Drug Information Center – Forum
Volume 1, Issue 6
Thursday, December 7, 2000
- Marissa Escobar
- Stanley Phillips
- James McAfee
- Melissa Schreur
- Audra Thomas
- Kris Zepeda
- New drug approvals
- New drug indications
- Drug recall
- Market Withdrawal
- Primary literature reviews
- This issue's review article
This information taken from http://www.fda.gov/cder/da/da.htm#latest
- Iron sucrose injection
- Approved for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy
- Manufactured by Luitpold Pharmaceuticals Inc.
- NDA 21-135
- Abacavir sulfate, lamivudine, and zidovudine tablets
- Approved for the treatment of HIV-1 infection, either alone or in combination with other antiretroviral agents
- Manufactured by Glaxo Wellcome Inc.
- NDA 21-205
- Telmisartan and Hydrochlorothiazide tablets
- Approved for the treatment of hypertension
- Manufactured by Boehringer Ingelheim Pharmaceuticals Inc.
- NDA 20-850
- Oseltamivir phosphate capsules
- Approved for the prophylaxis of influenza virus in adults and adolescents 13 years and older
- Manufactured by Hoffmann La Roche Inc.
- NDA 21-087/SE1-002
- Enoxaparin sodium injection
- Approved for the thromboprophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
- Manufactured by Aventis Pharmaceuticals Inc.
- NDA 20-164
11/13/00 Mumps Skin Test Antigen, lot # U0225AA, exp. 5/01
- Reason: the manufacturer found that the potency of the lot had fallen below the product specification prior to the product's expiration date.
- Manufacturer: Aventis Pasteur
- Source: http://www.pshp.org/RECALL.HTM
- Lotronex (alosetron hydrochloride)
- Glaxo Wellcome, of Research Triangle Park, NC, has informed the FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market on November 27, 2000. Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women. This action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex. The FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation).
Gail A. Greendale; Bradley Wells; Robert Marcus, et. al
Arch Intern Med November 13, 2000;160(20):3065-3071.
This two year randomized, placebo-controlled study examines the effect of postmenopausal hormone replacement therapy on bone mineral density (BMD) loss. 875 postmenopausal women between the ages of 45 and 64 years were randomized to 5 different groups, and given different dosages of estrogen, medroxyprogesterone acetate, and combinations of the two hormones or placebo. The women were measured 2 times at the spine and the hip, at 12 months and 12-36 months. The researchers concluded that bone loss is rare while taking postmenopausal hormones, nor is it guaranteed in women who are untreated.
Reviewed by: Marissa Escobar
Michael B. Kays and Michelle Conklin
Pharmacotherapy November 11, 2000; 20 (11): 1310-1317.
This study suggests that fluoroquinolones have concentration-dependent anti-bacterial activity that can be used in therapy to maximize drug concentrations in accordance to the MIC (minimum inhibitory concentration) for a pathogen. Five fluoroquinolones were compared in relation to their in vitro activity and pharmacodynamics against isolates of Streptococcus pneumoniae. The study looked at 201 Streptococcus pneumoniae isolates to determine the MICs using E tests of the following five fluoroquinolones: ciprofloxacin, levofloxacin, trovafloxacin, gatifloxacin, and clinafloxacin. According to the comparative analysis, the most potent agents against S. pneumoniae are clinafloxacin and trovafloxacin. Ciprofloxacin, levofloxacin, and gatifloxacin had higher MICs and were therefore less potent.
Reviewed by James McAfee
Harold D. Holder, Paul J. Gruenewald, William R. Ponicki, et al.
JAMA November 8, 2000; 284(18): 2341-2347.
This four-year study examined the effects of community-based interventions on alcohol-related injuries in 3 communities. Each community was racially and ethnically diverse with a population of approximately 100,000 each. Types of interventions employed included community mobilization and awareness, increased enforcement of local drinking and driving laws, and the reduction of underage access to alcohol. Random general population surveys, traffic record data, and emergency department surveys were used to determine the effects of the interventions. The data collected indicated a reduction in nighttime auto injury crashes and assault injuries. A reduction in individual alcohol consumption was also seen. The authors concluded that community-based interventions can reduce high-risk alcohol consumption and alcohol-related injuries.
Reviewed by Stan Phillips
Alisha B. Dunn, C. Michael White, Prabashni Reddy, et al.
Ann Pharmcother November 2000; 34: 1233-1237.
Ibutilide has been approved by the FDA for atrial flutter (AFl) and the rapid conversion of atrial fibrillation (AF). A randomized, placebo controlled trail reported that first-line treatment with ibutilide and electrical cardioversion (EC) was less expensive and more effective than first-line treatment with EC alone from the perspective of a third-party payer. These results prompted another study on the safety, cost, and efficacy of ibutilide in a clinical setting. This study was conducted with 60 patients who were given a 1 mg dose of ibutilide (for patients over 60, 0.01 mg/kg) over 10 minutes, followed by a second dose if the arrhythmia persisted. The drug was considered effective if the patient's sinus rhythm was successfully converted within 60 minutes and maintained until patient discharge. Incidences of sustained and nonsustained torsade de pointes were evaluated for safety. Also, the cost of first-line ibutilide and EC was compared to the projected cost of first-line EC for all patients. The researchers concluded that use of ibutilide would not provide savings from a hospital perspective, but would from a payer's perspective.
Reviewed by Audra Thomas
Am J Health-Syst Pharm Nov 15, 2000; 57:2048-2056.
DHEA is used to treat a variety of diseases, although its clinical role remains unclear. Several clinical trials have indicated that DHEA may be helpful in reducing HIV-induced fatigue and depression and in improving bone density in post-menopausal women. DHEA has been shown to increase serum DHEA and DHEAS (sulfate) concentrations, both of which have been reported to be inversely related to incidence of cancer, cardiovascular disease, Alzheimer's disease, immune function, and progression of HIV infection. Recommended daily dose for DHEA for healthy people older than 40 is 20-50mg/day for men and 10-30mg/day for women. However, it is important to note that DHEA supplementation should only be done under medical supervision.
Reviewed by Kris Zepeda.
H. Glenn Anderson, Jr Pharm.D.
Ann L. McIlvain Pharm.D
Texas Tech Drug Information Center