Drug induced hemolytic anemia

[LAHoward]

What is the name of your state? MA

Back in March 2003, I had surgery to reverse a colostomy from a Feb 2003 perforated intestine due to diverticulitis. I was given cefotetan pre-op, which caused an immediate reaction -- severe backpain, shivers, etc. This was just before going under for the surgery. When I awoke from surgery, I already had symptoms of serious problems -- extremely dark urine. This is a long story, but within 24 hours I ended up rushed from the community hospital to a trauma facility with a blood pressure of 80/30. I was in ICU for 3 days, had to receive plasmaphoresis in the morning and dialysis in the afternoon for 1 week (had complete renal failure). Long story short is that I had experienced a near fatal episode of drug induced autoimmune hemolytic anemia.

I have never fully recovered, as I ended up with a diagnosis of fibromyalgia that has effected every aspect of my life (I had been an energetic professional with a MBA that had worked hard and in senior positions for 15 years prior to this -- I am currently a PT freelancer, as flare-ups from the fibro makes it impossible to put in the hours that I needed to in my prior position).

Question is -- while I don't necessarily think there was medical malpractice here, there are many, many articles in the medical literature about cefotetan being the leading cause of drug induced autoimmune hemolytic anemia -- 30% fatal. Is there any possibility of compensation from the manufacturer of the cefotetan?? My life has been forever changed, and I constantly wonder whether there is anything legally that can be done for those that suffer from known potential adverse reactions from medications?

Thank you for your feedback.

 

[ellencee]

What is the name of your state? MA

Back in March 2003, I had surgery to reverse a colostomy from a Feb 2003 perforated intestine due to diverticulitis. I was given cefotetan pre-op, which caused an immediate reaction -- severe backpain, shivers, etc. This was just before going under for the surgery. When I awoke from surgery, I already had symptoms of serious problems -- extremely dark urine. This is a long story, but within 24 hours I ended up rushed from the community hospital to a trauma facility with a blood pressure of 80/30. I was in ICU for 3 days, had to receive plasmaphoresis in the morning and dialysis in the afternoon for 1 week (had complete renal failure). Long story short is that I had experienced a near fatal episode of drug induced autoimmune hemolytic anemia.

I have never fully recovered, as I ended up with a diagnosis of fibromyalgia that has effected every aspect of my life (I had been an energetic professional with a MBA that had worked hard and in senior positions for 15 years prior to this -- I am currently a PT freelancer, as flare-ups from the fibro makes it impossible to put in the hours that I needed to in my prior position).

Question is -- while I don't necessarily think there was medical malpractice here, there are many, many articles in the medical literature about cefotetan being the leading cause of drug induced autoimmune hemolytic anemia -- 30% fatal. Is there any possibility of compensation from the manufacturer of the cefotetan?? My life has been forever changed, and I constantly wonder whether there is anything legally that can be done for those that suffer from known potential adverse reactions from medications?

Thank you for your feedback.

You had an allergic reaction to the medication; that's no one's fault unless your physician knew you were allergic to the medication and administered it to you anyway. The manufacturer has not withheld information about the potential development of hemolytic anemia in an allergic reaction to this medication.

Many people work everyday and enjoy personal and financial success despite having fibromyalgia. Allowing this event to forever mar your life is your decision as is allowing fibromyalgia to keep you from enjoying success.

EC

 

[LAHoward]

Thank you for your reply. Actually, I did have a record of a Positive Coombs test after receiving the cefotetan in the first surgery. I was never informed that I ever had a Coombs test done, and still do not know why they did it. (I had the same surgeon for both surgeries.) Maybe it was because my blood counts were anemic and I had an unexplainable fever after the first surgery??

Also, I found out after the fact that as soon as I had the reaction to the cefotetan (in the preop room immediately prior to the second surgery), a possible adverse reaction form indicating the possibility of developing life threatening drug induced immune anemia was initiated by preop and filled out and signed by the surgeon. He still went on with the elective reversal surgery. I will never know whether I would have been spared a month in the hospital and lifelong fibro if the surgery had been postponed.

Anyways, I did check with an attorney on the above, but they felt it was not sufficient cause for malpractice.

My original question here was simple, is there recourse for life altering effects due to known potential adverse reactions to drugs. The company knows that this frequently fatal drug induced immune reaction happens. Are they at all responsible for compensating those that are in the % that develop long term damage from the medication? I didn't choose to be where I am right now. I am here, pure and simple, as a result of the effects of the cefotetan.

