Ditropan Lawsuit

Ditropan and Ditropan XL have been prescribed in the U.S. for the treatment of overactive bladder (OAB) and other bladder conditions for decades. A growing amount of evidence, however, connects their continued use with an increased risk of dementia, particularly in older people.

The Ditropan lawyers at Chaffin Luhana are currently examining cases in which patients used Ditropan, Ditropan XL, or other forms of the medication oxybutynin, and then developed cognitive disorders. Call our experienced attorneys to schedule a complimentary consultation at 1-888-480-1123.

What Is Ditropan?

Manufactured by Janssen Pharmaceuticals, Ditropan (oxybutynin chloride) is a medication used to treat certain bladder and urinary conditions like overactive bladder. Ditropan XL or “extended release” is also available.

The drug belongs to a class of medications called anticholinergic, which means that it relieves spasms in involuntary muscles like the bladder. It’s also an “anticholinergic” drug, which means it inhibits the action of a neurotransmitter called acetylcholine, the chief chemical messenger controlling parasympathetic functions.

With these combined actions, Ditropan helps relax the muscles in the bladder and prevent them from contracting more than they should. This eases symptoms like urinary urgency and frequent urination. Doctors also use the medication to treat loss of bladder control or incontinence as well as increased night-time urination.

The usual adult dose is one 5-mg tablet 2-3 times a day. The maximum recommended dose is one 5-mg tablet four times a day. The extended-release tablet is usually taken once a day, the Ditropan XL label does state no more than 30-mg should be taken a day.

The drug may also be prescribed for children six years of age and older, often for bed wetting. The recommended dose of one 5-mg tablet two times a day. There are syrup versions available.

Common side effects of the medication include drowsiness, dizziness, headaches, constipation, dry mouth, dry eyes, blurred vision, and reduced sweating, which can create an increased risk of heat stroke in high temperatures.

What is Overactive Bladder (OAB)?

According to a 2016 study, OAB affects one out of seven U.S. women and a similar proportion of men. The Urology Care Foundation states that as many as 30 percent of men and 40 percent of women in the U.S. live with OAB symptoms.

OAB is a syndrome characterized by a sudden and compelling need to urinate, even when the bladder is not necessarily full. It can create a strong urge that may be difficult to control. Those with OAB may feel like they have to run to the bathroom many times during the day and night, and may also suffer from some degree of urinary incontinence or leakage.

OAB can have a detrimental effect on the quality of life. It can get in the way of work, social activities, exercise, and sleep. Some people end up avoiding social events because of it, and that can lead to additional problems like isolation. If it affects sleep, it can lead to other health problems like fatigue and a weakened immune system. Many people feel embarrassed about OAB and may be afraid to ask for help.

According to a 2018 study, OAB often affects people in their older age. Nocturia—or frequent waking to go to the bathroom at night—is the most bothersome symptom in the elderly population. Consequently, it’s often the elderly that are prescribed drugs like Ditropan to help deal with the symptoms of OAB.

The History of Ditropan

Ditropan tablets were first approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) in 1975. The syrup was approved for the same indication in 1979, so these products have been on the market for a long time.

The FDA approved the extended-release form of the drug—Ditropan XL—in 1998, and a transdermal patch containing oxybutynin (Oxytrol TDS) in 2003. Researchers reported that the extended-release version seemed to improve the drug’s tolerability.

Over the decades, these drugs have retained their popularity as common treatments for OAB and other urinary problems. Usage estimates for 2020 indicate that over 1.7 million people in the U.S. use oxybutynin.

Recently, newer medications with more specific action on the bladder have become available. These are often referred to as “antimuscarinic agents” because they are specifically known for blocking muscarinic receptors from the action of acetylcholine. Though muscarinic receptors are present in the brain, they are also in other tissues of the body like the heart, bladder, and intestine.

These newer drugs have a more specific approach that helps decrease the action of the smooth muscle cells in the urinary tract while increasing the tone of the sphincters controlling urination. Oxybutynin is often lumped together into the same class with these newer drugs, as it also has antimuscarinic activity, but its action is not as specific, meaning that it may have a greater effect on other areas of the body as well.

Does Ditropan Cause Dementia?

Early studies suggested that Ditropan was safe for use in the elderly. Yet the concern about cognitive side effects has been there for years. This is because the aging brain is, overall, deficient in cholinergic neurotransmission, and muscarinic mechanisms are required for several cognitive processes, including short-term memory.

Medications like Ditropan, which inhibit these actions, are known to have the potential to cause cognitive problems.

We already know, for instance, that acetylcholine dysfunction contributes to cognitive decline in those with Alzheimer’s disease. Reduced anticholinergic activity is also associated with cognitive impairment.

Researchers say that it is “well-established” that the use of medication with antimuscarinic properties is associated with cognitive impairment in older people. In 2003, scientists found that patients with Parkinson’s disease who were treated with antimuscarinic medications had 2.5-fold higher amyloid plaque densities than those who weren’t. These plaques show the type of brain damage that is related to Alzheimer’s disease.

In a 2005 study—before some newer drugs came onto the market—scientists wrote that though antimuscarinic agents can be effective at reducing the symptoms of OAB in older patients, “most currently available agents lack selectivity for the M3 receptor subtype, and interaction with other muscarinic receptor subtypes throughout the body may adversely affect a variety of physiological functions and result in unwanted side effects, including cognitive dysfunction.”

Studies Connect Use of Drugs like Ditropan to Increased Risk of Dementia

Several studies have noticed that elderly patients taking drugs like Ditropan are more likely to suffer from dementia. Yet this is the population in which the drug is most often prescribed. According to researchers writing in a 2011 published study, the prevalence of OAB increases with age, and because older people seem to experience more severe incontinence syndromes than their younger counterparts, they are also more likely to ask for medication to treat them.

