Drug Safety

US Opioid Overdose Deaths Reach Record Number

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

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

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

FDA Rejects Treatment for Uterine Fibroids Based on Safety Concerns

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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

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

Blister Packs for Several Meds Recalled Due to Risk of Harm to Children

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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

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

FDA Cracks Down on Illegal Online Sales of Opioids

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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.

Naloxone Recalled Due to Potential Health Risks

Naloxone Recalled Due to Potential Health Risks

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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.

FDA Warns Companies Promoting Ineffective "Sunscreen Pills"

FDA Warns Companies Promoting Ineffective "Sunscreen Pills"

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Alternative sun protection products, including pills and dietary supplements, are misleading consumers through false marketing and advertising.

Studies ID Impact of US Opioid-Related Mortality, Prescription Patterns

Studies ID Impact of US Opioid-Related Mortality, Prescription Patterns

Burden of deaths up; most patients receiving opioid analgesics use immediate-release formulations

CDC: Administration Errors Reported With New Shingles Vaccine

CDC: Administration Errors Reported With New Shingles Vaccine

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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.

FDA: Updated Safety Alert Regarding Benzocaine-Associated Methemoglobinemia

FDA: Updated Safety Alert Regarding Benzocaine-Associated Methemoglobinemia

The Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.

FDA: Possible Risk of Neural Tube Birth Defects With Certain HIV Meds

FDA: Possible Risk of Neural Tube Birth Defects With Certain HIV Meds

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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.

Some Anticholinergic Drugs May Be Linked to Dementia

Some Anticholinergic Drugs May Be Linked to Dementia

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Anticholinergic drugs for depression, urologic conditions, or Parkinson disease are associated with potential dementia occurrences up to 20 years after drug exposure.

Fycompa sNDA Submitted for Pediatric Seizure Indications

Fycompa sNDA Submitted for Pediatric Seizure Indications

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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.

FDA: Kratom-containing products to be recalled, destroyed

FDA: Kratom-containing products to be recalled, destroyed

A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer stated the US Food and Drug Administration.

Walmart releases an opioid disposal solution

Walmart releases an opioid disposal solution

DisposeRx is a free method to safely and responsibly dispose of prescription opioids.

Evidence of marijuana's effect on cardiovascular events still scarce

Evidence of marijuana's effect on cardiovascular events still scarce

Future studies may help to assess the relation between chronic marijuana use and cardiovascular risks.

Ibuprofen use may compromise reproductive health in men

Ibuprofen use may compromise reproductive health in men

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Increased ibuprofen administration elevates LH and decreases testosterone to LH and inhibin B to FSH ratios in young adult men.

Use of potentially lethal drug combinations increases in the elderly

Use of potentially lethal drug combinations increases in the elderly

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The rates of dangerous drug combinations, supplement use, and polypharmacy are increasing among older adult patients.

Off-label prescription use leads to high rates of adverse events, serious side effects

Off-label prescription use leads to high rates of adverse events, serious side effects

Research shows that off-label drug uses puts patients at high risk for potentially serious side effects.

FDA issues warning for two hepatitis C drugs

FDA issues warning for two hepatitis C drugs

Hepatitis C drugs Viekira Pak and Technivie have been recently linked to serious liver damage in patients with advanced liver disease, said the FDA.

Improved prescribing practices needed to curb opioid abuse

Improved prescribing practices needed to curb opioid abuse

A comprehensive approach is needed to improve prescribing practices and ultimately reduce opioid abuse and related overdose death rates across the country.

Grapefruit contraindicated with increasing numbers of drugs

Grapefruit contraindicated with increasing numbers of drugs

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Take thorough dietary histories to be sure patients are not taking medications that adversely interact with the fruit.

Experts question safety of acetaminophen

Experts question safety of acetaminophen

Heavy use of acetaminophen is associated with kidney disease and bleeding in the digestive tract.

Missed drug side effect turns toxic

Missed drug side effect turns toxic

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One clinician misdiagnoses an adverse effect of a drug prescribed by another.

Fumaric acid esters effective psoriasis treatment in Germany

Fumaric acid esters effective psoriasis treatment in Germany

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The long-term safety profile of continuous fumaric acid esters treatment is favorable.

More oversight needed for compounded drugs, says OIG

More oversight needed for compounded drugs, says OIG

The report suggests CMS consider requiring more than 50 practices for accreditors to use to oversee compounded sterile preparations (CSPs).

Patients may be mixing medications with alcohol

Patients may be mixing medications with alcohol

Nearly 42% of patients considered current drinkers reported taking a medication that can interact with alcohol.

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