Guest guest Posted March 27, 2008 Report Share Posted March 27, 2008 The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends healthcare professionals discuss the potential risks and benefits of using Regranex with their patients. This early communication is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public. Read the complete 2008 FDA Safety Summary, including a link to the FDA Early Communication About An Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex So what type of recall is this? Jeanetta CPhT BS Jeanetta Mastron CPhT BS Chemistry <rxjm2002@...> wrote: PharmacyOneSource.com Drug Shortage, Product Recall & Alert Newsletter. The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The 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. 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 the FDA's review is complete, healthcare professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public. Read the complete 2008 FDA MedWatch Safety Summary, including a link to the FDA Early Communication About an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#abacavir Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 27, 2008 Report Share Posted March 27, 2008 Once again this is a REAL communication but it is NOT a Recall it is an Alert! After more research and data the FDA may decide to recall or issue a black box warning. One who is in the field should keep an eye open for more possible alerts or future recalls about this drug. Hope this helps. Jeanetta Mastron CPhT BS Founder/Owner PharmacyOneSource.com Drug Shortage, Product Recall & Alert Newsletter. > > The FDA issued an Early Communication about recent findings of The > Data Collection on Adverse Events of Anti-HIV Drugs Study. Data > analyses from this study indicate a higher risk of heart attack in > patients infected with HIV-1 who were taking Ziagen (abacavir) or > Videx (didanosine) as part of their drug therapy. The 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. 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 the > FDA's review is complete, healthcare professionals should evaluate > the potential risks and benefits of each HIV-1 antiretroviral drug > their patients are taking. > > This early communication is in keeping with the FDA's commitment to > inform the public about its ongoing safety reviews of drugs. As soon > as this review is complete, the FDA will communicate the conclusions > and recommendations to the public. > > Read the complete 2008 FDA MedWatch Safety Summary, including a link > to the FDA Early Communication About an Ongoing Safety Review > regarding this issue at: > http://www.fda.gov/medwatch/safety/2008/safety08.htm#abacavir > > > > > > > Quote Link to comment Share on other sites More sharing options...
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