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Xyrem® (sodium oxybate) postmarketing adverse event reporting system
Sleep Medicine 11 (2010) 595–597
Contents lists available at ScienceDirect
Sleep Medicine journal homepage: www.elsevier.com/locate/sleep
Letters to the Editor XyremÒ (sodium oxybate) postmarketing adverse event reporting system To the Editor: In their response to Dr. Bassetti et al. [1], Drs. Zvosec and Smith [2] stated that postmarketing adverse events (AEs) for XyremÒ were impossible for the public to determine and limited to scattered case reports and that Jazz Pharmaceuticals Inc. (JPI) did not detect deaths reported by them. We wish to provide clarification on these points. XyremÒ is distributed in the US through a central pharmacy, providing more patient contact than traditional pharmaceutical dispensing and offering patients more opportunities to report AEs. JPI collects these AEs in addition to spontaneous postmarketing AE reports. The pharmacy contacts patients at each prescription and before each shipment and follows up any early refill requests and suspected misuse. New patients may choose four additional contacts with nurses during the first 2 months of treatment. In cases of patient death, the pharmacy halts drug shipments and notifies JPI, allowing deaths to be captured with perhaps greater accuracy than is typical. JPI seeks additional information on every reported AE, including cases that may have been reported multiple times. This was why Dr. Zvosec was contacted by JPI concerning the deaths they reported. To ensure thorough reporting, JPI provides all cases to regulators, including those for which multiple reports of a single case cannot be excluded definitively. XyremÒ is approved to treat certain symptoms of narcolepsy in the US, Europe, and Canada. Worldwide AEs are collected and analyzed by JPI on an ongoing basis and reported to regulators routinely. Safety data were solicited prospectively from physicians during the first 3 years of marketing [3]. A comprehensive postmarketing safety analysis recently described XyremÒ’s low incidence of abuse, dependence, and diversion [4]. In addition to published data and product labeling, AE information is available on request from FDA via FOIA. We believe the safety profile for XyremÒ is well characterized. Disclosures Y. Grace Wang is an employee of Jazz Pharmaceuticals and owns stock and stock options in the company. She currently serves as a Director of Clinical Development (2009 – present). Prior to this current position, she was a Director in Drug Safety at Jazz Pharmaceuticals. She has overseen XyremÒ postmarketing safety and safety of sodium oxybate in clinical trials for fibromyalgia for the past 4 years. Dr. Wang has 6 years experience in Drug Safety.
References [1] Lammers GJ, Bassetti C, Billiard M, Black J, Broughton R, et al. Sodium oxybate is an effective and safe treatment for narcolepsy. Sleep Med 2010;11(1):105–6. [2] Zvosec DL, Smith SW. Response from the authors. Sleep Med 2010;11(1):106–8. [3] Wedin GP, Hornfeldt CS, Ylitalo LM. The clinical development of chydroxybutyrate (GHB). Curr Drug Safety 2006;1:99–106.
[4] Wang YG, Swick TJ, Carter LP, Thorpy MJ, Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009;54:365–71.
Y. Grace Wang Jazz Pharmaceuticals Inc., 3180 Porter Dr., Palo Alto, CA 94304, USA Tel.: +1 650 496 2687. E-mail address: [email protected] Available online 1 April 2010
1389-9457/$ - see front matter Ó 2010 Elsevier B.V. All rights reserved. doi:10.1016/j.sleep.2010.02.003
Response to ‘‘XyremÒ (sodium oxybate) postmarketing adverse event reporting system”
We appreciate the letter submitted by Dr. Wang [1] in response to our earlier letter [2] and original article [3] and will respond to several points that she raises. First, we would like to clarify that we stated that data on postmarketing adverse events (AEs) related to XyremÒ/sodium oxybate (a pharmaceutical formulation of gamma hydroxybutyrate, GHB) are ‘‘virtually impossible for members of the public to determine,” and that AE surveillance data collected by Jazz Pharmaceuticals, Inc. (JPI) ‘‘are not readily available to the public, as far as we are aware.” Our focus was on ready access to information by members of the public, including potential prescribing physicians, not by federal regulators or JPI. Thus, while we appreciate Dr. Wang’s statement that one can request data on postmarketing surveillance through a Freedom of Information Act (FOIA) request, we do not feel that this qualifies as ‘‘ready access”; in fact, a FOIA request that we previously made for data on GHB-associated fatalities was denied due to privacy concerns, despite our specification that any and all personal identifying information be removed. The postmarketing safety analysis by Wang et al. [4] was not available to us at the time that we prepared our initial response; however, we did access it later during the review process and referenced it in an Addendum. We agree with Dr. Wang that the distribution of XyremÒ through a central pharmacy provides more opportunities for patient contact and AE reporting than with traditional pharmaceutical dispensing, which is beneficial for patients and JPI monitoring, although, again, data from these interactions and communications are not available to the public or prescribing physicians. We also appreciate that aspects of the XyremÒ Patient Success Program provide critically important and necessary opportunities for patient and physician education regarding use of XyremÒ due to the risk of AEs, abuse, diversion, etc.; we made specific note of this in our original article [3]. Regarding detection of XyremÒ-associated deaths, we appreciate that JPI collects and reports fatality data to regulators, regardless of whether this may result in multiple reports of a single case. Further,
