Links between SSRIs and a number of other serious adverse (and withdrawal) effects--such as aggression, akathisia
, mania and the wider realm of suicidality--have also been postulated (e.g., Breggin, 2003; Glenmullen, 2000; Healy, 2004a; Medawar, Herxheimer, Bell & Jofre, 2002; Whitaker, 2005), although the research evidence is less well established (see for instance Healy, Herxheimer, & Menkes, 2006, regarding the links between SSRIs and violence).
Because the FDA had never been asked to consider whether the warnings on metoclopramide regarding akathisia
ought to be strengthened, there could be "no conflict between state and federal law, and preemption does not apply."
In the short term, there is evidence that Fuphenazine increases a person's chances of experiencing akathisia
(n=227, 2 RCTs, RR 3.43 CI 1.2 to 9.6, NNH 13 CI 4 to 128), facial rigidity (n=190, RR 2.77 CI 1.0 to 7.5, NNH 12 CI 4 to 654), 'loss of associated movements' (n=190, RR 6.39 CI 2.0 to 21.0, NNH 7 CI 2 to 35), rigidity (n=227, 2 RCTs, RR 3.54 CI 1.8 to 7.1, NNH 6 CI 3 to 17) and tremor (n=227, 2 RCTs, RR 3.19 CI 1.3 to 8.1, NNH 11 CI 4 to 94).
Given the increase in these concerns, the FDA recently warned of the following antidepressant side-effects: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia
, hypomania, and mania (FDA, 2004b).
Prozac's own clinical trials, prior to its launch in 1988 and post-launch, recorded rates of agitation and akathisia
from between five and 25 percent.
The other untreatable disorder is tardive akathisia
involving painful feelings of inner anxiety and a compulsive drive to move the body.
The group will also look at factors such as family history, activation, overstimulation, restlessness, and akathisia
, which may be linked to suicidality.
Parkinsonism can be treated with benztropine and trihexyphenidyl (Artane); however, akathisia
usually does not respond to these medications (Janicak, Davis, Preskorn, & Ayd, 1997; Nurnberg & Levine, 1986; Sajatovic & Schulz, 1997).
Researcher Theodore Van Putten reported that nearly half of the 110 persons in the study had experienced akathisia
. "[One woman] started to bang her head against the wall three days after an injection of [a major tranquilizer].
An association between low serum iron levels or iron deficiency anaemia and development of the restless legs syndrome (RLS], a condition with many similarities to akathisia
, was reported more than 30 years ago (7)(8)(9)(10).
is a feeling of internal restlessness, which may result in continuous leg movements and leaves some patients feeling compelled to pace.
In the pivotal, 12-week, fixed-dose, placebo-controlled clinical trial of AL 441 mg or 882 mg monthly for adults with an acute exacerbation of schizophrenia, the only adverse effect that occurred in [greater than or equal to] 5% of AL-treated patients and a rate at least twice that of placebo was akathisia
(441 mg: 11%; 882 mg: 11%; placebo: 4%).