go back to the hospital and was admitted at once. That afternoon I was told that there was a blood clot underneath the valve and that the surgery needed to be redone. I was back in the operating room the following morning at 8AM.

Christina
Congenital Aortic Stenosis
AVR's 8/7/00 & 8/18/00
St.Jude's Mechanical

 

[Guest]

As far as I know, the only problem with Lovenox occurred is pregnant women with valves. They were part of a study to try to determine an optimal dose during pregnancy.

Pregnancy is a HUGE risk factor for clotting because as the delivery time draws near, then body produces large amounts of clotting factors. From an evolutionary standpoint this is necessary so that the new Mom does not bleed to death.

Warfarin causes birth defects when taken between weeks 6 and 12 - often before a woman realizes she is pregnant. Also, doctors have tried to get women on heparin before delivery because warfarin prolongs the bleeding time too much. Unfortunately, these women were underdosed and died. As a result we may never know what would be an effective dose of Lovenox for a woman near term in pregnancy. This is devastating for women who have heart valves and want to have children.

You cannot draw any conculsions as to the safety of Lovenox in other people because of what happened to this special class of people.

 

[Blanche]

Al:
I'm glad to have your insight on the issue of Lovenox and prosthetic heart valves. When I saw the FDA MedWarch Safety Alert, I remembered a previous post where you discussed pregnant womenand stated that this could not be applied to all women. However, I am still quite concerned because both the Alert and the boxed instructions specifically state:"Prosthetic Heart Valves: The use of Lovenox Injection is not recommended for thrombophylaxis in patients with prosthetic valves who have received enoxaparin for thrombprophlaxis." It does go on to say, "Some of these cases were pregnant women in whom thrombosis led to maternal deaths and fetal deaths."

When I called Aventis they told me that Lovenox was not approved by the FDA for anyone with a prosthetic valve, as the warning states. They also said that doctors could choose to go off-label and use the drug. I also talked to our doctor who said that the research done included problems with pregnant women and other groups of people with prosthetic heart valves. He also said that some doctors might be willing to go off-label, but he would not be confortable using a drug that did not have FDA approval.

I'm still quite confused because the warning is directed at all people with prosthetic heart valves. Is this just an over reaction to the problems pregnant women face? What are the issues involved in going off-label? I know that for years doctors went off-label and prescribed Fosamax for men when it was approved only for women. Is that the same kind of thing? Is the warning just a procedural thing that covers doctors if they go off-label and get into some difficulty? Appreciate any help that you might provide here.

 

[Guest]

Blanche,

Your doctor's answer about unlabeled uses does not ring true. Ask him if he ever prescribes heparin as an IV drip for patients with heart attacks. All docotrs do. But it is not an approved usage.

The use of heparin for this probably predates the FDA. Still every time he orders it, he is contradicting his answer about off-label uses. The point is that doctors do not differentiate between approved and unapproved uses unless someone points out a problem to them.

Aventis is covering its backside by saying that it should not be used in patients with mechanical heart valves and winking its corporate eye every time it rings up a sale for someone with a valve who is undergoing a procedure that they need to be off warfarin for.

Ask yourself, am I better off taking nothing when I need to go off warfarin for surgery? Wouldn't you be better off with some protection even if were not 100%?

 

[LUVMyBirman]

Lovenox and such

Lovenox and such

Seems I missed a lot here in this thread. This does have me concerned. In the same breath I do believe that the makers of Lovenox are CYA because of the tragic events that happened to the pregnant woman with prosthetic valves. I would tend to agree with Al's quote below.

"Ask yourself, am I better off taking nothing when I need to go off warfarin for surgery? Wouldn't you be better off with some protection even if were not 100%?"

This does necessitate further investigation. If this proves to be true, those of use with prosthetic valves will need to sit patiently at the IV pole when coming off coumadin. In my case, takes 10 days to retain a level of 2.5. Still out of range for my valve.