Tag Archives: Parkinson’s Disease

Parkinson’s, Overactive Bladder Meds May Raise Dementia Risk

A new study published in the British Medical Journal has found that several common medications, such as anticholinergic drugs, heighten the risk of dementia by an alarming 30%.

Researchers collected data from the UK’s Clinical Practice Research Database where they identified 40,770 patients, aged 65 to 99, who were diagnosed with dementia between April 2006 and July 2015.

To assess whether anticholinergic drugs are associated with an increased risk of dementia, researchers compared patients who were prescribed specific classes of anticholinergic drugs (examples includes Parkinson’s medications and antipsychotics) 4 to 20 years before being diagnosed with dementia to nearly 300,000 people who didn’t have the disease.

The results indicated that patients who took anticholinergics used to treat depression, Parkinson’s and a bladder disorder for more than a year had around a 30% increased risk of developing dementia later on in life. However, those taking other classes of anticholinergics for the treatment of asthma and gastrointestinal issues did not have a heightened risk of developing dementia.

“For the urological and antidepressants, there’s quite a clear association between their long-term use and dementia incidence” lead study author George Savva, PhD, University of East Anglia School of Health Sciences, told CNN. “For anti-Parkinson’s medications, the risk is there, but there’s far fewer of those prescriptions in the database, so there’s a lot less certainty.”

Quick Hits: Pregnant Moms and Antidepressants, Deaths Linked to Parkinson’s Drug & More

Mothers-to-be who take common SSRI antidepressants, such as Lexapro (escitalopram) and Prozac (fluoxetine), may unknowingly alter the brain development of their unborn child. Researchers from Columbia University Medical Center examined brain scans of nearly 100 newborns. Some of those babies were born to mothers who took SSRIs (selective serotonin reuptake inhibitors) while pregnant. The scans revealed that babies who were exposed to certain antidepressants while in the womb had alterations in both the gray and white matter of their brains. Researchers indicated that these alterations could ultimately increase the child’s risk of depression and anxiety. Alarmingly, the changes identified were “much greater than the brain changes or abnormalities associated with psychiatric disorders” that the researchers usually detect in children or adults. The study did not demonstrate cause and effect and did not test long-term consequences of the brain changes linked to antidepressant use during pregnancy. Posted April 9, 2018. Via JAMA Pediatrics.

The Parkinson’s disease drug Nuplazid may be responsible for hundreds of deaths. Nuplazid (pimavanserin), manufactured by Acadia Pharmaceuticals in San Diego, was created to regulate Parkinson’s disease psychosis. A CNN article reports that more than 700 patients have died after they started taking Nuplazid. A report from the non-profit Institute for Safe Medication Practices indicated that 244 patients who took the drug died between the drug’s launch in 2016 and March 2017. The FDA approved Nuplazid in 2016, and the agency classified the drug as a “breakthrough therapy” and granted a “priority review,” which sped up the review process. Posted April 9, 2018. Via CNN.

Increasing cigarette prices would curb extreme poverty and poor health around the world. According to an analysis, low-income people would benefit from the price increase the most. After examining 500 million male smokers in 13 countries, researchers discovered that a 50% price increase in cigarettes would lead to 67 million men abandoning cigarettes. Also, the price increase would allow 15.5 million men to dodge catastrophic health spending in the 7 out of 13 countries without universal health coverage. “A higher price would encourage cessation, lead to better health, and save money much more strongly for the poor than the rich,” said lead researcher Prabhat Jha, MD, DPhil, director of the Centre for Global Health Research of St. Michael’s Hospital. Posted April 11, 2018. Via BMJ.

Let’s Answer the Questions About Marijuana

I’ve written in the past about the unknowns of marijuana. We don’t have concrete proof confirming the medical benefits that cannabis proponents make. The “high” experienced is different every time for every person. We don’t have a way of measuring impairment that drug creates. There are many strains which all have differing effects and so much more.

It seems crazy, but marijuana is still classified as a “Schedule 1” drug according to the Controlled Substances Act. That means officially the US government’s stance on cannabis is that it has “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.” This puts it in the same group as drugs such as heroin, LSD and ecstasy.

We Need Research

Marijuana is believed to have many medical benefits but it also has side effects. There is evidence that it can help with pain, stimulate the appetite for people undergoing chemotherapy and treat glaucoma, Parkinson’s disease and seizures, but it is mostly anecdotal or observational in nature. To unleash all the benefits of marijuana and to make sure it is used safely, we need research.

