Rowasa (Mesalamine Rectal Suspension Enema) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Ulcerative Colitis »

What is Ulcerative Colitis?

Ulcerative colitis is a chronic inflammation of the large intestine (colon). The colon is the part of the digestive system where waste material is stored. The rectum is the end of the colon adjacent to the anus. In patients with ulcerative colitis, ulcers and inflammation of the inner lining of the colon lead to symptoms of abdominal pain, diarrhea, and rectal bleeding.

Ulcerative colitis is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's diseases are chronic conditions that can last years to decades. They affect approximately 500,000 to 2 million people In the United States. Men and women are affected equally. They most commonly begin during adolescence and early adulthood, but they also can begin during childhood and later in life.

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SIDE EFFECTS

Clinical Adverse Experience

ROWASA® (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF ROWASA® (MESALAMINE) RECTAL SUSPENSION
ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

	ROWASA®		PLACEBO
	N =815		N =128
SYMPTOM	N	%	N	%
Abdominal Pain/Cramps/Discomforl	66	8.10	10	7.81
Headache	53	6.50	16	12.50
Gas/Flatulence	50	6.13	5	3.91
Nausea	47	5.77	12	9.38
Flu	43	5.28	1	0.78
Tired/Weak/Malaise/Fatigue	28	3.44	8	6.25
Fever	26	3.19	0	0.00
Rash/Spots	23	2.82	4	3.12
Cold/Sore Throat	19	2.33	9	7.03
Diarrhea	17	2.09	5	3.91
Leg/Joint Pain	17	2.09	1	0.78
Dizziness	15	1.84	3	2.34
Bloating	12	1.47	2	1.56
Back Pain	11	1.35	1	0.78
Pain on Insertion of Enema Tip	11	1.35	1	0.78
Hemorrhoids	11	1.35	0	0.00
Itching	10	1.23	1	0.78
Rectal Pain	10	1.23	0	0.00
Constipation	3	0.98	4	3.12
Hair Loss	7	0.86	0	0.00
Peripheral Edema	5	0.61	11	8.59
UTI/Urinary Burning	5	0.61	4	3.12
Rectal Pain/Soreness/Burning	5	0.61	3	2.34
Asthenia	1	0.12	4	3.12
Insomnia	1	0.12	3	2.34

In addition, the following adverse events have been identified during post approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.