I would print off both documents and maybe highlight the areas of concern for her convenience.
http://www.fda.gov/d...e/UCM172866.pdf
The following document was issued by the FDA warning of the severity of Cymbalta Discontinuation Syndrome.
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Cymbalta (Duloxetine) Discontinuation Syndrome
Issues of Scope, Severity, Duration & Management
June 9, 2009
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The effects of discontinuation can be severe and extend for weeks or even months
Extreme mood swings (anger, irritability)
Debilitating “Brain Zaps”
Physical and neurological problems
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Claims
Cymbalta discontinuation syndrome is more severe and much more widespread than acknowledged by Eli-Lilly
⦁ Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of discontinuation syndrome
⦁ Lilly Direct to Consumer (DTC) advertizing is misleading related to the probability, severity and complexity of Cymbalta discontinuation
⦁ Lilly has not developed and fielded a clinically proven protocol for safely discontinuing Cymbalta
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⦁ 2) Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of Cymbalta discontinuation syndrome
⦁ Unaware physicians unable to discuss Cymbalta benefit-risk profile (including discontinuation) with their patients
⦁ Physicians can not make an accurate comparative assessment of Cymbalta vs. alternatives
⦁ Patients can not make an fully informed choice to take the drug
⦁ Practical effects (common in anecdotal reports):Patient becomes totally distrustful of the physician who did not advise/warn them in the first place
⦁ Doctor /patient relationship is wrecked
⦁ Patient in distress refuses to ingest Cymbalta under any pretext
⦁ Tapering is taken off the table
⦁ Patient fires the doctor or the doctor disengages from the patient
⦁ Syndrome mood swings militate anger directed at the physician
⦁ Physician may deny syndrome even exists
⦁ Physician may jettison a newly “difficult” patient
⦁ Physician seeks to avoid malpractice implications
⦁ Patient becomes deeply suspicious of any psychotropic medication
⦁ Underlying problem may go untreated
⦁ This is a process flaw – there is no excuse for it
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⦁ Lilly Direct to Consumer (DTC) advertizing is misleading related to the probability, severity and complexity of Cymbalta discontinuation
Also states that “opening the capsule is required to taper”
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⦁ Lilly does not offer small dose Cymbalta formulations to facilitate tapering Patient required to open capsules and count drug beads
⦁ Patient may require compounding pharmacy services at his/her expense
⦁ Tapering may take weeks or months
https://dailymed.nlm...f2-c185fbad64ba
Cymbalta Drug Insert
2.7 Discontinuing CYMBALTA
Adverse reactions after discontinuation of CYMBALTA, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].
Section 5.7
Patients should be monitored for these symptoms when discontinuing treatment with CYMBALTA. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate [see Dosage and Administration (2.7)].
Section - Dosage and Administration
Discontinuing CYMBALTA: Gradually reduce dosage to avoid discontinuation symptoms (2.7, 5.7)
Section - Warnings and Precautions
Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue (5.7)
6.12 Postmarketing Spontaneous Reports
The following adverse reactions have been identified during post approval use of CYMBALTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions reported since market introduction that were temporally related to CYMBALTA therapy and not mentioned elsewhere in labeling include: acute pancreatitis, anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, colitis (microscopic or unspecified), cutaneous vasculitis (sometimes associated with systemic involvement), extrapyramidal disorder, galactorrhea, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, restless legs syndrome, seizures upon treatment discontinuation, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria.
6. discontinuation symptoms: Do not stop Cymbalta without first talking to your healthcare provider. Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:
⦁ anxiety
⦁ irritability
⦁ feeling tired or problems sleeping
⦁ headache
⦁ sweating
⦁ dizziness
⦁ electric shock-like sensations
⦁ vomiting or nausea
⦁ diarrhea