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Medication Can Be Bitter Pill : The Easley Case Is an Example of the Abuse of Over-The-Counter Products. The Danger Is That Such Abuse Can Have Unknowing Victims.

August 12, 1990|ELLIOTT ALMOND | TIMES STAFF WRITER

Filed away in the vast, sterile Rockville, Md., complex of the Food and Drug Administration are 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% 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 recording every drug side-effect they encounter.

Still, the case of one-time Seattle Seahawk star Kenny Easley reminds consumers of the dangers of taking medications that become household products.

Easley was a five-time Pro Bowl safety for the Seahawks, 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 Seahawk lineman, said players would take as much medication as necessary to numb their pain. He said the Seahawk 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 disorder.

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 he took them 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 nephrotic 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% 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, the FDA's John Harter said.

Another study at the National Institute for Environmental Health Sciences showed that ibuprofen can cause kidney failure in individuals who have health problems, including high blood pressure, heart disease and pre-existing kidney problems.

The Advil label 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.

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