World of Drugs

World of Drugs - Volume 7, Issue 1 - March 1996


In This Issue ...
 Search Tip 
 Staff Profile 
 Search Strategies -- Current Clinical Issues 
 The IDIS Thesaurus 
 1995 FDA Drug Approvals 
 1996 FDA Drug Approvals 
 Exhibit Schedule 
SEARCH TIP: Searching for drug induced side effect using the IDIS System CD-ROM

It is beneficial to perform a title and abstract search when looking for very specific side effects. Important, noteworthy side effects often appear in article titles and abstracts in the medical literature. Otherwise, eighteen different side effect descriptors identifying drug induced side effects reported in the medical literature are available for searching. These descriptors represent drug induced side effects by organ system, but also include descriptors 49 SIDE EF DEPEND REBOUND, 48 SIDE EF FETAL EFFECT and the general side effect descriptor term 46 SIDE EF ADVERSE REACTION. Specific drug induced side effects noted in the literature are cross referenced to one of these eighteen valid side effect descriptors. Cross references for a specific side effect are found in the Thesaurus which is accessed by selecting F3 and then Thesaurus. The Thesaurus is a combination of the Drug, Disease and Descriptor cross references and valid terms. Descriptor cross references are prefaced with (DE).

When using the Descriptor field of the Field Search template, a valid side effect descriptor term must be used. It is permissible however, to use only part of the complete valid term. For example, descriptor 82 SIDE EF CARDIOVASCULAR may be entered in the Descriptor field using only the code number, 82, or CARDIOVASCULAR.

When using the Global Search template, the descriptor code number searching is not recommended because searching is not limited to the descriptor field. A descriptor code number is likely to match journal volume, page, and issue numbers. In this case, it is best to use either the complete term, 82 SIDE EF CARDIOVASCULAR, or, at least, SIDE EF CARDIOVASCULAR.

The valid terms for all eighteen side effect descriptors begin with SIDE EF. To find all side effects reported for a specific drug, search using only SIDE EF. Searching with only descriptor 46 SIDE EF ADVERSE REACTION would not be the appropriate way to find all side effects for a drug. This side effect descriptor is currently used only when "side effects" (or absence of) are mentioned without further clarification.

Brad Gilchrist, R.Ph.

IDIS STAFF PROFILE

Helen Scott

Helen Scott

Helen rejoined the IDIS team in January 1995. Since graduation with a Bachelor of Pharmacy degree from the South Australian Institute of Technology (now the University of South Australia) Helen has gained extensive experience in clinical hospital pharmacy practice, and provision of drug information services in Australia, the U.K. and the U.S.A. Before rejoining IDIS, Helen was most recently employed as a clinical pharmacist by The Drug and Therapeutics Information Service (DATIS), an educational outreach and academic detailing service based at the Repatriation General Hospital in Adelaide, South Australia, Australia.

Helen's responsibilities at IDIS include indexing articles added to the database each month, providing information and assistance to current and prospective subscribers, planning quality improvement/quality assurance activities, and communicating with IDIS's on-line and CD-ROM vendors; KnightRidder Information, Ovid Technologies and SilverPlatter.

Helen enjoys reading, teaching Sunday school and walking with her husband in the picturesque state parks surrounding Iowa City. They are both looking forward to the birth of their first child in June.


CURRENT CLINICAL ISSUES -- SEARCH STRATEGIES
Interferon for the Treatment of Multiple Sclerosis

The IDIS SYSTEM/CD-ROM database can be used to effectively retrieve valuable information covering a multitude of current issues in clinical practice. In the following examples, the topic of interferon treatment in multiple sclerosis is used to illustrate some of the search strategies formulated to retrieve current clinical information.

1. TOPIC OVERVIEW

A. Search strategy: Identifying drug and disease terms - Searching for review articles

Several options are available in performing a broad search of the database. Press the F3 function key (Select Search) and select the Thesaurus from the pull-down menu, to identify correct terms for drug and disease in the IDIS database.

Type, interferon, or truncate the term using the asterisk. There are a large number of entries (over 50) for this drug term, including interferon alfa, interferon beta, interferon gamma, interferons, interferon beta-1b. Press the Escape key twice to return to the Thesaurus and type, multiple sclerosis. There is only one disease term listed SCLEROSIS, MULTIPLE 340. Select F3 again and choose the field search template. Enter interferon ( or interfer*) in the drug field and multiple sclerosis ( or the disease number 340.) in the disease field. Over 70 citations will be retrieved. Alternately, a global search can be conducted, using the same two terms. After browsing the titles, index records and abstracts of the citations retrieved, it is possible to identify the specific drug, interferon beta-1b, which has recently shown promising results in the treatment of multiple sclerosis.

