Naloxone May Fail for Overdoses Tainted With ‘Tranq,’ FDA Warns

The US Food and Drug Administration (FDA) is alerting healthcare professionals about the special management required for opioid overdoses tainted with xylazine, an animal tranquilizer known on the street as tranq, tranq dope, sleep-cut, Philly dope, and zombie drug. The tranquilizer is often combined with fentanyl or heroin, or occasionally with a stimulant, said the … Read more

The Hunt for N-Acetylcysteine: Medicine or Dietary Supplement?

Medicine or dietary supplement? N-acetylcysteine ​​(NAC) is marketed as both and in 2021, the supplement abruptly became difficult to find, causing distress to people who had been using it for a variety of conditions. The story behind its disappearance is one of a cat-and-mouse chase between manufacturers, advocacy agencies, and the Food and Drug Administration. … Read more

CMS Spent Billions on Meds Without Confirmed Benefits OIG Says

The Medicare and Medicaid programs spent more than $18 billion over 3 years on medications for which there was no proof of a significant clinical benefit, a new federal report shows. On Tuesday, the Office of the Inspector General (OIG) for the Department of Health and Human Services released an initial take on its ongoing … Read more

Brodalumab Suicide Risk Similar to Other Biologics, Study Finds

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis. The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an … Read more

FDA Panel Rejects Pimavanserin for Alzheimer’s Psychosis

A US Food and Drug Administration (FDA) advisory panel has rejected the atypical antipsychotic pimavanserin (Nuplazid, Acadia Pharmaceuticals) for the treatment of Alzheimer’s disease psychosis (ADP). In a 9-3 vote, the Psychopharmacologic Drugs Advisory Committee (PDAC) found that the drug’s manufacturer failed to offer convincing evidence of its efficacy in patients with ADP. Today’s rejection … Read more

Genetic Testing for Best Antidepressant Accurate, Cost-Effective

Genetic testing to determine the best antidepressant for patients with major depressive disorder (MDD) has the potential to lead to an optimal drug choice on the first try and reduce healthcare costs, new research suggests. CYP2D6 and CYP2C19, from the cytochrome P450 family, are involved in the metabolism and elimination of various molecules, including medications. … Read more

FDA Denies Petition to Disqualify Researchers Over Controversial Ketamine Studies

The US Food and Drug Administration (FDA) has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC), who conducted controversial studies involving ketamine and other sedatives in agitated persons without their consent. A citizen filed by Public Citizen, a consumer advocacy group, had asked the FDA to … Read more

Docs Check Mail for Ways to Return — and Ruin — Extra Opioids

Mail carriers could play a key role in reducing opioid misuse, according to researchers and regulators. One strategy under consideration by the US Food and Drug Administration (FDA) would require that opioid analgesics be dispensed with prepaid mail-back envelopes so patients can return leftover medication. Another approach — which is not part of the FDA … Read more

New Med for Severe Mental Illness Tied to Less Weight Gain

Olanzapine plus samidorphan (Lybalvi) vs olanzapine alone is associated with less weight gain while achieving similar clinical outcomes in patients with recent-onset severe mental illness, new research suggests. However, least one expert says the weight difference between the two drugs is of “questionable clinical benefit.” Last year, the US Food and Drug Administration (FDA) approved … Read more

Medications for Opioid Addiction Vastly Underutilized

Despite a record number of drug overdose deaths in the US and a large body of evidence supporting the efficacy of medications to treat opioid use disorder (OUD) these drugs remain vastly underutilized, new research shows. Based on data from the National Survey on Drug Use and Health (NSDUH), investigators found only one in four … Read more