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Acetaminophen-Codeine Inferior to OTC Ibuprofen for Treating Kids' Broken Arms

Aug 18, 2009 | Parker Waichman LLP Acetaminophen and codeine combo drugs are not the best choice for treating the  pain from a child's broken arm, a new study says.  Rather, researchers at the Medical College of Wisconsin have concluded that parents and doctors would do better to choose an over- the-counter (OTC) ibuprofen product to treat such pain.

According to The Wall Street Journal the study involved 366 children, ages 4 to 18, treated for broken arms at the Children's Hospital of Wisconsin. Each were assigned  liquid versions of either ibuprofen or the acetaminophen-codeine combo.  The researchers focused on pain that occurred three days after the arm was broken.

At the end of the study, full results were available for 244 children, the Journal said.  They revealed that children taking OTC ibuprofen were more likely to play,  ate better and  had fewer adverse effects than those treated with  acetaminophen-codeine medications.  Half of those on the combo medicine reported side effects like nausea versus 30% of those given ibuprofen.

According to an earlier Dow Jones report, acetaminophen is one of the most widely used drugs in the U.S.  However, there are growing concerns about the safety of acetaminophen.  Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage.  As we've reported previously, it is known that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Alcohol use can also increase the risk of liver damage with acetaminophen.

In April, the Food & Drug Administration (FDA) mandated that OTC medications made with acetaminophen bear new warnings regarding potential side effects, including liver damage.  Manufacturers of the affected drugs were given one year to relabel their products.

In July, an FDA advisory panel recommended in a 21-16 vote  that the maximum daily dosage for OTC acetaminophen products be lowered.  By a 21-17 margin, the panel also voted to recommend that  prescription drugs combining acetaminophen with other painkillers be eliminated.  However, in a 36-1 vote, the advisors recommended that if such combo drugs remained on the market,  they be required to bear a Black Box Warning—the FDA's strongest safety notice — regarding potential side effects.  

Although the FDA is not required to follow the recommendations of its advisory panels, it usually does so.

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