Drug Information Center – Forum
Volume 1, Issue 5
Thursday, November 16, 2000
- Stephanie Bivins
- Jason Bui
- Leslie Castillo
- Jason Chow
- Sylvia Jacob
- Sao Ly
- New drug approvals
- New drug indications
- Market Withdrawals
- Primary literature reviews
- This issue's review article
This information taken from http://www.fda.gov/cder/da/da.htm#latest
- Mitoxantrone hydrochloride
- Approved for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (ie., patients whose neurologic status is significantly abnormal between relapses)
- Manufactured by Immunex Corp
- NDA 21-120
- Indinavir Sulfate (200mg, 400mg)
- In combination with antiretroviral agents is indicated for the treatment of HIV infection
- Manufactured by Merck Research Laboratories
- NDA 020-685/S022
- Fluvastatin Sodium (20mg, 40mg)
- Approved for use as a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerosis vascular disease due to hypercholesterolemia
- Manufactured by Novartis Pharmaceuticals Corporation
- NDA 20-261/S018
- Clarithromycin (250mg, 500mg)
- For the addition of Haemophilus influenzae to the previously approved indication of Community-Aquired Pneumonia for Biaxin Filmtab.
- Manufactured by Abbott Laboratories
- NDA 50-662/S029
- For the treatment of pulmonary tuberculosis in conjunction with at least one other antituberculosis drug to which the isolate is susceptible
- Manufactured by Aventis Pharmaceuticals Inc
- NDA 21-024/SE7-005
- For use as an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above
- Manufactured by Parke Davis Pharmaceutical Research Div Warner Lambert Co
- NDA 20-235/ S11
- The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products. FDA issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenypropanolamine hydrochloride.
Peter Schenk, Christian Madl, et al.
Ann Intern Med November 7, 2000;133:701-706.
The hepatopulmonary syndrome is a combination of liver disease, pulmonary gas exchange abnormalities, and widespread pulmonary vasodilation. This open trial in seven patients with severe hepatopulmonary syndrome examines the effectiveness of intravenous methylene blue, an oxidizing agent which inhibits NO-induced vasodilation.
Methylene blue administration led to an increase in PaO2 in all patients, with a maximum effect after 5 hours. The results of this trial indicate that methylene blue may be a treatment worthy of further study in the treatment of hepatopulmonary syndrome.
Reviewed by Jason Bui
Christopher Alderman, Andrew Gilbert, John Condon
Ann Pharmacother November 2000;34;1243-1248.
This study examines tranquilizer use by Australian Vietnam War veterans. Fifty-one Australian Vietnam War veterans were interviewed in order to gather information on their medical and psychiatric history and their use of alcohol, tobacco, and other substances. Subjects were also assessed using the Hamilton Anxiety Rating Scale (Ham-A) and a tranquilizer dependence rating scale. Most subjects used a tranquilizer for nighttime sedation, and a majority of subjects met the criteria for tranquilizer dependence. The researchers conclude that this is an area where intervention may be needed.
Reviewed by Jason Chow
Frederick G. Hayden, Larisa V. Gubareva, Arnold S. Monto, et al.
New Engl J Med November 2, 2000;343:1282-1289.
This double-blind controlled trial studies inhaled zanamivir in the treatment and prevention of influenza in families. 337 families (1158 participants) were randomized to receive either inhaled zanamivir or placebo after any member of the family developed a flu-like illness. The families who received zanamivir after being in contact with an infected family member were found to be less likely to develop influenza than were those who received the placebo. Therefore, it is concluded that zanamivir is effective in the prevention of influenza.
Reviewed by Sylvia Jacob
Bleeding and Pneumonia In Intensive Care Patients Given Ranitidine and Sucralfate for Prevention of Stress Ulcer: Meta-Analysis of Randomized Controlled Trials
A. Messori, S. Trippoli, M. Vaiani, et al.
Brit Med J November 4, 2000;321:1103-
Using published studies retrieved through Medline and other databases, this meta-analysis evaluates the effectiveness of ranitidine and sucralfate in the prevention of stress ulcers in critically ill patients and assesses whether these treatments affect the risk of nosocomial pneumonia. This study included comparisons of ranitidine vs. placebo, sucralfate vs. placebo, and ranitidine vs. sucralfate from eighteen published studies. In the analysis of ranitidine vs. placebo, ranitidine was found to have the same effectiveness as placebo. In the placebo controlled studies, ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine significantly increased the incidence of nosocomial pneumonia. The authors conclude that ranitidine is ineffective in the prevention of gastrointestinal bleeding in critically ill patients and might increase the risk of pneumonia. However, the sucralfate studies were based on small numbers of patients and firm conclusions cannot be proposed from this study.
Reviewed by Lora Johnson
Jane R. Mort, Rajender R. Aparasu
Archive of Internal Medicine October 9,2000; 160(18): 2825-2831.
In a study of 29,806 elderly patients, potentially inappropriate psychotropic medications were prescribed in 27.2% of visits to physician offices and hospital outpatient departments. Of the visits associated with inappropriate psychotropic medication, 95.34% were associated in causing a high-severity type of adverse effect. Most of these visits involved the prescription of amitriptyline and long-acting benzodiazepines. Further research is needed to help quantify the impact of prescribing inappropriate psychotropic medications to the elderly.
Reviewed by Sao Ly
Donald P. Kolter
Ann Intern Med October 17, 2000;133(8):622-634.
This article reviews the physiologic, metabolic, and behavioral changes of cachexia along with treatments such as appetite stimulants, anticytokine therapies, hypercaloric feeding, and more. Cachexia is the clinical consequence of a chronic, systemic inflammatory response. Cachexia is one of the most distressing symptoms of cancer and some other diseases, robbing people of their energy, sense of well-being, and quality of life, and increasing their dependence on others. The foremost sign of cachexia is weight loss, not only of fatty tissue but also of muscle tissue and even bone. In addition, there is loss of appetite (anotexia), weakness (asthenia), and a drop in hemoglobin (anemia). Appetite stimulants are used to increase caloric intake. Megestrol acetate promotes caloric intake in patients with cancer or HIV infection. Anti-inflammatory agents plus erythropoietin can improve nutritional status, blood counts, and exercise capacity. More widespread application of nutritional therapies will require demonstration of their safety and efficacy.
reviewed by Stephanie Bivins
H. Glenn Anderson, Jr Pharm.D.
Ann L. McIlvain Pharm.D
Texas Tech Drug Information Center