Tag Archives: autism

Quick Hits: Autism and Antipsychotics, Online Opioids & More

Kids with autism taking antipsychotics are more likely to experience side effects, according to a study from Swansea University. Researchers examined 3,028 children from birth up to 18 years old from the UK’s National Health Service who had been prescribed an antipsychotic. Analysts discovered that 2.8% of children with an intellectual disability or autism were more likely to be given an antipsychotic drug, and 75% of them had autism. Their evidence indicated that all of the young people on antipsychotics had higher rates of epilepsy, diabetes and respiratory infection requiring hospitalization. The results, which are published in the Journal of Child and Adolescent Psychopharmacology, indicated that antipsychotics were being prescribed to younger children with an intellectual disability or autism for a longer period of time, compared to those without autism. Posted April 4, 2018. Via Swansea University.

FDA Commissioner Scott Gottlieb has called on Internet service providers to rid the Internet of firms selling Rx opioids, such as fentanyl. “Internet firms simply aren’t taking practical steps to find and remove these illegal opioid listings,” Gottlieb said during a speech on April 4. “There’s ample evidence of narcotics being advertised and sold online.” Gottlieb shared some insight on a congressional investigation that identified just how easy it is to locate and purchase the powerful opioid fentanyl online. According to the commissioner, the drug can be purchased through online payment systems such as PayPal, and can also be received easily through the US Postal Service. This investigation pinpointed 500 transactions that were worth $230,000 with 300 people in 43 states, Gottlieb said. Alarmingly, they also identified 7 people who died of overdoses after receiving drugs online. There may soon be talks of requiring mandatory drug prescription and pain management training for healthcare professionals. Posted April 5, 2018. Via The Washington Post.

The FDA ordered a rare mandatory recall after a kratom manufacturer resisted a voluntary recall following reports their products were tainted with salmonella. The mandatory recall stemmed from “the imminent health risk posed by the contamination of this product with salmonella,” according to the agency. After many attempts to encourage Triangle Pharmanaturals to voluntarily recall their product, the FDA took matters into their own hands since the company failed to cooperate. All consumers are being advised to throw away any products that may contain kratom, including supplements such as Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, Raw Form Organics Maeng Da Kratom Ruby Red and any other kratom products made or handled by Triangle Pharmanaturals. Posted April 3, 2018. Via FDA.

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.


Quick Hits: Long-Term Opioid Use in Neuropathy, Risk of Health Issues Seen with MS Drug & More

Patients with polyneuropathy – a type of nerve damage characterized by numbness and burning pain in parts of the body – who take opioids for 90 days or more have a higher risk for depression, dependency and overdose compared to those taking opioids for a shorter period. Researchers compared the results of 2,892 patients with polyneuropathy who had been treated with opioids for at least 90 days with the results of 14,435 patients who received opioids for a shorter time. Researchers, writing in JAMA Neurology, found that long-term opioid chronic therapy was associated with negative outcomes and failed to improve functional status. Via JAMA Neurology. Posted May 22, 2017.

People with multiple sclerosis (MS) that take Avonex or Rebif (interferon beta) are at a higher risk for several serious health issues, according to a new study. The new finding, published in Neurology, highlights the need for further investigation of the drug. The health records of more than 2,000 patients with relapsing-remitting MS were examined. Researchers identified an increased risk of stroke, migraine and depression among patients with MS treated with interferon beta compared to those not on the medication. Additionally, they found that patients had blood abnormalities. However, researchers also found that those taking interferon beta for at least 2 years had a reduced risk of bronchitis and upper respiratory infections. The study authors noted they hope the research will spur the development of biomarkers that can identify patients most likely to experience these adverse events. Via Neurology. Posted May 12, 2017.

A 100-year-old drug called suramin – initially developed to treat parasitic infections found mostly in Africa – displayed significant, but temporary, improvement in core symptoms of autism. A total of 10 boys with autism who received a suramin infusion displayed improvements in language and social behavior. However, suramin’s effectiveness was short-lived because the improvements peaked and then gradually faded after several weeks as the single dose of suramin wore off. Posted May 26, 2017. Via UC San Diego Health.

New Studies Find No Link Between Antidepressant Use in Pregnancy and Autism, ADHD Risk

The offspring of pregnant women who take an antidepressant are not at increased risk of developing autism spectrum disorder or attention-deficit/hyperactivity disorder (ADHD), according to a pair of new studies.