As for living with the fibromyalgia, yes, there are those that manage the condition well. Others are disabled by fibromyalgia. I do know that you really can't judge the impact of fibromyalgia unless you have it yourself. I truly am not choosing to be where I am right now, it's not just a "get over it" situation. If it was, I would have moved on!

I am actually doing very well with the condition, other than the fibro has significantly altered my plans for my life. I had been looking forward to, and planning on, returning to a high-pressure, full time senior management position once my children were both in college (2 years from now). Instead, I very recently had to leave my PT job due to what ends up being approximately 4-5 days per month of uncontrollable full body pain that leaves me housebound, often brought on by stress, along with the chronic effects that I live with daily of reduced energy and impaired mental capacity. I will be OK, as I am capable of doing freelance work at home that will accomodate the unpredictable nature of my condition. However, I will always have to struggle with what was taken away from me because of cefotetan, and will always have to suffer financially because I have been denied the ability to return to the type of work for which I obtained my MBA and had been trained to do. It's particularly difficult right now as we are facing college bills!

I was pretty sure that there was no recourse for the adverse reaction, but as the time slips by, I thought I'd ask one more time. It really doesn't seem right that pharmaceutical companies can reap the profits of medications, without setting aside reserves to at least partially compensate the patients that do suffer when given these drugs.

Again, thank you for your reply -- the only one I received! I do want to put this all behind me, and the knowledge that there is no recourse for adverse drug reactions helps me do so. Believe me, it does help to know that the medication has likely helped many,many others, I was just on the very short end of the stick this time.

 

[rmet4nzkx]

There is a condition called Drug Hypersensitivity Syndrome, there are 4 factors required to have this, it is accumulative in nature so once it manifists it's self management is going to be a problem, going back through your medical history will possibly give some clues. You more than likely have difficulity metabolizing sulfer related substances to some degree. You might try supplements which combine cal/mag/zinc this helps bind and remove metabolites, limit/avoid high sulfer foods. Get your potassium levels checked. Are you anemic still? What medications?

 

[LAHoward]

Thanks for the reply. Hadn't heard of this possibility for a diagnosis -- the research showed a clear tie between cefotetan and drug induced immune hemolytic anemia. I also had extremely low platelet counts post second surgery, which resulted in a temporary diagnosis of Evan's Syndrome (combo of hemolytic anemia & thrombocytopenia). Platelet counts went down to 9 at one point, which required re-hospitalization for 1 week. The most recent labwork done in Feb 05 showed RBC of 4.17, which is slightly low, but very good platelet count at 284.

Both the anemia and the platelet issues resolved after a 6 month course of high dose Prednisone treatment. That's when the muscle pain, chronic fatigue, mental fog symptoms started, resulting in the fibromyalgia diagnosis in 11/03. Those are the symptoms that have continued to today.

As for meds, I have been able to decrease the meds that I had been put on post surgery in 2003 down to metoprolil for heart palps, low dose ritalin that helps with mental clarity, and low dose amytriptilin at night for sleep.

I'd be interested in hearing more on the Drug Hypersensitivity Syndrome, and the 4 points you mentioned.

 

[ellencee]

I think your questioning whether or not continuing with the surgery was prudent is worth some collaborative efforts in finding an answer.
We don't have an anesthesist that answers posts or not one of whom I am aware; so, we need to find out if the allergic reaction symptom of back pain should have raised sufficient concern to postpone the surgery.

I feel more than reasonably sure that you received proper antihistamine treatment at the time of your allergic reaction. The question is, should the anesthesist and/or the surgeon have known that you would more likely than not suffer significant damage if the surgical procedure continued?

The drug manufacturer is not negligent. You need to accept that and move forward in your thinking. Drugs to which no one is allergic are an impossibility.

The physician ordering Cefotan had a duty to know that any person taking Cefotan has the potential to develop a life-threatening hemolytic reaction and had a duty to know how and when to treat such a reaction.

Hemolytic allergic reactions are currently the allergic reaction of study by the medical community. Its prevalence has been grossly under-estimated, probably because the patient dies of severe anaphylaxis before hemolytic anemia and thrombocytopenia can develop. The fact that the medical community is in a learning curve on this issue may taint any claim of negligence/malpractice; you need to be aware of that.

