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Postmarketing Drug Safety Evaluations

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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 Findings	Actions 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.	( 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.

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