Abnormal Bleeding
SSRIs and SNRIs, including duloxetine, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation.
Activation of Mania/Hypomania
In placebo-controlled trials in patients with major depressive disorder, activation of mania or hypomania was reported in 0.1% (2/2,489) of duloxetine-treated patients and 0.1% (1/1,625) of placebo-treated patients. No activation of mania or hypomania was reported in DPNP, GAD, or fibromyalgia placebo-controlled trials. Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. As with these other agents, Cymbalta should be used cautiously in patients with a history of mania.
Hyponatremia
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Cymbalta. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported and appeared to be reversible when Cymbalta was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [see Use in Specific Populations]. Discontinuation of Cymbalta should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death.
Use in Patients with Concomitant Illness
Clinical experience with Cymbalta in patients with concomitant systemic illnesses is limited. There is no information on the effect that alterations in gastric motility may have on the stability of Cymbalta's enteric coating. In extremely acidic conditions, Cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (e.g., some diabetics).
Cymbalta has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. Patients with these diagnoses were generally excluded from clinical studies during the product's premarketing testing.
Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Signs and Symptoms
In postmarketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as 1000 mg. Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Cymbalta should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Hepatotoxicity
There have been reports of hepatic failure, sometimes fatal, in patients treated with Cymbalta. These cases have presented as hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than twenty times the upper limit of normal with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established.
Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Other postmarketing reports indicate that elevated transaminases, bilirubin, and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis.
Cymbalta increased the risk of elevation of serum transaminase levels in development program clinical trials. Liver transaminase elevations resulted in the discontinuation of 0.3% (82/27,229) of Cymbalta-treated patients. In these patients, the median time to detection of the transaminase elevation was about two months. In placebo-controlled trials in any indication, elevation of ALT > 3 times the upper limit of normal occurred in 1.1% (85/7,632) of Cymbalta-treated patients compared to 0.2% (13/5,578) of placebo-treated patients. In placebo-controlled studies using a fixed dose design, there was evidence of a dose response relationship for ALT and AST elevation of > 3 times the upper limit of normal and > 5 times the upper limit of normal, respectively.
Because it is possible that duloxetine and alcohol may interact to cause liver injury or that duloxetine may aggravate pre-existing liver disease, Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Cymbalta treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
Bumping this up for others to see...........
Scratch out the part above about Kalina possibly transferring to another local hospital. I just reviewed the info., and I made a mistake. That hospital does NOT have an eating disorder unit. There is one other possible hospital. I have to talk to Kalina and the social worker and see what she wants to do.
Well, we got through the meeting. The social worker is sympathetic to Kalina's plight and even shared his own medical history of having thyroid surgery for his own depression. However, a couple of important things came out of the meeting: Kalina needs continuing treatment for an eating disorder (which her insurance will not pay for within an affiliation of this psych. hospital) as well as for her depression. The social worker will see if she can be transfered to another local hospital that has an eating disorder unit (one which is in the hospital system where her new doctor has privleges). Also, it is apparent that Kalina's doctor (both a psychiatrist and a family medicine doc) did NOTHING in terms of follow up RE: her thyroid problems. There are no transferred medical records in the file, there is no evidence of any thyroid testing at all, and I heard through the grapevine that Kalina's psychiatrist made a statement like, "I've never known a patient to die of low magnesium." So, it is probably just as well that she goes to another facility. I'll let everyone on the forum know what happens in the next couple of days.
I just wanted to thank everyone and ask one question. Your support and prayers have been SO helpful to me. I try to protect my daughter's privacy, so I haven't told poeple in our church (except for a few) about the hospitalizations. It's a bit hard when the pastor asked my husband, "Is she in sin?" Felt like asking him if HIS elderly father was "in sin" because he was recently diagnosed with Parkinson's! Anyway, I got over being hot about that one, and we are working hard to EDUCATE folks about how complex these endocrine disorders are and how they mask as mental illness.
Here is my question: the psych. docs just put Kalina on Cymbalta (don't know what dosage) about last Wednesday. Has anyone heard of any interaction issues with Cymbalta and Armour thyroid? Just on Tuesday it seemed to me that the brain fog was lifing and Kalina was starting to actively plan about getting discharged. Now she is reporting to her dad that she is having trouble sleeping, her anxiety is increasing, and she is trying to make fine cuts on her arms (with the plastic wrist band that she pried off). Sounds like bad side effects to me!
