Are your painkiller drugs safe?

Source:  United Press International

(A painkiller is any member of the diverse group of drugs used to relieve pain.)

The U.S. Food and Drug Administration proposed new rules that would tighten safety warnings for over-the-counter pain relievers used by hundreds of millions of Americans.

Aspirin, Ibuprofen, Naproxen & Tylenol
The move would require packages to caution of potential severe liver damage with the use of acetaminophen, the pain reliever used in Tylenol.

Warnings would also go onto non-steroidal anti-inflammatory pain relievers, including ibuprofen, aspirin and naproxen, cautioning of a risk of gastrointestinal bleeding with overuse of the drugs.

Many non-prescription drug brands already display similar warnings. But FDA officials said they want to make the alerts more visible because of reports suggesting that injury related to pain relievers — while uncommon — is more prevalent than once thought.

‘The consumers have to be more cognizant of what they’re taking for pain relief,’ said Charles Ganley, director of the FDA`s office of non-prescription products.

There are more than 20 different forms of NSAID pain relievers, although not all are available without a prescription. Together with acetaminophen, they comprise hundreds of products.

The FDA said it intends to require acetaminophen manufacturers to display the words liver warning in prominent type on packaging. Labels must alert consumers that severe liver damage can result if they take more than the recommended maximum daily dose, combine the pills with other drugs or drink more than three alcoholic drinks per day while taking the drug.

NSAID drugs would have to carry similarly prominent warnings saying the drugs can lead to gastrointestinal bleeding in patients over 60, those with existing stomach bleeding and in patients already taking a corticosteroid like prednisone.

The drugs would also continue to carry existing alerts about exceeding the maximum daily dose and missing them with alcohol, the agency said.

The warnings will also apply to patients taking daily aspirin to cut the risk of heart attack or stroke.

Ganley said that the agency believes acetaminophen to be ‘quite safe’, but that risk of liver failure is impacting hundreds of millions of Americans who take the drugs.

‘Those rare circumstances are adding up to large numbers,’ he told reporters. The agency is unsure of how many Americans are injured each year by over-the-counter pain relievers because it is difficult to track the use of non-prescription drugs, he said.

The FDA investigated acetaminophen risks in public hearings in 2002. At the time, manufacturers projected that OTC use of the drug could lead to at most 200 cases of acute liver failure per year.

McNeil Consumer Healthcare, manufacturer of both Tylenol and Motrin, a brand of ibuprofen, said in a statement Tuesday it had already moved to include many of the warnings proposed by the FDA.

The company ‘will continue to work with the FDA to ensure appropriate information is provided to consumers,’ read the statement from the company, which is owned by Johnson & Johnson.

A 2004 study published in the journal Hetatology reported that half of all cases of acute liver failure in the United States were attributable to acetaminophen. Scientists still debate how many of those injuries stem from accidental poisonings during regular use, versus suicide attempts.

Companies have 90 days to comment on the FDA`s proposed regulations. Ganley said final rules ordering the changes are unlikely to occur by the end of 2007.  ‘We are asking that people voluntarily comply in the interim,’ he said.

The Mayo Clinic
The Mayo Clinic web site provides their thoughts on OTC pain relievers.  Please be sure to read the section on common side effects and possible serious complications.

They also discuss terms and meanings of OTC meds at terms and meanings .  They say “

Over-the-counter pain relievers aren’t all the same. Understanding the common terms used on these products will help you choose the one that’s best for you.

THE FDA
Here is a quote from the FDA web site. “The Food and Drug Administration advises consumers to follow directions when using common pain and fever reducers. The active ingredients, acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), are safe and effective when the labeling directions or the advice from a healthcare professional is followed. Using more than recommended can cause serious injury.”

Wellness Online’s comments
Employees who participate in health risk assessment programs that include tests for liver enzymes can determine whether or not there is existing liver damage.  An enzyme released by the liver such as GGT (gamma glutamyl transferase) when elevated is a sign of possible liver damage.

The Healics HRA has shown that people who combine painkillers with alcohol consumption tend to have elevated GGT’s.  If this has been the case for you, then you need to have testing done by your doctor.

If you have had an HRA done and GGT plus other liver enzymes are in the safe zone that is a strong indicator that you have a healthy liver.

Popularity: 1% [?]