| Date Released |
Drug (s) Involved |
Additional Information |
| December 11, 2008 |
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep) |
www.fda.gov/cder/drug/infopage/OSP_solution/default.htm |
| December 2, 2008 |
Innohep (tinzaparin sodium injection) |
www.fda.gov/cder/drug/early_comm/tinzaparin.htm |
| November 24, 2008 |
Dilantin, Phenytek (phenytoin) and Cerebyx (fosphenytoin sodium) |
www.fda.gov/cder/drug/InfoSheets/HCP/phenytoin_fosphenytoinHCP.htm |
| November 12, 2008 |
Fosamax,
Fosamax Plus D (alendronate),
Didronel (etidronate),
Boniva (ibandronate),
Aredia (pamidronate),
Actonel,
Actonel w/ Calcium(risedronate),
Skelid (tiludronate),
and Reclast,
Zometa (zoledronic acid) |
www.fda.gov/cder/drug/early_comm/bisphosphonates_update_200811.htm |
| October 17, 2008 |
Raptiva (efalizumab) |
www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html |
| October 7, 2008 |
Spiriva Handihaler (tiotropium) |
www.fda.gov/cder/drug/early_comm/tiotropium.htm |
| September 26, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/cder/drug/early_comm/epoetin_alfa.htm |
| September 12, 2008 |
Tarceva (erlotinib) |
www.fda.gov/medwatch/safety/2008/tarceva_dhcp_letter.pdf |
| September 11, 2008 |
Rituxan (rituximab) |
www.fda.gov/medwatch/safety/2008/rituxan_DHCP_Final%209411700.pdf |
| September 4, 2008 |
Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) |
www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm |
| August 26, 2008 |
Tysabri (natalizumab) |
www.fda.gov/cder/drug/InfoSheets/HCP/natalizumab2008HCP.htm |
| August 21, 2008 |
Zocor (simvastatin), Vytorin (ezetimibe/simvastatin), Zetia (ezetimibe) |
www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm |
| August 18, 2008 |
Byetta (exenatide) |
www.fda.gov/cder/drug/InfoSheets/HCP/exenatide2008HCP.htm |
| August 12, 2008 |
Vivitrol (naltrexone) |
www.fda.gov/cder/drug/InfoSheets/HCP/naltrexoneHCP.htm |
| August 8, 2008 |
Zocor (simvastatin) or Vytorin (ezetimibe/simvastatin) used with Cordarone/Paceerone (amiodarone) |
www.fda.gov/cder/drug/InfoSheets/HCP/simvastatin_amiodaroneHCP.htm |
| August 7, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/medwatch/safety/2008/ESA_DHCP_Aug2008.pdf |
| July 29, 2008 |
Novantrone (mitoxantrone hydrochloride) |
www.fda.gov/cder/drug/InfoSheets/HCP/mitroxantroneHCP.htm |
| July 24, 2008 |
Ziagen (abacavir) |
www.fda.gov/cder/drug/InfoSheets/HCP/abacavirHCP.htm |
| July 11, 2008 |
Avastin (bevacizumab) in combination with sunitinib malate |
www.fda.gov/medwatch/safety/2008/MAHA_DHCP.pdf |
| July 8, 2008 |
Fluoroquinolone Antimicrobial Drugs |
www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm |
| July 30, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid) |
www.fda.gov/medwatch/safety/2008/Myfortic_DHCP_june2008.pdf |
| June 16, 2008 |
Conventional and Atypical Antipsychotic use in Elderly patients treated for dementia-related psychosis |
www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm |
| June 3, 2008 |
Tumor Necrosis Factor (TNF) Blockers (Remicade, Enbrel, Humira, Cimzia) |
www.fda.gov/cder/drug/early_comm/TNF_blockers.htm |
| May 16, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid)
|
www.fda.gov/cder/drug/InfoSheets/HCP/mycophelolateHCP.htm |
| April 10, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid) |
www.fda.gov/cder/drug/early_comm/mycophenolate.htm |
| April 9, 2008 |
Exubera (insulin human rDNA origin) Inhalation Powder |
www.fda.gov/medwatch/safety/2008/Exubera_DHCP.pdf |
| April 1, 2008 |
Relenza (zanamivir) |
www.fda.gov/medwatch/safety/2008/relenza_DHCP.pdf |
| March 27, 2008 |
Ziagen (abacavir) and Videx (Didanosine) |
www.fda.gov/cder/drug/early_comm/abacavir.htm |
| March 27, 2008 |
Regranex (becaplermin) Gel |
www.fda.gov/cder/drug/early_comm/becaplermin.htm |
| March 27, 2008 |
Singulair (montelukast) |
www.fda.gov/cder/drug/early_comm/montelukast.htm |
| March 18, 2008 |
Spiriva (tiotropium) |
www.fda.gov/cder/drug/early_comm/tiotropium.htm |
| March 12, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/medwatch/safety/2008/epo_DHCP_03102008.pdf |
| March 12, 2008 |
Prezista (darunavir) |
www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf |
| March 11, 2008 |
Tussionex Pennkinetic (Chlorpheniramine/ Hydrocodone Extended-Release Suspension) |
www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html |