Researchers in the first study examined data on nearly 36,000 live births. In pregnancies where the mother was taking an antidepressant – either a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor – 2% of the offspring developed autism. While this percentage was higher when compared to mothers who didn’t take an antidepressant, when confounding factors were considered, there was no statistically significant difference between the 2 groups, researchers reported in JAMA.

“Although a causal relationship cannot be ruled out, the previously observed association may be explained by other factors,” the authors wrote.

Another study, also published in JAMA, examined 1.5 million births in Sweden and maternal antidepressant use. While maternal antidepressant use during the first trimester of pregnancy, compared to women who didn’t use an antidepressant, was associated with a small increased risk of preterm birth, there was no increased risk for low birth weight, autism or ADHD.

“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” the authors of the second study wrote.

Tylenol in Pregnancy: Real Concern or Unnecessary Fear?

Acetaminophen, better known under the brand name Tylenol, is an over-the-counter pain- and fever-reducing medication that is generally considered safe to use, even during pregnancy. In recent years, however, a slew of studies have cast some doubt on its safety during pregnancy. Some have claimed use of acetaminophen during pregnancy is linked to autism, ADHD (attention deficit/hyperactivity disorder) and behavioral issues in children.

While this may raise alarm bells for parents, it is important to understand how these studies were conducted in coming to their conclusions. In many cases, a closer examination of the data reveals that the risks have been overstated.

There have been 6 studies on this topic dating back to 2013 — the most recent came out just last month. All of these studies have reached similar conclusions, linking acetaminophen use during pregnancy to various behavioral issues in children.

FDA: No Clear Evidence Linking Tylenol to Developmental Issues

However, after conducting a review in January 2015 of studies to date, the FDA concluded that the results of the studies were too limited to make any definitive recommendations. Hal C. Lawrence, MD, executive vice president and CEO of the American College of Obstetricians and Gynecologists (ACOG), agrees.

The JAMA Pediatrics study in August “and other studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and developmental issues in children,” he tells MedShadow.

Let’s take a closer look at that JAMA Pediatrics study, which created scary headlines with the conclusion that behavioral problems were 20% to 45% more common in children whose moms took acetaminophen during pregnancy. The women were asked while pregnant about their acetaminophen use, but interestingly, were never asked how much they took or why. Also, the women who took Tylenol were more likely to have smoked or drank during the pregnancy, and more likely to have underlying psychiatric issues -– all factors that could influence behavior in their offspring.

the difference in the relative risk between women who did and did not take acetaminophen is extremely small.

As NPR pointed out, when these observations were factored in, the increase in behavioral problems in those whose mothers took acetaminophen greatly diminished, and even disappeared in some subgroups, compared to women who never took Tylenol.

Overall, the study found that a little less than 5% of the children examined in the study had behavioral problems. But only 2 percentage points separated those whose mothers had taken acetaminophen compared to those who hadn’t. In other words, the difference in the relative risk between women who did and did not take acetaminophen is extremely small.

Limitations in the Studies

Another limitation of many of these studies is that although they were based on interviews, many times, they were asked about acetaminophen use after their pregnancy. Studies that ask people to recall drugs they took a long time in the past are often inaccurate due to faulty memory.

The PLoS One study is perhaps the most significant evidence to date as it evaluates several medications — aspirin, antacids, NSAIDs (non-steroidal anti-inflammatory drugs), antibiotics and acetaminophen — whereas a majority of studies have only assessed the one medication. But again, this study showed a correlation, not a causation, between acetaminophen use and behavioral problems in children, and there could be other confounding factors involved.

All of these studies have “several limitations as it is not clear what dose of acetaminophen the mothers took, how long they took it, and for what reason. This is all critical information that is missing in order to begin to ascertain a cause and effect,” says Lawrence.

Therefore, “patients should not be frightened away from the many benefits of acetaminophen. The ACOG and obstetricians and gynecologists across the country have always identified acetaminophen as one of the only safe pain relievers for women during pregnancy,” he adds.

Behavioral disorders are a concern for parents as they affect 10-15% of children globally, with ADHD the most widely studied disorder. However, it is important to recognize that “behavioral disorders are multifactorial and very difficult to associate with a singular cause,” says Lawrence. “The brain does not stop developing until at least 15 months of age, which leaves room for children to be exposed to a number of factors that could potentially lead to behavioral issues.”