But research is limited because legal access by scientists for study is restricted because it’s a Schedule 1 drug. It’s such a long and cumbersome process requiring paperwork from many different federal agencies that it discourages many researchers from even trying. The Drug Enforcement Agency (DEA) tightly controls access to marijuana for research and has just one main location, the University of Mississippi, where it is grown for this purpose.

Reassign Pot to Schedule II

A solution would be to reassign marijuana as a Schedule 2 drug. This would allow much more research to take place that we can find out if marijuana truly has all the benefits people are talking about and what the risks are. For more information on this topic, please read Pot Research: Why It Matters.)

At MedShadow Foundation, we’ve drafted a petition that will be sent to the DEA and other federal agencies asking them to change marijuana from a Schedule 1 to Schedule 2 drug, which will facilitate medical research on it. If you agree we need more research now, please, sign our petition. And share it with you friends and family too.

Statins May Accelerate Onset of Parkinson’s

Statins, which are widely used to lower cholesterol, may end up accelerating the onset of Parkinson’s disease in some patients.

Researchers at Penn State College of Medicine examined insurance claims data from 50 million people. They found 22,000 people that were diagnosed with Parkinson’s, though only 2,322 were newly diagnosed. They identified patients who were taking statins and determined how long they were taking the medication before Parkinson’s was diagnosed.

Patients that were on statins had a higher risk of developing Parkinson’s, the researchers reported in the journal Movement Disorders. Results also indicated that the association between statin use and Parkinson’s was strongest within the first 2.5 years a patient was on the drug. Researchers say that indicates that statins may facilitate the onset of Parkinson’s.

Prior research had suggested that statins might actually protect against Parkinson’s. One study found that people who stopped using statins were more likely to be diagnosed with the disease. But a different explanation for that finding has come to light.

“Use of statins may lead to new Parkinson’s disease-related symptoms, thus causing patients to stop using statins,” lead author Xuemei Huang, MD, said in a statement.

She cautioned that the results should not be interpreted as saying statins cause Parkinson’s. Instead, the findings indicate that statins serve no neuroprotective role. In addition, the data did not include people over the age of 65.

“If your mom has Parkinson’s disease and your grandmother has Parkinson’s disease, and you don’t have a family history of heart attacks or strokes, then you might want to ask your physician more questions to understand the reasons and risks of taking statins,” Huang said.

Are There Side Effects Associated with At-Home Genetic Health Risk Tests?

If you could find out whether you are at increased risk for developing a serious condition, such as Alzheimer’s disease or Parkinson’s disease, based on your genes, would you? Undoubtedly, many people would say yes since as a result, they might be able to make lifestyle changes or alert their doctors.

This is the appeal of genetic health risk (GHR) tests. A matter of weeks ago, the FDA gave approval to the first-ever direct-to-consumer version of such a test, made by a company called 23andMe. The test is simple: Spit in a tube to get a saliva sample, return it to 23andMe, and using an analysis of genetic variants in a person’s DNA, determine if they are at increased genetic risk for 10 diseases or conditions.

At face value, it seems like there could be little to argue against such a test – except perhaps for the $199 price tag (23andMe also includes an assessment of your ancestry in that figure). However, there are some concerns. The first that comes to my mind is how a person interprets the results. Let’s say a person finds out that they are at an increased risk for Parkinson’s based on a genetic variation. They might immediately think they will get the memory-robbing disease, leading to emotions including anger, anxiety and depression.

Excessive Worry As a Side Effect

At MedShadow, we like to talk about side effects of drugs and how you should be aware of them. While there aren’t side effects from the test itself, I do worry that another side effect may manifest itself in some people when they get the results: Panic. Finding out you may be at risk for a serious condition is sure to unnerve even the calmest person. Similarly, if a test comes back negative for any of the 10 diseases, it might give a person a false sense of security they won’t eventually develop any of them.

One side effect that may occur in some people when they get the results: Panic.

“It’s important for people to know that even if they have a mutation in the genes, by and large they won’t get Parkinson’s disease,” James Beck, chief scientific officer of the Parkinson’s Foundation, told STAT.

There’s also a risk that the test could provide a false positive or negative. That’s why the FDA rightly recommends that consumers speak to their doctor if they have questions about the results.

