Drug Information Center – Forum
Volume 1, Issue 4
Thursday, November 2, 2000
- Jack Armstrong
- Luvy Interial-Amaya
- Ben Brister
- Brice Coffman
- Sarah Fiscus
- Wesley Jones
- Jason Shuster
- New drug approvals
- New drug indications
- Drug recalls
- Primary literature reviews
- This issue's review article
This information taken from http://www.fda.gov/cder/da/da.htm#latest
Lescol XLâ 10-6-00
- Fluvastatin sodium extended release tablets
- Approved for the use as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate; to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels
- Manufactured by Novartis Pharmaceuticals Corp
- NDA 21-192
Lunelle Monthly Contraceptive Injectionâ 10-5-00
- Medroxyprogesterone acetate/ethinyl estradiol injection
- Approved for the prevention of pregnancy
- Manufactured by Pharmacia and Upjohn Co
- NDA 20-874
- Sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP tablets
- Approved for cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older
- Manufactured by InKine Pharmaceutical Company, Inc.
- NDA 21-097
Atacand Tabletsâ 9-5-00
- Candesartan cilexetil - hydrochlorothiazide tablets, (16-12.5 and 32-12.5 mg)
- Approved for the treatment of hypertension
- Manufactured by AstraZeneca LP
- NDA 21-093
- Ramipril capsules, (1.25, 2.5, 5, and 10 mg)
- Approved for the reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes
- Manufactured by King Pharmaceuticals Inc
- NDA 19-901/S-028
- Glimepiride tablets, (1 mg, 2 mg, 4 mg)
- Indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone
- Manufactured by Aventis Pharmaceuticals, Inc.
- NDA 20-296/S-005
- Levofloxacin tablets and injection, (250 mg, 500 mg, & 750 mg / IV - 25 mg/mL; 20 & 30 mL (new) vials 5 mg/mL; 50, 100, & 150 mL (new))
- Approved for treatment of complicated skin and skin structure infections.
- Manufactured by R. W. Johnson Pharmaceutical Research Institute
- NDA 20-634/S-013 & 20-635/S-010
10/11 Pulmozyme Inhalation Solution, lot # K9721A, exp. 10-01
- Reason: voluntary recall because an unapproved re-filtration step was utilized to remove metal particulates that had been found in the concentrated bulk drug substance.
- Manufacturer: Genentech Inc.
- for more information: http://www.pshp.org/RECALL.HTM#pulmozyme1000
10/9 Urokinase, all lots
- Reason: The product has not been approved by the FDA, and therefore there is no assurance that the product is safe and effective for its intended use. The drug was also manufactured under conditions which are not in compliance with Current Good Manufacturing Practices which could increase the risk of transmitting infectious agents.
- Manufacturer: Medicine Shoppe of Kingsport, TN
9/20 Tubex Products,
Reason: Volunteer recall because the Tubex may be chipped or cracked in the following products:
- Digoxin Injection USP 0.25 mg per ml, 1 ml Tubex cartridge, Lot No. 4990194 Exp. 5/01
- Dimenhydrinate Injection USP 50 mg per ml, 1 ml Tubex cartridge, Lot No. 49990197 exp. 10/01
- Diphenhydramine HCl Injection USP 50 mg per ml, 1 ml Tubex cartridge, Lot No. 49990052 exp. 2/02
- Manufacturer: Wyeth-Ayerst Pharmaceutical
- Kefurox® (cefuroxime) injection USP, 1.5 g; and Mandol® (cefamandole nafate) injection USP, 1 g
- Reason: Volunteer Class II recall because of a lack of assurance of sterility
- Manufacturer: Eli Lilly
Vanceril®, 84 mcg beclomethasome dipropionate, double-strength inhalation aerosol, lot Nos. 9-DMT-157, 9-DMT-158, 9-DMT-160, 9-DMT-161, and 9-DMT-163 (distributed in Nov. 1999 and expire July 2000)
- Reason: A number of canisters in the lots may not contain the active drug
- Manufacturer: Schering/Key Pharmaceuticals
- Source: http://www.pshp.org/RECALL.HTM
- Reason: Volunteer recall because the Tubex may be chipped or cracked in the following products:
Amnon Sonnenberg, Fabiola Delco, and John M. Inadomi, et al.
Ann Intern Med October 17, 2000;133(8):573-584.
Using computer models, this study compared the cost-effectiveness of annual fecal occult blood testing, flexible sigmoidoscopy every 5 years, or colonoscopy every 10 years in a hypothetical population of 100,000 people over 50 years old. Effectiveness of screening was measured it terms of life-years saved through prevention. Without screening, 40% of colorectal cancers result in death within 5 years. Early detection of colorectal cancer at earlier stages improves the overall 5-year survival rate. The authors concluded that colonoscopy every 10 years is the most cost-effective alternative because enough additional life-years are saved to justify additional costs.
