Primary Hyperlipidemia: In clinical trials, the adverse reactions observed in greater than or equal to 2% of patients - and more commonly with Welchol than placebo - regardless of investigator assessment of causality were constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs. 3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%), pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% vs. 3.1%), rhinitis (3.2% vs. 3.1%) and myalgia (2.1% vs. 0.4%).
Type 2 Diabetes: In clinical trials, the adverse reactions observed in greater than or equal to 2% of patients - and more commonly with Welchol than placebo - regardless of investigator assessment of causality were constipation (8.7% vs. 2.0%), nasopharyngitis (4.1% vs. 3.6%), dyspepsia (3.9% vs. 1.4%), hypoglycemia (3.0% vs. 2.3%), nausea (3.0% vs. 1.4%) and hypertension (2.8% vs. 1.6%).
Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship. Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol. Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol.
Welchol is Pregnancy Category B.
For more information on Welchol, call 877-4-DSPROD (877-431-7763), or go to the Welchol web site at http://www.Welchol.com.
About Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the
U.S. subsidiary of Daiichi Sankyo Co., Ltd., one of Japan's leading
pharmaceutical companies and a global leader in pharmaceutical innovation
whose roots date back to 1899. The company is dedicated to the discovery,
development and commercialization of innovative medicines that im
|SOURCE Daiichi Sankyo, Inc.|
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