Tests, Not Medical Diagnoses

If you are interested in the 23andMe test, you should understand that it is not a medical diagnosis. Nor is it a complete assessment of your risk for a disease. As the FDA noted in a news release, GHR tests “cannot determine a person’s overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors.”

In the end, the 23andMe test may not tell you all that much about your future health risk. And while the financial cost is $199, there may be additional costs to people in terms of needless worrying and reading too much into genetic test results.

Feeling Anxious? Depressed? Check Your Meds

If you find yourself feeling on edge for no apparent reason while taking a cold medicine or diuretic, you most likely wouldn’t connect the two. However, anxiety happens to be just one of many mood-altering symptoms that can be brought on by certain meds.

“Many medications, whether prescribed or found over the counter, can cause psychiatric symptoms,” says Shiyun Kim, PharmD, BCACP, BCPP, CDE, a clinical pharmacist and clinical assistant professor at the University of Illinois Hospital & Health Sciences System, and a spokesperson for the American Pharmacists Association.

She explains that a wide range of factors influence the way a drug affects each person, including things like metabolism, underlying illness, and interactions with other drugs. “Any variations that occur, such as with improper doses or individual reactions, can result in undesirable psychiatric symptoms,” though they are relatively uncommon.

If you feel that you may be suffering from these side effects, notify your providers immediately. “Keep in mind that some medications can be stopped abruptly, while others need to be tapered to prevent further adverse effects,” Dr. Kim emphasizes. “Your provider can make the best decision with you.”

Take note of the following medications that can have these kinds of effects, and read on to find out how to minimize the risks.

Oxycontin and Similar Pain Medications

“Most prescription pain medication, such as oxycodone (OxyContin) or hydrocodone, can cause drowsiness, which can make one feel ‘cloudy’ and lack motivation — and these symptoms closely mimic depression,” according to Bree Meinzer, PharmD, CTTS, a pharmacy practice resident at Ohio Northern University. Opioids can also lead to more severe symptoms like paranoia, hallucinations, psychosis and dementia, especially at high doses. Signs that you may have taken too much of an opioid include trouble breathing and unconsciousness. People with opioid dependence and those who suffer from HIV, liver or lung disease or suffer from depression may be more susceptible to these effects, according to the World Health Organization. If you are on a pain medication that makes you drowsy or “cloudy” and you do not like how it makes you feel, you should talk to your doctor about other ways to adequately manage your pain.

Lasix, Microzide and Other Diuretics

Medications that reduce fluid retention and swelling, including furosemide (Lasix) and hydrochlorothiazide (Microzide), increase urination. This can lead to dehydration, especially in the elderly, and can result in hallucinations and dizziness, says Dr. Meinzer. SGLT2 inhibitors such as canagliflozin (Invokana) and empagliflozin (Jardiance), which are drugs used to treat diabetes, can also increase urination and cause dehydration. If you are taking these types of medication, be sure to drink plenty of water to stay sufficiently hydrated. The amount of water to drink should be discussed with your doctor and is dependent on your weight. “These medications should also be taken in the morning or early afternoon to avoid frequent urination at night,” which could disrupt sleep, she advises.

Ask your doctor to take a look at your current medication regimen to rule out potential drug-drug interactions that could cause psychiatric side effects.

Requip and Other Dopamine Agonists. Medications like ropinirole (Requip), often prescribed for restless leg syndrome and Parkinson’s disease, increase the brain chemical dopamine, which helps regulate mood and behavior. Too much dopamine can cause hallucinations, notes Dr. Meinzer, and more extreme potential side effects include confusion, mania, depression and impulse control disorders like compulsive gambling or eating. “There are other options for restless leg syndrome that don’t increase dopamine, though medications like ropinirole typically work best.” There are also different medications for Parkinson’s, though you and your doctor should carefully consider your particular treatment needs. If you experience these kinds of symptoms while taking this type of medication, it may be that your dose is too high.

Ritalin, Adderall and Other Stimulants

Drugs that are commonly used for the treatment of attention-deficit hyperactivity disorder (ADHD) include those sold under the brand names Ritalin and Adderall. Although these stimulant medications “help children and adolescents focus and stay on task, side effects include increased heart rate and insomnia, which can often cause anxiety and restlessness,” says Dr. Meinzer. Stimulants “excite the central nervous system and can disrupt normal communication between cells in the brain,” adds Dr. Kim. “This class of drugs may also cause bizarre behavior, agitation, mania, paranoia and nightmares.” Dr. Meinzer suggests talking to your healthcare provider if you feel extremely restless and anxious while taking this type of medication. Again, it is possible that your dose is simply too high.