There are varying stages of hemolytic allergic reactions, too. Those with localized hemolytic reactions to venomous insect or snake bites are at high risk of developing full-blown hemoltyic anaphylaxis. Do you have a history of any similar reaction to contact irritants [develop petechiae (little red bruises)] and if so, was your surgeon/anesthesist aware of your type of allergic reaction?

You should consult with a medmal attorney ASAP because of the need to protect the statute of limitations. An attorney may not be willing to take the case on contingency. You may have to pay for expert anesthesist review and expert surgeon review; that's about $10,000.

In the meantime, I will need assistance from others to research the issue(s). Maybe we can find enough facts to encourage an attorney to review your claim on a contingency basis.

EC

 

[rmet4nzkx]

The problem is very complex and a lot will depend on your medical history, especially your history of atypical reactions to medications. Having a reaction in and of it's self may not be actionable and the FM may resolve over time and simply may be the result of the trauma your body experienced. Did you have any edema following the proceedure or the medications? When did you start having palpatations? Have you been tested for other genetic disorders or for bleeding disorders, if so, when during or after a reaction? I have gone through something simlar myself and it may take years to get answers or to your questions.

 

[LAHoward]

Hi All -

Thank you for the kinder responses! As I said in the original post, this was a fairly complicated set of circumstances surrounding my second surgery. I actually did have an attorney review the case for potential negligence/malpractice, but the complicated history of prior surgery, with the positive Coombs on record from the earlier surgery (though again, I only found out about this when the atty noted the entry--still don't know why they gave me a Coombs test??), made that atty practice conclude that it would be too difficult to prove that this wasn't just a "sleeping dragon" in my body waiting to be roused. The attys also said that where I live, juries don't give out good settlements, and it wouldn't be worth their effort or mine to pursue this further. There opinion was to just "move on" with my life.

I have to be honest that the case was also complicated by the fact that during the first 24 hours post op Mar 03 surgery, I was being treated for the blood in the urine and beginning to get better. The surgeon brought on board a kidney specialist, and they were both closely monitoring my condition. I didn't even realize there was a real concern at that point, only that I wasn't allowed out of bed due to there being blood in my urine. I was never told that an "adverse reaction" report had been prepared by the surgeon after my severe reaction from receiving the cefotetan preop.
Only received a copy of the ADR report after my second attempt to receive ALL of the medical records from the hospital. I cried when I read that piece of paper, signed by the surgeon just before I went into the op room.

I only became aware that there were real complications the second day post op, when (I found out later) a nurse had given me a dose of phenegran too close to the last morphine dose that resulted in my immediately passing out, being transported to ICU, requiring Narcane to counter that drug interaction, vitals did not respond, at which time a decision was made to transfer me to an acute care facility able to perform plasmapheresis (tentative diagnosis of potentially fatal TTP). Last thing I remember hearing was EMTs in the ambulance saying that my bp was 80/30, and realizing that I was losing all sensation in my arms/legs. With a background in hospice, I knew I was in trouble.

So anyways, while the surgeon told me in Feb that he felt I was healthy enough to go in 6 weeks later for the reversal of the colostomy, either I wasn't healthy enough, or something happened with the meds/treatment to take my health away?? Prior to that period of time, I had been a member at the local gym for 4 years, working out 4-5 times per week, took yoga classes, weight training classes etc. I did have seasonal allergies, nothing requiring medical intervention. I ate healthy, worked hard, was involved in most of my children's after school activities, kept the house clean, etc. Now, I am often unable to do many of these activities due to pain, fatigue, etc. Believe me, this is not a head game, I've tried to just ignore the symptoms and move ahead. The problem with fibro, is that whenever you overdo it, you pay the price with the unbearable full body muscle pain.

Final so anyways, I knew from the review of the case by the attys that they felt it was much too complicated to pursue malpractice or negligence. It may not sound it, but I really am adjusting to my new life and am trying hard to create a successful part time freelance business. We are also considering selling our home and downsizing to cover college costs that were supposed to come from my return to full time senior management employment.

Recently though, I knew the time was ticking with the 3 year statute of limitations coming up in March 06, and had heard again about the adverse drug reactions. I thought I'd make this last stab to see if the pharmaceutical companies ever had funds set aside for those that do end up with the adverse reaction. My whole spiral started when my kidneys blew out on me immediately upon receiving the dose of cefotetan preop, the literature shows cefotetan as the leading cause of drug induced hemolytic anemia, so thought I'd ask. (BTW - My coombs test as of my last appt with my hemotologist in Nov 2004 is negative).

