Topiramate increases the risk of oral clefts

The anti-epileptic drug topiramate has been increasingly prescribed over the last decade not only to prevent seizures, but also to treat bipolar disorder and migraine headaches. In addition, topiramate is a component of a recently FDA-approved drug for weight loss. Past studies have found that women taking topiramate during early pregnancy to prevent epileptic seizures had greater chance of giving birth to a baby with an oral cleft, but such studies did not focus on women taking the drug at a lower dose for non-seizure related conditions.

 A new study by investigators from Brigham and Women's Hospital and the Harvard T.H. Chan School of Public Health suggest that using topiramate in early pregnancy, particularly at the high doses used for epilepsy, increases the risk of oral clefts. The new work leverages nationwide Medicaid data on more than 1 million live births from between 2000 and 2010.

The team examined the risk of oral clefts -- including cleft palate or cleft lip -- among three groups: infants born to women who had taken topiramate in their first trimester; infants born to women who had taken the drug lamotrigine (an unrelated drug used to treat bipolar disorder and epilepsy); and infants who had not been exposed to anti-epileptic medications in utero.

They found that the risk of oral clefts was approximately three times higher for the topiramate group than for either the lamotrigine or the unexposed group. Approximately one out of every 1,000 infants are born with an oral cleft, but among infants exposed to low doses of topiramate (median 100-mg daily dose) in the first trimester, that risk was 2.1 out of every 1,000 live births.

Among women taking higher dose topiramate (median 200-mg daily dose), the risk was much higher -- 12.3 for every 1,000 live births. Women with epilepsy on topiramate have the highest relative risk of giving birth to a baby with cleft lip or cleft palate, likely due to the higher doses of topiramate when used for controlling seizures.
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Links between epigenetic aging and bipolar disorder

Bipolar disorder may involve accelerated epigenetic aging, which could explain why persons with the disorder are more likely to die from age-related diseases. Chronological age is measured in the amount of time that a person has been alive, epigenetic age measures molecular markers of chemical modifications to DNA. Bipolar disorder has been previously associated with accelerated aging but the mechanisms are unknown.

The chemical modifications could be precipitated by the disorder itself or by poor lifestyle habits in diet, exercise, tobacco use and illegal substance use. Controlling these factors is just as important as taking medications. Using blood samples, the researchers compared patients with bipolar disorder,  siblings of bipolar patients and healthy controls.

They also found that while older bipolar disorder patients had significantly accelerated epigenetic aging compared to controls, no difference was found in younger patients.A difference wasn't detected in younger patients because they haven't had as much exposure to stressful events. This gave us a hint that cumulative chronic exposure to stress would relate to accelerated aging.

 We would see it more in older people who have experienced a lifetime of stress in dealing with the disease. Along with the epigenetic clock, the study included two other biologic clocks: telomere length and mitochondrial DNA copy numbers. The epigenetic acceleration correlated with the number of copies of mitochondrial DNA, suggesting that the cross-talk between the nucleus and the mitochondria might be underlying the premature aging in bipolar disorder.
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Abilify MyCite for treating schizophrenia

The U.S. Food and Drug Administration has approved the first drug with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal. Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.

Schizophrenia is a chronic, severe and disabling brain disorder. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep. Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.
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Amphetamine for treating attention deficit hyperactivity disorder

Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. It is used to treat attention deficit hyperactivity disorder. ADHD
Amphetamine may be habit-forming, and the medicine is a drug of abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Do not use amphetamine if you have used an MAO inhibitor in the past two weeks, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine may cause new or worsening psychosis- unusual thoughts or behavior, especially if you have a history of depression, mental illness, or bipolar disorder. You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes after using the drug.

Call your doctor if you have: signs of heart problems, feeling light-headed or short of breath; signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems--unexplained wounds on your fingers or toes.

Do not use amphetamine if you are allergic to any stimulant medicine, or if you have: moderate to severe high blood pressure; overactive thyroid;
severe anxiety, tension, or agitation.
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