Oversight symptoms and conditions

Lamictal with lithium was the latest sentence for a lifetime of depression. Not only did the depression then intensify over anything I've dealt with for the last 40 years, but anger, rage, weight gain, memory loss, difficulty communicating, (could this be dementia at 60 yrs?) and loss of taste especially coffee and chocolate were now defining my life. I had been a happy, productive, exciting, witty, professional self-employed woman. So, I've been reducing my 250 mg dosage for the last 6 weeks with Dr. oversight. My last dose of 25 mg was last Wednesday. Throughout this experience, I've experienced confusion, head aches, zombie days, spatial disorientation, muscle weakness, muscle spasms, jumbled speech and thinking, and THE FOG. But, guess what? Today, I'M BACK. My head is clear, I have a plan for the day and I'm 4 pounds lighter than I was last Thursday. The surprise about the weight is that we went to dinner in restaurants twice in this last week and I haven't taken any special steps to lose the pounds. I knew it was time to evaluate myself without medication when the Dr. wanted to add just one more medication to level off the mood swings. Of course, this is a continuing drama, but it's great to be able to see me without the drug-colored lenses. I would not have done this without Dr. supervision, and I'm so glad he co-operated with my wishes. Sometimes you just have to throw the project away and start fresh. Have a beautiful day.

Everyone should go to 2004 postings for a reality check. It blows my mind that people were reporting disturbing behaviors/moods in their children in 2004 and we're still talking about it in 2008. Where's the oversight?

Hey to All.
I know that the ALA study got everyone upset and I am happy we all emailed her.We all pretty much got the same response from Heather,defending the study and the integrity of the results.If only this investigation would conclude!
The Merck company contacted our Senator and indicated there was a conclusion and then ,they never got back to her before the weekend.I will have news early in the week.Please everyone just keep on voicing your concerns by reaching out any way you can.Sometimes it seems unbearable and I have to take a break with the communications on this website but,I continue my communication with my local contacts and the FDA.
I would love quick results and everyone would love this to get the publicity this story deserves but,if you look at how far we have come getting attention focused on this drug it is amazing.
This website has been here for years and people have complained and nothing has been accomplished until now.Our system is so broken it will take time to fix it.Drugs get approved everyday and when they are put out for multi use,the population benefit -risk ratio changes and there is little oversight on this matter.
The problem is much bigger than just notification of updated side effects,which indeed is why our son died from this drug.It is reporting adverse events to the FDA and the drug company and following up on your report.We can only fight within the system of the government that is in place at the moment and push for change to take place in there programs.
This is what has take place as of this year,The FDA's new 'Safe Use "iniative(which when it gets further developed will increase our partnerships with physicians as well as patients) and the July 2008 AAM report" Education in Safe and Effective Prescribing Practices" which aims to address the education of the next generation of physicians on how to best use medicines.This may help in notification practices and over prescribing but, we want the drug companies to lose the unprecedented control over the clinical research and and evaluation of there own drugs.What other company in the USA, gets to self regulate.Change will come ,we have asked for accountability by having a signature exchange when new and updated side effects are found.Full disclosure of all reported adverse events to doctors from the company representatives,with signature required upon full understanding of the benefit -risk ratio change. A prescriber should know all the good and the bad about a medicine they have chosen to dispense,if not then they should not be able to dispense it.If we were not knowledgeable about selling mushrooms and we sold the poisonous ones ,because we did not take the time it would take to educate ourselves about them,would we not be legally responsible for our actions.
Accountability is what we are asking for and maybe the candyland doctor prescribing practices would stop.They seem to ,not have a responsibility to their patients and the company has no responsibility to the prescribers,so who is responsible for our safety?
I will keep fighting for real change and all you people must do the same ,make an appointment with your representatives and have them contact our Congress representative of NY,maybe with enough onboard we can get the legislation we need to put a law in place for proper notification practices.Kirsten E. Gillibrand Member of the US House of Representatives 120 Cannon House Office Builing Washington, D.C. 20515
This is how change is made ,if you want to help please go forward and do this and don't stop until they listen.I am always willing to do whatever I can,it is physically exhausting and sometimes I just have to step away but, my daily review of this site has not stopped and my fight will continue.Dave and I sit here and our hearts just break for all but, we need people to push their Representatives they do work for the people just remind them of that.Any one with questions or that wants to communicate via private email just ask for my email address or phone number or leave me yours and a time and I will be sure to contact you,Kate M.

