FDA Want Stricter And Clearer Safety Labels On Over The Counter Painkillers

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Main Category: Pharma Industry / Biotech Industry
Also Included In: Pain / Anesthetics;  Compliance
Article Date: 20 Dec 2006 - 5:00 PDT

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The American Food and Drug Administration (FDA) are proposing to make the warnings on over the counter painkillers clearer and stricter. They are targetting Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) products because although the risk to the average person using the drugs correctly is tiny, their misuse is linked to thousands of US deaths each year due to stomach bleeding and liver failure.

The drugs affected include: acetaminophen (also known as paracetomol) commonly sold as Tylenol (US, Canada) and Panadol (UK); and nonsteroidal anti-inflammatory drugs (termed NSAIDs). These are aspirin, ibuprofen (Nurofen, Dorival, Motrin, Advil, Act-3), naproxen (Anaprox, Naprelan, Aleve) and ketoprofen (Orudis, Oruvail).

Although each year, hundreds of millions of people in the US use painkillers safely, there are thousands who die from misuse. The FDA give their reason for acting now to be that while the risk to the average person using the drugs correctly is tiny, the numbers of deaths are mounting up and cannot be ignored. Something needs to be done to raise consumer awareness of the risks of misuse and one effective way to do this is through regulating safety information on the product labels.

The FDA is also considering whether products should be sold over the counter in smaller amounts, as this would reduce the likelihood of overdose. This regulation already exists in the UK.

Acetaminophen (or paracetomol) is an analgesic (painkilling) and antipyretic (fever-reducing) drug available over the counter in pure form or as an active ingredient of various remedies for colds, headaches, flu, fever, and general aches and pains. NSAIDs have analgesic and antipyretic properties but they are also anti-inflammatory or anti-rheumatic.

Unlike the NSAID drugs such as aspirin and ibuprofen, acetaminophen has very weak anti-inflammatory properties so it does not irritate the stomach lining or affect the kidneys. However, incorrect use can lead to liver damage.

Acetaminophen is often used in combination with other drugs. For instance to manage painful inflammations where it is combined with low-dosage NSAIDs.

The proposed regulations would require manufacturers to display the safety information in a consistent manner. For instance the labels on acetaminophen packaging would have to show the warning about liver damage prominently and toward the top of the label. And the label for NSAIDs would have to warn about the risk of stomach bleeding to: the over-60s, anyone with previous stomach problems like ulcers, alcohol drinkers, and people on blood thinners.

In all cases the label would have to show clearly the non-brand name of the product - for instance the text "Acetaminophen" or "NSAID" would have to be clearly marked on the principal display panel (PDP) of the product's "immediate container and the outer carton (if applicable)".

FDA are following the usual procedure of proposing the ruling first so that public consultation can progress. The final enforcement date has not been revealed.

Click here for advice on using over the counter medicines (FDA).

Written by: Catharine Paddock
Writer: Medical News Today


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