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Context: Adverse drug reactions (ADR) due to antipsychotic therapy have significant impact on a psychiatric patient's quality of life. Few studies have been conducted in India to monitor adverse drug reactions due to antispsychotics and none has been done to determine their impact on quality of life. Aims: The present study was conducted to monitor ADRs due to antipsychotics and ascertain the impact of ADRs on quality of life. Settings and Design: This prospective observational study was conducted in the psychiatry outpatients department in New Delhi for 1 year. Patients and Methods: A total of 224 patients enrolled were followed up for a period of 3 months. ADRs were monitored using the standard form of the Central Drugs Standard Control Organization and causality was determined using the Naranjo algorithm. The WHO Quality of Life BREF (WHOQOL-BREF) scale was used to study the effect of ADR on the quality of life. Statistical Analysis Used: The data were entered and analyzed using the statistical software SPSS 17.0. Unpaired t-test was used to compare the quality of life of patients who encountered ADRs and those who did not. P < 0.05 was considered statistically significant. Results: Of the total 224 patients, 38 adverse drug events occurred. Adverse drug events were mostly with risperidone (10), followed by olanzapine (8) owing to high usage. Majority of the events were classified as probable (34). The occurrence of adverse drug events decreased the scores on physical and psychological domain scores of WHO-QOL BREF at 3 months compared to baseline. Conclusions: The study provides information on the existing incidence of ADRs in the setup with an established pharmacovigilance center. The nature of ADRs correlates with the prevalence pattern of usage of atypical antipsychotics. Clinicians need to weigh benefit versus the impact on quality of life while prescribing antipsychotics.

Herbal supplements are classified as foods rather than drugs and are not required to undergo premarketing review by the Food and Drug Administration. Yohimbine is an alpha(2)-antagonist available in both prescription and herbal supplement products.To determine the prevalence and severity of yohimbine-related adverse drug events (ADEs) reported to the California Poison Control System (CPCS).A retrospective review of the CPCS electronic database of cases within a 7-year period (2000-2006) was conducted. Cases involving adults aged 18 and older who were symptomatic following exposure to a yohimbine-containing product, with a causality rating of possible or better on the Naranjo scale, were included.A total of 238 cases were identified. There was a substantial increase in the annual prevalence of yohimbine-associated ADEs reported to the CPCS between 2000 and 2006; specifically, the prevalence (per 10,000 total adult exposures) increased from 1.8 cases in 2000 to 8.0 cases in 2006). The majority (98.7%) of cases involved herbal (vs prescription) yohimbine products. Common reasons for use included sexual enhancement (27.7%), weight loss (9.2%), and stimulant effects (7.6%). Common ADEs reported included: gastrointestinal distress (46%), tachycardia (43%), anxiety/agitation (33%), and hypertension (25%). Yohimbine exposures were associated with a significantly greater proportion of severe outcomes and were more likely to require management at a health-care facility than the average substance exposure reported to the CPCS (odds ratios [95% CIs] were 5.81 [4.43 to 7.64] and 2.35 [1.82 to 3.04], respectively).A substantial increase in the prevalence of ADEs associated with yohimbine herbal products was seen between 2000 and 2006. These ADEs were associated with significantly more serious outcomes than the average exposures reported to the CPCS. A reexamination of whether yohimbine should be considered a "safe" dietary supplement under the Dietary Supplement Health and Education Act is warranted.

OBJECTIVE: To report a case of rhabdomyolysis resulting from concurrent use of cerivastatin and gemfibrozil. CASE SUMMARY: An 82-year-old white man presented to the emergency department with severe muscle weakness and inability to walk approximately one month after starting cerivastatin. He had been taking gemfibrozil for several years without any known adverse effects. Both medications were discontinued and the patient recovered. He was discharged with a diagnosis of rhabdomyolysis secondary to his medications. DISCUSSION: Four previous reports describing rhabdomyolysis in patients on concomitant cerivastatin and gemfibrozil have been cited. Although monotherapy with cerivastatin is well tolerated and has a low frequency of adverse events, the combination with nicotinic acid (i.e., niacin) or a fibric-acid derivative (i.e., gemfibrozil, fenofibrate) may result in severe skeletal muscle toxicity and rhabdomyolysis. CONCLUSIONS: According to the Naranjo scale, a probable relationship exists between the concomitant use of gemfibrozil and cerivastatin with the resulting development of rhabdomyolysis. Concurrent use of gemfibrozil and cerivastatin is therefore contraindicated.

Objective: To document the frequency of abacavir hypersensitivity reactions in HIV-positive patients followed in a Veterans Affairs outpatient clinic. Methods: Abacavir's manufacturer lists the incidence of hypersensitivity as 5%. We conducted a retrospective review of all patients in our clinic who received abacavir from January 1999 to December 1999 to document the rate of discontinuation of the drug due to possible hypersensitivity reactions. The duration of abacavir therapy, concomitant antiretrovirals, most recent CD4+ count, most recent viral load, number of antiretroviral regimens previously tried, and the number and types of new antiretrovirals started concomitant with abacavir were collected. Results: Of 24 patients analyzed, nine (38%) discontinued abacavir, with six (25%) having a potential hypersensitivity reaction. Four reactions were classified as probable and two as possible according to the Naranjo scale. Only one patient was hospitalized for the reaction. Patients who discontinued abacavir due to a hypersensitivity reaction had similar CD4+ counts, viral loads, and had received a similar number of antiretroviral regimens compared with patients who continued the drug. However, 67% of patients who discontinued abacavir due to a hypersensitivity reaction had at least one previously documented adverse event that led to the discontinuation of another antiretroviral, compared with 7% of the patients who continued the drug (p = 0.02). Conclusions: The frequency of possible hypersensitivity reactions to abacavir in patients seen in our HIV clinic is higher than the manufacturer's reported rate of 5%. These patients may be more prone to adverse reactions based on previous medication history and adverse events.