Tag Archives: Noctiva

Recent Drug Approval Highlights Less Stringent FDA Criteria

The FDA’s March approval of Noctiva (desmopressin) is an example of the agency approving a drug where the risks outweigh the benefits, two physicians argue.

Noctiva was approved to treat nocturia, a condition characterized by frequently waking up in the middle of the night to urinate. Michael Fralick, MD, and Aaron S. Kesselheim, MD, say that nocturia is a symptom rather than a disease, and nocturia itself can be a side effect of a medication or an indication of a more significant health problem.

Writing in a JAMA op-ed piece, Fralick and Kesselheim, who are both affiliated with Brigham and Women’s Hospital and Harvard Medical School in Boston, note that the benefit of desmopressin was moderate. Yet, the drug was approved with a “black box” warning — the most severe the FDA can require — on potentially life-threatening hyponatremia, a condition where the sodium level in the blood is too low, leading to swelling in cells.

Incidentally, desmopressin is not a new drug at all. It was approved back in the 1970s to treat bedwetting in children.

Desmopressin was tested in several clinical trials. In 2 of them, Fralick and Kesselheim say that the drug failed to work in terms of reducing the number of trips to the bathroom. In 2 other trials, they noted that researchers excluded many patients the drug would likely be used on, including those with diabetes, congestive heart failure, poor kidney functioning or hyponatremia.

“It is becoming increasingly important for physicians to critically examine the underlying data and communicate the totality of the expected benefits to patients,” the pair wrote.

Quick Hits: Nighttime Urination Treatment Approved, Using Aricept & More

Noctiva (desmopressin acetate), a prescription nasal spray for adults who urinate frequently throughout night, was approved by FDA. The drug is the first FDA-approved treatment for the condition known as nocturnal polyuria, which is overproduction of urine during the night. Patients who plan to take this Noctiva should take precautions since the drug has a boxed warning. Noctiva can cause hyponatremia, which is low sodium levels in the blood. If it is not promptly diagnosed and treated, hyponatremia can be fatal — leading to seizures, coma, respiratory arrest or death. Doctors should ensure that a patient’s sodium level is normal before prescribing Noctiva, and should check sodium levels within 1 week and approximately 1 month after starting treatment and periodically thereafter. Posted March 3, 2017. Via FDA.

People with milder cognitive impairment should be given a genetic test before using Aricept (donepezil) to treat Alzheimer’s disease. Researchers at the UCLA School of Nursing found Aricept could speed mental decline in someone with mild cognitive impairment who has a specific genetic variation, they reported in the Journal of Alzheimer’s Disease. Patients with the K-variant of the butyrylcholinesterase (BChE) gene who took Aricept deteriorated faster than those who took a placebo. Posted March 7, 2017. Via Medline Plus.

Patients who have psychiatric ailments are more likely to reject treatment if only medication is involved. Researchers analyzed 186 studies of patients who sought help for mental health conditions. The results, published in the journal Psychotherapy, found that the treatment refusal rate was more than 8% on average. Patients were almost twice as likely to refuse drug treatment alone compared to those offered talk therapy alone. Patients with depression were more than 2 times more likely to refuse drug therapy alone and patients with panic disorders were nearly 3 times more likely to refuse drug therapy alone. Researchers explained that patients usually prefer talking with a caring individual who could talk them through their emotional distress. Posted March 6, 2017. Via Medline Plus.