Drug utilization, safety and clinical use of Actos and Avandia.

BACKGROUND AND OBJECTIVE: The impetus for this review was recent increased warnings of cardiovascular toxicity, fractures and bladder cancer associated with glitazone use. METHODS: A drug utilization review was performed regarding the use of Actos (pioglitazone) and Avandia (rosiglitazone) at Cooper Green Mercy Hospital (CGMH), an inner city safety net hospital in Birmingham, Alabama. Pharmacy records were reviewed hospital-wide to determine usage patterns of all anti-diabetic medications. Medline and the FDA websites were searched for articles on safety and efficacy of pioglitazone and rosiglitazone. Considerations were relative utilization profile, comparative efficacy, indications, relative cost, and safety profile of the two available medications in this drug class. RESULTS: On the basis of all of these factors, a hospital-wide switch of all rosiglitazone prescriptions to all pioglitazone was implemented, which was estimated to result in savings of $83,000 for the first year. No episodes of worsening of control of diabetes were anticipated, nor were episodes of decreased efficacy or adverse effects as a result of automatically switching patients from rosiglitazone to pioglitazone at the time of prescription filling. CONCLUSIONS: The conclusions can be summarized in a number of key points. • Clinicians should follow the American Diabetes Association guidelines [1] for treatment. • The basis for diabetic control is weight loss, diet and exercise. • Initial medication management for type II Diabetes Mellitus includes metformin and insulin. • There are no circumstances in which use of glitazone medications is preferable to other medication groups, and there are no clinical circumstances in which use of glitazone medications is absolutely necessary, as opposed to other classes of diabetic medication. • There are significant contraindications, warnings and precautions to use of glitazones, which must be taken into consideration before use in every individual patient. • Glitazones in particular should not be used in the following circumstances: congestive heart failure (CHF), concurrent bladder cancer or severe osteoporosis.

Neurological complications of vaccination with outer surface protein A (OspA).

A wide range of neurological complications have been reported via the medical literature and the VAERS system after vaccination with recombinant outer surface protein A (OspA) of Borrelia. To explore this issue, 24 patients reporting neurological adverse events (AE) after vaccination with Lymerix, out of a group of 94 patients reporting adverse events after Lymerix vaccination, were examined for causation. Five reports of cerebral ischemia, two transient Ischemic attacks, five demyelinating events, two optic neuritis, two reports of transverse myelitis, and one non-specific demyelinating condition are evaluated in this paper. Caution is raised on not actively looking for neurologic AE, and for not considering causation when the incidence rate is too low to raise a calculable difference to natural occurence.

Cardiomyopathy due to ingestion of Adderall.

A patient is described who developed cardiomyopathy after receiving a therapeutic course of dextroamphetamine/amphetamine. The patient's cardiac function deteriorated to the point of heart failure, necessitating a heart transplantation. Cardiomyopathy associated with amphetamine use is a serious and potentially lethal condition. With early diagnosis, identification of the cause, and treatment, cardiomyopathy may be reversible. The dangers of therapeutic use of amphetamines are discussed, as well as problems and assumptions associated with U.S. Food and Drug Administration monitoring and removal from the market of harmful substances.

Use of fMRI to predict psychiatric adverse effects of interferon treatment for Hepatitis C - preliminary report.

Interferon alfa2 (IFN-alpha2) is a parenterally administered cytokine used to treat patients with Hepatitis C and B, and malignancy. Interferon (INF) has a relatively high rate of central nervous system (CNS) adverse effects, including agitation, depression, fatigue, cognitive dysfunction, suicidal thought and drug craving. Using functional magnetic resonance imaging (fMRI) we studied patients with Hepatitis C virus (HCV) infection who were not more than mildly clinically depressed at baseline for their CNS reaction to IFN-alpha2. During fMRI, patients underwent visual stimulation with pictures designed to induce feelings of depression. In the two patients who became clinically depressed or markedly anxious while on treatment with interferon, but not in patients who did not experience these effects, there was a significant activation in specific areas of the brain known to be involved with depression, along with an increase above baseline in the Beck Depression Scale for the patient who developed INF-induced depression. The activation pattern differed from that previously observed for endogenous depression, indicating that INF-induced depression may differ in its underlying neuropathology. Functional magnetic resonance imaging can be an important tool in understanding and monitoring for (INF and other) medication-induced CNS effects, and response to treatment.