Conduct the previous field searches again, this time using the specific drug term interferon beta-1b, to narrow the results. This search will retrieve between 40 and 50 citations. To obtain an overview of the topic, restrict the citations to review articles only by returning to the field search template and adding the term review to the descriptor field, or returning to the global search template and adding review. The citations retrieved (between 10-20) provide a good summary of the current published information.

B. Overview of information retrieved by the search

Interferon beta-1b was given FDA approved-labeling for use in relapsing-remitting multiple sclerosis in 1993, based on results of a landmark trial conducted in patients from the USA and Canada by the IFNB Multiple Sclerosis Study Group. This is the first controlled clinical trial where a treatment has been shown to favorably alter the natural course of multiple sclerosis. The trial produced evidence that interferon beta-1b effectively reduces relapse rates and disease burden as measured by magnetic resonance imaging in relapsing-remitting multiple sclerosis. Unfortunately, the trial was of relatively short duration, with only a three year follow-up. The vital question of whether treatment with interferon beta -1b will reduce long-term disability still remains unanswered, and is the subject of further investigation.

2. IDENTIFYING CLINICAL STUDIES

A. Search strategy: Retrieving clinical studies

After perusing the reviews, we see there is one major study on which the FDA drug approval was based. This study can be retrieved by searching the author field, title field or the journal field in the field search template, or a more general search for all clinical studies can be conducted. To perform a search for all clinical studies type in the same drug and disease terms, with the addition of the term study in the descriptor field. The study cited by the FDA is retrieved in this search.

B. Clinical Information: Study details

A randomized, double-blind study, enrolled 372 ambulatory patients with clinically or laboratory confirmed relapsing-remitting multiple sclerosis of more than one years' duration, and assigned patients to receive interferon beta-1b (1.6 or 8 million international units) or placebo subcutaneously on alternate days. All patients had comparable baseline characteristics prior to trial entry including gender, age, disease duration, disability, and previous number of exacerbations. To meet trial inclusion criteria, the patients were ambulatory, had experienced at least two exacerbations of disease in the last two years, were clinically stable, were 18-50 years of age, and had relapsing-remitting disease.

In this study, patients receiving 8 million international units (MIU) of interferon beta-1b experienced reduced exacerbation frequency and a greater proportion were exacerbation free than either the 1.6 MIU, or the placebo group. After two years both interferon treatment groups had lower exacerbation rates than the placebo group. The proportion of exacerbation free patients was lower in the 8 MIU group than the placebo group, but not in the 1.6 MIU group.

As with all new therapies, the relative costs and benefits of treatment require assessment, along with identification of patients likely to gain the most benefit from treatment. Interferon beta-1b therapy is relatively expensive, and not without adverse effects. Mental disorders with serious consequences were a disturbing finding in this study, and require further investigation. Assessment of the effects of interferon beta-1b treatment on patient quality of life has yet to be studied.

3. IDENTIFYING PATIENTS LIKELY TO GAIN MOST BENEFIT FROM THERAPY

A. Search strategy: Patient selection criteria

Most of the information regarding patient selection criteria is contained in the published clinical study data and these citations have already been retrieved. An additional title search for patient selection could be performed, using patie* select* in the title field of the field search template, with multiple sclerosis and interferon beta-1b in the disease and drug fields. One citation specifically addressing this issue was retrieved.

B. Clinical information: Patient selection criteria

As strict patient selection criteria were used in this study, the results can only be directly applied to that specific patient population: ambulatory patients with relapsing remitting multiple sclerosis. However, patients with other types of multiple sclerosis, ( progressive disease for example) other age groups, (age greater than 50 years) or patients who are not ambulatory or who have not experienced at least two exacerbations of disease in the last 12 months, may still find interferon beta-1b treatment helpful. For a more detailed discussion of patient selection criteria see the selected bibliography.

4. IDENTIFYING ADVERSE EFFECTS

A. Search strategy: All adverse effects

To search for all adverse effects of any drug, use the term side ef in the descriptor field, or in the global search template. To retrieve citations concerning specific adverse effects, use the Thesaurus to identify the specific descriptor terms.

