QuarterWatch monitors domestic, serious adverse drug events reported to the FDA. We identify trends in drug safety, report signals for specific drugs, and seek to improve the system.

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April 2017
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

QuarterWatch 2016 Q3  In this issue, we focus on depression and suicidality as adverse effects of therapeutic drugs. One part of our analysis focuses on two newer drugs with notably different medical uses. Apremilast (OTEZLA) is a drug for severe forms of psoriasis, while roflumilast (DALIRESP) is used to treat chronic obstructive pulmonary disease (COPD). But they share a risk of these psychiatric side effects though a common mechanism of action: inhibiting a widely distributed intracellular enzyme called phosphodiesterase-4 (PDE4). Also, a new perspective on risks of suicidal thoughts and behaviors comes through examining some striking cases of suicide and suicidal thoughts after taking suvorexant (BELSOMRA) that began when patients missed a dose or stopped the drug. Separately, we examine serious injuries reported for aspirin.

This issue focuses on the most recently released FAERS reports covering the 12 months ending September 30, 2016, with special attention to the most recent quarter of data, 2016 Q3. In Q3, the FDA received 259,941 new case reports of adverse drug events, a 10% decline from the previous quarter and a 26.6% decline from the same quarter one year earlier. Of special interest are domestic reports with a fatal, disabling, or serious outcome. For 2016 Q3 we identified 70,942 new cases, a decline of 17.7% from the previous quarter, and a similar decline from the same quarter one year earlier. After decades of steady growth in reported events, case report totals have been relatively stable for the past two years. However, in the most recent quarter, declines were seen in practically every category we monitor. Reports from consumers and health professionals, from foreign sources, and those indicating patient deaths all declined.

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January 2017
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

QuarterWatch 2016 Q2  In this issue we analyze two notably different adverse drug events. We identify drugs with signals for insomnia, one of the most common drug side effects that can both impair the quality of life and at times affect health. At the other extreme we examine the emerging risks of the new drugs for hepatitis C for triggering liver failure, a rare and catastrophic medical event that often ends in death or a liver transplant. We also summarize our recently published, peer-reviewed study of the harms of antipsychotic drugs.

The FDA received 269,776 new reports about adverse drug events in the second quarter of 2016, a decline of 20.8% from the previous quarter, but an increase of 5.9% from the same period one year earlier. The reports identified 1,386 different primary suspect drugs, but only 675 drugs accounted for 25 or more reports, and only 385 drugs for 100 or more reports. Among the new reports 78,123 cases (29%) described domestic, drug-related injuries that were serious, disabling, or fatal.  

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October 2016
Lessons from why new patch for migraines was withdrawn after nine months
Consumers struggle with the self-injection pen for a new diabetes drug

QuarterWatch 2016 Q1 In this issue we examine two signals for problems with devices that administer drugs to patients rather than the underlying risks of the drugs themselves. The Zecuity transdermal patch delivered sumatriptan for acute migraines with a novel technology using small electrical currents to deliver the drug ions through the skin and into body circulation. The Zecuity patch was withdrawn after just nine months on the market because of burns, scarring, and other skin injury. Also, we discovered patients were struggling to use the once-weekly self-injection pen for albiglutide (TANZEUM), a recently approved drug for type 2 diabetes. 

In the first quarter of 2016 the FDA received 320,102 new case reports about drug adverse events identifying 1,411 different primary suspect drugs, an increase of 19.2% cases over the previous quarter and 33.8% over the same quarter in 2015. However, there was a decline in the number of reports indicating fatal, disabling, or serious outcomes. In this key subset, the total of 74,834 new cases was 4% lower than the previous quarter, and 20.8% below the same quarter in the previous year. After many years of being relatively stable, reports directly volunteered to the FDA have increased in recent quarters and reached a record high of 12,864 new cases in 2016 Q1. Overall, 96% of the reports received into FAERS were prepared by drug manufacturers, who are required to report all adverse events that they learn about. However, these reports may be influenced by marketing and educational activities that cause companies to learn about more adverse event cases through contacts with health professionals and consumers. Reports sent directly to the FDA largely avoid these influences, are more complete than manufacturer cases reports, and more accurately capture the current safety concerns being identified by health professionals and consumers.

