LOS ANGELES -- Filed away in the vast, sterile Rockville, Md., complex of the Food and Drug Administration are reams and reams of physician reports on the effects of drugs. They are stored in cabinets or on computer disks.
These are the Form 1639s, Adverse Reaction Reports. They are perhaps the most detailed evidence available about the hazards of pharmaceuticals, from aspirin to zinc oxide.
One area is reserved for products that have ibuprofen, a painkiller categorized as a non-steroidal anti-inflammatory drug (NSAID). The analgesic can be found in such familiar pain relievers as Advil, Medipren, Motrin and Nuprin.
The reports under this category document side-effects of ibuprofen products, which command about 20 percent of the painkiller market.
But one of the most celebrated examples of alleged risks is not among the volumes in the FDA conservatory.
It is not an oversight. Physicians have enough paper to shuffle without the additional burden of recording every drug side-effect they encounter.
Still, the case of one-time Seattle Seahawks star Kenny Easley reminds consumers of the dangers of taking medications that become household products.
Easley was a five-time Pro Bowl safety and was once voted NFL defensive player of the year. Today, his football career is over, the result of kidney failure he claims in a lawsuit began with taking four tablets of Advil to help reduce swelling in an injured ankle. He said he subsequently took from 16 to 20 tablets of Advil daily for at least three months before a doctor told him to stop.
Jon Borchardt, a retired Seahawks lineman, said players would take as much medication as necessary to numb their pain. He said the Seahawks training room has large dispensers or boxes of Advil, Tylenol and other nonprescription medications.
"They're not even passed out, they're just available," Borchardt said.
Borchardt said the players were less concerned with warnings on labels than feeling good enough to play.
"Remember, there is tremendous pressure to win," he said. "When you're looking at a Kenny Easley, he is an integral part of winning. But to have an athlete's health compromised is inexcusable."
Although his kidney problems began sometime in 1986, Easley contends that he did not know of the seriousness of the disease until April 1988 when the Seahawks traded him to the Phoenix Cardinals. While administering a routine physical examination, Phoenix doctors discovered the kidney disease.
In the complaint, Easley contends that Advil caused kidney deterioration, a claim that has some medical credibility.
The questions of who suggested Easley take so many tablets and how he was monitored once treatment started will be central to the suit.
"We think it is a grievous example of a lack of professionalism on the part of the doctors and a fairly uncaring position by the drug manufacturer on disclosing what the potential side-effects are," said Fred Zeder, Easley's attorney.
Gerald Palm, a lawyer representing two of three doctors who are defendants, denied the charge.
"With regards to neglect, our defense in the matter is that the physicians never told Kenny to take 16 Advil a day, or any Advil," Palm said. "This is not a case of doctors failing to monitor him for something they told him to do."
Easley has testified in one deposition that he quit taking Advil in September, but the defendants claim it was in July.
The doctors expected his condition to reverse itself when he stopped taking the drug, as research has shown usually happens.
Instead, Easley did not improve. He suffered from a condition called idiopathic nephritic syndrome -- unknown kidney failure.
"Our feeling is certainly this is tragic, but it is not anything the doctors did or failed to do," Palm said. "We don't think it had anything to do with Advil either."
Perhaps the biggest issue is one that concerns every household -- the safe use of Advil and other ibuprofen products.
The link between ibuprofen and kidney failure is inconclusive, an FDA doctor said. But the evidence is strong enough to worry some kidney specialists.
One of the latest studies at Johns Hopkins Medical Institutions in Baltimore found that 25 percent of the patients suffered from acute kidney failure when taking ibuprofen. The condition was reversed when the patients stopped the drug use.
The 12 patients in the study all had pre-existing conditions that would lead to kidney failure with ibuprofen treatment, a fact that skews the study, said the FDA's John Harter.
Another study at the National Institute for Environmental Health Sciences showed ibuprofen can cause kidney failure in individuals who have health problems, including high blood pressure, heart disease and pre-existing kidney problems.
Although the Advil label is vague, it warns consumers not to take more than six tablets in a 24-hour period without consulting a physician.
As with most drugs, mega-doses can be hazardous. Ibuprofen interferes with the body's production of prostaglandin, a hormone or hormone-like substance involved in inflammation.
As ibuprofen reduces the production of prostaglandin, it obstructs blood flow throughout the body.
For most people, this does not present a risk. But for those who already have reduced blood flow to the kidneys, such a factor could result in kidney failure.
William L. Henrich, a kidney specialist at the University of Texas Southwestern Medical School in Dallas, has long advocated care in the blanket use of ibuprofen.
The drug was approved as an over-the-counter substance six years ago as a pain reliever. It still is prescribed by physicians in higher dosages.
Harter, an FDA physician, said ibuprofen causes fewer gastrointestinal tract problems than aspirin. He said acetaminophen (in analgesics like Tylenol) can be toxic to the liver.
"But the biggest advantage is that ibuprofen is much safer to have in your medicine chest if a 2-year-old gets into it and starts eating it," he said. "It's not as toxic on children."
In 1985, Henrich led members of the National Kidney Foundation to protest dispensing of ibuprofen as a nonprescription drug without detailed warnings.
They recommended the FDA alert consumers not to take the medication without physician supervision under certain conditions:
Those allergic to aspirin.
Those under a physician's care for asthma or stomach problems.
Those with heart disease, high blood pressure, liver disease or kidney disease.
Those older than 65.
Those using diuretics.
"We recognized that the risk of incurring kidney failure is low," Henrich said. "But even a low incident rate translates into a fair number of people because so many are taking it."
Henrich said the best way to safeguard against public misunderstanding was to have explicit warnings on each label. Others disagreed, claiming too detailed a label would further confuse consumers.
The FDA adopted the second course of action.
Harter said when specific medical information was given in a test of labels, people made specific medical decisions that were incorrect.
"Anyone who takes mega-doses of a drug without realizing there is a potential risk when the label says don't take more than six times a day . . . I don't think we can protect the public against that sort of thing," he said.
Henrich disagrees. He is concerned with the public perception that all over-the-counter medications are safe because they are federally approved. But he said as more powerful drugs become available, it becomes necessary for the buyer to understand labels.
"We've got an education problem," he said. "I believe the public thinks because they can take this with impunity, they can take it with little risk -- and that is a misconception."