B. Clinical information: Summary of some important adverse effects

Adverse effects of interferon beta-1b may vary with dose, route and regimen. For subcutaneous administration, interferon beta-1b is generally well tolerated. The most common adverse effects experienced during the IFNB Multiple Sclerosis Study Group trial include flu-like symptoms, fever, chills, myalgias, sweating, nausea, anorexia, fatigue, malaise and headache.

Other adverse effects reported with less frequency are mental disorders including depression, anxiety, emotional lability, depersonalization, confusion, and suicide attempts. One suicide and 4 attempts were reported among the 372 trial patients during the three year study period, all in patients assigned to interferon therapy. No suicide attempts were reported in the patients assigned to the placebo group. It is not yet known whether the mental disorders seen in the study are a consequence of interferon treatment, or underlying neurologic abnormalities in multiple sclerosis, or a combination of both.

A case report of severe necrotizing cutaneous reactions as a result of interferon beta-1b therapy was also retrieved.

5. IDENTIFYING DOSAGE REGIMEN AND COST

A.Search strategy: Dosage regimen - Cost

To search for dosage regimen use the term dosage in the descriptor field to retrieve all citations that contain dosing information. Over 20 citations are identified.

To search for cost of drug therapy, first check the thesaurus to find the correct descriptor, which is 129 ECON DRUG ECONOMICS. Use 129 in the descriptor field, in addition to the drug and disease terms in their appropriate fields.

B. Clinical information: Dosage regimen and cost of therapy

The recommended dosing regimen for interferon beta-1b treatment of patients with relapsing-remitting multiple sclerosis is 8.0 MIU administered subcutaneously on alternate days. The cost of treating a patient with this regimen is approximately US $7,500 to US $10,000 per year.

The above simple search strategies efficiently retrieved a large amount of pertinent clinical information and answered the following key questions:

As always, the IDIS pharmacy team is available to provide timely, relevant, clinical information from the primary literature. Contact us via phone (U.S. toll free 800-525-4347), fax, e-mail, our WWW home page address, or regular mail to make the most of your IDIS subscription, and take advantage of our free subscriber search service.

Helen Scott, B. Pharm., R.Ph.

BIBLIOGRAPHY

Article Number 329583: CONNELLY J F. INTERFERON BETA FOR MULTIPLE SCLEROSIS. ANN PHARMACOTHERAPY 1994, 28:610-616.

Article Number 337447: GOODKIN D E. INTERFERON BETA-1B. LANCET 1994, 344:1057-1060.

Article Number 354727: BECKER C C; GIDAL B E; FLEMING J O. IMMUNOTHERAPY IN MULTIPLE SCLEROSIS, PART 2. AM J HEALTH-SYST PHARM 1995, 52:2105-2120.

Article Number 342460: (EDITORIAL); MCDONALD W I. NEW TREATMENTS FOR MULTIPLE SCLEROSIS: MAY DELAY DETERIORATION. BMJ 1995, 310:345-346.

Article Number 313026: SIBLEY W A; EBERS G C; PANITCH H S; REDER A T; ET AL. INTERFERON BETA-1B IS EFFECTIVE IN RELAPSING-REMITTING MULTIPLE SCLEROSIS. I: CLINICAL RESULTS OF A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. NEUROLOGY 1993, 43:655-661.

Article Number 313027: PATY D W; LI D K B; TANTON E L; ZHAO G J; ET AL. INTERFERON BETA-1B IS EFFECTIVE IN RELAPSING-REMITTING MULTIPLE SCLEROSIS. II: MRI ANALYSIS RESULTS OF A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. NEUROLOGY 1993, 43:662-667

Article Number 350104: DUQUETTE P; KNOBLER R L; LUBLIN F D; FRANCIS G S; ET AL. INTERFERON BETA-1B IN THE TREATMENT OF MULTIPLE SCLEROSIS: FINAL OUTCOME OF THE RANDOMIZED CONTROLLED TRIAL. NEUROLOGY 1995, 45: 1277-1285.

Article Number 333877: ALTER M; BYRNE T N; DAUBE J R; FRANKLIN G; ET AL. PRACTICE ADVISORY ON SELECTION OF PATIENTS WITH MULTIPLE SCLEROSIS FOR TREATMENT WITH BETASERON. NEUROLOGY 1994, 44:1537-1540.

