An article Tuesday on a forthcoming Food and Drug Administration ban of the anti-pain drug phenacetin incorrectly said the prescription drug Norgesic contains phenacetin. Riker Laboratories, Norgesic's manufacturer, said that since 1981 Norgesic has contained orphenadrine, caffeine and aspirin.
APC pills, once handed out to almost every serviceman for almost every ailment imaginable, will be APCs no longer.
The "P" will soon be gone, leaving only aspirin and caffeine. The Food and Drug Administration said yesterday that the "P" ingredient--phenacetin--may cause kidney and blood disorders and possibly kidney and bladder cancer if taken in large doses or over long periods of time.
The FDA announced yesterday that it will ban all uses of phenacetin in prescription or non-prescription drugs starting Aug. 10, 1983. It said phenacetin can easily be replaced by aspirin and other drugs.
Until the last few years, phenacetin was actually one of the most swallowed painkillers of all time. It was also used in Anacin, Excedrin, Bromo-Seltzer, Super-Anahist and many other products. It was widely used at military clinics, including Washington's Walter Reed Army Medical Center, until about two years ago, the FDA said.
Many drug-makers started removing it two to four years ago, when it became clear that an FDA ban was on the way. Anacin--until then actually APCs with a better advertised name--became simply aspirin and caffeine. Many firms substituted acetaminophen, the painkiller in Tylenol and other products.
Unless a manufacturer appeals successfully, an FDA spokesman said, the agency's order will still affect at least these over-the-counter drugs: APCs, PACs, Coricidin, Decapryn (and Decapryn S) with APC, Thephorine, Thensadil, Hista-Pac, Inhiston-APC, Bristamine-APC, Cardui, Pamprin and Carbetapentane Citrate with SPC.
It will affect several prescription drugs containing the same painkiller, the FDA said, including Darvon Compound (though not other forms of Darvon), Soma, Norgesic, Zactirin and Sinubid.
FDA officials said anyone who took or takes these drugs according to instructions needn't worry. It is mainly long use or abuse that can cause injury or even death.
"I'd say you have to use the drug for months or years, not a couple of days or couple of weeks," said Herbert Gerstenzang, FDA consumer safety officer. Dr. Vardaman Buckalew Jr., co-author of one medical report, defined heavy or excess use as "taking four to six tablets a day for three years or more."
But Buckalew added that "we see many such chronic users," especially among southern factory and mill workers for whom headaches and headache pills or powders become a way of life.
Doctors at Bowman-Gray Medical School in North Carolina said that of 115 urinary cancer patients seen over three years, six were heavy users of analgesics, mainly phenacetin. Thirteen of every 100 patients admitted to one large kidney clinic had damage linked to analgesic, mainly phenacetin, abuse.
Consumer Drug Digest, a book published this year by the American Society of Hospital Pharmacists, says: "Taking too much phenacetin for too long can cause liver or kidney damage . . . . Children up to 12 years of age should not take it for more than five days in a row; adults . . . for more than 10 days in a row."
Rules like these were hardly followed in many Army and Navy dispensaries, some veterans recalled yesterday. APCs were often more common than aspirin, thanks to the belief that their "combination of ingredients" was more effective. The pills were nicknamed "All-Purpose Cures."
That isn't true, say authorities today. But APCs, said Col. Gordon Moore, Walter Reed's chief of pharmacy, were indeed "a popular item over the years--they were the cure for everything" once.