Corticosteroids

Medications like prednisone, cortisone and methylprednisolone are often prescribed “to help respiratory symptoms and decrease inflammation with chronic diseases,” Dr Meinzer explains. They are typically only “used for a short term to help alleviate symptoms, but if you are on these medications for a long time, they can cause some unwanted side effects.” Use of these drugs for more than a few months can increase the chances of experiencing mania, anxiety, depression, paranoia and psychosis, which have mostly been reported by patients using high doses or abusing the medication, says Dr Kim. Though experts are unclear about the exact reasons for such side effects with these drugs, research suggests that it may have to do with the way steroids work in the area of the brain that influences memory and emotion. It is also possible that “high levels of steroids result in brain damage and cause cognitive dysfunction.”

Zarontin and Other Anticonvulsants

Medications such as ethosuximide (Zarontin), which are used to control seizures in people with epilepsy, can cause symptoms resembling depression. These drugs have also been found to increase suicidal thoughts and behavior. “If you start to experience these symptoms on an anticonvulsant, you should talk to your doctor about other regimens,” Dr. Meinzer recommends. “There are other medications in the same class that are less likely to cause this side effect,” though your doctor may want you to stay on the medication because it may be the one that is most effective for you. “Anticonvulsants are usually tricky to dose and may need lab monitoring to make sure they are in the proper range.”

Dr. Kim offers the following general tips to help prevent or deal with these side effects:

  • When you are prescribed a drug, ask your provider about potential side effects that are commonly noted and reported.
  • Ask your provider to take a look at your current medication regimen to rule out potential drug-drug interactions that could cause psychiatric side effects.
  • Withdrawal of some drugs can cause symptoms such as anxiety, agitation or depression. Therefore, call your doctor before stopping medications on your own.
  • When purchasing an over-the-counter (OTC) medication, take the time to read the instructions on the package. If anything is unclear, ask the pharmacist for guidance.

FDA Approves First Direct-to-Consumer Genetic Risk Tests

The FDA has approved the first-ever genetic tests that allow consumers to determine if they are at risk for developing certain diseases or conditions.

The 23andMe Personal Genome Service Genetic Health Risk (GHR) tests check for 10 diseases or conditions based on a person’s inherited genetics. The hope is that if someone knows they may be at risk for a certain disease, their doctor will also know and take necessary steps or make lifestyle changes.

The tests work by analyzing DNA in a saliva sample, which is then examined for more than 500,000 genetic variants. The presence or absence of some of these variants is linked to an increased risk for developing certain diseases or conditions, including Parkinson’s disease, Alzheimer’s disease, celiac disease and primary dystonia, a disorder characterized by uncontrolled muscular contractions or other movements.

Risks with the tests are primarily getting false positive or false negative readings. The FDA cautions that test results should not be used to diagnose or inform a treatment decision, and should be discussed with a health care professional.

Quick Hits: Pricey Cholesterol Drug and CV Risk, New Parkinson’s Treatment & More

An expensive new cholesterol drug was able to significantly reduce levels of bad cholesterol, though the medication’s ability to lower cardiovascular risk was more modest than expected. The drug, Repatha (evolocumab), is a biologic known as a PCSK9 inhibitor that works by lowering LDL, or bad cholesterol levels. A new study, sponsored by Amgen, Repatha’s manufacturer, found that while those on Repatha saw their LDL levels drop dramatically, their risk of cardiovascular events, such as heart attack or stroke, declined by only 15%. In addition, there was no reduction in the risk of death between those on Repatha and a statin compared to those on a statin alone, researchers reported in the New England Journal of Medicine. Posted March 17, 2017. Via NEJM.

The FDA approved a new Parkinson’s disease medication as an add-on therapy for patients that are experiencing an “off” episode. The drug, Xadago (safinamide), is to be given in addition to levodopa/carbidopa, a standard Parkinson’s treatment. “Off” episodes are when a patient with Parkinson’s is on medication, but it is not working well, leading to symptoms such as tremor and difficulty walking. In clinical trials, the most severe adverse reactions with Xadago were uncontrolled involuntary movement, falls, nausea and insomnia. Posted March 21, 2017. Via FDA.

