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The Family 

Pill to treat bedwetters fuels debate over safety

Aiding egos by prescription

Every night, about 200,000 children across Canada aged five to 19 turn out the lights, pull up the blankets and wet the bed.

Few afflictions are quite as bruising to a child's ego.

So this week, Health Canada approved a white tablet called DDAVP to prevent chronic bedwetting. Taken before bedtime, it limits the amount of urine produced at night so the bladder doesn't overflow.

But the synthetic hormone, which in rare cases can cause mental impairment, seizures and comas, is adding fuel to the growing debate over the use of prescription drugs to treat common travails of childhood. Boys who fidget too much get Ritalin. Kids with earaches or sniffles get penicillin. Shy or nervous kids get Prozac. And now, a drug for bedwetting.

"When you prescribe these drugs, you're treating the parents, not the kids," said an annoyed Toronto pediatrician.

"Bedwetting is a normal condition. It may upset parents, but it's normal for kids to pee in their sleep."

While some childhood disorders are so severe they require treatment, many experts say drugs, especially antibiotics and Ritalin, are greatly over-prescribed.

Others say drugs, including DDAVP, tend to mask deeper problems by treating only symptoms.

The publicity campaign for the bedwetting drug also raises questions about how such products are marketed in Canada.

In the United States, drugs can be advertised directly to the public. However, drug ads must include a product monograph, an exhaustive list of data and potential side effects. But Canada does not allow consumer advertising, so companies often try to persuade news organizations to write about their products.

This week, Ferring Pharmaceuticals Inc. released 13 pages of press material describing DDAVP tablets. These included a short paragraph that said DDAVP may cause headaches, stomach cramps or nausea in approximately 1% to 2% of children.

However, further investigation shows the drug has been responsible for far more serious problems.

Known by its generic name, desmopressin acetate, DDAVP has been used for years to treat a type of diabetes. According to Harvard Medical School's drug information Web site, desmopressin can cause "rare severe allergic reaction (skin rash, itching, wheezing, swelling of lips, tongue and throat). In some cases, water intoxication may occur, causing lethargy, nausea, vomiting, mental impairment, and in severe cases, seizures and coma."

It continues: "Adverse reactions may be more likely and more severe in children under the age of 18."

Ferring Pharmaceuticals medical director Dr. Anne Brusby said so few adverse reactions have been reported to the company -- only seven among the 5 million children already treated in the United States and Europe -- the company did not deem it necessary to mention them. (DDAVP has also been available for several years in Canada as a nasal spray, but it has not been widely embraced.)

Dr. Brusby said the company does its best to communicate the potential risks to doctors and parents.

"Because it helps you to concentrate urine, what happens is you don't pass out a lot of fluid," she explained.

"What happens is you retain the ... fluid in your body. And this holds the potential, though it's not common, to drop your sodium. And if that happens, and your sodium drops below [a certain level], then there is an increased risk of seizures, and if it drops very low, then your body puts you into a coma because your brain says 'this is not right.'

"Those things are rare, but they usually happen when somebody has not restricted fluids. So it's very important when the child takes this at bedtime that they also restrict fluids so they don't also get the dilution component. So yes, that is a concern, and we spend a lot of time making sure that people understand that -- that it's not just restricting fluids because of the bedwetting, but also because of the way the drug works."

Prior to the 1980s, most people thought bedwetting was a psychological or behavioural problem.

But research shows in many cases, those who regularly wet their beds lack a natural hormone called arginine vasopressin, which limits urine production. Most children start secreting the hormone between the ages of two and five. But in some it takes longer, particularly boys. In the meantime, they wet their bed almost every night. Doctors call this primary nocturnal enuresis. When a child once slept dry, but now wets the bed, it is called secondary nocturnal enuresis and may be caused by stress, such as that prompted by a marital breakup.

Primary nocturnal enuresis runs in families. If one parent was a bedwetter, a child has a 50% chance of being one. If both parents were bedwetters, the child's chances rise to approximately 80%.

The prevalence of bedwetting is surprisingly high.

At age four, 20% of children wet the bed. By age five, it falls to 15%. By 12 years of age, 3% of children still wet the bed; by 15, only 1% do.

A recent World Health Organization report calls bedwetting a significant threat to a child's quality of life. It can lead to embarrassment, anxiety and a loss of self-esteem.