Article Number 348229: (LETTER TO ED); SHEREMATA W A; TAYLOR J R; ELGART G W. SEVERE NECROTIZING CUTANEOUS LESIONS COMPLICATING TREATMENT WITH INTERFERON BETA-1B. N ENGL J MED 1995, 332:1584.

Article Number 355223: (LETTER TO ED); SHINOHARA K. MORE ON INTERFERON-INDUCED CUTANEOUS NECROSIS. N ENGL J MED 1995, 333: 1222.

Article Number 355224: (LETTER TO ED); TRAUTINGER F; KNOBLER R M. MORE ON INTERFERON-INDUCED CUTANEOUS NECROSIS. N ENGL J MED 1995, 333:1222-1223.

Article Number 355225: (LETTER TO ED); SHEREMATA W A; TAYLOR J R; ELGART G W. MORE ON INTERFERON-INDUCED CUTANEOUS NECROSIS (REPLY). N ENGL J MED 1995, 333:1223-1224.

THE IDIS THESAURUS -- Key to Vocabulary Management

Words. Despite the tremendous technological advances in information storage and display mediums, the written word still controls our access to stored information. Databases, index/abstract services, multimedia archives are all accessed by looking-up or searching with a word or phrase that has been chosen to unlock the information contained in the resource.

We choose the search word/phrase with the hope that it will retrieve only relevant material. A balance between retrieving everything possibly useful (too much) and retrieving only some of the relevant items (too little) can be achieved with the help of a controlled vocabulary and a thesaurus.

Pharmacy and medical literature is replete with words and phrases that have the same or very nearly the same definition or meaning. Authors of journal articles do not write with a standardized vocabulary for drugs, diseases, diagnostic tests or treatment modalities. While a clever searcher can identify all the synonyms, formats and permutations of a concept he or she wishes to search, this does take time and an expertise in multiple biological disciplines. The IDIS database has controlled this rich, but unwieldy, medical/pharmacy vocabulary by creating standardized drug, disease and descriptor vocabularies to index the concepts found in journal articles. One drug name (generally the United States Adopted Name) is used in the article index scheme regardless of the name appearing in the article. Likewise, one disease name (International Classification of Diseases - 9th Edition - Clinical Modifications) identifies all instances of the same disease concept. IDIS descriptors provide standardized access to journal articles' contents.

The goal of the searcher in retrieving information from a database, like IDIS, that uses a standardized or controlled vocabulary is to choose the single vocabulary term under which all relevant articles will be indexed. IDIS provides the searcher with a valuable tool -- the thesaurus. The IDIS thesaurus began in the mid-1960's as an in-house document to aid pharmacists indexing journal articles. Before long, the size and value of the thesaurus had grown considerably. It became apparent that IDIS subscribers' would also benefit from the thesaurus. The IDIS thesaurus evolved from paper copy, to microfilm to CD-ROM and expanded to include not only drug nomenclature but also diseases and descriptor terms. During 1995 the thesaurus grew by 464 drug, 1278 disease and 257 descriptor terms.

A controlled index vocabulary coupled with an extensive thesaurus provides searchers with the best opportunity to achieve a balanced search strategy sensitive enough to identify all possibly useful citations, but specific enough to limit the retrieval to only relevant citations.

Hazel H. Seaba, Director

Thesaurus Growth



1995 FDA DRUG APPROVALS

The FDA's approval of 85 new drugs and biological products in 1995 was highlighted by the continuing decline in drug median approval times and the approval of seven drugs for AIDS and other life-threatening disease in six months or less. One of these new products, saquinavir, was approved in 97 days. Fifteen of the approved new drug applications were in the "priority" category reserved for medications that are expected to have important therapeutic value. The median approval time for these products was 6 months, compared to that of 15 months in 1994.

Twenty-eight of the new drug approvals last year were new molecular entities, products containing an active substance that had never before been marketed in any form in the United States. This compares to 22 new molecular entities approved in 1994. Of the FDA new molecular entities approvals in 1995 almost 20% represented oncologic agents. Cardiovascular agents constituted another 20% and metabolic agents and antivirals comprised another fifth of the approvals. The median review time for these new molecular entities was 15.9 months, nine percent faster than the 17.5 months required for similar approvals in 1994. However, the FDA continues to approve a large proportion of these drugs at the end of the year. Nine (32%) of the total 1995 new molecular entities were approved in December.

