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Quick Hits: Abuse Warning for Rx Testosterone & More

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The FDA is adding a warning to all prescription testosterone products regarding abuse and dependence risks. Prescription testosterone was already designated a Schedule III controlled substance due to safety risks impacting the heart, brain, liver, mental health and endocrine system if taken more than directed. Additional case reports indicate that abuse of testosterone can lead to withdrawal symptoms such as depression, fatigue, irritability, loss of appetite, decreased libido and insomnia. Testosterone is prescribed to men as hormone replacement therapy, usually due to medical conditions such as genetic issues or chemotherapy. Posted October 25, 2016. Via FDA.

The DEA (Drug Enforcement Administration) will hold off on banning kratom, a plant said to have analgesic effects and an alternative to opioid painkillers, to entertain public comment. In late August, the DEA said it would designate kratom a Schedule I drug, meaning it has no medicinal value and a high risk of abuse. Other drugs in this category include heroin, LSD and marijuana. The DEA also said it will receive a scientific and medical recommendation on kratom from the FDA. The comment period ends on December 1, 2016. Posted October 13, 2016. Via Federal Register.

A new antipsychotic in development has been shown to have no additional side effects compared to a placebo in a late-stage trial. The drug, known as ITI-007, also demonstrated significant reduction in psychosis 4 weeks after patients began treatment. The researchers said the drug may provide similar efficacy to Risperdal (risperidone), but without the side effects associated with that drug. Whether ITI-007 will be approved by the FDA is questionable since a second Phase III trial of the drug showed no better efficacy than a placebo. Posted October 18, 2016. Via Medscape Medical News.

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