IRVINE — The Food and Drug Administration on Tuesday announced its formal approval of Pfizer Inc.'s national program to alert 19,000 doctors about potentially flawed valves for artificial hearts, which are blamed in about 260 deaths. But government officials said they still have some concerns about the program.
Earlier this week, it was disclosed that the FDA criticized Pfizer's Shiley Inc. unit for failing to include adequate warnings about potentially life-threatening fractures in the mechanical valves that have been implanted in 82,000 people worldwide. Irvine-based Shiley manufactured the valves, which the company voluntarily withdrew from the market in 1986.
After several news reports this week drew attention to the FDA's criticism, the agency released a statement Tuesday saying it had accepted Shiley's plan to find patients implanted with its Bjork-Shiley 60-degree Convexo-Concave valve.
"Those words are not meant to convey (that) we accept or endorse the packaging of the materials," said James Morrison, the FDA's deputy director of training and assistance.
Shiley had a different interpretation of the FDA's action. "This is almost a retraction of the statements yesterday," said Becky Zadro, a Shiley spokeswoman.
The FDA, Shiley and Public Citizen--a consumer group founded by Ralph Nader--have been working together since September on a plan for contacting physicians.
"We and the FDA mainly agree on the plan," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "We were snookered, though, about the packaging because they didn't show us those envelopes."
The FDA criticized the original packages that Pfizer sent to doctors, saying the envelopes resembled junk mail and were likely to be discarded by doctors. The envelopes showed a picture of a man and woman talking to a doctor.
About 82,000 people worldwide--23,000 of them in North America--were implanted with the valve; 55,000 of them are still living. According to FDA figures, 395 of the Shiley valves have fractured, resulting in about 260 deaths.
Shiley has contracted with Medic Alert, a nonprofit medical information foundation in Turlock in Northern California to build a national computerized registry of valve recipients that would be available to doctors and emergency medical personnel. There is some evidence that valve fracture victims can be saved if the problem is diagnosed in time.
Those people in the registry will receive identification cards and a bracelet or necklace--similar to those worn by diabetics--saying that they have a Bjork-Shiley valve.