In a 2009 study, researchers compared men and women 65 years and older who took medications like Ditropan with those who didn’t. They found that women who used them showed a greater decline over 4 years in verbal fluency and global cognitive functioning, whereas men had a greater decline in visual memory and executive function.

The researchers concluded that “elderly people taking anticholinergic drugs were at increased risk for cognitive decline and dementia.” They recommended that physicians “carefully consider” the prescription of these drugs in elderly people, particularly those at high genetic risk for cognitive disorders.

Comparing Oxybutynin with Newer, More Targeted Medications

There are several different muscarinic receptor subtypes, including M1, M2, and M3. It is the M3 receptor subtype that is most involved in bladder contractions. Thus, newer medications have sought to target that one more specifically. M1 and M2 receptors are both known to play a role in cognitive function. These receptors may be affected by older drugs like oxybutynin and others that don’t target the M3 receptor specifically.

In a 2006 study, researchers compared the effects of oxybutynin to a newer medication, darifenacin. They found that while darifenacin had no significant effects on memory, oxybutynin extended-release caused significant memory deterioration—comparable to the brain aging of 10 years.

In a 2008 review, researchers compared several medications including oxybutynin and darifenacin. They found that oxybutynin was “consistently associated with cognitive deficit” whereas darifenacin was not.

In 2009, scientists reported that oxybutynin was associated with statistically significant impairments in several measures of cognitive function, while solifenacin was not. Other studies have shown conflicting results with solifenacin, however.

Evidence Builds Connecting OAB Drugs Like Ditropan with an Increased Risk of Dementia

In 2015, researchers conducted a population-based study using data involving over 3,400 participants aged 65 years and older with no dementia at the start of the study. They then followed up with them every two years.

They found that higher cumulative use of anticholinergic drugs like oxybutynin was associated with an increased risk for dementia. More specifically, the findings suggested that a person taking oxybutynin chloride, 5mg/day, for more than three years would have a greater risk for dementia.

A 2017 study of patients with diabetes mellitus (DM) showed somewhat conflicting results. Those taking oxybutynin, solifenacin, and tolterodine were all at a greater risk of dementia than those who did not take antimuscarinic drugs. The results may suggest that the effects are different in those with other pre-existing conditions.

In 2017, a new analysis raised greater concerns over how oxybutynin may be affecting cognitive function in the elderly. Researchers found that oxybutynin was prescribed in more than a quarter of the cases of OAB (27.3 percent), even though there are now more targeted drugs available.

This could be because oxybutynin is the least expensive antimuscarinic used for OAB, and may more often be covered by Medicare. However, according to scientists, it is linked to greater cognitive decline in the elderly.

In a 2019 study involving over 58,000 patients with dementia and over 255,000 controls, scientists again found that anticholinergic drugs like bladder antimuscarinic drugs were associated with an increased risk of dementia in middle-aged and older people.

There was nearly a 50 percent increased odds of dementia associated with a total exposure of more than 1,095 total standardized daily doses within a 10-year period. This is equivalent to 3 years’ daily use of a single strong anticholinergic medication at the minimum effective dose recommended for older people.

The researchers added that if this association is causal (meaning that the drugs caused dementia), around 10 percent of all dementia diagnoses may be attributed to the use of these drugs.

In 2020, another study again showed that the use of anticholinergic medications among patients with OAB was associated with an increased risk of new-onset dementia. A later 2022 study showed similar results, specifically for oxybutynin and solifenacin.

Potential Injuries Related to Ditropan (Oxybutynin)

Use of Ditropan, particularly over a long-term period, may be related to:

  • A decline in short-term memory
  • Confusion
  • Slowed thinking
  • Forgetfulness
  • Dementia
  • Alzheimer’s disease

Ditropan Lawsuits

Plaintiffs who have used Ditropan, Ditropan XL, and other forms of oxybutynin and then suffered from symptoms of dementia may be eligible to file a personal injury lawsuit.

It’s interesting to note that as early as 1998, scientists were warning about oxybutynin’s potential cognitive effects. That year, a small study published in the Journal of the American Geriatric Society found that oxybutynin caused “significant cognitive decrements on seven of 15 cognitive measures” after only 90 minutes.

“ These findings demonstrate that oxybutynin can cause cognitive impairment and suggest that physicians prescribing it should monitor their patients to facilitate the early recognition of those who experience drug-related cognitive deficits,” the researchers wrote.

Yet the manufacturers—Janssen Pharmaceuticals and parent company Johnson & Johnson—failed to warn about these potential effects or to recommend that doctors screen for cognitive deficits before prescribing the drug.

If you used Ditropan, Ditropan XL, or other forms of oxybutynin and then suffered from cognitive deficits, call our experienced attorneys to schedule a complimentary consultation at 1-888-480-1123.

Frequently Asked Questions

If I Took Ditropan, Will I Develop Dementia?

Scientific studies show that medications like Ditropan may increase the risk of dementia. That means some patients may be more likely to develop cognitive problems if they take these drugs than if they don’t. But it depends on the person’s risk of dementia, such as whether they have a family history of the disease. It may also depend on a person’s current health at the time they are prescribed the medication, and how long they take the drug.

If you are taking OAB medications and are concerned, ask your doctor about newer, more targeted options. Then continue to monitor your cognitive health.

Should I Stop Taking Ditropan?

Don’t stop taking your medication without consulting with your doctor. Share your concerns and ask if you may be eligible for a different medication that may come with a lower risk of dementia.

Am I Eligible for a Ditropan Lawsuit?

If you used Ditropan or Ditropan XL and subsequently developed dementia, Alzheimer’s disease, or another form of cognitive impairment, you may be eligible to file a Ditropan lawsuit. Talk to a Ditropan attorney about your options.