OTC drugs are not always safe: the safety updates

Over-the-counter drugs, known as OTC drugs for short, are drugs available at your pharmacists without a doctor’s prescription. Normally, the status of OTC is only granted by drug authorities to drugs whose safety has been well-established over years and years of use. Many of the medications you have in your medicine cabinet at home are OTC, from the pills you take for fever and toothache (acetaminophen, ibuprofen, or aspirin) to your common cough and cold drugs (cough syrup, cold rubs, etc.) to your nutritional supplements. Many of these medicines are even used in children. However, recent studies have reported that some OTC drugs may present some health risks and side effects which are more serious than previously thought. That is why the US Food and Drug Administration (US FDA) has stepped on the safety of OTC drugs. This resource post brings you an update of these safety issues.

OTC drugs for adults

FDA toughens warnings on over-the-counter painkillers
In April this year, the US FDA announced new requirements for labelling OTC anti-fever and pain killer drugs such acetaminophen (also known as paracetamol, marketed as Tylenol) and non-steroidal anti-inflammatory drugs, or NSAIDs (e.g. ibuprofen, aspirin, marketed under Advil, Motrin and Aleve). The drugmakers are required to “more prominently display safety warnings” on the package inserts and labels of the said drugs. Specifically, the FDA are concerned about liver damage that can be caused by these drugs in case of overdose, those with chronic liver problems, and the danger of combining acetaminophen and NSAIDs with alcoholic drinks. There is also the risk of stomach bleeding when taking NSAIDs and the blood thinning drugs aspirin and warfarin.

OTC drugs for teens

What teen s don’t know about OTC medications can hurt them
OTC drugs present risks to teens who are usually start to take their own health care in their hands but still lack the knowledge of proper use of medications. This can lead to complications, inadvertent as well as intentional abuse. A study by researchers at the University of Rochester Medical Center interviewed 100 youths age 14 to 20 years old, with the following results:

44% had ample knowledge about appropriate use of OTC drug.
75% had taken OTC drugs without adult supervision during the previous month.

“This tells health professionals that we need to teach our young people about safe use of over-the-counter pain medications,” says Dr. Karen Wilson, one of the study authors.

OTC drugs for children

In 2007, people were shocked about the news that several little children suffered from serious adverse events, some of them fatal, after taking OTC cough and cold medicines, as reported by the Philadelphia Medical Examiners Office.

In response, the US FDA had a second look at the safety of these OTC drugs. In January 2008, the regulatory body issued new OTC products recommendations which were later updated in October 2008. The new advisory strong advises against the use of OTC cough and drugs in children under the age of 2.

Study finds parents use cough medicines on under-2s despite the warnings
Despite the warnings, an Australian study revealed that 40% parents surveyed still use OTC drugs in under-two’s. Here are some of the figures from the study:

98% had purchased an OTC medication in the past year;

Paracetamol was the most commonly used drug (95.9%);

47.3% had given their children topical teething gels;

Almost half (42.8%) had given their children cough and cold medicines containing anti-histamines;

Nearly all parents had used OTC medications to combat pain and fever;

About 7% of parents had given their child over-the-counter medication to induce sleep or settle their child;

Two parents had given their children paracetamol because they were “cranky”.

Treat with Care
This year, the OTC drug manufacturers in the US acted responsibly enough by taking the following steps:

changing OTC drug labels.
launching a large-scale public service campaign called “Treat with Care“.

“Treat with Care” is run by the Consumer Healthcare Products Association (CHPA), a not-for-profit association representing the makers of over-the-counter (OTC) products and the consumers who use these healthcare products

For the “Treat with Care” campaign, CHPA had no other than actress Chandra Wilson as their spokesperson. Wilson is best known for her role as the surgeon Dr. Miranda Bailey in the popular medical soap Grey’s Anatomy. In real life, Wilson is a mom of two whose youngest is in the age group affected by the OTC safety issues.

The Treat with Care campaign says:

Always read and follow medicine labels exactly and use the measuring device that comes with the medicine.

Do not give a medicine only intended for adults to your child.

Only give the medicine that treats your child’s specific symptoms.

Never give two medicines at the same time that contain the same active ingredient.

Do not use oral cough and cold medicines for children under age 4.

Never use an OTC medicine to sedate or make your child sleepy.

Never give aspirin-containing products to your child for cold or flu symptoms unless told to do so by a doctor.

If your child develops any side effects or reactions that concern you, stop giving the OTC medicine and contact a doctor immediately.

Keep all medicines out of your child’s reach and sight.

Talk to a doctor, pharmacist, or other healthcare provider if you have any questions.