| March 4, 2008 |
Tamiflu (oseltamivir phosphate) |
www.fda.gov/medwatch/safety/2008/Tamiflu_DHCP.pdf |
| February 29, 2008 |
Spiriva (tiotropium bromide inhalation powder)
Foradil (formoterol fumarate inhalation powder) |
www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm |
| February 27, 2008 |
Tysabri (natalizumab) |
www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf |
| February 26, 2008 |
Avandia (rosiglitazone maleate) Medication Guide |
www.fda.gov/cder/Offices/ODS/MG/Avandia_MG.pdf |
| February 8, 2008 |
Botox (botulinum toxin type A)
Myobloc (botulinum toxin type B) |
www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm |
| February 1, 2008 |
Chantix (varenicline) |
www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm |
| January 31, 2008 |
Antiepileptic Medications |
http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm |
| January 25, 2008 |
Zetia (ezetimibe)
Vytorin (ezetimibe/ simvastatin) |
http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm |
| January 18, 2008 |
Ortho Evra Transdermal Patch (ethinyl estradiol /norelgestromin) |
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html |
| January 17, 2008 |
Nonprescription Cough and Cold Medicine Use in Children |
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm |
| January 16, 2008 |
Endrate (edetate disodium) |
http://www.fda.gov/cder/drug/advisory/edetate_disodium.htm |
| January 7, 2008 |
Actonel (risedronate)
Fosamax (alendronate)
Boniva (ibandronate) |
http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm |
| January 3, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01769.html |
| December 21, 2007 |
Duragesic (fentanyl transdermal system) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.htm |
| December 12, 2007 |
Tegretol, Carbatrol (carbamazepine) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm |
| December 4, 2007 |
DDAVP (Desmopressin Acetate) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm |
| November 27, 2007 |
Myfortic (mycophenolic acid) |
http://www.fda.gov/medwatch/safety/2007/Myfortic_DHCP_Letter.pdf |
| November 20, 2007 |
Chantix (varenicline) |
http://www.fda.gov/cder/drug/early_comm/varenicline.htm |
| November 14, 2007 |
Revatio (sildenafil) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/ED_HCP.htm |
| October 24, 2007 |
Provigil (modafinil) |
http://www.fda.gov/medwatch/safety/2007/Provigil_dhcpletter091207_final.pdf |
| October 18, 2007 |
Revatio (sildenafil) |
http://www.fda.gov/cder/consumerinfo/viagra/default.htm |
| October 16, 2007 |
Byetta (exenatide) |
http://www.fda.gov/cder/drug/infopage/exenatide/default.htm |
| October 1, 2007 |
Bisphosphonates |
http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm |
| September 28, 2007 |
Unapproved Hydrocodone Products |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html |
| September 26, 2007 |
Fentora (fentanyl buccal tablets) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_buccal.htm |
| September 17, 2007 |
Haldol (haloperidol) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm |
| September 10, 2007 |
Viracept (nelfinavir) |
http://www.fda.gov/medwatch/safety/2007/VIRACEPT_HCPLetter_9_10_07.pdf |
| August 17, 2007 |
Codeine Products Used by Nursing Mothers |
http://www.fda.gov/cder/drug/infopage/codeine/default.htm |
| August 16, 2007 |
Coumadin (warfarin) |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html |
| August 15, 2007 |
Nonprescription Cough and Cold Medicine Use in Children |
http://www.fda.gov/cder/drug/advisory/cough_cold.htm |
| August 6, 2007 |
Kaletra (lopinavir/ritonavir) Oral Solution |
http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf |
| July 5, 2007 |
Rocephin (ceftriaxone) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/ceftriaxone.htm |
| May 14, 2007 |
Exjade (deferasirox) |
http://www.fda.gov/medwatch/safety/2007/Exjade_DHCPL_May2007.pdf |
| March 16, 2007 |
Zyvox (linezolid) |
http://www.fda.gov/cder/drug/infopage/linezolid/default.htm |
| March 14, 2007 |
Sedative/Hypnotic Medications |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html |
| March 9, 2007 |
Actimmune (interferon gamma 1b) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/interferon_gamma1bHCP.pdf |
| January 24, 2007 |
Lucentis (ranibizumab) |
http://www.fda.gov/medwatch/safety/2007/Lucentis_DHCP_01-24-2007.pdf |