Patients ordering drugs online for depression and insomnia instead received schizophrenia medication that caused them to seek emergency medical treatment for breathing problems, the Food and Drug Administration learned yesterday.
Internet orders for Sanofi-Aventis SA’s Ambien, Pfizer Inc.’s Xanax, Forest Laboratories Inc.’s Lexapro and Wyeth’s Ativan, arrived labeled as the right medication but later proved to contain the powerful anti-psychotic drug haloperidol, made by Janssen Pharmaceutica in Belgium, which is owned by New Brunswick, N.J., company Johnson & Johnson.
So far, the FDA is aware of five incidents in which haloperidol was substituted for one of the drugs. The cases occurred in Texas, Pennsylvania, California, New Jersey and New York. Side effects ranged from muscle spasms to difficulty breathing. None of the cases resulted in death, although in at least three cases a patient required a trip to the emergency room, the FDA said.
It is not certain if Janssen or Johnson & Johnson reported the cases to the FDA. Upon learning of the fraudulent packages, the agency yesterday alerted the public, partly to obtain more information.
“It’s early in the process right now. We need the public’s help to identify the culprit Web sites,” said Ilisa Bernstein, director of pharmacy affairs at FDA, who said a preliminary analysis showed the pill contained haloperidol.
Ms. Bernstein said it is difficult to pinpoint where the drugs were sold from because Web site operators are able to cover their tracks quickly.
“These people operate under deceptive practices,” she said. “People go to one site and are automatically redirected to another and then their credit card is billed to yet another Web site. The Web is difficult because it’s easy to shut down fast and people can be somebody they are not.”
The FDA knows the packages were postmarked from Greece.
The agency put photos of the mislabeled pills and the packages they came in on its Web site. The investigation is ongoing.
FDA officials do not know how many people purchase their drugs on the Internet but warn on their Web site of the dangers associated with buying prescription drugs online. Safety tips include: Avoid getting a diagnosis over the Internet and make sure an online pharmacy is U.S. state-licensed.
The FDA says this is the first instance of haloperidol infiltrating drugs bought on the Internet.
However, in December 2005, the FDA said an internal investigation found nearly half of imported drugs federal authorities intercepted were shipped to fill orders that consumers thought they were placing with Canadian pharmacies.
Only 15 percent of the drugs obtained by the FDA originated in Canada. The remaining 85 percent were manufactured in 27 countries and promoted as being made in Canada.
“This operation suggests that drugs ordered from so-called ‘Canadian’ Internet sites are not drugs of safety and efficacy,” Andrew von Eschenbach, then FDA commissioner, said at the time.
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