Contents lists available at ScienceDirect
Sleep Medicine journal homepage: www.elsevier.com/locate/sleep
Letters to the Editor XyremÒ (sodium oxybate) postmarketing adverse event reporting system To the Editor: In their response to Dr. Bassetti et al. [1], Drs. Zvosec and Smith [2] stated that postmarketing adverse events (AEs) for XyremÒ were impossible for the public to determine and limited to scattered case reports and that Jazz Pharmaceuticals Inc. (JPI) did not detect deaths reported by them. We wish to provide clarification on these points. XyremÒ is distributed in the US through a central pharmacy, providing more patient contact than traditional pharmaceutical dispensing and offering patients more opportunities to report AEs. JPI collects these AEs in addition to spontaneous postmarketing AE reports. The pharmacy contacts patients at each prescription and before each shipment and follows up any early refill requests and suspected misuse. New patients may choose four additional contacts with nurses during the first 2 months of treatment. In cases of patient death, the pharmacy halts drug shipments and notifies JPI, allowing deaths to be captured with perhaps greater accuracy than is typical. JPI seeks additional information on every reported AE, including cases that may have been reported multiple times. This was why Dr. Zvosec was contacted by JPI concerning the deaths they reported. To ensure thorough reporting, JPI provides all cases to regulators, including those for which multiple reports of a single case cannot be excluded definitively. XyremÒ is approved to treat certain symptoms of narcolepsy in the US, Europe, and Canada. Worldwide AEs are collected and analyzed by JPI on an ongoing basis and reported to regulators routinely. Safety data were solicited prospectively from physicians during the first 3 years of marketing [3]. A comprehensive postmarketing safety analysis recently described XyremÒ’s low incidence of abuse, dependence, and diversion [4]. In addition to published data and product labeling, AE information is available on request from FDA via FOIA. We believe the safety profile for XyremÒ is well characterized. Disclosures Y. Grace Wang is an employee of Jazz Pharmaceuticals and owns stock and stock options in the company. She currently serves as a Director of Clinical Development (2009 – present). Prior to this current position, she was a Director in Drug Safety at Jazz Pharmaceuticals. She has overseen XyremÒ postmarketing safety and safety of sodium oxybate in clinical trials for fibromyalgia for the past 4 years. Dr. Wang has 6 years experience in Drug Safety.
References [1] Lammers GJ, Bassetti C, Billiard M, Black J, Broughton R, et al. Sodium oxybate is an effective and safe treatment for narcolepsy. Sleep Med 2010;11(1):105–6. [2] Zvosec DL, Smith SW. Response from the authors. Sleep Med 2010;11(1):106–8. [3] Wedin GP, Hornfeldt CS, Ylitalo LM. The clinical development of chydroxybutyrate (GHB). Curr Drug Safety 2006;1:99–106.
[4] Wang YG, Swick TJ, Carter LP, Thorpy MJ, Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009;54:365–71.
Y. Grace Wang Jazz Pharmaceuticals Inc., 3180 Porter Dr., Palo Alto, CA 94304, USA Tel.: +1 650 496 2687. E-mail address: [email protected] Available online 1 April 2010
1389-9457/$ - see front matter Ó 2010 Elsevier B.V. All rights reserved. doi:10.1016/j.sleep.2010.02.003
Response to ‘‘XyremÒ (sodium oxybate) postmarketing adverse event reporting system”
We appreciate the letter submitted by Dr. Wang [1] in response to our earlier letter [2] and original article [3] and will respond to several points that she raises. First, we would like to clarify that we stated that data on postmarketing adverse events (AEs) related to XyremÒ/sodium oxybate (a pharmaceutical formulation of gamma hydroxybutyrate, GHB) are ‘‘virtually impossible for members of the public to determine,” and that AE surveillance data collected by Jazz Pharmaceuticals, Inc. (JPI) ‘‘are not readily available to the public, as far as we are aware.” Our focus was on ready access to information by members of the public, including potential prescribing physicians, not by federal regulators or JPI. Thus, while we appreciate Dr. Wang’s statement that one can request data on postmarketing surveillance through a Freedom of Information Act (FOIA) request, we do not feel that this qualifies as ‘‘ready access”; in fact, a FOIA request that we previously made for data on GHB-associated fatalities was denied due to privacy concerns, despite our specification that any and all personal identifying information be removed. The postmarketing safety analysis by Wang et al. [4] was not available to us at the time that we prepared our initial response; however, we did access it later during the review process and referenced it in an Addendum. We agree with Dr. Wang that the distribution of XyremÒ through a central pharmacy provides more opportunities for patient contact and AE reporting than with traditional pharmaceutical dispensing, which is beneficial for patients and JPI monitoring, although, again, data from these interactions and communications are not available to the public or prescribing physicians. We also appreciate that aspects of the XyremÒ Patient Success Program provide critically important and necessary opportunities for patient and physician education regarding use of XyremÒ due to the risk of AEs, abuse, diversion, etc.; we made specific note of this in our original article [3]. Regarding detection of XyremÒ-associated deaths, we appreciate that JPI collects and reports fatality data to regulators, regardless of whether this may result in multiple reports of a single case. Further,