Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
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Sunday, September 09, 2007

Seroxat Safe for adults eh?

This from the Therapeutic Goods Administration webpage. 11 years ago folks!

About halfway down the page - http://www.tga.gov.au/docs/html/aadrbltn/aadr9602.htm#ssris

Australian Adverse Drug Reactions Bulletin
Volume 15, Number 1, February 1996

SSRIs and withdrawal syndrome
Withdrawal syndromes have long been recognised with the opioids and benzodiazepines but are rarely reported with other drugs. Fluoxetine (Prozac), paroxetine (Aropax) and sertraline (Zoloft) are antidepressant drugs belonging to the class of selective serotonin reuptake inhibitors (SSRI's). To date the Committee has received 26 reports of withdrawal symptoms in connection with the use of these drugs as summarised in the table below. (Table can be found by clicking on above link)

The age (range 23 to 68 years) and sex distribution (23 females and 9 males) probably reflect usage. In those reports which included the information, duration of therapy ranged from several weeks to months and onset of the reaction was within the first week (usually in the first couple of days) after ceasing therapy. In 8 cases the symptoms abated on recommencing the drug but recurred in 3 of these after the drug was again stopped. One patient experienced withdrawal symptoms in connection with sertraline and later, also with paroxetine.

The symptoms most commonly reported on withdrawal were dizziness (15 reports) and nausea (10). Anxiety, headache (both 5 reports), agitation, insomnia, increased sweating, tremor and vertigo (4 of each), hallucinations, and depersonalisation (3 of each) were also described. There was a total of 51 different symptoms documented in the reports with a wide range of other neurological and psychiatric symptoms including amnesia, ataxia, blurred vision, confusion, dysarthria, delirium, fatigue, hyperacusis*, hypertonia, meningism, mood swings, neurosis, nervousness, nightmares, paraesthesia, rigors, sensory disturbance, tinnitus, and twitching. There was also a report of a neonatal withdrawal reaction. Eighteen of the patients had recovered at the time of reporting and there were no fatalities.

Interestingly, paroxetine accounted for the majority of reports and its shorter elimination half-life in addition to the fact that it lacks active metabolites are possibly pertinent in this context. In contrast, fluoxetine has a longer half-life and its active metabolite, norfluoxetine has a half-life of 6-9 days.


Ed:
Hyperacusis*

Hyperacusis is a health condition characterized by an over-sensitivity to certain frequency ranges of sound (a collapsed tolerance to normal environmental sound). A person with hyperacusis has difficulty tolerating everyday sounds, some of which may seem unpleasantly loud to that person but not to others.

It can be acquired as a result of damage sustained to the hearing apparatus, or inner ear. There is speculation that the efferent portion of the auditory nerve {olivocochlear bundle} has been affected (efferent meaning fibers that originate in the brain which serve to regulate sounds). This theory also suggests that the efferent fibers of the auditory nerve are selectively damaged, while the hair cells that allow us to hear pure tones in an audiometric evaluation remain intact. In cases not involving aural trauma to the inner ear, hyperacusis can also be acquired as a result of damage to the brain or the neurological system. In these cases, hyperacusis can be defined as a cerebral processing problem specific to how the brain perceives sound. In rare cases, hyperacusis may be caused by a vestibular disorder. This type of hyperacusis, called vestibular hyperacusis, is caused by the brain perceiving certain sounds as motion input as well as auditory input.


To this day I still suffer with this... and I've been Seroxat free for over two years!

Fid

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