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U.S. Department of Health and Human Services

Drugs

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Postmarketing Drug Safety Evaluation Summaries Completed from September 2007 through December 2009

 

Product Name: Trade (Active Ingredient)   

NDA/BLA Number 
Approval Date

Major Indication(s)Summary of Evaluation FindingsActions Taken and Ongoing Surveillance Activities

Afluria 
(Influenza Virus Vaccine)  

  

BLA 125254 

      

September 28, 2007

For active immunization of persons ages 6 months and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.No potential safety problems were identified.No labeling changes required at this time.

Alvesco (Ciclesonide) 

  

NDA 021658 

  

January 10, 2008

 

Maintenance treatment of asthma in patients 12 years of age and older.Adverse event reports related to drug ineffectiveness were identified and reviewed. These reports described problems with drug delivery (possible device malfunction) after a period of use.

No labeling changes required at this time.

FDA has requested additional information from the sponsor to further investigate this issue.

Anthelios 40 (Avobenzone, Ecamsule, Octocrylene, and Titanium dioxide cream)
   

NDA 022009  

  
March 31, 2008

Sunscreen cream.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Bystolic (Nebivolol  hydrochloride)

   
NDA 021742

  

December 17, 2007

 

Treatment of hypertension.Adverse event reports of liver toxicity and serious skin conditions were identified and reviewed.  These adverse events were analyzed and determined to be related to underlying disease, age, concomitant therapy, or other causes, rather than to Bystolic.No labeling changes required at this time.

Children's Zyrtec Hives Relief and Children's Zyrtec Allergy (Cetirizine hydrochloride)
 
NDA 022155

  

November 16, 2007

Temporary relief of allergy symptoms including hives (Children's Zyrtec Hives Relief), in patients 2 years of age and older.
 
Temporary relief of allergy symptoms including runny nose, sneezing, itching, and watery eyes, and itching of the nose and throat (Children's Zyrtec Allergy), in patients 2 years or age and older.		No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Combigan (Brimonidine tartrate and Timolol maleate)
 
NDA 021398

  

October 30, 2007

Treatment of elevated intraocular pressure (IOP) in patients with glaucoma.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Cosyntropin injection (Cosyntropin)

  

NDA 022028

  

February 21, 2008

 

For use in diagnosing patients with suspected adrenocortical insufficiency.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Doribax (Doripenem)

    

NDA 022106

  

October 12, 2007

Treatment of complicated intra-abdominal infections, complicated urinary tract infections, or kidney infections.

Serious adverse events involving liver disorder, low-platelets (thrombocytopenia"), and seizures ("convulsions") were identified.  On additional in-depth review FDA determined that these serious adverse events are adequately described in the current label.

Serious adverse events of the kidney ("renal impairment") were noted, but on further review it was determined these events were not attributed to doripenem.

No labeling changes required at this time.

Intelence (Etravirine)

  

NDA 022187

  

January 18, 2008

Treatment of patients with human immunodeficiency virus type 1 (HIV-1).Serious adverse event reports for skin and hypersensitivity reactions, liver disorders, coagulation ("bleeding") disorders, and neuro-psychiatric disorders were identified, and FDA determined these events are adequately described in the current labeling.No labeling changes required at this time.

Isentress (Raltegravir)   

   

NDA 022145   

  

October 12, 2007

Treatment of patients with human immunodeficiency virus type 1 (HIV-1).Serious adverse event reports for low platelets ("thrombocytopenia"), psychiatric events (depression, suicidality, insomnia, vivid dreams, nightmares and anxiety), serious skin and hypersensitivity reactions, liver injury ("hepatotoxicity"), and inflammation of the pancreas ("pancreatitis") were identified. FDA determined that low platelets, psychiatric events, serious skin reactions, and inflammation of the pancreas are adequately described in the current label.  No labeling changes required at this time.

