FDA Panel Warns Against Painkillers

(RTTNews) - Tuesday, a panel of outside advisors to the U.S. Food and Drug Administration, or FDA, voted 21-17 in favor of a ban on painkillers Vicodin and Percocet, as they combine Acetaminophen or APAP with a narcotic. The panel also simultaneously voted 21-16 to reduce the dosage of over-the-counter, or OTC painkillers that contain acetaminophen, like Tylenol.

For years, Tylenol has been the staple drug to pop to relieve fever, and ease headaches and body pain. The advisory panel urged lowering doses of Johnson & Johnson's (JNJ | Quote | Chart | News | PowerRating) Tylenol, including selling the extra-strength version by prescription only.

The drug Acetaminophen is used in many painkillers to relieve pain and fever. Prolonged use, over dosage, and abuse of medications containing Acetaminophen lead to liver anomalies and in extreme cases death.

Between 1990 and 2001, Acetaminophen overdose was linked to 458 deaths, 26,000 hospitalizations and 56,000 emergency-room visits annually, according to an internal agency report.

The FDA is not required to follow the panel's recommendations, but generally does so.

The FDA warned that side effects of Acetaminophen will rise when the drug is already in action inside the body, and another drug containing APAP is consumed. Increased alcohol consumption, three or more drinks every day, also raises the risk of liver failure.

Prescription drugs Vicodin, sold by Abbott Laboratories (ABT | Quote | Chart | News | PowerRating), and Percocet, marketed by Endo Pharmaceuticals, are highly popular in the U.S. These analgesics, of which generic versions are also sold, are generally taken to ease moderate and chronic pain, especially for osteoarthritis.

The panel has recommended that the drugs carry a black box warning, the most serious safety label available, if the drugs stay on the market and are not removed from store shelves.

The advisory panel has also recommended that people take less than 4,000 milligrams of Tylenol or other over-the-counter products containing APAP in a day, and only 650 milligrams, or two Regular Strength tablets, at one time. The usual dose is two 500-milligram Extra Strength tablets.

The FDA may not follow the recommended ban on Vicodin or Percocet, as it would lead consumers to switch to other drugs that are more harmful. The FDA may impose more strict regulations in labeling and promote customer consciousness about the hazards Acetaminophen in combination drugs.

Increased awareness about drug abuse and the harmful effects of drug overdose has led biotechnology companies to develop other methods tackle these issues.

BioElectronics Corp. (BIEL.PK), a maker of inexpensive, disposable drug-free anti-inflammatory devices, has come up with PEMF, or portable electromagnetic field, therapy that is a safe and effective alternative for many musculoskeletal disorders. PEMF has demonstrated effectiveness in speeding surgical recovery and in reducing, or completely eliminating, the amount of pain medication required.

Acura Pharmaceuticals Inc. (ACUR | Quote | Chart | News | PowerRating) has taken an alternative route in combating drug abuse by developing Acurox, an immediate release opioid analgesic that is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets. The drug is currently under priority review with the FDA.

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