US FDA panel calls for ban on two lethal pain killers

Dubai: Doctors in UAE are in agreement with US government recommendations calling for sweeping safety restrictions on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The US Food and Drug Administration (FDA) assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the US and sends 56,000 people to the emergency room annually. About 200 die each year. But over-the-counter cold medicines such as Nyquil and Theraflu that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes on Tuesday, the panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered. The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

“Vicodin and Percocet are restricted drugs in this part of the world anyway. But I do agree that safety restrictions should be applied on their use,'' Dr Ashok Kapoor, Chairman of Getwell Medical Center in Dubai, told Gulf News. “They contain a component known as deoxycodein, which has a sedative effect and can impair your efficiency. It acts on your nervous system. For example while driving these drugs can induce sleep,'' he said.

According to him such drugs acts as painkillers and are prescribed for flu and body ache. “Heavy dosage can affect vital organs. One cannot buy these drugs over the counter. It needs special prescription to buy these drugs. We avoid prescribing it as much as possible,'' Dr Kapoor said.

Dr Judith Kramer of Duke University Medical Center felt that the ban on the two drugs was proposed “because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact".

Dr. R.V.S. Ranavat from the Ramada Medical Center in Dubai was of similar opinion. According to him deoxycodein is completely banned in all Arab countries. “It is next to morphine… There is a special prescription a copy which goes to the Ministry of Health (MoH), another to the pharmacist, one copy is kept with us and towards the end of every month doctors have to provide a detail report to the ministry on the patient's history and the number of occasions these drugs were prescribed. It depresses the nervous system and induces sleep and makes the individual feel euphoric and physicians are very careful in prescribing it,'' he told Gulf News.

The FDA experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.