54.3 F
San Diego
Thursday, Mar 28, 2024
-Advertisement-

FDA Issues Alert Over Amylin’s Byetta

The Food and Drug Administration issued an alert Aug. 18 warning consumers of increased cases of a dangerous pancreas inflammation linked to patients taking diabetes drug Byetta. The agency said it received six reports of patients who were hospitalized because of complications related to pancreatitis, including two deaths.

San Diego biotechnology company Amylin co-markets the drug with partner Eli Lilly and Co. of Indianapolis. The companies are developing a long-acting release version of Byetta, which they plan to submit to regulators next year.

In response to the latest findings, the FDA said it would issue stronger warning labels on the drug, although it was unclear whether that would entail issuing a “black box” warning.

Amylin’s shares, traded under the symbol AMLN on the Nasdaq, closed down 13 percent at $29.76 on Aug. 18.

The news follows an earlier warning in October, when the FDA said it received 30 reports of pancreatitis in Byetta patients. The FDA said the drug was suspected in some cases, and Amylin agreed to update the drug’s label with additional risk-related information.

, Heather Chambers

-Advertisement-

Featured Articles

-Advertisement-
-Advertisement-

Related Articles

-Advertisement-
-Advertisement-
-Advertisement-