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Biomedical subjects

Nick C Patel

Publications and source records attributed to Nick C Patel.

6 recordsLinked to original sources

Adverse event reporting with selective serotonin-reuptake inhibitors.

OBJECTIVE: The Weber effect is a phenomenon which states that the number of reported adverse reactions for a drug increases until the middle to end of the second year of marketing. The purpose of this study was to examine the number of adverse event reports associated with specific selective serotonin-reuptake inhibitor (SSRI) use. METHODS: Data used in this study included voluntary adverse event reports submitted to the US federal government through the Spontaneous Reporting System and Adverse Event Reporting System. Adverse event reports were analyzed for the following SSRIs: citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline. RESULTS: Adverse event reporting associated with fluvoxamine demonstrates the Weber effect. Adverse events related to fluoxetine, paroxetine, and sertraline do not exhibit the Weber effect. Fluoxetine-related adverse events peaked at year 3, with peaks also occurring during the 10th and 12th years after market entry. Adverse event reports associated with paroxetine and sertraline use increased 5-8 years after market entry. CONCLUSIONS: Within 1 class of medications, it is possible for a few agents to exhibit the Weber effect, while there is no definite pattern with others. A new observation in adverse event reporting is introduced and suggests that a peak in adverse event reporting occurs 1-2 years after a medication receives approval for a new indication. Future research is necessary to validate this effect and examine the generalizability to other medications.

Adverse Drug Reaction Reporting Systems↗

Trends in antipsychotic use in a Texas medicaid population of children and adolescents: 1996 to 2000.

The purpose of this study was to examine the current trends in prescribing antipsychotics to children and adolescents within the Texas Medicaid Program. Total enrollments of children and adolescents, ranging from infants to 19-year-olds, in the Texas Medicaid Program were determined for each calendar year from 1996 to 2000. Prevalence was defined as the number of children and/or adolescents with at least one Medicaid prescription claim for an antipsychotic per 1,000 enrollees. Trends in prevalence were assessed over a 5-year period using annual descriptive analyses. In addition, total expenditures for antipsychotics were evaluated within this population. Over the 5-year period, an additional 12.25 children and adolescents per 1,000 enrollees (+160%) were prescribed antipsychotics. The prevalence of atypical antipsychotics increased by 13.29 per 1,000 enrollees (+494%) over the same period. In children and adolescents above 2 years of age, the prevalence of antipsychotic use increased in all groups. Antipsychotic usage was more common in children and adolescents between the ages of 10 and 14 years compared to other age groups. Male and female antipsychotic prevalence rates increased during the 5-year period. The increase in total expenditures was related to the increased utilization of atypical antipsychotics.

Adolescent↗

One-year rehospitalization rates of patients discharged on atypical versus conventional antipsychotics.

This study examined one-year rehospitalization rates for patients who were discharged from Austin State Hospital between August 1, 1997, and July 31, 1998, while taking olanzapine, risperidone, or a conventional antipsychotic. Time to readmission was measured by the product-limit formula. Although conventional antipsychotics were associated with a lower rehospitalization rate, no significant difference in the one-year rehospitalization rate was observed between the groups. At 180 days after initial discharge, the patients who received olanzapine had a higher rate of rehospitalization than patients who were taking conventional antipsychotics. Conventional antipsychotics were associated with a lower one-year rehospitalization rate than risperidone or olanzapine.

Adolescent↗

Sudden late onset of clozapine-induced agranulocytosis.

OBJECTIVE: To report a patient who suddenly developed agranulocytosis after long-term clozapine therapy. CASE SUMMARY: A 41-year-old white man suddenly developed agranulocytosis after 89 months of nearly continuous clozapine therapy. During this time, which included the addition of risperidone to the treatment regimen, his white blood cell (WBC) and granulocyte counts remained stable. One week after having stable hematologic counts, the patient suddenly developed agranulocytosis. WBC and granulocyte counts returned to baseline shortly after discontinuation of all medications and administration of sargramostim. DISCUSSION: The main factor limiting the use of clozapine as a first-line agent in mentally ill patients is the risk of agranulocytosis. Although the greatest risk of developing this adverse reaction is during the initial 6-month exposure, clozapine-induced agranulocytosis continues to pose a risk after years of exposure. Current product labeling requires weekly WBC and granulocyte monitoring for the first 6 months of treatment with clozapine, which may be decreased to biweekly monitoring after 6 months. Based on the sudden and late onset of agranulocytosis in our patient, clinicians may consider opting for weekly monitoring of hematologic function for patients on long-term clozapine therapy. The likelihood that clozapine was the cause of the agranulocytosis was rated possible according to the Naranjo probability scale. CONCLUSIONS: Clinicians must remain vigilant to trends in WBC and granulocyte counts and may wish to consider weekly hematologic monitoring regardless of duration of clozapine therapy. Patient and treatment system compliance with the registries' protocol regarding WBC monitoring is instrumental in reducing morbidity and mortality rates associated with clozapine use.

Adult↗

Secretin treatment for autistic disorder: a critical analysis.

We assessed evidence of the effects of secretin on behavior in individuals with autistic disorder. Articles were obtained through a MEDLINE search of the English-language literature from January 1966-November 2001; all investigations and case reports on the topic were included. Press releases obtained from the World Wide Web also were included. Secretin, a gastrointestinal hormone, is suggested to improve autistic symptoms, particularly social function and communication. Two formulations, porcine and synthetic human secretin, were evaluated in humans. A small body of literature and popular belief in autistic disorder communities supported the agent's efficacy. A number of controlled clinical trials did not show improvement in autistic symptoms with secretin compared with placebo, possibly indicating no role for the drug in autistic disorder.

Amino Acid Sequence↗