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Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.

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Title: Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.
Authors: Loder, Elizabeth W., Rayhill, Melissa, Burch, Rebecca C.
Source: Headache: The Journal of Head & Face Pain. Nov2018, Vol. 58 Issue 10, p1639-1657. 19p. 6 Charts.
Subjects: Chemical burns, Drug side effects, Labels, Marketing, MEDLINE, Migraine, Online information services, Patient safety, Pharmacy information services, Transdermal medication, United States. Food & Drug Administration, Drug development, Sumatriptan, Drug approval, Social media, Facebook (Web resource), Twitter (Web resource), Therapeutics
Abstract: Objective: We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems might be prevented in the future. Background: The Zecuity® sumatriptan iontophoretic transdermal system was marketed for acute treatment of migraine. The patch was withdrawn less than 10 months after its introduction because of multiple reports of scarring and burning. As of 2018, the FDA Adverse Event Reporting System public dashboard lists a total of 2889 reports of safety problems with the patch, 904 of which were classified as serious. Methods: For this narrative review, we examined US Food and Drug Administration documents related to the new drug application for this product and its approval. We searched Clinicaltrials.gov, PubMed, Google, Facebook, Twitter, and Instagram public posts for relevant information relating to the patch, its approval, marketing, and complications. Results: The FDA knew about problems with burns and scarring prior to approval of the product, and turned down the initial new drug application for this reason and because of other quality problems with the patch. The reapplication was approved despite continued concerns of several FDA reviewers about safety. The approval required the manufacturer to comply with enhanced postmarketing safety reporting. However, product information and labeling did not mention the possibility of burns or scarring. Approval was based on 1 clinical trial and 2 open label studies in which reporting of adverse events was suboptimal. The clinical trials had been prospectively registered but outcomes had been changed around the time the trial concluded. Aggressive marketing efforts and social media activity may have contributed to inaccurate perceptions of safety and efficacy, but social media also provided a written and photographic record of burns and other harm suffered by patients who used the patch. Conclusions: Our review identified several problems with the development, testing, approval, and marketing of the Zecuity patch. To improve the process of developing headache treatments, it is important to consider the lessons that can be drawn from an examination of this high‐profile failure of the drug development and regulatory system. [ABSTRACT FROM AUTHOR]
Copyright of Headache: The Journal of Head & Face Pain is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.
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  Data: <searchLink fieldCode="AR" term="%22Loder%2C+Elizabeth+W%2E%22">Loder, Elizabeth W.</searchLink><br /><searchLink fieldCode="AR" term="%22Rayhill%2C+Melissa%22">Rayhill, Melissa</searchLink><br /><searchLink fieldCode="AR" term="%22Burch%2C+Rebecca+C%2E%22">Burch, Rebecca C.</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Headache%3A+The+Journal+of+Head+%26+Face+Pain%22">Headache: The Journal of Head & Face Pain</searchLink>. Nov2018, Vol. 58 Issue 10, p1639-1657. 19p. 6 Charts.
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  Data: <searchLink fieldCode="DE" term="%22Chemical+burns%22">Chemical burns</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+side+effects%22">Drug side effects</searchLink><br /><searchLink fieldCode="DE" term="%22Labels%22">Labels</searchLink><br /><searchLink fieldCode="DE" term="%22Marketing%22">Marketing</searchLink><br /><searchLink fieldCode="DE" term="%22MEDLINE%22">MEDLINE</searchLink><br /><searchLink fieldCode="DE" term="%22Migraine%22">Migraine</searchLink><br /><searchLink fieldCode="DE" term="%22Online+information+services%22">Online information services</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmacy+information+services%22">Pharmacy information services</searchLink><br /><searchLink fieldCode="DE" term="%22Transdermal+medication%22">Transdermal medication</searchLink><br /><searchLink fieldCode="DE" term="%22United+States%2E+Food+%26+Drug+Administration%22">United States. Food & Drug Administration</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+development%22">Drug development</searchLink><br /><searchLink fieldCode="DE" term="%22Sumatriptan%22">Sumatriptan</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+approval%22">Drug approval</searchLink><br /><searchLink fieldCode="DE" term="%22Social+media%22">Social media</searchLink><br /><searchLink fieldCode="DE" term="%22Facebook+%28Web+resource%29%22">Facebook (Web resource)</searchLink><br /><searchLink fieldCode="DE" term="%22Twitter+%28Web+resource%29%22">Twitter (Web resource)</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objective: We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems might be prevented in the future. Background: The Zecuity® sumatriptan iontophoretic transdermal system was marketed for acute treatment of migraine. The patch was withdrawn less than 10 months after its introduction because of multiple reports of scarring and burning. As of 2018, the FDA Adverse Event Reporting System public dashboard lists a total of 2889 reports of safety problems with the patch, 904 of which were classified as serious. Methods: For this narrative review, we examined US Food and Drug Administration documents related to the new drug application for this product and its approval. We searched Clinicaltrials.gov, PubMed, Google, Facebook, Twitter, and Instagram public posts for relevant information relating to the patch, its approval, marketing, and complications. Results: The FDA knew about problems with burns and scarring prior to approval of the product, and turned down the initial new drug application for this reason and because of other quality problems with the patch. The reapplication was approved despite continued concerns of several FDA reviewers about safety. The approval required the manufacturer to comply with enhanced postmarketing safety reporting. However, product information and labeling did not mention the possibility of burns or scarring. Approval was based on 1 clinical trial and 2 open label studies in which reporting of adverse events was suboptimal. The clinical trials had been prospectively registered but outcomes had been changed around the time the trial concluded. Aggressive marketing efforts and social media activity may have contributed to inaccurate perceptions of safety and efficacy, but social media also provided a written and photographic record of burns and other harm suffered by patients who used the patch. Conclusions: Our review identified several problems with the development, testing, approval, and marketing of the Zecuity patch. To improve the process of developing headache treatments, it is important to consider the lessons that can be drawn from an examination of this high‐profile failure of the drug development and regulatory system. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Headache: The Journal of Head & Face Pain is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=133235694
RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1111/head.13424
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      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 19
        StartPage: 1639
    Subjects:
      – SubjectFull: Chemical burns
        Type: general
      – SubjectFull: Drug side effects
        Type: general
      – SubjectFull: Labels
        Type: general
      – SubjectFull: Marketing
        Type: general
      – SubjectFull: MEDLINE
        Type: general
      – SubjectFull: Migraine
        Type: general
      – SubjectFull: Online information services
        Type: general
      – SubjectFull: Patient safety
        Type: general
      – SubjectFull: Pharmacy information services
        Type: general
      – SubjectFull: Transdermal medication
        Type: general
      – SubjectFull: United States. Food & Drug Administration
        Type: general
      – SubjectFull: Drug development
        Type: general
      – SubjectFull: Sumatriptan
        Type: general
      – SubjectFull: Drug approval
        Type: general
      – SubjectFull: Social media
        Type: general
      – SubjectFull: Facebook (Web resource)
        Type: general
      – SubjectFull: Twitter (Web resource)
        Type: general
      – SubjectFull: Therapeutics
        Type: general
    Titles:
      – TitleFull: Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.
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            NameFull: Loder, Elizabeth W.
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            NameFull: Rayhill, Melissa
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            NameFull: Burch, Rebecca C.
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              Text: Nov2018
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              Value: 58
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            – TitleFull: Headache: The Journal of Head & Face Pain
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