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September 2016
strengthen warnings for varenicline (chantix)
Statement for the FDA advisory committee meeting on September 14, 2016
Evidence for suicidal behaviors and violence
A written submission to the US Food and Drug Administration (FDA), which is considering a request to remove the current Black Box warning and mandatory Medication Guide warning about suicidal behaviors and other serious psychiatric side effects associated with varenicline (CHANTIX), a smoking cessation aid.

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June 2016
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

QuarterWatch 2015 Q4  In this annual report issue we outline both positive and negative changes in 2015 with significant implications for patient safety. The year marked the rapid uptake of a new class of diabetes drugs, called sodium glucose cotransporter 2 (SGLT2) inhibitors, which have unproven clinical benefits and a growing number of safety problems. Use of oral anticoagulants–the highest risk outpatient drug treatment in older patients¬–increased as novel oral anticoagulants (NOACs) in part replaced the traditional warfarin and also expanded the patient population. In addition, we identified both positive and negative trends in utilization of opioids and sleep medications, and also report on the drugs that accounted for the most adverse event reports in four monitoring categories.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP) that monitors all adverse drug event reports submitted to the U.S. Food and Drug Administration. We analyze computer excerpts from the FDA Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval. We also receive dispensed outpatient prescription data from IMS Health Inc.

In 2015 the FDA received 1.2 million adverse drug event reports, a 32.9% increase over the previous year and nearly five times the total received 10 years ago. The largest share of this increase occurred because of information technology improvements and regulatory changes at the FDA that resulted in adding 354,000 lower-priority reports into its FAERS system that had previously not been accessible for analysis.

The 9.9% increase in serious injuries reported in the United States (Table 1) in 2015 provides a more realistic but still approximate measure of the trend in harms from the therapeutic use of prescription drugs. Reported serious injuries are increasing because of growing use of drugs with many toxic effects. The introduction of new classes of drugs that move into widespread clinical use also boosted event totals. Increased marketing of brand name drugs can also increase reports because to sell more drugs the manufacturers come into more frequent contact with prescribing physicians and individual patients, and therefore learn more about harms. 

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April 2016
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

QuarterWatch 2015 Q3 In this issue we identify major differences in reports of cancer associated with drugs for psoriasis, a common skin disorder affecting an estimated 7.5 million people. While corticosteroid and other topical drugs are sufficient for many cases, potent immunosuppressant drugs are used in increasing numbers. In this report we also provide new evidence that drugs for erectile dysfunction and pulmonary arterial hypertension can cause deafness or sudden hearing loss.

In the third quarter of 2015, the FDA received 332,226 new adverse drug event reports, a 31.2% increase over the previous calendar quarter, and a 59.7% increase from the same quarter one year earlier. The large increase in reports consisted almost entirely of non-serious events from drug manufacturers. The key subset of serious events occurring in the U.S. in fact declined 2.2% from 78,854 reports in Q2 to 77,117 in Q3.

The 190,911 reports about non-serious adverse drug events were of generally poor quality, with 72% lacking information about one or more of the following: age, gender, or an event date. Consumers were the original source for 80% of these cases, and the leading complaint was that the drug was ineffective.

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January 2016
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

QuarterWatch 2015 Q1-2 In this issue we examine safety questions about drugs used in three of the largest patient populations in medicine: A new drug for chronic insomnia, a problem affecting 10-30% of all adults; changes in the use of opioid medications for moderate to severe pain, a near universal issue in most lives at some point; and a new family of drugs for Type 2 diabetes, a disorder for which 21% of those age 65 years or older are currently being treated.

This report is based on combined data from the first and second quarters of 2015, but report trends focus on the second quarter. In the second quarter of 2015 the FDA received 235,540 new reports of injury associated with the therapeutic use of 1381 identifiable primary suspect drugs. The total included 71,825 (30.5%) reports indicating a serious injury in the United States, 57,328 (24.3%) reports of serious injury in foreign countries, and 103,136 (43.8%) domestic cases indicating an injury, but no serious outcome. The second quarter total represented a 16.2% decline from the previous quarter of new information, but an 8.1% increase from the same quarter one year previously. This issue of QuarterWatch features a broader scope of review to include more data and to adapt to changing reporting patterns. Previous issues focused primarily on the subset of domestic cases with a serious outcome.

