-FDA Panel to Consider Pain Indication for Antidepressant (excerpt)
Patients in the duloxetine arms were more likely to discontinue treatment because of adverse events, including nausea, sleep disturbances, dizziness, dry mouth, somnolence, constipation, and fatigue. Most of the events were dose-dependant.
Duloxetine use also appears to be associated with an increased risk of Stevens-Johnson syndrome, a skin disease that usually results from a drug reaction, as well as another form of the disease called toxic epidermal necrolysis. The FDA reviewers recommended that, if duloxetine is given the chronic pain indications, it should carry warning labels about the increased skin disease risks.
The FDA also has concerns about duloxetine's risk of serious liver toxicity, already included in the drug's labeling.
No deaths were reported during the trials.
The safety findings aren't new or unexpected and are very similar to duloxetine's current safety label, the FDA reviewers said.
The drug also carries a boxed warning for suicidality in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.
"...duloxetine is not universally tolerated nor free of safety risks," wrote Eli Lilly staff in the company's briefing documents posted on the FDA's website. However, the safety profile is "well-characterized" and not any different for chronic pain patients than it is for other patients who are already using the drug.
Consider that you do encounter much higher risk with these and may other drugs used for pain relief. Lyrica for example depletes your platelets and they don't mention that in the TV ads.
from Natural Health News Search
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