Wednesday, February 8, 2023

Tag: off-label

Most Direct-to-Consumer Drug Advertisements Do Not Adhere to FDA Guidelines

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Few DTC drug advertisements fully adhere to FDA guidelines, the overall quality of information provided in DTC advertisements is low, and some advertisements market off-label indications.

Most Off-Label Prescribing of Antidepressants Lacks Strong Scientific Evidence

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A new study, published in the British Medical Journal, investigates the prevalence of off-label prescribing for antidepressant medication in primary care settings.

FDA Memo Rebuffs Many Suggestions for Expanding Off-label Marketing

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"After weeks of anticipation, the FDA has issued a lengthy memo about the extent to which so-called off-label information about medicines may be disseminated...

“Jury Smacks J&J with $70M in Damages in Latest Risperdal Breast...

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Fierce Pharma reports: "Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and...

“The Overdiagnosis of ADHD”

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The general theme, that various "mental illnesses" are being "overdiagnosed" is gaining popularity in recent years among some psychiatrists, presumably in an effort to distance themselves from the trend of psychiatric-drugs-on-demand-for-every-conceivable-human-problem that has become an escalating and undeniable feature of American psychiatric practice. But the implicit assumptions – that there is a correct level of such labeling, and that the label has some valid ontological significance – are emphatically false.

Experts Decry Dangerous Use of Antipsychotics in Children

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In a featured article for Psychiatric Services, psychiatrists from Dartmouth raise the alarm on the increasing numbers of children prescribed dangerous antipsychotic drugs. Despite the fact that data on the safety of long-term use of these drugs in this vulnerable population “do not exist,” the rate of children and adolescents being prescribed antipsychotic drugs have continued to increase over the past fifteen years.

“Risk of Off-Label Uses for Prescription Drugs”

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The Wall Street Journal highlights a new study that found that off-label medications represent about 12% of drug prescriptions and are resulting in negative...

Rise in Psychiatric Prescriptions With NOS Diagnosis

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A “not otherwise specified” (NOS) diagnosis is often used when an individual may have some symptoms related to a psychiatric diagnosis but does not meet enough criteria to warrant a particular diagnosis. A new study, published online ahead of print in Psychiatric Services, reveals that the proportion of mental health visits resulting in such NOS diagnoses rose to nearly fifty percent, and that these diagnoses do not result in more conservative psychiatric drug prescriptions.

“Direct-to-Consumer Advertising — Selling Drugs or Diseases?”

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With the American Medical Association (AMA) declaring its opposition to direct-to-consumer (DTC) drug advertising, Martha Rosenberg asks, did DTC increase the number of people who have "diseases"?

Off-Label Prescribing Increases Risk of Adverse Effects

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The first systematic investigation of the adverse effects associated with prescribing drugs “off-label” found that the common practice of using drugs for conditions for which they are not approved increases the risk of adverse effects.

“Drugs, Greed and a Dead Boy”

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New York Times columnist, Nicholas Kristof, relates the story of Andrew Francesco, a boy who began taking Ritalin at age five and died from complications with Seroquel when he was fifteen. His father, a former pharmaceutical industry executive, reveals the industry’s greed in his memoir “Overmedicated and Undertreated.” Now the industry is pushing for a first-amendment right to market its drugs for off-label uses.

More Than Two-Thirds of Antidepressants Prescribed Against Guidelines

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Results of a new study reveal that sixty-nine percent, or more than two-thirds, of patients prescribed antidepressant drugs have never, in their medical history, met the criteria for major depression. The study, published in the Journal of Clinical Psychiatry this month, also found that several demographic factors, like race and gender, were associated with the prescription of antidepressants.

SSRI Antidepressants Increase Surgery Risks

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There is accumulating evidence that taking SSRI antidepressants increases the risk of bleeding and other complications during surgery, according to a review published in the British Journal of Anaesthesia.

HuffPo Features 15 Part DocuSerial on Risperdal Corruption

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Huffington Post and journalist Steve Brill have combined to launch a 15 part series about how Johnson & Johnson illegally violated FDA restrictions by pushing the antipsychotic drug, Risperdal, for use with adolescents and the elderly. The series, entitled “America’s Most Admired Lawbreaker,” launched yesterday and will include mixed media, videos, podcasts, source documents, as well as 15 written chapters. Click more for a synopsis of part 1.

The Use of Antipsychotic Medications in Children

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Since the mid-1990s antipsychotic medications have been increasingly prescribed for children, adolescents, and adults. The most recent report finds an increase in use for older children from 2006 to 2008. Most of the prescriptions of antipsychotics for children reported by the study were for conditions which had not been approved by the FDA (called off-label use).

On Relaxing Off-Label Meds: Do the Opposite. Especially for Children. Especially Antipsychotics

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The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea. I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.