Ruth Ann Calloway, M.S., R.Ph.

1995 FDA DRUG/BIOLOGIC APPROVALS

Generic Name (FDA Therapeutic Classification)

Trade Name
Sponsor
(Approval Date)

Valid IDIS Drug Term

Drug Number

(IDIS Citations)*

Indication/Use

Valid IDIS Disease Term

Modified ICD-9-CM Number

Acarbose (1S)**
Precose
Bayer
(Sep. 6)
ACARBOSE
44100011
(60 citations)
Treatment of non-insulin dependent diabetes mellitus Diabetes Mellitus
250.

Alendronate Sodium (1P)***
Fosamax
Merck
(Sep. 29)
ALENDRONATE
92000234
(26 citations)
Treatment of postmenopausal osteoporosis and Paget's Disease Osteoporosis
733.0

Disorder, Menopause/Post NEC
627.

Osteitis Deformans
731.0

Amifostine (1P)
Ethyol
U.S. Bioscience
(Dec. 8)
AMIFOSTINE
78080003
(38 citations)
Reduction of cumulative renal toxicity associated with repeated administration of cisplatin in advanced ovarian cancer Neop, Mgn-Ovary
183.0

Disorder, Kidney/Ureter NEC
593.

Anastrozole (1S)
Arimidex
Zeneca
(Dec. 27)
ANASTROZOLE
10120127
(3 citations)
Treatment of advanced breast cancer in postmenopausal women who have progressed on tamoxifen therapy Neop, Mgn-Female Breast
174.

Disorder, Menopause/Post NEC
627.

Azelaic Acid (1S)
Azelex
Allergan
(Sep. 13)
AZELAIC ACID
84500401
(21 citations)
Topical treatment of mild-to-moderate inflammatory acne vulgaris Acne
706.0

Bicalutamide (1S)
Casodex
Zeneca
(Oct. 4)
BICALUTAMIDE
68080407
(24 citations)
Treatment of advanced prostate cancer (used in combination with a luteinizing hormone-releasing hormone analog Neop, Mgn-Prostate
185.
Carvedilol (1S)
Coreg
SmithKline Beecham
(Sep. 14)
CARVEDILOL
12160153
(60 citations)
Treatment of hypertension Hypertension
401.
Ceftibuten (1S)
Cedax
Schering-Plough
(Dec. 20)
CEFTIBUTEN
8120656
(37 citations)
Treatment of acute bacterial exacerbations of chronic bronchitis, otitis media, and pharyngitis/tonsillitis Bronchitis, Chronic NEC
491.

Otitis Media
381.

Pharyngitis, Acute
462.

Cetirizine (1S)
Zyrtec
Pfizer
(Dec. 8)
CETIRIZINE
4000031
(248 citations)
Relief of symptoms with seasonal and perennial allergic rhinitis and chronic urticaria Urticaria NEC
708.

Allergic Rhinitis NEC
477.

Dexrazoxane (1P)
Zinecard
Pharmacia & Upjohn
(May 26)
DEXRAZOXANE
10120118
(28 citations)
Cardioprotective Cardiomyopathy
425.

Failure, Heart, Congestive
428.0

Dirithromycin (1S)
Dynabac
Lilly
(Jun. 19)
DIRITHROMYCIN
8121221
(18 citations)
Treatment of acute bacterial exacerbations of chronic bronchitis & secondary bacterial infection of acute bronchitis due to Moraxella catarrhalis or Streptococcus pneumoniae

Treatment of community-acquired pneumonia due to Streptococcus pneumoniae, Mycoplasma pneumoniae, & Legionella pneumophila

Bronchitis, Acute
466.0

Pneumonia, Pneumococcus
481.

Pneumonia, Mycoplasma Pneumoni
483.0

Pneumonia, Bacteria NEC
482.

