Swiss Pharmaceutical Regulator States That Side Effect Risks Outweigh Benefits

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a brief June 1, 2007 Wall Street Journal (WSJ) article it was reported that Switzerland’s pharmaceuticals regulator has ordered Novartis AG to recall Zelnorm from the market because the irritable bowel drug’s risk of serious side effects outweighed its therapeutic benefits.  In parts of Europe, including Switzerland, Zelnorm is known as Zelmac.

Zelnorm was pulled from the U.S. market on March 30, 2007 after it was linked to a higher chance of heart attacks and strokes.

According to the June 1 WSJ article, the Swiss regulator, Swissmedic, and Novartis disagreed about the safety profile of Zelnorm:

Swissmedic said a new analysis of data from clinical studies revealed an increased risk of angina, heart attacks and strokes when compared with a placebo. Novartis, based in Switzerland, said it is complying with the order but remains convinced that Zelmac has important benefits for certain patients.

According to a May 31, 2007 Reuters article about this Zelnorm recall in Switzerland, that country had approved the use of Zelmac / Zelnorm in women with irritable bowel syndrome in 2001.