Prostate cancer treatments have different and varying rates of side effects. A new study examined the incidence of side effects based on multiple types of prostate cancer therapies. Prostatectomy was linked to higher sexual dysfunction and urinary leakage than the other options, the researchers reported in JAMA. At 2 years after treatment, more than 57% of men who had normal sexual function prior to treatment reported poor sexual function after surgery, compared with 27% who reported poor sexual function after external beam radiation, 34% after brachytherapy, and 25% after active surveillance. Researchers say they hope the data helps guide patients and doctors to make better treatment choices. Posted March 21, 2017. Via JAMA.

5 Drug Classes That May Cause Depression

Depression can be a complex disorder with many causes, but depressive feelings can also result as a side effect of medication. For most medications, the risk is small, but if you have experienced depression in the past, you may be more likely to develop depression again when you take one of these drugs.

It can be difficult to tell whether depression is due to a drug, says Linda Lang, MD, chair of the Department of Psychiatry at Christiana Care Health System in Delaware, especially if a person also has an illness that itself can lead to depression. “We have to be mindful of the potential that somebody who has breast cancer is put on tamoxifen and they’re depressed,” she says.

“You might say ‘Well of course they’re depressed, they have breast cancer’ but it might be the tamoxifen.” For the same reason, researchers have a hard time concluding whether the drug causes depression because a lot of patients with a cancer diagnosis might develop depression anyway.

Depression isn’t just sadness. Symptoms to watch out for include feelings of hopelessness, change in appetite, thoughts of death, difficulty sleeping, or irritability. You probably won’t feel these effects right away, but they may set in after a few weeks.

Cardiovascular Drugs

Beta-blockers reduce your blood pressure by blocking the effect of the hormone epinephrine, also known as adrenaline. Researchers have suspected a connection between this class of drugs and depression for nearly 50 years, without strong evidence to answer the question either way. The risk for depression, if it exists, is probably small.

Statins, the cholesterol-lowering drugs, are also possibly linked with depression. Statins can interfere with the way the body uses serotonin, and serotonin is important to the brain’s functioning. As with beta-blockers, studies looking for the connection have had mixed results, with some even finding that statins may have an antidepressant effect.

Hormonal Agents

Drugs that interfere with the way hormones operate in the body can affect mood. Corticosteroids, for example, can lower serotonin levels and might be able to cause depression. This class of drugs includes cortisone and prednisone.

Tamoxifen, a breast cancer treatment, also has possible connections with depression. Tamoxifen interferes with estrogen, with different effects in different parts of the body. It’s possible, though not fully proven, that this can lead to depression.

Birth control pills have also been linked with depression, but again the relationship is hard to untangle. A recent study of Danish women found that those on contraceptives were slightly more likely to fill a prescription for an antidepressant. But women who go to the doctor for birth control may have simply been more likely to have an opportunity to get their depression diagnosed.

Antiepileptic Drugs

Antiepileptics are drugs used to treat seizure disorders, and may also be used for other purposes. Topamax (topiramate) can be used to prevent migraines, for example. These drugs both act on neurotransmitters and their receptors in the brain.

Both of these drugs have been linked with depression, even though topiramate can also be used to treat certain kinds of depression. Topiramate was one of the drugs associated with an increased risk of committing suicide in one Danish study. People taking that drug were twice as likely to commit suicide as people who were not taking it. That means the numbers are still small — very few people commit suicide — but the risk is still concerning.

Other anticonvulsants share this risk, and may be worse than topiramate. Since 2008, the FDA has required all anti-epileptic drugs to carry a warning about an increased risk of suicidal thoughts and actions. The agency notes that the increased risk applies to eleven different drugs, that work in different ways and are prescribed for different reasons, so they consider the warning to apply to all antiepileptic drugs.

Parkinson’s Disease Medications

Parkinson’s disease is often treated with drugs like levodopa that increase the amount of dopamine in the brain. That makes sense, since Parkinson’s results from the death of dopamine-generating cells in the brain. “But as a result of increasing dopamine we can induce depression,” Dr. Lang says.

Dopamine, serotonin, and norepinephrine are neurotransmitters that all have some link to depression, so drugs that change the amounts of these chemicals in the brain may cause depression.

Retin-A (Isotretinoin)

Retin-A (isotretinoin) is a form of retinoic acid used to treat acne. The FDA received a large number of reports of suicides and suicidal thoughts while people were using this drug. As with many of the other drugs linked to depression, it is unclear whether isotretinoin truly causes an increased risk of depression and suicidal thoughts.

