drug label

Off-label Drug Use: Fact vs. Fiction

Posted by cdavenport on Friday Aug 17, 2012 Under Drug Promotion, Drug Safety, FDA

The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.   The article format addresses 10 common questions and their answers about off-label drug use.  The breadth of application, its acceptance, and the liabilities of off-label use are explored.  A history of FDA regulations surrounding the practice is presented, which helps to put its evolution into proper perspective.  Off-label use, which occurs in every medical specialty, is more common in patient populations not likely to be included in clinical trials (e.g., pediatric, pregnant, or psychiatric patients).  Once a medication is marketed, the FDA does not limit or control how the medication is prescribed by physicians. The pros and cons of the distribution of information regarding the off-label use of medications by pharmaceutical companies, the use of informed consent, and the liability of prescribing physicians are discussed.

SourceMayo Clinic Proceedings  – pdf of full article.

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Linguamatics, the leader in natural language processing (NLP)-based text mining, announced that the Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has licensed its 12E text mining platform as a discovery and decision support tool to supplement laboratory research efforts on drug safety.  The FDA will use the platform to review published literature and drug product labels to address key biomedical issues, including mechanisms of drug toxicity and disease processes.  In addition to document retrieval, the 12E platform can identify, extract, synthesize, and analyze relevant facts and relationships (e.g., between genes and diseases, drugs and side effects).  Customers include top tier commercial, academic, and governmental organizations, including 9 of the top 10 global pharmaceutical companies.  The 12E platform is available both as an in-house or cloud-based system.

Typical applications in pharmaceutical, biotechnology, and healthcare include:
•    Mapping gene-disease relationships and identifying potentially novel therapeutic targets
•    Biomarker discovery
•    Drug repurposing
•    Drug safety
•    Patent analysis
•    Clinical trial site selection and study design
•    Mining electronic medical records to improve prediction of health outcomes
•    Translational medicine
•    Competitive intelligence
•    Social media mining
•    Subjective data mining (sentiment analysis, key opinion mining)

SourcesBioSpace and Business Weekly

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FDA Pharamacogenomic Biomarker Database

Posted by cdavenport on Thursday Jul 5, 2012 Under Databases, Drug Safety, FDA, Genetic Toxicology, Regulatory

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe:

    • Drug exposure and clinical response variability
    • Risk for adverse events
    • Genotype-specific dosing
    • Mechanisms of drug action
    • Polymorphic drug target and disposition genes

This resource table lists FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.

Source:  FDA

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Drug Safety: Tip of the Iceberg

Posted by cdavenport on Thursday Jun 7, 2012 Under Drug Safety, FDA, Post-market Surveillance, Risk Management, toxicity

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.  It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs.  On one hand, this shows that FDA and manufacturer safety surveillance programs have identified these significant safety risks. On the other, it illustrates that placing warnings in product information only begins the process of managing drug safety risks.   Relative rates vs. report expectations are detailed.

These data come from QuarterWatch™ an Institute for Safe Medication Practices surveillance program that monitors all serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration through MedWatch, its adverse event reporting system.  The goal is to identify signals that may represent important new drug safety issues.

Source:  Philly.com/Health

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Nonclinical Toxicology: FDA Guidance Agenda for 2012

Posted by cdavenport on Monday Mar 26, 2012 Under Drug Safety, FDA, Preclinical, Regulatory

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012.  There are about 50 such guidances planned.  Below are a few select highlights relevant to the preclinical safety space, with emphasis on the drug development of small molecules.

Electronic Submissions

  • Providing Regulatory Submissions in Electronic Format – General Considerations
  • Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions.  Using the eCTD Specifications
  • Providing Regulatory Submissions in Electronic Format – Study Data
  • Providing Regulatory Submissions in Electronic Format – Standardized Study Data


  • Integrated Summary of Safety
  • Investigational New Drug (IND) Applications prepared and submitted by Clinical Sponsor Investigators


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Drug Labels May Inadequately Address Efficacy and Risk

Posted by cdavenport on Thursday Nov 25, 2010 Under Drug Safety, FDA, toxicity

FDA approval does not mean that a drug works well; it means only that the Agency deemed its benefits to outweigh its harms.  Comparative efficacy data, other than to placebo, may be missing from the label.  In 2006, the FDA revised the drug label design, adding a “highlights” section to emphasize the drug’s indications and warnings.  It also issued guidance about reporting trial results in the label and emphasized the importance of effectiveness data.  Yet some recent label updates (e.g., for Lunesta and Rozerem) are substantively unchanged.  Use of “Prescription Drug Facts Boxes,” featuring a data table of benefits and toxicities has been proposed.  Recently, the FDA’s Risk Advisory Committee recommended that the FDA adopt these boxes as the standard for their communications.  FDA leadership is deciding whether and how to use the boxes in reviews, labels, or both.  Also proposed is the generation of a standardized executive summary of FDA drug reviews.  These summaries should include data tables of the main results of the phase 3 trials, highlight reviewers’ uncertainties, and note whether drug approval was conditional upon a post-approval study.  While publication of new comparative-effectiveness results is helpful, publications generally occur post approval.  In contrast, much is known about drug effectiveness and drug safety at approval that could better guide physician and patient choice if this information was more widely disseminated.

Source: New England Journal of Medicine

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Four proposals that address drug advertising and marketing issues, which have not been widely discussed, may be incorporated into the final health care reform bill.

1)  Of most concern to the pharmaceutical industry is a proposal to eliminate the tax deduction for drug advertising.  Direct-to-consumer (DTC) advertising is a prime target due to concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive use of new drugs before their safety is fully known.

2)  Health care reform bills in both the House and the Senate contain transparency provisions, akin to those in the Physicians Payments Sunshine Act of 2009, which propose for the disclosure of drug and device company payments to doctors to be federally mandated.

3)  Section 138 of the health care reform bill  bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data.”  If passed, Section 138 would end drug representatives’  current practice of tailoring their sales messages to each doctor’s prescribing history, which can put more pressure on doctors to prescribe newer, more expensive medications.

4)  The health care reform bill would authorize the FDA to evaluate whether use of a “drug facts box” format on drug labels – to more clearly present a drug’s benefits and risks – would improve health care decision making.  This  bill would also allow the FDA to set standards for comparative clinical effectiveness information to be included in drug labeling and advertising.

Source:  Health Reform Watch, 2 October 2009.

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