FDA Approval Packages Provide Access to Unbiased Reviews of Published and Unpublished Studies

There is a growing body of evidence which suggests that reporting of clinical trial results is biased (Publication Bias Found Among Trials Submitted To FDA: New Study). One recent study concluded that more than 50% of all trials submitted to the FDA during the drug approval process remain unpublished five years after the drugs are approved (Half Of Trials Supporting FDA Applications Go Unpublished).

With IDIS, you have access to the entire FDA Approval Package for a particular drug, so you can read about all the trials reviewed by the FDA for a particular drug, not just the ones that have been published.

FDA Approval Packages contain the research information on new drugs or biologics submitted to the FDA by drug sponsors that has been analyzed and critiqued by experts at the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Once a new drug or biologic is approved for marketing, the FDA is required to make the Approval Package available to the public.

Approval Packages are typically large, unwieldy documents ranging from 50 to 1500 pages. To make these documents manageable, we prepare a Table of Contents and identify the pivotal studies for each package. These are the studies the drug sponsors believe prove the efficacy and safety of their submitted drug or biologic.

Drug Approval Packages available in IDIS for drugs approved in 2008 include those for Cimzia, Cinryze, Durezol, Entereg, Intelence, Lexiscan, Relistor, and Treanda. To search for these in IDIS, enter the drug name in Title field, and use Descriptor 155 - FDA Approval Package. New Approval Packages are continually added to the IDIS database.

Practice Search Questions Available

Want some practice searching in IDIS? Click here for 117 practice questions. Educators and non-student subscribers, please contact us at idis@uiowa.edu for the answer key. Students, please contact the person at your school who is in charge of IDIS for help.

The link to these questions has also been posted under "Our Favorite Links" on the right side of this blog.

IDIS Blog Goes Live

Welcome to our Blog!

This Blog has been in the testing phase for the past few months, but today we started publicizing it. During the testing phase, the posts were few and far between. Now that the Blog is up and running, we will be updating it more frequently.

To subscribe to the Blog, click on the Posts link under the Subscribe To section on the right side of the page, and add it to your favorite feed reader. This way you can always stay up-to-date.

IDIS subscribers, we'd love to hear from you about what you'd like to see on this Blog. To leave a comment, click on the comments link at the end of this post.

The Link Between Acetaminophen and Asthma

The News:

A study published in this week's Lancet concluded that babies who were given acetaminophen for fever had a higher risk of developing asthma during childhood. (Source - MedPage Today)

IDIS Related Question:

Have there been any recent review articles about the use of acetaminophen in febrile children and the association with asthma?

IDIS Search:

Drug(s): "ACETAMINOPHEN 28081221"

Disease(s): "PYREXIA, UNKNOWN ORIGIN 780.6"

Descriptor(s): "SIDE EF RESPIRATORY 79" and "REVIEW PEDIATRIC 21"

IDIS Results:

IDIS article 589221

Gene Testing Prior to Abacavir Therapy

The News:

The FDA alerted healthcare professionals yesterday that all patients starting or restarting treatment with abacavir or abacavir-containing drugs should be screened for the HLA-B*5701 allele. Patients with this allele are more likely to have serious and sometimes fatal hypersensitivity reactions. If a patient tests positive for this allele, abacavir should not be used. (Source - FDA Safety Alert)

IDIS Related Question:

Locate randomized studies (in adults) about hypersensitivy reactions with abacavir and the use of genetic screening prior to its use.