One important point to recognize in this discussion is that because acetaminophen is considered so safe, it is one of the most popular medications that pregnant women take. Between 40% and 65% of women in the studies said they used it during pregnancy. This compares to other commonly used medications during pregnancy, such as antibiotics (23.5%), antacids (17.4%), aspirin (5.3%) and NSAIDs (1.3%).

“The takeaways here are that physicians should not change clinical practice until definitive prospective research is done,” Lawrence notes. “And, as always, any medication taken during pregnancy should be used only as needed, in moderation, and after the expectant mother has consulted with her doctor.”

Antipsychotic Use in Children: A Q&A With Dr. Candida Fink

While antipsychotic drugs are most associated with treating conditions such as bipolar disorder and schizophrenia, they are often prescribed to adolescents and young children as well. Oftentimes, antipsychotic prescriptions are written for children for conditions that the drugs are not even approved for, such as irritability associated with ADHD (attention-deficit/hyperactivity disorder). A study published last year found that 60% of children between the ages of 7 and 12 were given an antipsychotic for the treatment of ADHD.

Dr. Candida Fink

Dr. Candida Fink

Antipsychotics can also have severe side effects, such as weight gain, elevated cholesterol, higher diabetes risk and tremor. MedShadow Content Editor Jonathan Block recently sat down with Candida Fink, MD, a board certified child and adolescent psychiatrist –- and a member of MedShadow’s board of directors –- about the use of antipsychotics in children.

Fink is the co-author of The Ups and Downs of Raising a Bipolar Child (with Judith Lederman, Simon and Schuster, 2003) and Bipolar Disorder for Dummies (with Joe Kraynak, John Wiley & Sons, 2015). Based in New Rochelle, NY, Dr. Fink specializes in child and adolescent psychiatry, with expertise in developmental disabilities, ADHD, pediatric anxiety and mental health issues in school settings. You can find out more about her at www.finkshrink.com.

Jonathan Block: What conditions would an antipsychotic be prescribed to a child for?

Dr. Candida Fink: The most appropriate and FDA indicated uses of antipsychotics in adolescents and younger are for schizophrenia and bipolar disorder. And, in younger kids, there are 2 that are approved for autism. It would not be to treat autism, but to treat the irritability associated with autism. Those are the biggest, most common antipsychotic indications.

They are clearly used for a wide variety of other things. Antipsychotics are sedating, and so they have found this usage in kids who are aggressive or having outbursts – even when you don’t necessarily have a clear diagnosis of bipolar disorder or any clear diagnosis of a psychotic situation or it’s not autism. So I think that’s the place where it’s most overused. Just the other thing to mention is that it is used to augment antidepressant treatment and treatment-resistant depression [even though] there are no childhood FDA indications for that and the research is limited using it as an add-on.

JB: There are first- and second-generation antipsychotics. Which ones tend to be safer and/or more effective?

Dr. Candida Fink: There was a big meta-analysis done in 2009 that basically showed that the first generation and second generation had mostly equivalent benefits, except for clozapine, which is sort of in its own world. The difference is more about what type of side effects that you got. The older ones don’t have the weight gain and metabolic disorders as much. The newer ones don’t have the movement disorders and the Parkinsonism, so those are trade-offs. In this day and age, almost no one is going to use a first generation in a child except maybe in the most extreme state hospital scenarios. Interestingly, if you go back and look, Haldol has FDA indications down to 3-year-olds for non-psychotic behavior disorder, which is a term for psychosis.

So, with that being said, for schizophrenia treatment, it probably looks like both are similar. In adult schizophrenia, they are very equivalent and effective for the most part, but different in types of side effects, Because the side effects of the first generation are not considered very severe or not more severe, but more life altering. As the second generation came out, the first thought was [these drugs do not have] Parkinson-like side effects, and they’re not going to give them tardive dyskinesia, they’re not going to make them have distorted movements permanently for the rest of their life.

JB: When kids are generally given an antipsychotic, is the hope that it is a short-term thing or is it generally considered a lifetime?

Dr. Candida Fink: When it’s used appropriately, you want to think about it in terms of the shortest possible time, such as to get through a crisis, to wait while other medications [take effect] or wait while we’re putting on non-medical interventions, maturation and growing up. Unless you have a lifelong disorder like schizophrenia, and sometimes autism, you really want to be thinking about this, when possible, always want to be as short term as possible. That, of course, being one way to minimize the weight gain…but the longer-term metabolic side effects really can be serious.