For any of these drugs, Dr. Lang says, your doctor should be monitoring your mental health, for example through depression screenings questionnaires. People taking these drugs are often at increased risk for depression, whether due to the drug itself or to the condition it causes.

If a medication seems to be causing any symptoms of depression, talk to your doctor about your options. In many cases, they can change your medication. If you need to stay on that medication, they can help you manage the depression, for example with anti-depressants or other therapy.

Drugs With Highest Risk for Dehydration or Heat-Related Illness

People who start certain drugs, such as blood thinners (anticoagulants), cardiovascular medicines, over-the-counter pain killers (NSAIDs/non-steroidal anti-inflammatory drugs), antipsychotics, antidepressants and anticholinergic agents (used to treat asthma, incontinence) face a higher risk of heat-related illnesses and dehydration that may require a trip to the hospital.

Australian researchers conducted an analysis, published in the Journal of Clinical Pharmacy and Therapeutics, of the prescription drug intake of 6,700 veterans who were admitted to a hospital for a heat-related illness or dehydration.

Among drug classes with a higher than normal risk of hospital admission for dehydration or heat-related illness, patients who had started SSRIs (selective serotonin reuptake inhibitors), a common type of antidepressants, had the lowest additional risk with 1.17.

But the highest risk — 2.79 — was seen in veterans who had initiated treatment with an ACE inhibitor, drugs used to treat high blood pressure, and diuretics, which are pills used to rid of the body of water and salt as part of high blood pressure treatment.

There was no additional risk for hospital admission for dehydration or heat-related illness associated with anticonvulsants, Parkinson’s disease drugs, hypnotics, anti-anxiety drugs or antihistamines.

“Prescribers and patients should be aware of the potential for medicines to be associated with increased risk of dehydration and heat-related illness,” the researchers conclude.

The Lowdown on New Drug for Parkinson’s Hallucinations, Delusions

The FDA on Friday, April 29, granted approval to the first drug ever to treat the hallucinations and delusions that are seen in as many as 40% of people with Parkinson’s disease. While Nuplazid (pimavanserin) certainly meets an unmet medical need for this population, some questions remain over whether the medication is more effective than other antipsychotics used off-label to treat these psychotic effects, as well as the drug’s long-term safety.

The decision follows a March FDA advisory committee vote of 12-2 affirming that the benefits of pimavanserin outweigh the risks in Parkinson’s Disease Psychosis (PDP). Some members expressed concerns about the drug’s safety, but given the few alternatives to treat the condition and no approved treatments, they ultimately gave pimavanserin the nod.

Acadia Pharmaceuticals, Nuplazid’s developer, won approval based on a 6-week trial involving 199 people that found the drug was better than a placebo in reducing the frequency or severity of hallucinations and delusions without making Parkinson’s motor symptoms any worse. The most common side effects seen in this and other trials it conducted was swelling, primarily in the ankles, feet and legs because of edema, nausea, as well as a confused state.

The drug, which is taken by pill once daily, works by targeting certain serotonin receptors in the brain, with the effect of reducing hallucinations, delusions and agitation. Acadia plans to make the medication available next month.

PDP is currently treated primarily through off-label use of other antipsychotics, such as Risperdal (risperidone), Seroquel (quetiapine) and Zyprexa (olanzapine). However, there is a downside associated with these three drugs since they can block a chemical in the brain called dopamine, which drugs used to treat Parkinson’s symptoms attempt to increase production of.

Just like other atypical antipsychotics, pimavanserin has a boxed warning noting higher risk of death associated with its use in older adults who have psychosis related to dementia -– an off-label use.

While the FDA and Acadia celebrate pimavanserin’s approval, there are no long-term studies on the efficacy and safety of the drug, and no studies examining whether the drug works better than off-label use of other antipsychotics.

In 2014, Whitney Tabares, PharmD, writing in the Kansas University School of Pharmacy Department of Pharmacy Practice’s Journal Club Digest, did a thorough evaluation of the efficacy and tolerability of pimavanserin in the treatment of PDP.

“While comparing pimavanserin to atypical antipsychotics that are currently used for PDP such as clozapine and quetiapine, it is difficult to properly assess its efficacy and determine which is more beneficial,” she wrote.

But why? For starters, there are no head-to-head studies comparing pimavanserin to clozapine or Seroquel, Tabares notes. In order to win FDA approval for a new drug, a pharmaceutical company only has to prove its medication works better than placebo, not whether it has better efficacy compared with a drug already on the market.

