Shares of Novo Nordisk A/S, the world’s largest maker of diabetes drugs, may fall after the Danish company and Canadian regulators warned that Novo’s GlucoNorm treatment may have a potentially fatal side effect when taken with another medicine.
The combination of Novo’s GlucoNorm diabetes therapy with a generic cholesterol-lowering drug called gemfibrozil may cause severe low blood sugar, the Bagsvaerd, Denmark-based company said in a statement yesterday. GlucoNorm is sold as Prandin in the U.S.
Gemfibrozil has been implicated in other potentially deadly drug interactions. In 2001, German drugmaker Bayer AG pulled its Baycol cholesterol treatment off the market because more than 1,000 patients who took the medication along with gemfibrozil developed a muscle-weakening disease. Regulators also linked the combination to more than 100 deaths.
“In both cases, it looks like (gemfibrozil) increases the blood levels of the other drug, so you get lower blood sugar than you would with GlucoNorm on its own,” said Sidney Wolfe, director of Public Citizen’s health research group, in an interview. Public Citizen is a consumer watchdog organization in Washington.
Shares of Novo Nordisk fell 2 kroner to 226 kroner as of yesterday’s close of trading in Copenhagen, before the statement on GlucoNorm was released. The shares have risen 11 percent this year.
Novo Nordisk Canada has received three reports of the condition from the U.S. and two from France, the statement said.
In the U.S., the drug’s prescribing label already warns against use with gemfibrozil, said Susan Cruzan, a spokeswoman for the U.S. Food and Drug Administration. Wolfe recommended that GlucoNorm’s drug information include the FDA’s most severe advisory, a so-called “black-box” warning, to alert patients and doctors about the interaction.
Officials from the Danish drugmaker are discussing the U.S. label with regulators, said company spokeswoman Susan Jackson.
Pfizer Inc. sells gemfibrozil under the brand name Lopid. Other companies, including Watson Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., sell generic versions.