Thanks again for the followup posts. It's extremely frustrating to hear folks make comments to just "pull yourself together and get over it". Believe me, I'm a very strong person...if it was possible to recover what I've lost, I would.
I am also educated -- so I know that when March 06 comes along, I'll have no choice to bury the thought of any compensation for these life altering after effects of the March 03 surgery.

 

[rmet4nzkx]

Here is an objective review of the Rx you were given and on the face of it with the history you have given your risk of drug reaction was small and the risk of infection for the type of surgery you had was greater than for the risk of your drug reaction. The link will allow you to research if the doses were appropriate. Also understand that reactions may even be somewhat delayed. You have stated that specialist were called in and appropriate reporting of the reaction was made. You have also had your potential lawsuit evaluated by an attorney who informed you of the potential based on the merits of your case and the evidence you presented.
Cefotan http://www.rxlist.com/cgi/generic2/cefotet_wcp.htm

Were you tested for von Willebrand's disease if so, when because a negative test during a reaction my not rule out this disorder which makes you more at risk for bleeding, have you been tested for platlet disorders? Here is a site that may help you and during the week they have a live person to answer your questions as well as information available. http://www.itppeople.com/lowplate.htm
Insofar as diet, eating healthy may not be healthy for you.
Search platlet disorders, adverse drug reactions, hypersensitivity and bleeding disorders.

You might look into the possibility of a trial on Provigil in place of the Retilan and possibly somehting else for sleep since you had palpatations.

 

[LAHoward]

The problem is very complex and a lot will depend on your medical history, especially your history of atypical reactions to medications. Having a reaction in and of it's self may not be actionable and the FM may resolve over time and simply may be the result of the trauma your body experienced. Did you have any edema following the proceedure or the medications? When did you start having palpatations? Have you been tested for other genetic disorders or for bleeding disorders, if so, when during or after a reaction? I have gone through something simlar myself and it may take years to get answers or to your questions.

Sorry - didn't answer these questions. I have had very extensive medical testing done, but only after the transfer to the acute care facility -- testing for everything up to, and including an AIDS test. I don't recall the specifics, but there were many medical specialists that took part in saving my life while at the acute care facility, none of which had a definitive diagnosis until the last diagnosis of Evan's Syndrome, purely based on the acute hemolytic anemia and thrombocytopenia.

I don't recall all of the tests done (I beleive they looked at all autoimmune -- lupus, etc) but I was under the hemotoligists care for over a year, with daily blood work tapering to his discharging me as a patient in 11/2004. There were no other genetic disorders or bleeding disorders uncovered. In fact, as I mentioned in my last post, my 11/04 Coombs test was negative!! Sounds drug induced to me!! The hemotologist concluded that the blood condition has resolved, and that I did not have Evan's Syndrome -- thank God, if you look at the prognosis for Evan's!!

I do agree that the fibro is a direct result of the trauma. My physician and my own research indicate that while not in itself life-threatening, fibro is not a "curable" or even fully "treatable" condition. I have it managed, but with significant life changes, meds, etc.

I wish you well in your recovery from your situation, and than you for your replies and questions.

Best Regards.

 

[LAHoward]

Here is an objective review of the Rx you were given and on the face of it with the history you have given your risk of drug reaction was small and the risk of infection for the type of surgery you had was greater than for the risk of your drug reaction. The link will allow you to research if the doses were appropriate. Also understand that reactions may even be somewhat delayed. You have stated that specialist were called in and appropriate reporting of the reaction was made. You have also had your potential lawsuit evaluated by an attorney who informed you of the potential based on the merits of your case and the evidence you presented.
Cefotan http://www.rxlist.com/cgi/generic2/cefotet_wcp.htm

Were you tested for von Willebrand's disease if so, when because a negative test during a reaction my not rule out this disorder which makes you more at risk for bleeding, have you been tested for platlet disorders? Here is a site that may help you and during the week they have a live person to answer your questions as well as information available. http://www.itppeople.com/lowplate.htm
Insofar as diet, eating healthy may not be healthy for you.
Search platlet disorders, adverse drug reactions, hypersensitivity and bleeding disorders.

You might look into the possibility of a trial on Provigil in place of the Retilan and possibly somehting else for sleep since you had palpatations.

As I noted, very, very, fortunately there is absolutely no evidence of a permanent blood disorder.

I did try the provigil, not nearly as effective as Ritaling for my newly developed ADD symptoms.

I guess I am "lucky" that all I'm left with is the fibro!