Right now I am going to check out 2 other hospitals that have mental health inpatient units. This currentl hospital is not only NOT helping her, it seems to be making things worse. One of the hospitals I will check out is a hospital where the new doc she has an appt. for tomorrow morning has privleges. Since it doesn't look like she will be ready to be discharged today, maybe this will be a way to finally get her thyroid treatment pushed into first priority. I would appreciate your thoughts and prayers!!!
Here is some keys points you and I discussed to get this doctor the information she needs to do the evaluation if you chose to see her next week.
1. gather up her recent labs she had done and get a hardcopy of the report.
A. - look that over and see if the Free T3 and Free T4 along with TSH was done.
1a. Keep in mind keys things if these frees were done. The Free T3 should be on the high end of the reference guide ( very top) and the Free T4 should be mid high/high(er) there too on that sheet - comparible to the ratios. I bet my house there 2 labs are off.
2a. The TSH (althrough not so important as frees) should be near the .5 or lower but it must be looked at with the frees. If her frees are not optimal - do not pay attention to the TSH.
3a. - check for autoimmune antibody testing and see if they "may " have lloked for Hashitoxicosis. That would require a TPOab and a TgAb test confirming her TSI/ Graves antibodies were still present - along with the tests listed on line 1a. sub paragraph.
2. Out of curiosity, try to also get her reports from when she was dx'd Graves - 3 yrs ago. After we shared more information that she had RAI done with NO UPTAKE ( I am still appauld by that if true) scan and was only based on blood labs - I am sure this doctor would like to review the reports then too - to confirm FOR SURE - Graves was really involved to the degree of recieving RAI for permanent ablation or if other measures should be done. Another reason why looking at that would be the toxicosis theroy. If Graves is/was suppressed and was to some degree then toxicity would not be a dx. BUT - however Hashimoto may be present and only TPOab testing could help here too with proper treatment for that - that is being missed probably.
3. Find out what meds she is on and the quanities used daily. Given the run down of meds you told me you will need to provide this to the doctor and the dosages.
4. Write a brief synopsis of her thyroid/health history with your daughter involved too if possible. It does not need to be in length but key points of her symptoms, mood swings, anything she has described to you since RAI - or at her worst with (Graves?) , should be down on paper and released to this doctor so she can associate quicker with Collena and understand her issues. One thing would be to describe the highs and lows Collena has daily with morning highs and crashes in the afternoon. This specifically points to her adrenals are dragged down and should be written with the other things so this doctor can put that together.
5. Make sure K allows you to be on HIPPA release - or her dad. This will be critical for you - as not sick - be able to help her - as sick - until her mental anquish becomes less. Your family will need to be her advocate at this time and if Kalina allows it - I am proud to step into her corner too.
6. Adrenals testing.... It would be wise for me to give you the saliva test as this doctor suggested for her to test the adrenals through her saliva. I have the test and will give you it. Let me know what you decide but it takes 10 days to look it over and get it back. K will not have true results and thyroid treatment could be difficult - even with correct treatment as you will get - if the adrenals are not resolved to proper health first or with thyroid medication working with too.
7. All those things should be done and handed in to the doctors office for her to review the case prior to your visit - As arranged she will do this free of charge and you will be involved in a short paid visit with this doctor after she reviews the reports to go over real results to get kalina back and away from those butchers ready to shock her. I am horrorified at this whole ordeal!
8. For you Debbie - research the Free T3 hormone and neurologic side effects online. Understand it so you can be there to logically help K with understanding. Also - finally, relax.... it was fate for you to go online today and for me to pick up the post as I did being so close locally. You will get your daughter back emotionally - I promise!
9. For K ( if you show her this Debbie) - Hi :) my name is Nikki and I'd like to talk to you about this horrible disease and condition you have right now. My history of it is very common to yours and I spent years learning how to get myself well. Even though I did not get into as much professional mental issues as you are in being in the hospital - I can tell you certainly - I was very close to losing my life both - health and mind over how bad I was treated after I had RAI for my Graves disease. It sounds easy in the beginning with doctors telling you - but so many of us know - just taking a pill to ablate the thyroid with RAI and go on another pill for thyroid life isn't that easy.
I - as many others- have spent years learning so much and found doctors willing to really help. What you have been asked to do - of you going through shock therapy I think is wrong and could hurt you more. I know its tough and could cause anger to listen to someone who you don't know but at least get the second opinion as I gave your mom on "complete" thyroid help and go with that before any shock treatment.
As God is my witness K, I promise now that your mom and I met - I will try not let you down and you will feel better.
9. Debbie - also read about conversion based off T4 Synthroid drugs into the direct T3 hormone w/ RAI patients.
We've got alot of things to get done this weekend so K gets better. I'll reach out anyway you see fit Debbie.
Sending Hugs.... me.