Reviewed by Luvy Interial-Amaya
Oded Langer, Deborah L. Conway, Michael D. Berkus, et al.
N Engl J Med October 19, 2000;343(16):1134-1138.
Sulfonylurea drugs have traditionally not been used to treat women with diabetes during pregnancy, due to concern about teratogenicity and neonatal hypoglycemia. This study compares Glyburide® with insulin in the treatment of 404 women with gestational diabetes. The mean blood glucose concentrations in the Glyburide® group were 105 +/- 16mg/dL, and in the insulin group ranged from 105 +/- 18mg/dL. There were no significant differences between in the neonatal outcomes of the two groups. There was no Glyburide® detected in cord serum of any of the infants, and the rate of infants who were large of gestational age for Glyburide® and insulin were 12% and 13% respectively. The authors conclude that Glyburide® is a safe and effective alternative to insulin in the treatment of gestational diabetes.
Reviewed by Jack Armstrong
Carolyn Buxton Bridges, William W. Thompson, Martin I. Meltzer, Gordon R. Reeve, et al.
JAMA October 4, 2000; 284(13): 1655-1663.
This double-blind, randomized, placebo-controlled trial examined whether the administration of influenza vaccines to adults between the ages of 18 and 64 reduces societal costs. The study was conducted over two influenza seasons using participants who all worked for the same manufacturing firm. Reduction in symptoms, physician visits and lost workdays were tabulated. The researchers concluded that there is a net cost to society when influenza vaccine is given to people in this age group. This cost was less during the season when the vaccine was similar to the circulating virus than it was when the vaccine differed from virus.
Reviewed by Brice R. Coffman
Robert Holloway, Ira Shoulson, Karl Kieburtz, Michael McDermott, Pierre Tariot, et al.
JAMA October 18, 2000; 284(15):1931-38.
The treatment of early Parkinson disease with pramipexole vs. levopoda was evaluated in this randomized, double-blind controlled trial. The 300 subjects involved in the study were 30 years of age or older and had had Parkinson disease for 7 years or less. The study lasted for 23.5 months at selected clinics in the U.S. and Canada. All of the subjects involved required dopaminergic antiparkinsonian therapy prior to enrolling. The study found that dopaminergic motor complications were reduced more significantly with pramipexole than with levodopa. A greater prevalence of somnolence is observed with pramipexole. Levodopa, on the other hand, seemed to wear off more quickly and result in impairment of movement and motor fluctuations. The authors concluded that levodopa improved the adverse parkinsonian features measured by the Unified Parkinson's Disease Rating Scale (UPDRS) more effectively than the pramipexole.
Reviewed by Wesley Jones
Lone Agertoft, Soren Pedersen
N Engl J Med Oct. 12, 2000; 343:1064-1069.
Short-term studies have shown that inhaled corticosteroids can reduce the growth of children with asthma. However, effects of long-term treatment on adult height is uncertain. This study of 211 children examined the long-term effects of inhaled budesonide treatment on adult height. The treatment group consisted of 142 budesonide-treated children with asthma, while the control group consisted of 18 patients with asthma, and 51 non-asthmatic siblings of patients in the budesonide group. All of the children reached full expected adult height. No evidence of a dose-response relation between the mean daily dose of budesonide, the cumulative dose of budesonide, or the duration of budesonide treatment and the difference between the measured and target adult heights was found.
Reviewed by Jason Shuster
Peter Blower, Celeste Lindley
Am J Health-Syst Pharm September 15, 2000;57(18):1685-1694.
This article explores the pharmacology, pharmacokinetics, clinical efficacy, and therapeutic role of oral serotonin type 3-receptor antagonists used to prevent chemotherapy-induced emesis. Antineoplastic drugs promote the release of serotonin from enterochromaffin cells in the gut mucosa. Serotonin stimulates the peripheral vagal afferent nerves thereby causing emesis. Clinical trials of the serotonin antagonists granisetron, ondansetron, and dolasetron are reviewed. In a study of oral granisetron, over 4,500 patients receiving highly or moderately emetogenic chemotherapy were included. Approximately half of the patients were able to totally control emesis; complete response rates ranged from 70-94%. Oral ondansetron was also proven effective in controlling emesis. One study showed that oral ondansetron given thirty minutes prior to cisplatin-based chemotherapy was more efficient at controlling emesis than I.V. injected granisetron or ondansetron. Oral dolasetron was also shown to be useful for controlling emesis.
Reviewed by Ben Brister
H. Glenn Anderson, Jr Pharm.D.
Ann L. McIlvain Pharm.D
Texas Tech Drug Information Center