The Food and Drug Administration has issued its strongest warning possible — a black box — for the painkiller OxyContin's package insert, following reports of widespread abuse of the drug.

        The warning to health-care professionals, which drugmaker Purdue Pharma LLP must ship overnight in a letter to millions of doctors and pharmacists nationwide, states that OxyContin “has an abuse liability similar to morphine.”

        The black box is a hairline box around text on the package insert.

BLACK BOX WARNINGS

Many prescription drugs, especially painkillers, have black box warnings to alert physicians and pharmacists of certain dangers.    Some of those drugs include:    • Flagyl, used for treating infections caused by certain bacteria, was found to be carcinogenic in mice and rats.    • Solganal, used for treating early rheumatoid arthritis, can cause toxic reactions.    • Rezulin, used to treate Type II diabetes, can cause liver damage, liver failure and even death. The former manufacturer, Parke-Davis/Warner-Lambert, no longer makes the drug.    • ReVia, also known as Naltrexone, used to reduce alcohol cravings and cause drinking to be less pleasurable, was found to be damaging to the liver.    • Lamictal, used for treating epilepsy, produced life-threatening rashes.    Source: FDA

        FDA spokesman Brad Stone said the purpose is to alert physicians and pharmacists of the dangers of particular drugs. “When we see a pattern that appears to be disturbing, we try to take action to highlight the danger in order to minimize the risks or the chances that the products will be inappropriately prescribed,” he said.

        OxyContin was approved by the FDA in 1996, with larger-dose tablets of 80mg and 160mg approved in 1997 and 2000, respectively. This year, reports of abuse began surfacing through law enforcement officials in Ohio, Kentucky, Virginia and West Virginia. Abuse cases since have been reported from Maine to Florida.

        In February, federal law enforcement officials arrested 200 people in eastern Kentucky in the state's largest drug bust ever.

        The Enquirer reported in February that the drug was the most diverted prescription drug in the Tristate and that drug enforcement officials estimated that it was involved in at least 59 deaths by overdose.

        People who suffer from severe pain benefit from the drug's time-release capsule, which releases the painkiller oxycodone into the body over 12 hours.

        Abusers crush the pill and snort or inject it to get the full dose of oxycodone at one time. The feeling is similar to the euphoria produced by heroin.

        New text on the revised package insert states that the 80mg and 160mg tablets “may cause fatal respiratory depression” — essentially, stop the breathing of — patients who are not opioid-tolerant.

        The warning also strongly advises that abuse of the painkiller through breaking, crushing or chewing the pills breaks the medication's time-release element and can deliver a fatal dose.

        An FDA news release said the warning is intended to “lessen the chance that OxyContin will be prescribed inappropriately for pain of lesser severity than the approved use or for other disorders or conditions inappropriate for a Schedule II narcotic.”

        A copy of Purdue's letter to health-care professionals suggests the company had been negotiating with the FDA for at least several weeks. The letter is dated July 18. In a news release, Purdue Pharma said the package insert change was part of the company's efforts to “reduce the serious problem of abuse and diversion of the prescription pain medication.”

        “While we believe that the prior package insert provided accurate and proper information about the drug, given the recent serious problem of abuse and diversion of the product in some areas of the country, the company believes it is appropriate to make these changes at this time,” said Michael Friedman, Purdue chief executive officer, in a news release.

        Lawsuits alleging wrongful death, product liability and deceptive marketing have been filed in most states where abuse has been reported.

        Janet Abaray, a Cincinnati attorney with Lopez, Hodes, Restaino, Milman, Skikos & Polos, who is working with a combination of lawyers in Ohio and Kentucky on a class-action suit against Purdue Pharma, called the warning an “important development.”

        “The black box signifies that the addictive properties of the drug needs to be addressed,” Ms. Abaray said.

        Mr. Stone, the FDA spokesman, said plenty of prescription drugs have black box warnings. He added that it doesn't mean the drugs are close to being removed from the market.

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