IDIS Search:

Drug(s): "ABACAVIR 8180817"

Descriptor(s): "SIDE EF IMMUNOLOGIC 90" and "STUDY RANDOMIZE ADULT 135" and "PHARMACOGENETICS 150"

IDIS Results:

IDIS article 590386

Recent Additions to IDIN Answers

The following questions were recently added to IDIN Answers:

What is the Orange Book rating for Nifedical XL 30mg (NDC 00093081901, Teva, Biovail? Is this product bioequivalent to Procardia XL and/or Adalat CC?
(IDIN Answer)

Please see what you can find regarding protocols for acute IV, epidural and SQ pain management. This would entail opiates, local anesthetics and combinations of the two. Ideally we're looking for suggested standard basal and bolus rates as well as maximum basal and bolus rates.
(IDIN Answer)

Do you have any information on gentamicin administered intrathecally?
(IDIN Answer)

How would you taper a patient who mistakenly took 240 mg of prednisone per day?
(IDIN Answer)

Can you please send me daclizumab (Zenapax) dosing information directed towards patients other than renal transplant recipients?
(IDIN Answer)

Can you please check to see if you can find any stability data for iron dextran diluted with normal saline and stored in a plastic syringe?
(IDIN Answer)

I would like any articles or information you can find about continuous infusion of anti-emetics.
(IDIN Answer)

Medication Errors in Neonates

The News:

A medication error with heparin resulted in up to 17 newborns being given an overdose of the drug at a hospital in Texas last week. At least two of these babies have died, but it is unclear if the heparin overdose caused their deaths. Preliminary information indicated that the error originated in the hospital's pharmacy. (Source - theheart.org from WebMD)

IDIS Related Question:

In case reports, what are some other drugs that have been associated with medication errors in neonates?

IDIS Search:

Disease(s): "NEONATE V39."

Descriptor(s): "CASE REPORT PEDIATRIC 1" and "MEDICATION ERROR 158"

IDIS Results:

Acetaminophen (IDIS articles 508779, 467883)

Acyclovir (IDIS article 507354)

Aminophylline (IDIS article 440171)

Epinephrine (IDIS articles 538727, 442155)

Penicillin G benzathine (IDIS articles 454121, 440162)

Cholesterol Medications in Children

The News:

A new guideline issued earlier this month by the American Academy of Pediatrics recommends considering the use of cholesterol-lowering medications in children 8 years or older who have high concentrations of low-density lipoprotein (LDL). (Source - American Academy of Pediatrics Press Release)

IDIS Related Question:

Randomized studies have evaluated the use of statins in children with what disease states?

IDIS Search Strategy:

Drug(s): 240602*

Descriptor(s): "STUDY RANDOMIZE PEDIATRIC 136"

IDIS Results:

Familial hypercholesterolemia (IDIS articles 366237, 488641, 491161, 502435, 518227, 542407, 543590, 580785,
597105)

Severe hypercholesterolemia (IDIS article 502435)

Glomerulonephritis (IDIS article 531359)

IgA nephropathy (IDIS article 501728)

Antiepileptic Drugs and Risk of Suicide

The News:

On July 10, 2008, two FDA Advisory Committees voted not to require that 11 epilepsy drugs carry a black box warning about the risk of suicide ideation and behavior. The drugs being considered for this warning were carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, and zonisamide. (Source - MedPage Today)

IDIS Related Question:

What black box warnings, if any, do these 11 drugs currently carry?

IDIS Search Strategy:

Drug(s): "CARBAMAZEPINE 28122007" or "VALPROIC ACID 28122015" or "FELBAMATE 28122022" or "GABAPENTIN 28122020" or "LAMOTRIGINE 28122024" or "LEVETIRACETAM 28122040" or "OXCARBAZEPINE 28122011" or "PREGABALIN 28122016" or "TIAGABINE 28122034" or "TOPIRAMATE 28122035" or "ZONISAMIDE 28122004"

Descriptor(s): "FDA BLACK BOX WARNING 165"

IDIS Results:

Carbamazepine: 1) serious dermatologic reactions and HLA-B*1502 allele 2) aplastic anemia (IDIS article 592789)

Divalproex sodium: 1) hepatotoxicity and 2) teratogenicity (IDIS article 561301)

Felbamate: aplastic anemia (IDIS article 557094)

Lamotrigine: serious rashes requiring hospitalization and discontinuation of treatment (IDIS article 559571)