Eight of the 24 developed valve problems after they took the drugs. So on Thursday morning, FDA officials asked representatives of Wyeth-Ayerst Laboratories, a division of American Home Products, and Interneuron Pharmaceuticals Inc., a small biotechnology company that makes dexfenfluramine, to come to the agency's headquarters on Friday to hear some new information about the drugs. When the company officials arrived, agency officials told them about the findings in patients without symptoms and asked them to withdraw the drugs from the market. Both American Home Products and Interneuron will suffer financially. Interneuron will be hit even harder, because dexfenfluramine is its only product on the market, said William Boni, a company spokesman.
Drug recalls are highly unusual.
The FDA says that just 12 drugs have been withdrawn from the market in the past 17 years. But in this case, said Dr. Alan Hillman, who directs the Center for Health Policy at the University of Pennsylvania, the companies really had no choice. With these statistics, for a company to leave a drug on the market, they are asking for class-action suits in the billions of dollars. Dexfenfluramine had been used by dieters in Europe for decades. Friedman said he could only speculate.