| Innohep (tinzaparin sodium injection) |
| Clinical study stopped early because of interim finding of increase in all-cause mortality in patients who received Innohep.
12/02/2008
|
| Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) |
| (UPDATE) FDA issued Q and As for recently approved Medication Guides.
12/02/2008
|
| December 2008 Patient Safety News |
| Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
12/01/2008
|
| Starcaps Dietary Supplement Capsules |
| Recall due to undeclared drug, Bumetanide, resulting in drug interactions including risk of hypotension (low blood pressure), or fainting (syncope).
11/26/2008
|
| Zhen De Shou Fat Loss Capsules |
| Recall due to undeclared sibutramine, an appetite suppressant known to substantially increase blood pressure and/or pulse rate in some patients.
11/26/2008
|
| Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics) |
| Potential increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen allele, HLA-B*1502.
11/24/2008
|
| Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump |
| Potential for device to stop administering insulin, resulting in hyperglycemia or hypoglycemia.
11/20/2008
|
| Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel |
| Voluntary recall due to samples of the products containing Burkholderia Cepacia bacteria.
11/17/2008
|
| Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa) |
| Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation
11/12/2008
|
| Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) |
| Product recalled because some bottles of the product could include metal fragments.
11/12/2008
|
