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Attention Deficit
Hyperactivity Disorder (ADHD) drug products - Medication Guides required to
alert patients to possible cardiovascular and psychiatric risks
Unsafe, Misrepresented Drugs
Purchased Over the Internet: Ambien (zolpidem tartrate), Xanax (alprazolam),
Lexapro (escitalopram oxalate), Ativan (lorazepam)
Attention Deficit Hyperactivity
Disorder (ADHD) drug products - Medication Guides required to alert patients to
possible cardiovascular and psychiatric risks
Source:
FDA notified
healthcare professionals that the manufacturers of all drug products approved
for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)have been
directed to develop Patient Medication Guides to alert patients to possible
cardiovascular risks and risks of adverse psychiatric symptoms associated with
the medicines and to advise them of precautions that can be taken. Patient
Medication Guides are handouts given to patients, families and caregivers each
time a medicine is dispensed. The guides contain FDA-approved patient
information that could help prevent serious adverse events.
An FDA review of reports of serious cardiovascular adverse events in patients
taking usual doses of ADHD products revealed reports of sudden death in patients
with underlying serious heart problems or defects, and reports of stroke and
heart attack in adults with certain risk factors.
FDA recommends that children, adolescents, or adults who are being considered
for treatment with ADHD drug products work with their physician or other health
care professional to develop a treatment plan that includes a careful health
history and evaluation of current status, particularly for cardiovascular and
psychiatric problems (including assessment for a family history of such problems).
Read the complete MedWatch 2007 Safety summary, including links to the draft
version of the Medication Guides and the FDA press statement, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ADHD
FDA informed consumers and healthcare professionals regarding the possible
dangers of buying prescription medications online. Individuals who
ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product
that contained haloperidol, a powerful anti-psychotic drug. Several
consumers experienced difficulty in breathing, muscle spasms and muscle
stiffness after ingesting the suspect product and had to seek emergency medical
treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and
sedation. Taking medication that contains an active ingredient other than what
is prescribed by qualified healthcare professionals is generally unsafe. FDA
urges consumers to review the FDA website for additional information prior to
making purchases of medications over the internet (http://www.fda.gov/buyonline/
).
Read the complete MedWatch 2007 Safety summary, including links to the FDA Press
Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#internet
Source:
The Journal of Clinical Psychiatry 2007; 68: 52-7
A post hoc analysis of an open-label clinical trial
suggests that patients with depression who show
worsening of symptoms when started on fluoxetine may be
less likely to respond to treatment.
The authors note that a proportion of patients do report
a worsening of mood after starting antidepressive
treatment, but that there is little data on whether this
has any prognostic significance.
They therefore used data from a large open-label study
of fluoxetine in outpatients with major depressive
illness to investigate the frequency of worsening during
fluoxetine treatment and its relationship to treatment
outcome. Patients had diagnosed non-psychotic major
depressive episode, and after a run-in week with no
treatment were given fluoxetine 20mg daily for up to
twelve weeks. They were assessed at baseline, then
weekly until week four, and two-weekly until week twelve.
Those not showing adequate response at week ten were
dropped from the trial. A modified intention to treat (at
least one post-baseline visit) analysis was used, and
worsening was defined as at least five point increase in
the modified Hamilton Rating Scale for Depression (mHAM-D)
compared to previous visit and occurring after at least
a week of active treatment. Patients were divided into
two groups on this criterion, as worsened or not
worsened within the first six weeks, and compared for
response, remission, and dropout. Those showing
worsening within the first week were excluded to reduce
the impact of adverse effects.
A total of 839 patients entered the study of whom 830
had at least one post-baseline visit and 694 were
included in the analysis. Of this group, 211 (30.4%)
experienced worsening between weeks two and six. The two
groups were generally similar at baseline, and any
differences disappeared after correction for multiple
testing. At week twelve, significantly fewer patients
showing early worsening were considered to have
responded or be in remission compared to those who did
not (48.3% vs. 69.2%, p=0.0001). The authors conclude
that worsening of depressive symptoms between weeks two
and six after starting fluoxetine treatment were
associated with a poorer outcome. They discuss a number
of potential explanations for this effect, and note that
there are no clear guidelines on how to treat patients
whose symptoms deteriorate on treatment. They note the
inevitable limitations of their study, and suggest that
controlled clinical trials are needed to confirm the
effect and determine whether it applies to other people
with depression and other antidepressive drugs.
Link:
http://www.psychiatrist.com/
(subscription required)
Boletín de Actualización en Neuropsicofarmacología (BAN)