1 reply to this topic

[LickiTyClick]

-----WARNINGS AND PRECAUTIONS----------------------
•
Suicidality: Monitor for clinical worsening and suicide risk (5.1).
•
Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. 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. Cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease (5.2).
•
Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy (5.3).
•
Serotonin Syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions: Serotonin syndrome or NMS-like reactions have been reported with SSRIs and SNRIs. Discontinue Cymbalta and initiate supportive treatment (5.4, 7.14).
•
Abnormal Bleeding: Cymbalta may increase the risk of bleeding events. 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 (5.5, 7.4).
•
Discontinuation: May result in symptoms, including dizziness, nausea, headache, paresthesia, fatigue, vomiting, irritability, insomnia, diarrhea, anxiety, and hyperhidrosis (5.6).
•
Activation of mania or hypomania has occurred (5.7).
•
Seizures: Prescribe with care in patients with a history of seizure disorder (5.8).
•
Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment (5.9).
•
Inhibitors of CYP1A2 or Thioridazine: Should not administer with Cymbalta (5.10).
•
Hyponatremia: Cases of hyponatremia have been reported (5.11).
•
Hepatic Insufficiency and Severe Renal Impairment: Should ordinarily not be administered to these patients (5.12).
•
Controlled Narrow-Angle Glaucoma: Use cautiously in these patients (5.12).
•
Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, HbA1c, and total cholesterol have been observed (5.12).
•
Conditions that Slow Gastric Emptying: Use cautiously in these patients (5.12).
•
Urinary Hesitation and Retention (5.13).
---------------------------------ADVERSE REACTIONS----------------------------
• Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, fatigue, constipation, decreased appetite, and hyperhidrosis (6.3).
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


this is from the fda.gov website location: http://www.accessdat...1427s036lbl.pdf

another website to check out: http://www.fda.gov/d...e/UCM172866.pdf

[LickiTyClick]

Okay, If you are getting this wonderful experience of withdrawal from CYMBALTA, and you want to make an official complaint I found the place to do so. Go to the FDA (Food and Drug Administration) website and they have a form to fill out and be sure and give them the facts and not the "words" you may want to pitch into their eyes. I know and can feel the hell we are going through, but let's get it done right. Mention the drug, dose, mg, length of time you've been on Cymbalta, most importantly your withdrawal symptoms. Let's give them the heads up as each individual has it happen and you run access this site. Here is the web address just click on the link and look on the right hand side where it says begin and click (BEGIN)
My link