Current Situation

Acetaminophen can be purchased OTC in large amounts, including bottles that contain hundreds of doses.

Options

More than one potential option exists under this general category.

• Limit the number of acetaminophen doses that can be contained in each package of OTC acetaminophen product

• Require acetaminophen tablets to be packaged in blister packs instead of bottles

• Impose restrictions on sales to limit the amount of acetaminophen that may be purchased by an individual at any one time.

Intended Effect

• To decrease the incidence of intentional ingestion of large overdoses by making it more difficult to accumulate large numbers of tablets.

• Blister packs could also help consumers track how many pills they have taken.

Considerations Related to Incidence of Hepatotoxicity (liver injury)

• Limits on amounts of OTC acetaminophen that could be purchased at one time could reduce incidence of overdose due to intentional injury.

• Limiting the availability of acetaminophen could move consumers to use other analgesics to treat pain with their attendant risk of adverse effects.

 Considerations Related to Implementation

• Limiting package size could cause substantial inconvenience to consumers, particularly to those who use OTC acetaminophen routinely under a doctor’s care to treat chronic pain or arthritis.

• Blister packs could further adversely affect consumers (especially those with arthritis) because of the extra effort it takes to open blister packs.

• Manufacturer repackaging, whether in smaller container sizes, or blister packs could be costly and such costs could be passed on to consumers.

Don’t Double Up on Acetaminophen

You have flu symptoms, so you’ve been getting some relief for the past two days by taking a cough and flu medicine every few hours. Late in the day, you have a headache and you think about grabbing a couple of acetaminophen tablets to treat the pain.

Stop right there.

What you may not realize is that more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches and to reduce fever. It is also used in combination medicines, which have more than one active ingredient to treat more than one symptom.

‘Tis Cold and Flu Season

The National Institutes of Health (NIH) says that Americans catch one billion colds per year and as many as 20% of Americans get the flu. Moreover, 7 in 10 Americans use OTC medicines to treat cold, cough and flu symptoms.

Fathia Gibril, M.D., M.HSc., a supervisory medical officer at the Food and Drug Administration (FDA), explains that consumers looking for relief from a cold or the flu may not know that acetaminophen comes in combination with many other medications used to treat those symptoms. “So if you’re taking more than one medicine at a time,” she says, “you may be putting yourself at risk for liver damage.”

Symptoms of acetaminophen overdose may take many days to appear, and even when they become apparent, they may mimic flu or cold symptoms. The current maximum recommended adult dose of acetaminophen is 4,000 milligrams per day, To avoid exceeding that dose:

• don’t take more than one OTC product containing acetaminophen,
• don’t take a prescription and an OTC product containing acetaminophen, and
• don’t exceed the recommended dose on any product containing acetaminophen.

“When you’re at the store deciding which product to buy, check the ‘Drug Facts’ label of OTC cold, cough and flu products before using two or more products at the same time,” Gibril says. If you’re still not sure which to buy, ask the pharmacist for advice.

Rely on Health Care Experts

Acetaminophen is used in many commonly prescribed medications in combination with pain relievers such as codeine, oxycodone and hydrocodone. As of January 2011, FDA reported that overdoses from prescription medicines containing acetaminophen accounted for nearly half of all cases of acetaminophen-related liver injury in the U.S. When your health care professionals prescribe a drug, be sure to ask if it contains this active ingredient, and also to inform them of all other medicines (prescription and OTC) and supplements you take.

Even if you still have fever or pain, it’s important not to take more than directed on the prescription or package label, notes FDA supervisory medical officer Sharon Hertz, M.D. But be careful, the word “acetaminophen” is not always spelled out in full on the container’s prescription label. Abbreviations such as APAP, Acetaminoph, Acetaminop, Acetamin, or Acetam may be used instead.

When buying OTC products, Hertz suggests you make it a habit of telling the pharmacist what other medications and supplements you’re taking and asking if taking acetaminophen in addition is safe.

When the medicine is intended for children, the “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child’s weight or age is not listed on the label and you can’t tell how much to give, ask your pharmacist or doctor what to do.

If you’re planning to use a medication containing acetaminophen, you should tell your health care professional if you have or have ever have had liver disease.

Acetaminophen and alcohol may not be a good mix, either, Hertz says. If you drink three or more alcoholic drinks a day, be sure to talk to your health care professional before you use a medicine containing acetaminophen.