FDA: Kratom Products Have High Levels of Heavy Metals
New concern added to list of the agency’s warnings about the herbal supplement.
Drug Safety
Drug Overdose Mortality Rates Highest in United States
Highest average annual percentage of change from 2001 to 2015 seen for Estonia, then US.
US Opioid Overdose Deaths Reach Record Number
Heroin, fentanyl, and other opioids continue to be the highest drug threat in the nation.
High Cost of Clinical Trials Under FDA Pediatric Exclusivity Program Examined
The costs to patients are high when trials are carried out under the FDA’s pediatric exclusivity program.
ASPREE Trial: Aspirin Associated With Higher Mortality, Hemorrhage Risk in Older Adults
The use of aspirin in healthy elderly patients as a preventative strategy was associated with no prolongation of long-term disability-free survival compared with placebo.
FDA Rejects Treatment for Uterine Fibroids Based on Safety Concerns
The NDA included data from two Phase 3 clinical trials (VENUS I and VENUS II), all four Phase 3 European Union registration studies, and real-world data of >700,000 women with uterine fibroids across 80 countries.
Any Opioid Use Tied to Involvement in Criminal Justice System
History of involvement with criminal justice system increased with intensity of drug use.
Blister Packs for Several Meds Recalled Due to Risk of Harm to Children
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
CDC: Invasive MRSA More Likely Among Injection Drug Users
From 2011 to 2016, increase in invasive MRSA cases from 4.1 to 9.2 percent among injection drug users.
FDA Cracks Down on Illegal Online Sales of Opioids
The U.S. Food and Drug Administration has issued warnings to 9 online companies selling illegal opioid medications on 53 websites, in direct violation of the Federal Food, Drug, and Cosmetic Act.
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