Heroin, fentanyl, and other opioids continue to be the highest drug threat in the nation.
The costs to patients are high when trials are carried out under the FDA's pediatric exclusivity program.
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.
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.
History of involvement with criminal justice system increased with intensity of drug use.
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.
From 2011 to 2016, increase in invasive MRSA cases from 4.1 to 9.2 percent among injection drug users.
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.
Two lots of naloxone hydrochloride injections, USP have been recalled by Hospira, Inc., due to concerns regarding the presence of particulates on the syringe plunger.
Alternative sun protection products, including pills and dietary supplements, are misleading consumers through false marketing and advertising.
Burden of deaths up; most patients receiving opioid analgesics use immediate-release formulations
Between October 20, 2017 and February 20, 2018, the Vaccine Adverse Event Reporting System (VAERS) received 155 reports involving RZV, with 13 (8%) involving an administrative error.
The Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.
The Agency has received reports of serious neural tube birth defects involving the brain, spine, and spinal cord in babies born to women who received dolutegravir for HIV treatment.
Anticholinergic drugs for depression, urologic conditions, or Parkinson disease are associated with potential dementia occurrences up to 20 years after drug exposure.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.
A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer stated the US Food and Drug Administration.
DisposeRx is a free method to safely and responsibly dispose of prescription opioids.
Future studies may help to assess the relation between chronic marijuana use and cardiovascular risks.
Increased ibuprofen administration elevates LH and decreases testosterone to LH and inhibin B to FSH ratios in young adult men.
The rates of dangerous drug combinations, supplement use, and polypharmacy are increasing among older adult patients.
Research shows that off-label drug uses puts patients at high risk for potentially serious side effects.
Hepatitis C drugs Viekira Pak and Technivie have been recently linked to serious liver damage in patients with advanced liver disease, said the FDA.
A comprehensive approach is needed to improve prescribing practices and ultimately reduce opioid abuse and related overdose death rates across the country.
Take thorough dietary histories to be sure patients are not taking medications that adversely interact with the fruit.
Heavy use of acetaminophen is associated with kidney disease and bleeding in the digestive tract.
One clinician misdiagnoses an adverse effect of a drug prescribed by another.
The long-term safety profile of continuous fumaric acid esters treatment is favorable.
The report suggests CMS consider requiring more than 50 practices for accreditors to use to oversee compounded sterile preparations (CSPs).
Nearly 42% of patients considered current drinkers reported taking a medication that can interact with alcohol.