QuarterWatch™ Reports

An independent perspective on emerging drug risks

QuarterWatch™ is the publication of an independent ISMP surveillance program that monitors adverse drug events reported to the US Food and Drug Administration (FDA) by manufacturers, health professionals, and the public. FDA releases, for research and data analysis, excerpts of all domestic and foreign reports it receives into the FDA Adverse Event Reporting System (FAERS). The goal of QuarterWatch™ is to identify signals that may represent important drug safety issues, which often require further investigation to determine their frequency and establish a causal relationship to the suspect drug. QuarterWatch™ is published four times a year as a public service to provide an independent perspective on emerging drug risks.

Browse Issues

Major drop in patients exposed to prescription opioids | Adult use of amphetamine-like stimulants grows rapidly | Methotrexate: growing use and medication errors that are fatal | Underreporting of serious and fatal adverse events
Severe allergic reactions for a new flu treatment, baloxavir (XOFLUZA) | Underestimated adverse effects of a new class of products for migraine prevention | Rating manufacturer performance in reporting adverse effects of newly approved drugs.
10 million adults use GABA analogs gabapentin (Neurontin) or pregabalin (Lyrica) | Analogs linked to dependence, mental impairment, and used in untested combinations | Unwarranted FDA reassurance on pimavanserin (Nuplazid) safety profile.
Safety profile of a new generation of cholesterol-lowering drugs | Complaints that a new psoriasis treatment could aggravate the condition | Eye inflammation linked to a novel immunosuppressant for atopic dermatitis.
Rhabdomyolysis: Severe damage to skeletal muscle | Serotonin or Neuroleptic Malignant Syndrome: Key neurotransmitters disrupted | SJS/TEN: Autoimmune reaction destroys large areas of skin | PML: A deadly viral infection of the brain
How Well Do Antidepressant Drugs Work? Vortioxetine (TRINTELLIX) Case Study • Dispensing Errors, Name Confusion for Breo, Anoro, and other Ellipta Inhalers• Abuse of a Widely Used OTC Drug for Diarrhea
Limited system for removing/replacing expiring implants and IUDs • Emergency contraception reports mostly about abnormal menses • Psychiatric symptoms linked to hormonal contraceptives • Missed dose, thrombotic events top issues for combination oral products
Hallucinations and pimavanserin (NUPLAZID), a new kind of drug for psychosis • Hypotension with sacubitril-valsartan (ENTRESTO) for heart failure
Oral anticoagulants the nation’s top risk of acute injury from drugs • Millions at risk from withdrawal symptoms • FAERS: A key monitoring system suffering from continued neglect
Exploring the link with therapeutic drugs • Emotional problems linked to suvorexant (BELSOMRA) started with missed doses • Very different phosphodiesterase-4 (PDE4) drugs can cause psychiatric problems
Antidepressants, allergy drugs among 87 products with signals for insomnia • Liver failure and antiviral failure with hepatitis C direct-acting drugs • Harms of antipsychotic drugs reappraised
SGLT2 Inhibitors - a health gamble with a new class of drugs for diabetes • Oral anticoagulants linked to nearly 3,000 reported patient deaths, 16,000 hemorrhages • Overall opioid use drops, but oxycodone use grows
Cancer risks of biological products for psoriasis • Tadalafil (CIALIS), sildenafil (VIAGRA) and sudden hearing loss• Non-serious reports increase FDA case total by 60% over previous year
Signals for new sleep medication suvorexant (BELSOMRA) • Opioids: Hydrocodone exposure declines while higher potency drugs increase • Update on new diabetes drugs blocking kidney glucose reabsorption
Two tumor necrosis factor blockers lead overall report totals in 2014 • Novel oral anticoagulant safety profiles diverge, but risks remain high • Atorvastatin (LIPITOR) accounts for most safety-related lawsuit reports
Zolpidem (AMBIEN) safety profile shows widespread unsafe use • Adverse event signals for canagliflozin (INVOKANA), a new diabetes medication • 20,632 incomplete rosiglitazone (AVANDIA) reports of heart attack and stroke