Another regulatory SSRI fail.

On theorectical grounds of increased cardiac risk and case reports, the FDA recommended that no one prescribe more than 40 mg of citalopram. Clinically, higher doses have been used in co occuring anxiety disorders with depression.

What happened is the number of admissions increased. There was no decrease in cardiovascular deaths. The FDA panicked. One wonders if they will be accountable for the consequences.

appi.ajp.2016.15111444f1

The at-risk cohort of 35,848 veterans (mean age, 58 years [SD=11]; 92% male) had citalopram prescriptions for 64 mg/day (SD=8.3), on average. Within 180 days after the safety communication was issued, 60% had filled prescriptions for ?40 mg/day. All-cause hospitalizations or deaths were found to significantly increase after dosage reductions (adjusted hazard ratio=4.5, 95% CI=4.1–5.0), as were hospitalizations for depression or all-cause death (adjusted hazard ratio=2.2, 95% CI=1.8–2.6). Mortality did not decline (adjusted hazard ratio=1.0, 95% CI=0.8–1.3), and neither did hospitalizations for arrhythmias or all-cause deaths (adjusted hazard ratio=1.3, 95% CI=1.0–1.7).

This is a second paper indicating that this risk was overstated. There is a suggestion that this guidance caused harm: it is interesting that there is a proportion of people — about one in five — who remained on the higher dose.

Because clinicians treat people, not guidelines or regulations.

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