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Sedative-hypnotic drug products: labeling strengthened to include
warnings about risk of severe allergic reactions and sleep-driving
Antipsychotics
and sedatives may hasten deterioration in Alzheimer's disease
FDA notified
healthcare professionals and consumers of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or
maintain sleep, strengthen their product labeling to include stronger language
concerning potential risks. These risks include severe allergic
reactions and complex sleep-related behaviors, which may include sleep-driving.
Sleep driving is defined as driving while not fully awake after ingestion of a
sedative-hypnotic product, with no memory of the event. FDA also requested that
each product manufacturer send letters to health care providers to notify them
about the new warnings, and that manufacturers develop patient Medication Guides
for the products to inform consumers about risks and advise them of potential
precautions that can be taken.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA
press release, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative
Results of a study suggests that there is considerable
variation in the rate of decline associated with various drugs prescribed for
patients with Alzheimer's disease (AD).
The authors sought to examine the effects of drugs on the progression of disease
in a representative group of patients with AD. They recruited 224 patients with
the diagnosis of probable Alzheimer's disease from the community and recorded
the drugs prescribed at initial assessment; this information was then correlated
with disease progression, defined as an increase of at least one point in the
Global Deterioration Scale over the following 12 months. The main findings were
as follows:
• Patients who were taking antipsychotic drugs and sedatives had a significantly
higher risk of deterioration than those who were taking none (odds ratios (ORs)
2.74 (95% CI 1.17 to 6.41) and 2.77 (1.14 to 6.73), respectively)
• A higher risk of deterioration was observed in those who were taking
antipsychotics and sedatives together (OR 3.86; 1.28 to 11.7)
• Patients taking drugs licensed for dementia, drugs affecting the renin-angiotensin
system and statins had a significantly lower risk of deterioration than those
who were not taking any of these drugs (ORs 0.49 (0.25 to 0.97), 0.31 (0.11 to
0.85) and 0.12 (0.03 to 0.52), respectively)
The authors recommend that ‘clinicians should carefully weigh any potential
benefits of antipsychotics and benzodiazepines, especially in combination,
against the risk of increased decline’.
Source:
Ann Gen Psych 2007;6:7
According to the results of a case control study
published in the Annals of General Psychiatry, the use
of a selective serotonin reuptake inhibitor (SSRI) may
lead to apathy in depressed elderly patients.
Researchers used a database to identify 384 elderly
depressed patients treated in a day hospital in Canada
between 1986-2005, of which 160 were treated with an
SSRI and 224 with a non-SSRI antidepressant. The
patients were divided into groups according to
antidepressant use at discharge (SSRI vs. non-SSRI) and
the presence of apathy (apathetic vs. non-apathetic). As
scales for directly assessing apathy were not included
in the database, data were extracted from associated
items from the Geriatric Depression Scale (GDS) and the
21-item Hamilton Rating Scale for Depression (HAMD-21).
The main findings
were as follows:
• Among 384 patients (160 SSRI and 224 non-SSRI), mean
GDS and HAM-D at discharge were 12.46 and 10.61 in SSRI
users, and were 11.37 and 9.30 in non-SSRI users,
respectively.
• Using the GDS subscale for apathy assessment, 83.7% of
patients in the SSRI group and 73.4% in the non-SSRI
group remained apathetic at discharge.
• As evaluated by the HAMD-21 subscale, 44.2% of
patients in the SSRI group and 36.5% in the non-SSRI
group remained apathetic.
• SSRI use was not found to be a predictor of apathy at
admission, while it was at discharge (p = 0.029).
• The SSRI user group showed more patients with apathy
than the non-SSRI user group, with an adjusted odds
ratio of 1.90 (1.14–3.17).
• Using the HAMD-21 subscale, age 70–75 years and living
situation were associated with apathy at discharge (p =
0.032 and 0.038 respectively).
The authors note that among both SSRI users and non-SSRI
users, all apathy scores were lower at discharge than at
admission to the day hospital. Therefore, both SSRIs and
non-SSRIs appeared to be somewhat effective in treating
the apathy of depression. They conclude that "patients
and caregivers should be informed to be more aware of
this potential adverse effect when using SSRIs. Careful
monitoring for apathy, and consideration of switching
antidepressant class in patients presenting with apathy,
should be undertaken in all patients receiving an SSRI."
Link to Abstract:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1820592&rendertype=abstractBoletín de Actualización en Neuropsicofarmacología (BAN)