| EPOETIN ALFA | | FDA | 23-Sep-08 | FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.
The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product.
Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%).
Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.
FDA anticipates the receipt of additional data within the next several weeks.
As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public.
The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
|
| DARBEPOETIN ALFA | | MHRA | 04-Aug-08 | MHRA has issued drug updates:
Antiepileptics: suicidal thoughts and behaviour
Recombinant human erythropoietins: new recommendations for treatment of anaemia in cancer
Thalidomide and lenalidomide for multiple myeloma
Moxifloxacin: restricted use
Caffeine for apnoea of prematurity: check dose regimen before use
Accusol 35 solutions: precipitate formation during haemofiltration
Intrathecal drug pumps: disrupted drug delivery
Metronidazole for Clostridium-difficile-associated diarrhoea: use oral formulation
|
| EPOETIN ALFA | | MHRA | 04-Aug-08 | MHRA has issued drug updates:
Antiepileptics: suicidal thoughts and behaviour
Recombinant human erythropoietins: new recommendations for treatment of anaemia in cancer
Thalidomide and lenalidomide for multiple myeloma
Moxifloxacin: restricted use
Caffeine for apnoea of prematurity: check dose regimen before use
Accusol 35 solutions: precipitate formation during haemofiltration
Intrathecal drug pumps: disrupted drug delivery
Metronidazole for Clostridium-difficile-associated diarrhoea: use oral formulation
|
| EPOETIN ALFA HEXAL | | MHRA | 04-Aug-08 | MHRA has issued drug updates:
Antiepileptics: suicidal thoughts and behaviour
Recombinant human erythropoietins: new recommendations for treatment of anaemia in cancer
Thalidomide and lenalidomide for multiple myeloma
Moxifloxacin: restricted use
Caffeine for apnoea of prematurity: check dose regimen before use
Accusol 35 solutions: precipitate formation during haemofiltration
Intrathecal drug pumps: disrupted drug delivery
Metronidazole for Clostridium-difficile-associated diarrhoea: use oral formulation
|
| DARBEPOETIN ALFA | | FDA | 30-Jul-08 | FDA issued Q&As for recently approved Medication Guides.
The Medication Guides were developed to provide patients with important information about the risks of using ESAs.
The information in the Medication Guides may affect a patientâ¬(TM)s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.
FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs).
The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming.
FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.
|
| EPOETIN ALFA | | FDA | 30-Jul-08 | FDA issued Q&As for recently approved Medication Guides.
The Medication Guides were developed to provide patients with important information about the risks of using ESAs.
The information in the Medication Guides may affect a patientâ¬(TM)s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.
FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs).
The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming.
FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.
|
| DARBEPOETIN ALFA | | FDA | 07-Mar-08 | Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs.
Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of â0¥ 12 g/dL.
|
| EPOETIN ALFA | | FDA | 07-Mar-08 | Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs.
Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of â0¥ 12 g/dL.
|
| DARBEPOETIN ALFA | | MHRA | 03-Dec-07 | MHRA has issued drug updates:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting ß agonists: myocardial ischaemia
Varenicline: possible effects on driving, and psychiatric illness*
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events |
| EPOETIN ALFA | | MHRA | 03-Dec-07 | MHRA has issued drug updates:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting ß agonists: myocardial ischaemia
Varenicline: possible effects on driving, and psychiatric illness*
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events |
|