OK guys, I have been reading all your side effects for a couple of weeks now, and finally decided to jump into this pot! You will not believe this, but I have been on Diovan 80 mg twice a day along with a couple of other blood pressure medications. It's been about 2 years, maybe a little less, and for the past 10-12 months, I have complained to my doctor that my joints and muscles ache so much that I feel like a 100 year old person. I also have has every side effect mentioned on the 9 pages listed here with all of you. I have had every test imaginable for artery's/veins/muscles/joints/sleeplessness/hair loss/weight gain/swollen ankles...you name it, I've been tested for it. They can find nothing wrong with me at all. NOTHING! I'm sure they feel that it's all in my head, since I've been quite sensitive to a lot of meds. in the past!

I am usually very active and run around like a crazy woman most of the time, but I was absolutely walking like I'd been hit by a truck. I went to my doctor with all of the complaints listed under Diovan printed out, and believe me, she took notice. We stopped Diovan that night and I started on a couple of new meds. that have absolutely no side effects. It will be two weeks this coming Wednesday (June 4) and I am almost a new person. I'd say, about 98% pain free. I actually felt relief after being off for about 5 days. It's getting better day by day. I actually feel that this stuff was killing me slowly. Get off asap!
By the way, I tried to look up the new meds, and they are so new that I can't find anything. For me, they are an answer to prayer.

Sorry, I can't just walk away.

When you find patents or patent applications for certain purposes, then you know that your ideas are well founded. There are several patents for using an anti-malaria drug for asthma. I would bet that somebody had that idea all the way back to the 1960's. So it is very possibly no coincidence at all that a chloroquinoline or other quinoline ring would be part of montelukast's chemical structure.

Here is one of the patents.

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It is well known that quinoline rings can be toxic to some people even very rapidly. As in this very extreme example.
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PEDIATRICS Vol. 27 No. 1 January 1961, pp. 95-102 This Article

FATAL ACUTE CHLOROQUINE POISONING IN CHILDREN
Howard M. Cann M.D.1 and Henry L. Verhulst M.S.1

1 National Clearinghouse for Poison Control Centers, Accident Prevention Program, Public Health Service, U. S. Department of Health, Education, and Welfare
Four cases of acute chloroquine poisoning in children are presented. In three instances death occurred within 2 hours of ingestion of larger than therapeutic amounts of the drug. The rapid occurrence of death in acute chloroquine poisoning is probably explained by complete and rapid absorption of the drug from the gastrointestinal tract resulting in high blood concentrations which depress vasomotor function and respiration. Cardiac arrest follows and may be caused by the direct myocardial action of chloroquine, to anoxia, or to both. The similarity of the manifestations of acute chloroquine poisoning and those of acute quinine and quinidine poisoning suggests that acute toxicity may be attributed to the quinoline ring portion of these drugs.

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I don't think that we are seeing extreme examples. But we may be seeing less extreme immediate reactions or reactions where the toxicity builds up over time.

Quinoline rings are know to cause neurotoxicity. There are theories about how that happens. One of the theories is about blocking connexins which are gap junction proteins in the brains.

I don't know how montelukast could be breaking up so that it causes toxicity. Or if the problem is the how rapidly the liver enzymes can metabolize it. But there is plenty, plenty, plenty of clinical evidence that there is a quinoline ring culprit somewhere in the picture. Or some by-product of that causing problems.

Somehow it was decided that montelukast did not have the safety issues that the other drugs in the same category have. See this.

"The starting point in the development of montelukast appears to be a quinoline-containing structure, likely identified as a weak random screening lead (Figure 3). The Merck group hypothesized that this molecule was mimicking the olefin backbone of cysLTs, and that the addition of mimics for the acid and peptide regions of LTD4, might improve its potency. As a first step, the dithioacetal linkage first seen in some SmithKline compounds was incorporated; this led to a compound with greatly increased in vitro potency but poor oral bioavailability. When one of the carboxylic acids was replaced by an amide, forming MK-571, the new antagonist had even greater potency and good efficacy following oral administration. The enantiomers were resolved to yield MK-679 (verlukast), a compound with better clinical effects than MK-571, but whose clinical development was stopped for safety reasons. Further structure-activity relationship studies led to the development of montelukast (16), an antagonist that appears free of the safety concerns plaguing earlier members of this series."

If we can find out why the earlier versions were not safe and how they thought fixed it, then maybe we can find out what is going on with the quinoline ring in some people.

I would be very surprised if the FDA will address our concerns. Why does it always seem like they wait for enough people to die like in Vioxx? Wasn't Vioxx responsible for thousands of deaths?

The new April 2008 issue of Reader's Digest has a long article on how the FDA approves drugs and the many problems associated with the agency entitled "Can We Trust the FDA?" The lack of oversight and the fraudulent studies conducted by the pharm industry is all there, it's no wonder this drug was approved. Please read.

If any one is following what research is being done, here is the description of the new study in children.

http://clinicaltrials.gov/ct2/show/NCT00540839?intr=%22Montelukast%22&rank=19