• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Postmarketing Drug Safety Evaluation Summaries Completed from January 2010 through September 2010

 

Product Name: Trade (Active Ingredient)   

NDA/BLA Number 
Approval Date

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

Acanya
(Benzoyl peroxide and Clindamycin phosphate)

 
NDA 050819
 
October 21, 2008 
Topical treatment of acne vulgaris in patients 12 years or older.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Aplenzin
(Bupropion hydrobromide)

 
NDA 022108
 
April 23, 2008 
Treatment of major depressive disorder (“depression”).No unlabeled or unexpected serious adverse events were identified.

No labeling changes required at this time.

ARTISS
[fibrin sealant (human)]

 
BLA 125266
 
March 19, 2008
For use to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.No new safety concerns were identified.No labeling changes required at this time.

Astepro
(Azelastine)

 
NDA 022203
 
October 15, 2008 
Relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older.Reports of nausea were identified and reviewed. All the events of nausea were non-serious, but a majority of these events were associated with discontinuation of therapy.FDA is requesting that the sponsor add the term “nausea” to the product labeling.

Claritin
(Loratadine)

 
NDA 021952

 

June 16, 2008

For the temporary relief of symptoms due to hay fever or other respiratory allergies:
  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itching of nose and throat
No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Durezol
(Difluprednate)

 
NDA 022212
 
June 23, 2008 
Treatment of inflammation and pain following ocular (eye) surgery.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Entereg
(Alvimopan)

 
NDA 021775
 
May 20, 2008
To accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.Adverse event report of gastrointestinal perforation and myocardial infarction were identified and reviewed. The reports of gastrointestinal perforation were complicated by the patients’ underlying surgical condition, making a causal attribution to Entereg uncertain. The reports of myocardial infarction were determined to be related to underlying coronary artery disease, age, or other causes, rather than to Entereg.No labeling changes required at this time.

KINRIX
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)    

 

BLA 125260

  

June 24, 2008

Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX™ and/or PEDIARIX™ for the first three doses and INFANRIX for the fourth dose.

No new safety concerns were identified.

No labeling changes required at this time.

LoSeasonique
(Ethinyl estradiol; Levonorgestrel)  

   

NDA 022262  

  

October 24, 2008

An estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Nexium
(Esomeprazole)

 

NDA 022101

 
February 27, 2008
Treatment of gastroesophageal reflux disease (GERD); risk reduction of Non-Steroidal Anti-inflammatory Drug (NSAID) associated gastric ulcer; eradication of H. pylori bacterial infection (along with other therapy) to reduce the risk of duodenal ulcer recurrence; and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.

Nicardipine
(Nicardipine) 

  

NDA 022276  

  

July 24, 2008

Short-term treatment of hypertension when oral therapy is not feasible.
This product was recalled approximately 3 months after approval for failing to meet impurity specifications and has not been remarketed.

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

Omeprazole

(Omeprazole)

  

NDA 022032  

  

December 4, 2007

Frequent heartburn (occurs 2 or more days a week). Not intended for immediate relief of heartburn.
 
Not intended for use for more than 14 days.
Serious adverse events related to low blood magnesium including seizure and muscle weakness were noted in patients receiving long term treatment with Omeprazole and other proton pump inhibitors. 

All events were reported in patients receiving more than 14 days treatment.

(Updated 5/2011)


FDA issued a Drug Safety Communication.


The Warnings and Precautions section of the labeling for all prescription PPIs will be updated to include the potential risks of low serum magnesium levels with long term use

Over-the-counter (OTC) PPIs are only intended for a 14 day course of treatment up to 3 times a year, therefore OTC PPI labels will not be revised.

Pentacel
[Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus influenzae type b, Conjugate (Tetanus Toxoid Conjugate) Vaccine]

  

BLA 125145  

 

June 20, 2008

Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).No new safety concerns were identified. No labeling changes required at this time.

Recothrom
[Thrombin, topical (recombinant)]  

 

BLA 125248

  

January 17, 2008

For use as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of minor bleeding by standard surgical techniques is ineffective or impractical.
Adverse event reports of thromboembolism when Recothrom was injected or administered via a method other than direct topical application were identified and reviewed. The current label includes the risk of thrombosis and indicates that Recothrom is for topical use only, via direct topical application or an absorbable gelatin sponge.
FDA is continuing to evaluate this issue to determine the need for appropriate action.

Requip XL
(Ropinirole)  

  

NDA 022008   

  

July 1, 2008

Treatment of signs and symptoms of idiopathic Parkinson’s disease.

Reports of fatigue, asthenia (weakness), and malaise were identified and reviewed.

 

FDA is continuing to evaluate these issues to determine if regulatory action is required.

Sancuso
(Granisetron) 

 
NDA 022198
 
September 12, 2008
Prevention of nausea and vomiting in patients receiving certain types of chemotherapy for up to 5 consecutive days.
No unlabeled or unexpected serious adverse events were identified.No labeling changes required at this time.