QuarterWatchâ„¢ monitors all adverse drug events reported to the FDA, identifies signals, and seeks to improve postmarket surveillance.

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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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September 2014
Perspectives in This Issue
Dimethyl fumarate (TECFIDERA): tolerability problems with a new multiple sclerosis drug
Varenicline (CHANTIX): reports of suicidal/homicidal thoughts surpass all other drugs
Sodium oxybate (XYREM): a restricted drug with severe side effects
Fingolimod (GILENYA): cardiac, vision, and pregnancy risks

QuarterWatch 2013 Quarters 3-4  In this issue we analyze severe gastrointestinal toxicity and hypersensitivity reactions reported for the new oral drug for multiple sclerosis (MS), dimethyl fumarate (TECFIDERA). The risks of serious psychiatric side effects are highlighted in a new analysis of varenicline (CHANTIX), an aid to smoking cessation. We also examine the frequent and broad spectrum of serious adverse effects on the brain of sodium oxybate (XYREM), an orphan drug for narcolepsy. Cardiac, ocular, infection, and pregnancy risks are reviewed for a second newer MS drug, fingolimod (GILENYA).

Because the FDA has corrected its previously delayed quarterly releases of serious adverse event reports, this issue of QuarterWatch includes data from two calendar quarters of 2013, Q2 and Q3. Totals from the two quarters reveal that after many years of a steady increase in reported fatal, disabling and serious adverse drug events, reports have hit a plateau in 2013. The Q3 total of 47,864 was almost unchanged (+108) from the preceding quarter Q2, and was 8.7% lower than Q3 of the preceding year.

An Evolving Adverse Event World

This report focuses on three drugs (dimethyl fumarate, sodium oxybate, fingolimod) that share several characteristics with substantial effects on the total number of adverse event reports submitted. All three are expensive medications (more than $50,000 per patient-year) for small patient populations (10,000-25,000 patient-years). The high costs and small patient populations lead to marketing and safety surveillance plans that place the manufacturer in contact with every new patient. In the case of sodium oxybate, the central pharmacy calls every patient every month before shipping a refill. For all three drugs, manufacturers have extensive contact with practically all patients as treatment is initiated to assist in navigating insurance coverage for these high-cost specialty drugs. This leads to a different adverse event reporting environment compared with traditional brand name drugs where patient contacts by the manufacturer are limited, but contacts with physicians are more extensive. Nevertheless, the exact same reporting regulations apply to both quite different settings.

These high-patient-contact settings provide a new opportunity to achieve unprecedented and high-quality postmarket surveillance. It would be especially valuable for orphan drugs with clinical trials for efficacy in patient populations of just 100-200 subjects on the active drugs. Given that patient contact is already occurring for commercial and safety reasons, additional costs would be minimal. But to achieve these benefits, the FDA, manufacturers and stakeholders need to develop regulations, guidances and contact protocols to cover a steadily growing number of drugs.

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May 2014
perspective on drug hypersensitivity
Allergic reactions second most frequently reported serious event
Hypersensitivity signals for omalizumab (XOLAIR) and telaprevir (INCIVEK)
Update on anticoagulants, rivaroxaban (XARELTO) and dabigatran (PRADAXA)

QuarterWatch 2013 Q1 This issue focuses on serious hypersensitivity reactions reported to the US Food and Drug Administration (FDA) for therapeutic drugs using data from the most recent 12 months available. It also surveys the newly released case reports for 2013, Quarter 1, and provides an update on the continuing drug safety issues surrounding anticoagulant drugs.

The FDA received 56,165 domestic reports of serious adverse drug events in the calendar quarter ending March 30, 2013. This was an apparent drop of 685 cases (-1.2%) from the previous quarter and a decline of 5,305 reports (-8.6%) from the same quarter in 2012. The total included 12,899 patient deaths and 2,653 cases indicating a possible medication error. The apparent decline is likely exaggerated. Historical records show the new quarter totals are artificially low since the agency typically releases additional reports for the quarter at a later date.
Hypersensitivity Highlights

Cases of reported drug hypersensitivity (mostly drug allergies) were identified using a standardized set of medical terms created by the pharmaceutical industry to classify possible cases of adverse drug events occurring in clinical trials or identified through postmarket surveillance. To identify suspect drugs, we screened 147,318 selected cases of serious adverse drug events from March 2012 through March 2013.

  • Hypersensitivity was very common, accounting for 13,042 cases (8.9%), and more than any other among 91 adverse reaction categories except non-specific gastrointestinal symptoms. We classified 4,045 of these cases as severe, involving death, disability, or a medical emergency.
  • A large and diverse selection of drugs was implicated, with 234 drugs having 10 or more hypersensitivity reports in one year. However, only 87 drugs fell into the subset of the 4,045 most severe cases.
  • A sample of prescribing information for health professionals for 20 drugs with 10 or more reported cases of severe hypersensitivity showed all 20 provided information about these reactions, and 14/20 (70%) had prominent warnings.
  • To highlight drugs with the most frequently reported severe hypersensitivity reactions, cases were divided into four categories: anaphylactic shock, a rapid onset systemic immune reaction; severe cutaneous, widespread skin eruptions that can be life-threatening; angioedema, a localized swelling of lips, tongue, eyelids, or other body parts; and other severe forms of hypersensitivity. The 10 most frequently reported drugs in each category are identified in the report, constituting useful clinical alert lists


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January 2014
Psychiatric side effects prominent in 10 of 15 most frequently reported drugs
Ibuprofen associated with severe hypersensitivity
Few reports for antibiotics and albuterol

QuarterWatch 2014  This report analyzes15 drugs that accounted for 41% of recent serious adverse events in children reported to the U.S. Food and Drug Administration (FDA) over the five years 2008-2012. In addition, we examine reporting trends from the same period for all domestic reports to the agency that identified adverse events in children under age 18.


Our study identified 45,610 adverse drug events reported in children less than 18 years of age. Of these, 64% (29,298) indicated a serious injury. Reports in children grew substantially over time--from 6,320 in 2008 to 11,401 in 2012, increasing at the same rate as for adult patients. Examined by year of age in children, the reports formed a U-shaped curve. The number was greatest in the first year of life, then declined and leveled off until adolescence, when cases again rose rapidly. There were insufficient data to evaluate 70% of the 741 drugs with reported serious adverse events in children because of fewer than 2 reports per year.

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