Glaxo’s Diabetes Drug Tied to Eye Risk, U.S. FDA Says (Update2)

Source | Bloomberg

January 5, 2006 

GlaxoSmithKline Plc’s Avandia diabetes drug has been linked to swelling in the back of the eye, which can reduce vision, U.S. regulators said.

The Food and Drug Administration sent an e-mail notice today about the complication, known as macular edema, to about 54,000 subscribers of MedWatch, the agency’s alert system. The FDA also forwarded a letter that Glaxo sent last month to doctors, saying the company received reports of both new and worsening cases of swelling in people taking Avandia.

People with diabetes already are at higher risk of eye complications because of the disorder, which results in the blood vessels at the back of the eye, or retina, becoming leaky and swelling. European regulators last month also said they are reviewing macular edema reports in people using Avandia and Takeda Pharmaceutical Co.’s similar Actos drug.

“Even though the reported incidence is very rare, we felt a need to alert doctors,'’ said Bernadette King, a Glaxo spokeswoman, in a telephone interview. She said the cause of the swelling is not clear.

The swelling can cause blurred vision and changes in how color and darkness are perceived, the Glaxo letter said.

There is less than one report of macular edema for every 10,000 patients estimated to have taken Avandia, King said. The FDA has said that complications often are not reported to the agency or doctors, making it difficult to get a true estimate how often injuries occur in people taking specific drugs.

4 Million Users

About 4 million people have used Avandia in the U.S., King said. Avandia and Actos are used by people with Type 2 diabetes, the most common form, in which the body fails to produce enough insulin to keep blood sugar well controlled. The medicines make the body more sensitive to the insulin it has available.

Third-quarter Avandia sales rose 29 percent to 299 pounds ($525 million).

London-based Glaxo is the world’s second-largest drugmaker, behind Pfizer Inc. American depositary receipts of Glaxo were unchanged at $51.95 as of 3:02 p.m. in New York Stock Exchange composite trading.

Calls to Takeda’s U.S. offices in Lincolnshire, Illinois, were not immediately returned.