MHRA ignores drug safety for psychiatric patients

MHRA ignores drug safety for psychiatric patients

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 8:57 am #1

MHRA ignores drug safety for psychiatric patients
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:00 am #2


http://www.mhra.gov.uk/home/groups/publ ... 510317.pdf

 

 

Opren = <strong>Benoxaprofen</strong>
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:02 am #3

Opren Drug Withdrawn REUTERS Published: September 8, 1982
Eli Lilly & Company's British subsidiary, Dista Products Ltd., has permanently withdrawn its antiarthritis drug Opren after Government health authorities imposed a 90-day suspension in August, a spokesman said today. He said the group was also withdrawing Opren from markets worldwide

 

http://209.85.229.132/search?q=cache:Yd ... en&ct=clnk
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:06 am #4

MHRA ignores drug safety for psychiatric patients
http://www.mhra.gov.uk/home/groups/publ ... 659787.pdf

 

Vioxx = BENOXAPROFEN
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:11 am #5

MHRA ignores drug safety for psychiatric patients
<table border="0" width="100%"><tr><td valign="top" colspan="2">CLOZAPINE Total number of ADR reports: 11560 Total number of fatal ADR reports: 936March 24 2009 at 10:40 PM</td><td align="right" valign="top">Anonymous </td></tr><tr><td colspan="2">

Response to Download Drug Analysis Prints (DAPs)
</td></tr><tr><td valign="bottom" colspan="3">
</td></tr><tr><td colspan="3">http://www.mhra.gov.uk/home/groups/publ ... 933291.pdf
 
</td></tr></table>
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:12 am #6

<table border="0" width="100%"><tr><td valign="top" colspan="2">withdrawal by manufacturer - before being reintroduced !!March 24 2009 at 11:16 PM</td><td align="right" valign="top">Anonymous </td></tr><tr><td colspan="2">

Response to introduced in Europe in 1971, but was voluntarily withdrawn by the manufacturer in 1975 !
</td></tr><tr><td valign="bottom" colspan="3">
</td></tr><tr><td colspan="3">
The first of the atypical antipsychotics to be developed, it was first introduced in Europe in 1971, but was voluntarily withdrawn by the manufacturer in 1975 after it was shown to cause agranulocytosis that led to death in some patients. In 1989, after studies demonstrated that it was more effective than any other antipsychotic for treating schizophrenia, the U.S. Food and Drug Administration (FDA) approved
</td></tr></table>
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:16 am #7




 

Professor Kent Woods
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:26 am #8

MHRA ignores drug safety for psychiatric patients
<font size="2" face="Arial"></font>
Total number of ADR reports: <font size="2" face="Arial">2366 </font><font size="2" face="Arial">Total number of fatal ADR reports: </font><font size="2" face="Arial">162</font>

<font size="2" face="Arial"></font> 

<font size="2" face="Arial">http://www.mhra.gov.uk/home/groups/publ ... 888788.pdf</font>

<font size="2" face="Arial"></font> 

<font size="2" face="Arial">Olanzapine = Zyprexa</font>
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:29 am #9




smug piece of ****
Quote
Like
Share

Joined: April 1st, 2004, 4:56 pm

March 25th, 2009, 9:56 am #10

MHRA ignores drug safety for psychiatric patients
<strong></strong> <strong><em>Use of antipsychotic drugs was associated with about twice the rate of sudden cardiac death as that in non-users</em></strong><strong></strong> <strong></strong> <strong></strong> <strong></strong> <strong></strong> <strong>NeLM news service</strong><img alt="" src="/images/newsItembar.gif"> <a rel="nofollow"></a>Sudden cardiac death with antipsychotics - risk is similar for typical and atypical drugs
Reference: <strong>N Engl J Med 2009; 360: 225-35, 294-6</strong>

Source: <strong>N Engl J Med</strong>

Date published: <strong>15/01/2009 14:40</strong>
Summaryby: <strong>Jim Glare</strong>
A large epidemiological study indicates that current users of antipsychotic drugs are at increased risk of sudden cardiac death, and that the increased risk is similar for both typical and atypical agents.

 

There is much evidence indicating an association between current use of older ('typical') antipsychotic drugs and an increased risk of sudden cardiac death, and these drugs are known to have adverse effects on cardiac electrophysiology. There is less evidence available on the newer ('atypical') antipsychotics, and this retrospective cohort study was intended to investigate the possibility further.

 

The authors used data from a large US healthcare database (Tennessee Medicaid) to construct a cohort of antipsychotic users who were then compared with non-user controls. Users included any enrolee who had been enrolled for at least two years and at least one day of antipsychotic drug use. They were followed from the first day of use until the end of the study period, death, termination of Medicaid enrolment, or loss of eligibility. Two non-user controls were selected for each user based on age, sex, and first day of follow-up. Residual confounding was assessed by a secondary analysis, in which propensity scoring was used to identify a cohort of non-users with a similar psychiatric illness profile to users, who were also propensity-matched to the user group. Primary outcome was sudden cardiac death in the community.

 

There were 93,300 baseline users in the primary cohort (44,218 typical and 46,089 atypical users respectively), and 186,600 matched non-users. Use covered a total of 1,042,159 person-years of follow-up. There were 1870 sudden cardiac deaths in the cohort, to give a rate of 17.9 per 10,000 person-years. Unadjusted rate increased tenfold according to age at baseline, from 4.7 deaths per 10,000 for age 30 to 34, to 47.6 per 10,000 for age 70 to 74; it was also more than twice as high for men as for women (27.1 vs. 12.9 per 10,000).

 

Use of antipsychotic drugs was associated with about twice the rate of sudden cardiac death as that in non-users, with adjusted incidence-rate ratios for typical and atypical agents of 1.99 (95% CI, 1.68 to 2.34) and 2.26 (95% CI, 1.88 to 2.72), respectively. The difference between the groups was not statistically significant, with an incidence-rate ratio for atypical use to typical use of 1.14 (95% CI, 0.93 to 1.39), and for both groups the increase in risk was dose-related. Risk for former users was not significantly different to that for controls (incidence-rate ratio, 1.13; 95% CI, 0.98 to 1.30).

 

The propensity-matched cohort included 67,824 users of antipsychotic drugs and 116,069 nonusers. In this analysis, the results were similar, with increased risk compared to controls for both drug groups (incidence-rate ratios 1.84; 95% CI, 1.50 to 2.26; and 1.99; 95% CI, 1.61 to 2.46 for typical and atypical respectively).

 

The authors conclude that current users of antipsychotic drugs are at increased risk of sudden cardiac death, with no significant difference between typical and atypical drugs. The increase in risk is dose-related, and disappeared in former users. They suggest that the most plausible mechanism is an increase in risk of serious ventricular arrhythmias, although other mechanisms may be involved. 

 

An accompanying editorial discusses the study and its implications. The authors comment that the study is well-designed and presents a clear case. They discuss whether the results should change practice: they conclude that where these medications have clear evidence of efficacy they should continue to be used, however use should be sharply reduced where the evidence is less clear. They comment that the absolute risk is still fairly low - in this study, it was 2.9 events per 1,000 patient years (or 3.3 in those on higher doses). This is lower than the rate of agranulocytosis associated with clozapine (6.8 per 1,000 users) but higher than the rate of fatal agranulocytosis in clozapine users (0.2 per 1,000). Based on this, they suggest that it would be reasonable to obtain an ECG before and shortly after initiating an antipsychotic drug, to screen for patients with prolonged QT interval.
<strong>About this library entry</strong>   http://www.nelm.nhs.uk/en/NeLM-Area/New ... cal-drugs/
Quote
Like
Share