Second, Tabares takes issue with scales used to evaluate the efficacy of the 3 drugs in treating PDP. She argues that they have not been validated to use in a PDP population. “The scales are focused on the schizophrenic population in particular,” she noted, adding that the pimavanserin trials used scales different from those used in clozapine or quetiapine trials.

While Tabares says that trials involving pimavanserin had many more subjects enrolled than clozapine or quetiapine in PDP, “clinical trials that evaluate the use of pimavanserin over a longer time frame would aide in visualizing potential long-term side effects….There are also no trials in that include patients with history of heart disease.”

Tavares notes that pimavanserin “appears” to be more effective in the treating PDP with fewer side effects than other drugs used for this purpose and should be considered as a first-line treatment.

But, “head-to-head trials of pimavanserin vs clozapine or quetiapine need to be conducted to determine if there is any additional benefit in using pimavanserin,” she writes.

Slideshow: Our Must-Read Stories of 2015

MedShadow has reached more people than ever this year — more than 3 times as many in fact — with articles and news on the side effects and long-term effects of prescription medication. Looking at the pros and cons, we continuously break down the reality behind the labels. In 2015, we tackled controversial topics and explained complicated ones. One highlight: Our FDA Watch blogger Sarah Smedley took on the agency’s approval of a drug to improve women’s libido despite a list of problems and minimal upside. Here’s a look at our Top 10 of 2015!

  • Do Statins Need a Re-Think

1: Do Statins Need a Re-think??

Are statins on the way out? This look at the emergence of PCSK9 inhibitors, new drugs to lower bad cholesterol, asks that question. But in looking at the risks and benefits, writer Jodi Helmer finds that it’s not a clear case of trading the old drug for the new. First of all, there’s the cost.

2: Did Hype Drive the FDA Decision on Women’s Libido Drug?

Our FDA Watch blogger, Sarah Smedley, takes a close look at the FDA approval of the so-called ‘Pink Viagra’ drug, Addyi (flibanserin). As Smedley points out, Addyi doesn’t work anything like the hormonal drug Viagra. It affects the brain, making it dangerous — and all for questionable results.

3: Antidepressants: New Risks of Side Effects

Steven Findlay, a long-time health writer/editor, joined us this year with a blog called Your Meds: Risks Vs Benefits. Using Consumer Reports’ Best Buy Drugs as a jumping off point, he takes an in-depth look at the pros and cons of categories of drugs. His examination of antidepressants is particularly noteworthy.

4: Crowdshare Drug Sites: Pros & Cons

MedShadow Foundation founder Suzanne Robotti’s MedShadow Blog engages readers with cogent opinions and analysis from the point of view of patient advocacy. Her blog on crowd-sourcing is a user-friendly intro to the latest sources of healthcare information

5: Drugs in Pregnancy

The importance of understanding the side effects of medication is perhaps no more acute than when pregnant. Health reporter Rita Colorito’s 7-part series, Drugs in Pregnancy, covers topics from antibiotics to painkillers and is a must-read for any expectant mother.

6: Food as Medicine: Celiac Disease

Recognizing that sometimes the best medicine isn’t a drug, Geri Anne Fennessey’s article Food As Medicine: Celiac looks at a nutritional approach to treating this confounding disease.

7: Drugs for Parkinson’s: The Shocking Side Effects

Our 2-part feature on Drugs for Parkinson’s by Elizabeth Marglin is an eye-opener. One class of drugs can cause compulsive behavior, including gambling, drinking and sexual addiction. Others trigger tremors and fatigue. The articles include 2 helpful videos from the Michael J. Fox Foundation.

8: HGH: Is Growth Hormone Safe for Kids?

Health journalist and author Tara Haelle’s article about the long-term effects of HGH given to children is an important read for parents. After a generation of HGH treatments, doctors are starting to understand the long-term effects of HGH. Haelle’s piece helps parents balance risk and benefits.

9: Are Seniors Being Overmedicated?

Elderly patients may be taking 4, 5, 6 or more drugs, even though little is known about the dangers of interactions. Called “polypharmacy,” over-medication presents risks that should to be on the radar of older adults and anyone caring for them.

10: Are There Drugs in Your Supplements?

And last but never least, Suzanne Robotti asks the question we always wanted to know the answer to: What’s in My Supplement? In her effort to find out, she takes readers on a path that might help you figure out what’s in yours!