Epoprostenol Sodium (1P)
Flolan
Glaxo Wellcome
(Sep. 20)
EPOPROSTENOL
20120610
(374 citations)
Long-term I.V. treatment of primary pulmonary hypertension in NYHA Class III & IV adult patients Hypertension, Pulm, Prim
416.0
Glimepiride (1S)
Amaryl
Hoechst Marion Roussel
(Nov. 30)
GLIMEPIRIDE
68200610
(1 citation)
Reduction of blood glucose in patients with noninsulin-dependent diabetes mellitus Diabetes Mellitus
250.
Hepatitis A Vaccine
Havrix
SmithKline Beecham
(Feb. 22)
HEPATITIS A VACCINE
80120037
(77 citations)
Prevention of hepatitis A Hepatitis, Viral A
070.0

Inoculation and Vaccination
99.3

Iopromide (1S)
Ultravist
Berlex
(May 10)
IOPROMIDE
36680039
(21 citations)
Contrast media for X-ray imaging and computed tomography Contrast Arterio-Aortography
88.42

Contrast Angiocardiography
88.5

Contrast Arterio- NEC
88.4

Pyelogram
87.73

Lamivudine (1P)
Epivir
Glaxo Wellcome
(Nov. 17)
LAMIVUDINE
8180077
(34 citations)
Antiviral used with zidovudine for AIDS Syn-Acq Immune Deficiency
042.

Infection, HIV, Asymptomatic
V08.

Lansoprazole (1S)
Prevacid
TAP
(May 10)
LANSOPRAZOLE
56400026
(51 citations)
Treatment of erosive esophagitis, duodenal ulcer, and hypersecretory conditions including Zollinger-Ellison Syndrome Esophagitis
530.1

Ulcer, Duodenal
532.

Abnormality, Gastrin Secret
251.5

Losartan (1S)
Cozaar
Merck
(Apr. 14
LOSARTAN
24080020
(43 citations)
Treatment of hypertension Hypertension
401.
Moexipril (1S)
Univasc
Schwarz Pharma
(Apr. 19)
MOEXIPRIL
24080232
(7 citations)
Treatment of hypertension Hypertension
401.
Mycophenolate Mofetil (1P)
Cellcept
Syntex/Roche
(May 3)
MYCOPHENOLATE MOFETIL
92000205
(29 citations)
Prophylaxis of organ rejection in patients receiving allogeneic renal transplants Complication, Organ Transpl
996.8

Transplant, Kidney
55.6

Nalmefene(1S)
Revex
Ohmeda
(Apr. 17)
NALMEFENE
28100006
(30 citations)
Opioid antagonist Condition, Brain NEC
348.
Nisoldipine (1S)
Sular
Miles/Zeneca
(Feb. 2)
NISOLDIPINE
24120406
(135 citations)
Treatment of hypertension Hypertension
401.
Porfimer Sodium (1P)
Photofrin
QLT PhotoTherapeutics
(Dec. 27)
PORFIMER
10120126
(24 citations)
For phototherapy of esophageal cancer obstructions Phototherapy NEC
99.83

Neop, Mgn-Esophagus
150.

Riluzole (1P)
Rilutek
Rhone-Poulenc Rorer
(Dec. 12)
RILUZOLE
92000236
(17 citations)
Treatment of amyotrophic lateral sclerosis Sclerosis, Amyotrophic
335.20
Saquinavir (1P)
Invirase
Roche
(Dec. 6)
SAQUINAVIR
8180076
(16 citations)
Use in combination with nucleoside analogs for advanced HIV Infection Syn-Acq Immune Deficiency
042.
Sevoflurane (1S)
Ultane
Abbott
(Jun. 7)
SEVOFLURANE
28040008
(144 citations)
General anesthetic Anesthesia/Paresthesia
782.0

Tramadol HCl (1S)
Ultram
RW Johnson
(Mar. 3)
TRAMADOL
28081217
(40 citations)
Management of moderate to moderately severe pain Pain NEC
782.2
Varicella Virus Vaccine Live
Varivax
Merck
(Mar. 17)
VARICELLA VACCINE
80120078
(137 citations)
Prevention of chickenpox Chickenpox
052.

Inoculation and Vaccination
99.3

*Complete bibliographic citations will be provided upon request.
**(1S) New Molecular Entity given standard review by FDA.
***(1P) New Molecular Entity given a priority review.


