Prescription For Disaster: Bad drug reactions, from minor to mortal

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Prescription For Disaster: Bad drug reactions, from minor to mortal

BY MARTA HEPLER DRAHOS

Traverse City Record Eagle - Traverse City,MI,USA-Published: March

16, 2008 09:47 am

<http://www.record-eagle.com/features/local_story_076094715.html?

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TRAVERSE CITY -- After an urgent care center prescribed an old,

trusted antibiotic for a sore throat that wouldn't go away, Margaret

Dodd was so desperate for relief that she swallowed the first dose at

the pharmacy drinking fountain.

" I took it and it fixed my throat up and I never thought anything

about it, " said Dodd, a former Traverse City mayor and city

commissioner.

Three months later, the normally energetic 63-year-old began to feel

tired and listless. She chalked it up to the hard work of scrubbing

out a refrigerator that had broken down in unseasonably hot weather

at the same time her air conditioner was on the fritz. But after

going to a friend's birthday party and spending the evening on the

couch, she decided to see her doctor the next day.

By then, she was so weak she had to hang on to the receptionist's

counter to check in.

That night, Dodd's doctor called with startling news: blood tests

revealed elevated liver enzyme levels that indicated severe liver

damage. It was the start of a three-year nightmare that liver

specialists at the University of Michigan Medical Center would trace

to doxycycline-- that old, trusted antibiotic.

Some 2.2 million people suffer adverse drug reactions every year

after taking FDA-approved drugs, according to the American Medical

Association. Although some aren't serious, others cause death,

hospitalization or serious injury.

Serious reactions include hypertension, stroke and cardiac failure.

But some of the most severe affect the liver. In fact, drug-induced

liver injury is the most common reason why drugs are not approved by

the FDA in the first place or are removed from the market after they

have been approved. And experts warn that chances of such injury are

rising as an aging population uses more and more prescription drugs,

over-the-counter medications and so-called " dietary supplements. "

" In the past 15 years in the U.S. alone, the frequency of patients

receiving medication has gone up, " said Fontana, an associate

professor of medicine and medical director of the liver transplant

program at the University of Michigan. " Invariably this problem is

not going to go away. The number of DILIs will go up as the number of

people on medication and multiple medications goes up. "

Though the majority of adverse reactions occur within the first year

of taking a drug, diagnosis and treatment are difficult, especially

when short-term antibiotics or painkillers are the culprit, Fontana

said. Patients taking the drugs can confuse adverse reactions with

symptoms of their illness. Accurate diagnosis can be delayed while

doctors rule out other causes.

" Ninety-nine times out of 100 it's not going to be a drug. It's going

to be a gallstone, a virus, a tumor: things that are way more

common, " he said. " It's a diagnosis of exclusion. "

Even when drug-induced injury is suspected, there is no means of

confidently singling out the offending drug from among many being

taken. And once injury occurs, Fontana said, " there's not a lot of

effective treatments. "

After her liver injury was traced to doxycycline, a member of the

tetracycline group of antibiotics developed and approved in the

1960s, Dodd was started on steroid treatment and subjected to daily

blood tests and frequent trips to Ann Arbor for evaluation and

specialty care. Frighteningly, she also was placed on a liver

transplant list and enrolled as " patient number 22 " in a national

study on drug-induced liver injury.

The National Institutes of Health study currently is following 400

patients and will enroll 60 percent more by 2009 in an effort to

discover why some people have unwanted liver reactions and others do

not, said Fontana, principal study investigator at the University of

Michigan clinic site.

Meanwhile, steroid treatment was wreaking havoc with Dodd's other

systems. She developed a host of highs, from blood pressure and blood

sugar to cholesterol. Her connective tissue began to fall apart. Her

eyes wouldn't focus, her short-term memory disappeared. She gained

weight -- 50 pounds in two months -- and lost her hair.

" Every month it was something else, " said Dodd, who updated her will,

planned her funeral and made a " bucket list " of things she wanted to

do before she died. " Twice my doctor here told me she thought they

lost me. "

Eventually she could no longer drive or work and had to give up all

but one local client in her growing consulting business. She needed

help to walk and at times used a wheelchair.

She hit rock bottom when she developed chronic pain behind her left

eye and what she calls " black holes " in her memory, leading her to

fear a brain tumor.

" Up to that point, I had been such a good sport, " she

recalled. " Every time something would hit me, I'd think, 'They'll get

it sorted out and I'll be back to where I was.' But I thought that

maybe this was it. I was at the stage where I thought, 'If my mind

goes, I don't want to deal with it; I'd just as soon fade away.' I

wanted to get better, but I didn't know if I had it in me to keep

fighting. "

Though cautions and side effects associated with the use of

doxycyclineinclude a " slim risk " of liver damage during prolonged

use, no one can predict who risks injury, Fontana said. But that

wasn't the case with the prescription pain medication Celebrex, said

Leslee Wiltjer, whose husband suffered a stroke in 2004 after

taking the drug on and off for about four years.

Since then, the drug has been linked to increased risk of heart

attack, stroke and sudden cardiac death -- risks the Boyne City woman

believes the drug's manufacturer kept from the FDA in order to gain

approval.

" If we'd known some of the side effects that weren't listed or known

to the public, my husband never would have taken it, " said Wiltjer,

55. " It's one thing to be given a drug and told, 'Now, if you have

any of these side effects, stop taking it.' But the strongest warning

in that insert is that if you're an elderly woman, it might cause

kidney problems and that if you have kidney problems, you shouldn't

be taking it. "

Before the stroke, her husband was a strong man with an appetite for

the outdoors, Wiltjer said. Now he can't shovel snow, chop wood, hunt

or ice fish. And although he returned to work after a year, he can't

do the job he did before and had to trade in the electronics field

work he loved for a desk job.

Worst of all, she said, " The way his mind works seems to have

altered. You know your spouse, your partner. You know what upsets

them, you know what's going to make him laugh. Well, I don't know

those things anymore. "

Wiltjer struggled to hold the family together through therapy and

other treatment. For all the physical damage suffered --

including hearing loss, balance problems and loss of strength in one

arm -- " the spiritual and mental effects were devastating, " she said.

The stroke was especially hard on the couple's daughter, Ashleigh,

now a 20-year-old student at North Central Michigan College.

" I can't even tell you how many nights she cried herself to sleep. "

Now the family lives in constant fear of a repeat stroke, she said.

And , who has to take 12 different medications, often wonders

which one might kill him.

" Once somebody's had a stroke or heart attack, your chance of having

a fatal one is 50 percent, " Wiltjer said. " We do know that his life

has been shortened and has been diminished by this stroke. "

Though doctors have told her she's the oldest person in the study to

recover without a liver transplant, Dodd is still fighting the

effects of her treatment. And while her liver grew back, " it didn't

grow back normally, " she said. " It's all lumps and crevices and

nastiness. " As a result, she is susceptible to liver cancer and has

to have ultrasound tests every few months.

" Every month I get to think, 'Is this the month I'll get cancer?' "

she said.

Now 65, she's concentrating on building up her strength and business

again -- and on checking off things on her bucket list, as in a

recently completed trip to Egypt. She's also keen to spread the word

that drug reactions can and do occur, even if nobody warns you, even

if months have passed since you swallowed your last pill.

" It can be a prescription drug, it can be a non-prescription drug, "

she said. " It can be something you've taken 100 times before, and the

101st time it hits the fan.

" If I had known, I would have been to the doctor earlier when I

started feeling icky, I would have been treated earlier, maybe the

damage wouldn't have been as severe. "