; 7bit Dear Colleague, As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent product safety information. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site. *_PRODUCT SAFETY INFORMATION_* *__* Communication about an Ongoing Safety Review Regranex (becaplermin) [ ] "(Mar 27)" FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers. This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers. ** FDA will communicate its conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program. For additional information about the product, the studies, and how to report adverse events, please visit Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine) [ ] "(Mar 27)" FDA has been made aware of recent findings from analyses of data collected from ""The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study"". The D:A:D Study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs. Analyses of data collected through February 1, 2007 examined the risk of myocardial infarction (heart attack) in patients taking selected HIV drugs from the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. The analyses, specifically, describe the relative risk of heart attack among cumulative use, recent use (currently using or use within the past 6 months), and past use (last use greater than 6 months ago) of these drugs. These analyses showed that recent use of abacavir or didanosine was associated with an increased risk of heart attack. Patients taking either of these drugs had a greater chance of developing a heart attack than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after abacavir or didanosine were stopped. FDA currently believes analyses conducted with D:A:D Study data are incomplete; no analyses were conducted evaluating the risk of heart attack when patients take tenofovir or emtricitabine, two other drugs in the class of NRTIs. However, FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with these products to the FDA MedWatch reporting program. For additional information about this communication including study details and how to report adverse events, please visit Early Communication About an Ongoing Safety Review of Montelukast (Singulair) [ ] "(Mar 27)" FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent asthma. Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008). FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood. For additional information including how to report adverse events associated with this product, please visit FDA Alert - Darunavir Ethalolate (marketed as Prezista) Information [ ] "(Mar 21)" FDA and Tibotec Therapeutics have reviewed information from clinical trials in which Prezista was administered and from postmarketing adverse event reports of hepatotoxicity in patients taking Prezista. While causality is not firmly established, an association between Prezista and hepatotoxicity is suspected. Prezista, a protease inhibitor indicated for the treatment of human virus (HIV) infection in antiretroviral adult patients, is co-administered with ritonavir, an antiretroviral drug associated with hepatotoxicity. In general, HIV antiretroviral medications are associated with liver enzyme elevations, however, for some medications, an association with hepatotoxicity is more firmly established. Healthcare providers should conduct appropriate hepatic laboratory testing prior to and after starting patients on Prezista. Patients should promptly seek medical attention if they experience unexplained fatigue, anorexia, nausea, jaundice, abdominal pain or dark urine. Healthcare professionals should consider interrupting or discontinuing Prezista if evidence of new or worsening liver injury arises. For additional information including links to Prezista prescribing information, please visit If you have any questions, you may send an email to or contact us at the numbers listed below. If you do not wish to receive this information updates, you may purchase at this link: FDA Consumer Health Information [ ]. Sincerely, "Brenda L. Evelyn, SBB(ASCP) Janelle Derbis, PharmD" "" "Office of Special Health Issues Office of Special Health Issues" "" "U.S". "Food and Drug Administration U.S. Food and Drug Administration" "" "5600 Fishers Lane"", Room 9-49 20 N. Michigan Avenue, Suite 510" "" "Rockville"", MD 20857 Chicago, IL 60602" "" "(301) 827-4460 (312) 596-6516" "" "(301) 443-4555 (fax) (312) 886-1682 (fax)" "" Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner Preferences Page [ ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ ]. [ ] [ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420 ; =09FDA Update for Healthcare Professionals =09 =09 =09 =09 body { =09font-size: 12px; =09font-family: arial, verdana, sans-serif; =09font-weight: normal; =09font-style: normal; } { =09color: gray; =09font-size: 10px; =09font-family: arial, verdana, sans-serif; =09font-weight: 100; } =09 =09 =09 =09 =09 =09 =09 =09 =09Dear Colleague, As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent product safety information. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site. PRODUCT SAFETY INFORMATION Communication about an Ongoing Safety Review Regranex (becaplermin) (Mar 27) FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers. This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers. FDA will communicate its conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program. For additional information about the product, the studies, and how to report adverse events, please visit Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine) (Mar 27) FDA has been made aware of recent findings from analyses of data collected from "The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study". The D:A:D Study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs. Analyses of data collected through February 1, 2007 examined the risk of myocardial infarction (heart attack) in patients taking selected HIV drugs from the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. The analyses, specifically, describe the relative risk of heart attack among cumulative use, recent use (currently using or use within the past 6 months), and past use (last use greater than 6 months ago) of these drugs. These analyses showed that recent use of abacavir or didanosine was associated with an increased risk of heart attack. Patients taking either of these drugs had a greater chance of developing a heart attack than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after abacavir or didanosine were stopped. FDA currently believes analyses conducted with D:A:D Study data are incomplete; no analyses were conducted evaluating the risk of heart attack when patients take tenofovir or emtricitabine, two other drugs in the class of NRTIs. However, FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with these products to the FDA MedWatch reporting program. For additional information about this communication including study details and how to report adverse events, please visit Early Communication About an Ongoing Safety Review of Montelukast (Singulair) (Mar 27) FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent asthma. Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008). FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood. For additional information including how to report adverse events associated with this product, please visit FDA Alert - Darunavir Ethalolate (marketed as Prezista) Information (Mar 21) FDA and Tibotec Therapeutics have reviewed information from clinical trials in which Prezista was administered and from postmarketing adverse event reports of hepatotoxicity in patients taking Prezista. While causality is not firmly established, an association between Prezista and hepatotoxicity is suspected. Prezista, a protease inhibitor indicated for the treatment of human virus (HIV) infection in antiretroviral adult patients, is co-administered with ritonavir, an antiretroviral drug associated with hepatotoxicity. In general, HIV antiretroviral medications are associated with liver enzyme elevations, however, for some medications, an association with hepatotoxicity is more firmly established. Healthcare providers should conduct appropriate hepatic laboratory testing prior to and after starting patients on should promptly seek medical attention if they experience unexplained fatigue, anorexia, nausea, jaundice, abdominal pain or dark urine. Healthcare professionals should consider interrupting or discontinuing Prezista if evidence of new or worsening liver injury arises. For additional information including links to Prezista prescribing information, please visit If you have any questions, you may send an email to or contact us at the numbers listed below. If you do not wish to receive this information updates, you may purchase at this link: FDA Consumer Health Information . Sincerely, Brenda L. Evelyn, SBB(ASCP)     Janelle Derbis, PharmD Office of Special Health Issues       Office of Special Health Issues U.S. Food and Drug Administration     U.S. Food and Drug Administration 5600 Fishers Lane, Room 9-49       20 N. Michigan Avenue, Suite 510 Rockville, MD 20857         Chicago, IL 60602 (301) 827-4460         (312) 596-6516 (301) 443-4555 (fax)         (312) 886-1682 (fax)       =09 =09 =09 =09 =09 Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). =09 =09=09 =09 =09 =09 =09 =09=09 Inc. sending on behalf of U.S. Food & Drug Administration (FDA) 5600 Fishers Lane =09=09=09 Rockville MD 20857 800-439-1420 =09=09 =09 =09

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