Meds with black box warnings

[Nomad]

What is your thoughts on meds with black box warnings?

Also I saw on another site that all IVIG has a black box warning? Does anyone know if this is true?

[Linda196]

Please let me preface my reply with this : I am responding as an individual, not as Sjogren's World staff, and my comments do not in any way reflect the opinions of Sjogren's World or it's other staff members.

I'm afraid my thoughts on black box warnings are less than PC, because I believe they are only necessary because of the litigious society in which we live.

My first thought is all drugs, invasive therapies, and even "natural" supplements, have the potential to cause harm, because in order to be effective they have to cause change in either physiology or function. My second thought is putting a black box around it only makes a warning more dramatic, not more appreciated or effective"

Before BBW, we were told, as an example, birth control could pills could cause blood clots; the choice to take them was then made by the patient and doctor, and adequate precautions were taken in women deemed to be at risk. Now, the labeling carries this dramatic warning, and some doctors or pharmacists may feel their need to note possible adverse effects is covered, so patients who don't read the fine print may blissfully carry on, not knowing the threat, and in the future, when presented with one of these effects, sue the company. I equate it to labeling carry out cups of coffee as "contains hot liquid" to avoid law suits from people who are burned by these hot liquids........the label goes a long way to protect the provider, but the only consumer who is protected is the one who actually reads it.

Years ago my only reliable chemical source of pain relief (propoxyphene or Darvon^TM)was black-boxed due to the possibility of addiction or overdose. Later it was taken off the market due to an adverse effect in cardioelectrical transmission (heart arrhythmia) which occurred when toxic levels were reached. For those of us dependent upon, and cautious with, this drug, our relief was taken away. I was told by my responsible physician, prior to the initial prescription, that dependence, addiction and overdose were all possibilities, and to take the med with caution, when absolutely required. My 30 day refills consistently lasted over 3 months, sometimes as long as 6, and yet I was being denied.  The same thing happened with Celebrex, and I was starting to feel like "the powers that be" simply didn't want me to have any relief from inflammatory polyarthritis pain. I took my needs elsewhere, to massage and meditation, and achieved some control, but still require occasional chemical pain control.

Yes, I believe in full disclosure of the possible adverse effects of medication; no, I do not believe that drawing a black box around it makes it any more or less dangerous. I take Prednisone, Methotrexate, and Plaquenil, all of which have a black box warning, and none of which will I give up until they are no longer useful, or they do actually produce one of the side effects that produces more problems than it relieves, and I consider it my right to make that decision. I have been advised by my physician and pharmacists of the possibilities, and we have discussed the "good vs evil" balance, and are all on the same page as far as continuing these meds.

And in answer to your second question, yes, IVIG does have a BBW, a double one actually, concerning the possibility of thrombosis (blood clots) more prevalent in elderly, dehydrated patients, and also the potential for renal (kidney) complications. These same concerns apply to the administration of any blood products in a clinical setting (nursing 101---watching for problems) but as far as I know, have not been issued a BBW.

[Jasper]

My thoughts about black box warnings are basically the same as Linda's thoughts.

All drugs have side effects, some serious, some not so serious. We do  not all get all of the side effects of every drug. We don't know which side effects we will get, if any.

I think it is beneficial and critical to point out serious, as well an non-serious, side effects of drugs.  The manufacturer insert does this, but most people don't read it.

The FDA mandates black box warnings on many drugs. Since the side effects and warnings are already iterated in the manufacturer insert, the black box warning merely highlights the side effects that the FDA considers the most injurious. I agree that the proliferation of black box warnings does stem from the fact that we live in a litigious society.

For me, the use of a drug depends on how the drug works and whether the benefit outweighs the risk. I have declined several drugs because I felt the benefit did not outweigh the risk. Plus, those drugs were treating symptoms, not the root cause of the problem.

On the other hand, I am on Rituximab infusions and Plaquenil, both of which have black box warnings, and I take Prednisone tapers periodically.  Despite the black box warnings on all of those drugs, I take them because I feel the benefits vastly outweigh the risks. I might add, since I have been on Rituximab, I have not needed any Prednisone tapers for flares because I have not had any flares while on Rituximab. In addition, all of my symptoms have vastly improved on Rituximab.  It has truly been a miracle drug for me.

[ohiolady]

I agree with Linda on this subject.  Though Domperidone doesn't have a black box warning it does come with cautions. But, if I am puking everyday and can't eat what kind of quality of life would I have.

I take a number of meds and all of them are absolutely necessary to my quality of life.

Anna

[warmwaters]

I think I'd like to ask the original poster what the question is? 

Before I started having a chronic illness, I would have been completely freaked out by taking a medicine with a severe side effect, whether black box warning or not.  I mostly took ibuprofen, the occasional antibiotic, and antihistamine.


When I was first diagnosed with Sjogren's and went on Plaquenil and prednisone, I was frightened about the possible side effects of these medicines.  I could lose my eyesight?  I could develop a permanent hump, and my bones could become brittle? YIKES.


Seven years later, I'm much more of a risk taker.  With the help of a rheumy who is good at assessing the risks for my particular set of circumstances, I've tried a wide range of things to try to improve my symptoms, including IVIG and Rituxan. However, having someone who knows my situation well makes a huge difference.  When I'm dealing with a doctor I haven't worked with before, I'm asking a huge, and probably irritating number of questions.   And reading the materials, and the research studies, and online sites that discuss what patients actually experience. Actually, I do all that with what my rheumy proscribes, too.

[Nomad]

There was an on line cancer series...something like The Truth about Cancer.

A disguised doctor talked bout BBWs.

He said there are a decent amount of instances where drugs that may or may not have been tested appropriately are passed by the FDA. Statistics are fudged.  Money exchanges hands.  And voila...they are approved with a BBW.  I'm not sure, but I think he was primarily talking about cancer drugs...like chemotherapy. Nothing validated here. Speculation, but interesting.

I know personally I would like to avoid these drugs.  View them as something for dire situations only.

Was saddened that ivig has a BBW (or two). A very helpful med/tx.
But, then again, there is the legal aspect of the entire matter...that is prob simply all there is to it.