PATIENTS OD'ING ON OTC DRUGS WARNINGS NOT SUFFICIENT, SOME CONTEND.

Byline: JUDY O'ROURKE Staff Writer

WESTWOOD VILLAGE -- A 25-year-old Valencia woman is among four women who unknowingly overdosed on over-the-counter painkillers and underwent liver transplants last month at UCLA Medical Center.

The Food and Drug Administration this week proposed explicit warning labels citing the potentially serious side effects of the nonprescription pain relievers acetaminophen, aspirin and ibuprofen.

``I don't know why it took the FDA so long to come to this decision to put the black box on over-the-counter medicines,'' said Ronald Busuttil, one of the nation's top liver transplant surgeons, who performed the surgeries. ``We have known about the issues of acetaminophen overdose for many years.''

Many who reach for Tylenol products on drugstore shelves know acetaminophen as the ingredient that provides pain relief and reduces fevers -- but they may be unaware acetaminophen is found in roughly 700 over-the-counter cough, cold, allergy and sinus medicines. It is also an ingredient in many prescription drugs. Taken as directed, acetaminophen is safe, Busuttil said, but taking too much in one day can trigger liver failure.

Valencia resident Jody McMullen was a secretary in Whittier who for the past two years relied on Tylenol P.M. to help her sleep so she could rise at 4 a.m. to get ready for work. She suffered injuries in a June car crash and in October she began taking a prescription painkiller that also contained acetaminophen. Unaware, she was poisoning her liver.

On Nov. 10, McMullen stopped breathing and seizures wracked her body. After a stay in Henry Mayo Newhall Memorial Hospital, she was transported to the UCLA Medical Center, where three days later doctors removed her liver. The diminutive young woman had a stroke and lay in a coma for three weeks. She has a tube in her throat now and mouths words or writes to communicate.

She misses iced tea, Subway sandwiches and macaroni and cheese. She has strange dreams now and doesn't remember getting sick and wonders how she'll be when she gets released from the hospital.

McMullen's new liver is a mismatch -- it's not her blood type and is so large doctors could barely close the incision -- but it seems to be working.

``She's one of our lucky ones,'' said nurse Erin Waki, who's worked the ICU for 18 years. ``Most of the people don't get this far.''

McMullen's mom had rushed her disoriented daughter to Newhall Memorial and calls the outcome a ``miracle'' -- but hopes others seeking pain relief won't need miracles.

``The biggest problem with people is they've been told all their lives to take (acetaminophen) not aspirin,'' said Sharon Divis. ``But you can't also mix Tylenol with cold products, with sleeping medicines, with anything else containing (acetaminophen) -- it all adds up to toxic amounts. With young people, it might not register. They may not make the connection.''

McMullen did not make the connection and likely did not tell the pain clinic doctor who prescribed Oxycodone she was taking a nighttime sleep aid.

Acetaminophen is found in many formulas for popular over-the-counter remedies such as TheraFlu, Robitussin, Actifed, Benadryl, NyQuil, DayQuil, Dimetapp, Triaminic and others. It is also found in prescription medicines such as Vicodin, Darvocet, Lorcet and Norco tablets.

UCLA's transplant program has pushed for warning labels on over-the-counter acetaminophen products, particularly children's medicines. Doctors there have performed 233 liver transplants this year.

In the past 15 years, roughly 25,000 people have waited annually on a kidney transplant list, but just about 5,000 livers are available. The operation can cost $1 million, and recipients must take immunosuppression drugs for the rest of their lives.

``People take (acetaminophen) and they assume it is completely safe,'' Busuttil said. ``You can take about 4 grams of acetaminophen in a day. In the 7-gram range you can go into liver failure.''

Cammie Detjen, 40, of Laguna Niguel, who also had a liver transplant, lies one bed over from McMullen in the intensive care unit. The former model, who lies pale and motionless in a vegetative state, began taking Norco in October to relieve pain from a fall. Norco has the same amount of acetaminophen as regular Tylenol, but she also was taking Tylenol.

``We went from a happy, three-person family in two months to where it's just total ... agony,'' said her husband Dean Detjen, 36. ``It's a waiting game.''

Detjen has a double master's degree in psychology and education and a teaching credential, but chose to stay at home with their son, Shanti, 9. Shanti cries and asks for his mom.

``It's too traumatic (for him) to visit,'' Dean Detjen said. ``He's never been away from her, but hasn't visited.''

Detjen's new liver is working and her kidneys are reviving, but swelling in her brain has caused it to atrophy, her husband said. Her prognosis is uncertain.

``The labeling on bottles is not sufficient to warn people this could be tremendously destructive to your liver,'' Dean Detjen said.

Those who consume more than three drinks a day could find their livers metabolize acetaminophen into a toxic by-product. And size might matter -- the size of a liver corresponds to one's overall girth.

FDA officials did not respond to several calls seeking comment on the matter.

On Tuesday, the FDA proposed a plan to revamp labels for over-the-counter pain and fever reliever medicines, including acetaminophen, to warn consumers about the possibility of stomach bleeding and liver damage.

A Dec. 19 press release said the warnings ``would highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol.''

Bottles, pill jars and package cartons would prominently identify acetaminophen as an ingredient.

Warnings would accompany acetaminophen products and anti-inflammatory drugs like ibuprofen, naproxen and ketoprofen -- and other products, such as cold medicines, that contain a mix of ingredients. Some drug companies have voluntarily changed their labels already.

The FDA's Web site says the agency would like to better understand if some people should not take the recommended dose of acetaminophen.

Busuttil said in 23 years he has never had five patients arrive in a 10-day period with acute liver failure, and hopes new warning labels will help increase awareness.

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Photo:

Valencia resident Keith Karzin will represent Cedars-Sinai Medical Center on the Donate Life Rose Parade Float on New Year's Day. Three years ago, Karzin donated half his liver to his mother-in-law, Sharon Dziubala, who needed a transplant.

John Lazar/Staff Photographer