Luvox CR (Fluvoxamine maleate)   

  

NDA 022033   

  

February 28, 2008

Treatment of social anxiety disorder ("social phobia"), and obsessions and compulsions in patients with symptoms of obsessive compulsive disorder.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Morphine Sulfate (Morphine sulfate; Oral Solution)   

  

NDA 022195   

  

March 17, 2008

Relief of moderate to severe acute and chronic pain where opioid pain relievers are appropriate.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Morphine Sulfate (Morphine sulfate; Tablets)   

  

NDA 022207   

  

March 17, 2008

Relief of moderate to severe acute and chronic pain where opioid pain relievers are appropriate.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Moxatag (Amoxicillin Tablets, Extended Release)   

  

NDA 050813   

  

January 23, 2008

Treatment of tonsillitis and/or sore throat due the bacteria Streptococcus pyogenes in patients 12 years of age and older.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Patanase (Olopatadine hydrochloride)   

  

NDA 021861   

  

April 15, 2008

Relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Pristiq (Desvenlafaxine succinate)   

  

NDA 021992   

  

February 29, 2008

Treatment of major depressive disorder ("depression").

Adverse event reports of pancreatitis were identified and reviewed. FDA determined that these reports either did not provide adequate clinical information or were confounded by various underlying conditions (including prior history of pancreatitis) and concomitant medications labeled for pancreatitis. None of these reports of pancreatitis provided compelling evidence to suggest a significant safety signal of pancreatitis associated with Pristiq.   

Adverse event reports of hostility and anger were identified and reviewed. FDA determined these events are adequately described in the current labeling.  

Adverse event reports of medication error reports were identified and reviewed. FDA decided that no action is necessary at this time based on the available information.  

No labeling changes required at this time.

Renvela (Sevelamer carbonate)   

  

NDA 022127   

  

October 19, 2007

Control of serum phosphorus ("phosphate binder") in patients with chronic kidney disease who are on dialysis.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Rotarix (Rotavirus Vaccine, Live, Oral)   

  

BLA 125265   

  

04/03/2008

For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.

Porcine Circovirus 1 is present in Rotarix.

Serious adverse events of gastroenteritis were identified, including reports of severe diarrhea and prolonged shedding of vaccine virus in infants later identified to have Severe Combined Immunodeficiency (SCID).  

On March 22, 2010, the FDA recommended that clinicians temporarily suspend use of Rotarix vaccine. Based on a careful evaluation of the information, a thorough review of the scientific literature, and input from scientific and public health experts, on May 14, 2010, the Agency revised its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.
See Update on Recommendations for the Use of Rotavirus Vaccines.  

In February 2010, a labeling change was completed for Rotarix to include SCID as a contraindication. 
See Rotavirus Vaccine, Live, Oral.  

Salonpas (Menthol and Methyl salicylate topical patch)   

  

NDA 022029   

  

February 20, 2008

Temporary relief of mild to moderate aches and pains of muscles and joints associated with strains, sprains, simple backache, arthritis, and bruises.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Simcor (Simvastatin and Niacin)   

  

NDA 022078   

  

February 15, 2008

To decrease various types of cholesterol and triglycerides, and to increase HDL cholesterol, among certain patient populations when treatment with either simvastatin monotherapy or niacin extended-release monotherapy is inadequate.  No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Taclonex Scalp (Calcipotriene and Betamethasone dipropionate)   

  

NDA 022185   

  

May 9, 2008

Treatment of severe psoriasis vulgaris of the scalp in patients 18 years of age and older.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Tekturna HCT (Aliskiren hemifumarate and Hydrochlorothiazide)   

  

NDA 022107   

  

January 18, 2008

Treatment of hypertension (high blood pressure) in patients who are not adequately controlled on single drug therapy ("monotherapy").No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Treximet (Sumatriptan succinate and Naproxen sodium)   

  

NDA 021926   

  

April 15, 2008

Treatment of acute migraine attacks with or without aura in adults.Adverse event reports of cardiovascular events were identified and reviewed. FDA determined that cardiovascular events are adequately described in the current label. Additionally, adverse event reports of drug administration errors were identified.

No labeling changes required at this time.   

FDA is currently reviewing the drug administration error reports.    

Venlafaxine hydrochloride ER (Venlafaxine hydrochloride extended release)   

  

NDA 022104   

  

May 20, 2008

Treatment of major depressive disorder ("depression") and social anxiety disorder.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Voltaren gel (Diclofenac Gel; Topical)   

  

NDA 022122   

  

October 17, 2007

Treatment of the pain of osteoarthritis of joints amenable to topical treatment, such as knee joints and hand jointsNo unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Xyzal (Levocetirizine dihydrochloride)   

  

NDA 022157   

  

January 28, 2008

Relief of symptoms associated with seasonal and perennial allergic rhinitis, and the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

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