Two years ago, psychologists at the Free University of Amsterdam in the Netherlands interviewed 98 children aged eight to 18 who had been diagnosed with nocturnal enuresis. They asked them to compare the stress of bedwetting with 10 other life traumas, such as parental divorce, trouble at school or surgery. Among teens, only a parental divorce was considered more stressful than bedwetting. Younger children ranked bedwetting third, after divorce and parents fighting.

Many children fear going for a sleepover at a friend's house or to summer camp, and may be embarrassed about a lingering odour of urine at home. Some doctors have tried treating the cycle of shame and frustration with anti-depressant drugs.

Parents often become frustrated by the endless laundry, expensive diapers and emotional stress of having a child who persistently wets the bed.

Traditional treatment for the condition includes restricting a child's fluids in the evening and using an alarm clock to wake the child during the night to urinate in the toilet. But many parents find this difficult and disruptive.

By limiting urine production at night, DDAVP works like natural arginine vasopressin. Some doctors who treat bedwetting say it can be very effective.

"As a pediatrician, I and my colleagues are pretty excited about the product," says Dr. Peter Nieman, a part-time faculty member of the University of Calgary school of medicine.

"If there are two words that capture this thing, they're 'new hope.' "

Dr. Nieman said he would consider prescribing DDAVP to patients seven or eight years of age with primary nocturnal enuresis who are suffering from low self-esteem. He said pre-schoolers should not be considered for this treatment.

"If it's a big issue, the self-esteem matter, then I think it's worth trying a course [of treatment], and knowing that there are side effects," he says, stressing he would not twist anyone's arm to take it.

"At the same time, no medication is without side effects. I think when the company says it's safe, what they mean is that it's been approved by Health Canada. But there's no doubt that there may be minor side effects, but in a very small percentage [of those taking the medication]."

Ferring Pharmaceuticals says up to 90% of patients are treated successfully, many of them after four to six months. But some experts are skeptical of this reported success rate.

"Sometimes they [work] temporarily and sometimes they are absolutely no help at all," says Barbara Moore, founder of the Enuresis Treatment Center, a Detroit clinic.

Ms. Moore argues bedwetting is an inherited sleep disorder, not a bladder problem. This theory is supported by research, which finds bedwetters are unusually deep sleepers.

"When you're in the deep sleep, brain and bladder can't make the connection to let you know the bladder is full and you wet [the bed]," Ms. Moore says. "You don't even know you're wetting. So if you're treating it with drugs, you're not treating the problem, you're treating the symptoms."

Ms. Moore says doctors in the United States prescribe DDAVP far too casually, often setting a patient up for a big disappointment.

"Children get their hopes up, then [if the drug does not work] it becomes another failure experience for them," she says.

Even when the drug works, children may return to bedwetting when they stop taking it. "It's the worst thing because they think the problem is gone but it's just putting a Band-Aid over a sore," Ms. Moore says.

For persistent cases, one of the best-known enuresis clinics, located at the Alfred I. duPont Hospital for Children in Wilmington, Del., encourages a behavioural approach.

"We treat hundreds of boys and girls each year in our clinic at duPont," Dr. Sandra Hassink says.

"Our approach stresses changes in behaviour, not use of medications. Some programs use the anti-diuretic hormone DDAVP ... before bed. Most of our patients have already tried these medications unsuccessfully by the time they see us. The one-year cure rate for the medications isn't as good as you would hope. In fact, it's less than half of that of the behavioural methods. And medications often are expensive. On the other hand, your child's doctor may be comfortable with this approach initially. For some it does work."

Dr. Hassink encourages making a child take responsibility by helping with the wet sheets, but not as a punishment. Instead, it makes children feel better by helping with the clean-up process.

"We suggest that the children stop using pull-up [diaper] pants for one to two months while they are on a program, and do bladder stretching exercises once a day. We also have the kids read a picture book about enuresis each night to reinforce staying dry."

For parents, the array of treatments may seem bewildering for a condition that, in 99% of cases, disappears by the age of 15.

"When I was growing up, these things were considered normal," says Mathilde St-John of Gatineau, Que.

A mother of five children, including one bedwetter, Ms. St-John is part of an informal network of parents who discuss their problems on the Internet. She intends to write a letter to Health Canada urging the department to restrict the use of DDAVP.

"Today, there is a medical word and a pill for everything," she says.

"Pills were [once] what old people took. Now children take all these pills. It worries me. I mean, what kid ever had seizures or a coma from wetting the bed?"

Reference: National Post
Edited by CMR Canada

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