1996 IDIS EXHIBIT SCHEDULE

American Society of Hospital Pharmacists (ASHP)
Home Care '96
Orlando, Florida
July 27-29

American College Clinical Pharmacy (ACCP)
Annual Meeting
Nashville, Tennessee
August 4-7

American Society of Hospital Pharmacists (ASHP)
Midyear Clinical Meeting (MCM)
New Orleans, Louisiana
December 4-8


1996 FDA DRUG APPROVALS

On January 19 the FDA announced licensing of Respiratory Syncytial Virus (RSV) Immune Globulin Intravenous (Human) (RSVIGIV) to protect high-risk infants against the worst effects of RSV disease, the most common cause of lower respiratory infections in children. While the product does not prevent infections by RSV, it is the first product that reduces serious RSV disease in high-risk children. RSVIGIV is given intravenously in five monthly doses, with the first dose given in November before the start of the RSV season. Rare allergic reactions to RSVIGIV are possible. In addition, infants with pulmonary disease may retain fluids and a small percentage of infants in the trials needed new or extra diuretics after receiving RSVIGIV. Because the product is made from human plasma, a small risk exists for the transmission of blood-borne viruses. However, the risk is low because plasma donors are screened carefully and the product is treated with a solvent-detergent viral inactivation procedure which inactivates most significant blood-borne viruses, including the one that causes AIDS.

The intravenous cephalosporin antibiotic cefepime was approved January 18 for uncomplicated and complicated urinary tract infections (UTIs), uncomplicated skin and skin structure infections and pneumonia. The recommended cefepime dose for mild to moderate UTIs is 0.5 g to 1g intravenously or intramuscularly twice daily for seven to 10 days; for severe UTIs, 2 g I.V. twice daily for 10 days; for pneumonia, 1 g to 2 g I.V. twice daily for 10 days; and for skin and skin structure infections, 2 g I.V. twice daily for 10 days. Intravenous administration should occur over approximately 30 minutes. Dosage administration of cefepime in the elderly should be adjusted as appropriate if the patient's creatinine clearance is 60 mL/minute or less. No dose adjustment is necessary for patients with impaired hepatic function.

Technetium TC99m tetrofosmin was approved by the FDA on February 9 for scintigraphic imaging of the myocardium following separate administrations under exercise and resting conditions. It is useful in the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium. Recommended dosing is 5-8 mCi at peak exercise and a second dose of 15-24 mCi approximately four hours later at rest. Recommended imaging time is 15 minutes at stress and 30 minutes at rest. In clinical trials three patients experienced serious episodes of angina after injection of the drug. Other adverse effects, occurring in less than 1% of the patients, included hypertension, torsades de pointes, vomiting, abdominal discomfort, cutaneous allergy, hypotension, dyspnea and effects on the senses.

Ruth Ann Calloway, M.S., R.Ph.

1996 FDA DRUG/BIOLOGIC APPROVALS

Generic Name (FDA Therapeutic Classification)

Trade Name
Sponsor
(Approval Date)

Valid IDIS Drug Term

Drug Number

(IDIS Citations)*

Indication/Use

Valid IDIS Disease Term

Modified ICD-9-CM Number

Cefepime (1S)**
Maxipime
Bristol-Meyers Squibb
(Jan. 18)
CEFEPIME
8120655
(77 citations)
For uncomplicated and complicated urinary tract infections; for uncomplicated skin and skin structure infections; and for pneumonia Infection, Urinary Tract
599.0

Infection, Skin/SQ NEC
686.

Pneumonia, Bacterial NEC
482.

Respiratory Syncytial Virus Immune Globulin Intravenous (Human)
RespiGam
MedImmune Inc.
(Jan. 19)
RESP SYNCYTIAL VIRUS IG
80040037
(12 citations)
Reduce serious RSV in high risk infants (under 2 years age) with lung problems due to chronic bronchopulmonary dysplasia or prematurity Pneumonia, Syncytial Virus
480.1
Technetium Tc 99m Tetrofosmin (1S)
Myoview
Medi-Physics
(Feb. 9)
TC 99M TETROFOSMIN
78040246
(19 citations)
Scintigraphic imaging of the myocardium Radioisotope Scan, Cardiovas
92.05

*Complete bibliographic citations will be provided upon request.
**(1S) New Molecular Entity given standard review by FDA.


World of Drugs is published quarterly (March, June, September, December)
by the Division of Drug Information Service.

Editor: Donna Brus
Production/Design: Jamie Siegel
Photographer: David Luck


Iowa Drug Information Service
The University of Iowa, 100 Oakdale Campus, N330 OH
Iowa City, IA 52242-5000 U.S.A.

Telephone: 319-335-4800 U.S. Toll-Free: 800-525-IDIS Fax: 319-335-4077
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