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September 2015
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

QuarterWatch 2014 Q3-4 This issue provides an overview of prominent drug safety issues as reflected in 833,076 adverse drug events reported to the U.S. Food and Drug Administration during 2014. For this annual review, we identify the drugs that account for the most reports overall and in key subgroups such as children, cases from legal claims, and reports indicating product problems. For each perspective it is important to consider both the insights revealed and the substantial limitations of the underlying data.

Although drug adverse effects are estimated to account for 100,000 to 200,000 patient deaths and 1 to 2 million hospitalizations each year, neither the FDA nor the Centers for Disease Control and Prevention publishes annual assessments of serious injury and death resulting from drugs in therapeutic use. Despite a world of proliferating digital data, the primary source for identifying injuries from therapeutic drugs remains the voluntary reports to the FDA’s Adverse Event Reporting System (FAERS). The QuarterWatch™ assessment is based on publicly released excerpts of case reports submitted for the first time in 2014.

The U.S. system for postmarket surveillance depends primarily on reports prepared by drug manufacturers. The types of reports that the FDA received in 2014 are described in Table 1. In 2014, manufacturers submitted 798,962 (95.9%) of the reports that the FDA received. The remaining 34,114 (4.1%) cases were submitted directly to the agency’s MedWatch drug information program portal by consumers and health professionals. Any individual who desires to report an adverse drug event has the option of either submitting one directly to the FDA or contacting a drug manufacturer. Manufacturers, in turn, are required to report every adverse event they learn of through any channel that could range from a consumer help-line telephone contact to a refill reminder that was returned indicating the patient had died. The strength of the system is that it collects information from a wide array of sources that range from episodes observed by hospital pharmacists to legal claims for drug-induced injury filed in state and federal courts. Reporting events to the FDA is closed to no one.

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May 2015
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

QuarterWatch 2014 Q2  In this issue, we examine why unsafe use of zolpidem (AMBIEN), a largely generic drug taken by more than 5 million people as a sleep aid, accounts for more emergency department visits for adverse effects than any other psychoactive drug. Also, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks. Finally, a flood of low-quality manufacturer reports for another diabetes drug—rosiglitazone (AVANDIA)—provide a notable example of why the U.S. Food and Drug Administration (FDA) needs to modernize its essential postmarket surveillance reporting program.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP) that monitors adverse drug events reported to the FDA. We analyze computer excerpts from the FDA Adverse Event Reporting System (FAERS) that are released for public research use. These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of therapeutic drugs after FDA marketing approval.

This issue of QuarterWatch analyses the latest FDA release of FAERS data–covering 2014 Q2. In this three-month period the agency received a total of 221,958 case reports of adverse drug events from all sources. Of this total we selected for our primary analysis 75,643 new domestic reports of fatal, disabling or serious injuries in which a marketed drug was a primary suspect. Totals included 7,071 patient deaths, 1,596 reports indicating sustained harm or disability, and 16,717 cases severe enough to require hospitalization. This group of reports identified 960 different drugs with a median of 7 cases per drug, but with some drugs accounting for hundreds of cases. Our primary analysis excludes foreign reports, injuries not classified as serious, and cases identified as originating in legal claims.

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January 2015
Perspectives in This Issue
A Critique of a Key Drug Safety Reporting System 

QuarterWatch 2014 Q1 The U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS)—based on MedWatch reports–is the government’s primary safety surveillance system designed to identify harms from therapeutic drugs. For the last six years these vital data have formed the core of ISMP’s QuarterWatch™ drug safety reports. In this issue we decided to look closely at the system itself. Our conclusion: it seems clear that this drug safety monitoring system is in need of modernization. It suffers from a flood of low quality reports from drug manufacturers and has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers. We discuss key problems below and offer some recommendations as an organization that relies heavily on data collected through FAERS.

This issue of QuarterWatch includes two recently released calendar quarters of FAERS data, from 2013 Q4, and 2014 Q1. To provide a broader perspective, the main analysis focuses on the 12 months ending with 2014 Q1, and includes all adverse event reports received by the FDA in that one-year period. Previous issues of QuarterWatch have focused on a subset of these case reports, those with a serious outcome and reported by patients in the United States.

Key Findings

  • Incomplete Manufacturer Reports
  • Was the Drug Responsible?
  • Gaps in System Coverage
  • Outdated FDA Regulations
  • Strengths of the System

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