JB: Do you know if there are any studies or is anyone looking into the threshold level of, say, if they’re on the antipsychotic for 3 months, the weight gain is this, on the fourth month that?

Dr. Candida Fink: I don’t think anyone is doing that research. I don’t think it’s been broken down in that detail. I think, in general, [you want to be on an antipsychotic] the shortest amount of time. But I am not aware of any research to sort of break it down with any medicines.

JB:  At MedShadow, we’re all about side effects.I wanted to discuss some of the side effects that are associated with the first- and second-generation antipsychotics in children?

Dr. Candida Fink: With the first generation, they all can be somewhat sedating. They have a range of sedative qualities. Some are much more sedating than others. Also, with the first generation, the biggest package of side effects that we are concerned about are, primarily, movement disorders, and there are 2 types, reversible and irreversible. The reversible are Parkinson’s-like symptoms. When we block dopamine in the brain, we’re causing disturbance in the sort of movement regulatory system, and so [children on antipsychotics can] have rigidity and stiffness and look like they have Parkinson’s. That is completely reversible and it’s not a permanent effect.

The side effects that we worry about most in second-generation really are related to metabolic disorders, primarily. Weight gain is by far and away one of the biggest side effects of the second generation, and then longer-term disruptions in the entire metabolic system.

The longer-term effect is called tardive dyskinesia, which is a movement disorder, but that tends to be regarded as longer [duration]. Those are involuntary deriving movements that tend to involve shoulders, And no one has a really good idea how to reverse it. So that’s the big bet with first generation.

Another thing … that is not common, is neuroleptic malignant syndrome, and I’m not sure how much less the second generation might be at risk, but any antipsychotic medicine can cause a very bad side effect on neuroleptic malignant syndrome, which can kill. So that’s when your body temperature goes up, changes.It’s a very bad potential side effect, rare, but it does happen.

The side effects that we worry about most in second-generation really are related to metabolic disorders, primarily. Weight gain is by far and away one of the biggest side effects of the second generation, and then longer-term disruptions in the entire metabolic system, decreased sensitivity in insulin, changes in glucose metabolism, type 2 diabetes, lipid changes. This places people at higher risk of cardiovascular disease and that kind of thing. So, there are absolutely the long-term risks.

Next: Are There Non-Medical Interventions? >>

Quick Hits: Hormone Replacement Therapy Cancer Risk, Metformin and Weight Loss, & More

Hormone replacement therapy (HRT), which is used to treat the symptoms of menopause, may increase breast cancer risk dramatically. A new study that followed more than 100,000 women over 40 years found that women who took HRT (an estrogen and progestin pill) for about 5 years were nearly 3 times more likely to develop breast cancer compared to those who were just taking an estrogen pill, or nothing at all. And the longer a woman was on HRT, the higher the cancer risk became, according to data published in the British Journal of Cancer. For example, the breast cancer risk was 3.3 times higher for women on HRT for 15 years. While about 14 in 1,000 women in their 50s are expected to develop breast cancer, the rate is 34 in 1,000 for women on HRT, the study argues. Posted August 22, 2016. Via The Telegraph.

A common diabetes drug may help to reduce weight gain that results from atypical antipsychotic use in children with autism. The atypical antipsychotics Risperdal (risperidone) and Abilify (aripiprazole) are approved by the FDA to treat irritability in children with autism. A research team enrolled 60 children and adolescents between the ages of 6 and 17 with autism. Children were also taking an atypical antipsychotic for at least a month and experienced at least a 7% increase in body mass index (BMI) since starting the medication. The children were then randomized to receive either placebo or metformin. Those on the placebo saw no change in the BMI, while those on metformin experienced a statistically significant change, the researchers reported in JAMA Psychiatry. Posted August 24, 2016. Via JAMA Psychiatry.

The severity of side effects from breast cancer hormone treatments may be influenced by whether a patient expects side effects to occur. A new study examined 111 women who had undergone surgery for breast cancer and were about to start hormone therapy with tamoxifen or aromatase inhibitors. At that point, the women were asked about their expectations of side effects. They were then asked again after 3 months and 2 years of treatment. At the beginning, 8% expected no side effects, 63% expected mild side effects and 29% said moderate to severe effects. The results, published in Annals of Oncology, showed that women who expected side effects to be bad had nearly twice as many side effects after 2 years than women who expected no side effects or mild ones. In addition, the women who expected severe side effects tended to have lower quality of life during treatment. Posted August 24, 2016. Via Medical News Today.