Drug Safety Alerts and Recalls

FDA reviews atypical subtrochanteric femur fractures risk with oral bisphophonates

March 11, 2010

The FDA has notified healthcare professionals and patients that at this point, the data that have been reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
 

FDA warns of intravascular hemolysis risk with WinRho SDF

March 10, 2010

The FDA, Cangene, and Baxter have notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF [Rho(D) immune globulin IV (human)].
 

OneTouch SureStep glucose meter test strips recalled

February 25, 2010

LifeScan has announced it is conducting a voluntary recall of eight lots of OneTouch SureStep glucose meter test strips because they may provide falsely low glucose results when the glucose level is >400mg/dL.
 

FDA reviews cardiac risk of Invirase in combination with Norvir

February 23, 2010

The FDA has notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart associated with the use of Invirase (saquinavir, from Roche) in combination with Norvir (ritonavir, from Abbott).
 

FDA reviews cardiovascular safety of Avandia

February 23, 2010

The FDA has notified healthcare professionals and patients that it is reviewing the primary clinical trial data from the long-term RECORD study to evaluate the cardiovascular safety of Avandia (rosiglitazone tablets, from GlaxoSmithKline).
 

New warning and safety controls for long-acting beta agonists

February 18, 2010

The FDA announced that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma.
 

Exjade gains boxed warning

February 18, 2010

The FDA and Novartis have notified healthcare professionals about changes to the Exjade (deferasirox tablets) Prescribing Information, including a Boxed Warning.
 

FDA warns of Maalox Total Relief medication errors

February 18, 2010

The FDA and Novartis Consumer Health have notified healthcare professionals about reports of serious medication errors involving patients who used Maalox Total Relief (bismuth subsalicylate) when they had intended to use a Maalox liquid antacid.
 

FDA announces safety plan for erythropoiesis-stimulating agents

February 16, 2010

The FDA has approved a risk management program to inform healthcare providers and patients about the risks of erythropoiesis-stimulating agents (ESAs).
 

Tysabri labeling to include safety information on risk of progressive multifocal leukoencephalopathy

February 05, 2010

The FDA has notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri (natalizumab, from Biogen Idec) infusions received.
 

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New Drug Products

ISTODAX

3/4/2010

Active Ingredient(s): Romidepsin 10mg/vial; pwd for IV infusion after reconstitution and dilution; contains povidone.
 

ARZERRA

2/25/2010

Active Ingredient(s): Ofatumumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
 

FANAPT

2/19/2010

Active Ingredient(s): Iloperidone 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.
 

ACTEMRA

2/12/2010

Active Ingredient(s): Tocilizumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
 

VOTRIENT

2/5/2010

Active Ingredient(s): Pazopanib 200mg, 400mg; tabs.
 

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