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QuarterWatch monitors all 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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 33 items in 4 pages
November 2017
***CURRENT ISSUE***
Safety Signals For Two Novel Drugs
Hallucinations and pimavanserin (NUPLAZID), a new kind of drug for psychosis
Hypotension with sacubitril-valsartan (ENTRESTO) for heart failure

QuarterWatch 2017 Q1  This issue of QuarterWatch focuses on early adverse event data for two new drugs with novel mechanisms of action, and intended for difficult-to-treat patient populations: Pimavanserin (NUPLAZID), approved in April 2016, provided a new biochemical approach to treating symptoms of psychosis such as hallucinations. The combination product sacubitril-valsartan (ENTRESTO), approved in July 2015, targeted a new pathway involved in the regulation of blood pressure, and was effective in patients with already damaged hearts. However, for both drugs we observed new safety signals warranting careful consideration, and likely further action.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. Food and Drug Administration (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. In 2017 Q1 the FDA received a total of 297,010 new adverse drug event reports identifying 1,445 primary suspect drugs with a median of 22 reports per drug. The report total was 8.4% higher than the previous quarter but 13.2% lower than the same quarter 1 year earlier.

Figure 1 illustrates the wide variation in the number of reports submitted for each of the 1,445 drugs with 1 or more cases.  The largest group of drugs (n = 687) fell into the category of 5 to 99 reports. At the extremes, just 66 drugs had 1,000 reports or more. This small group included the two newly approved drugs examined in this report. At the other extreme, a large group of drugs (n = 367) had had so few reports (1-4 cases) that assessing a safety profile would be challenging.

 

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July 2017
ANNUAL REPORT ISSUE
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

QuarterWatch 2016 Q4  This year’s annual report issue focuses on drugs and specific adverse reactions that affect large patient populations and involve substantial numbers of serious injuries. In the absence of any official or unofficial systematic assessments of overall harms attributable to the therapeutic use of drugs, we examine notable signals of significant drug risks as reflected in 1.2 million adverse drug event reports received by the U.S. Food and Drug Administration (FDA) in 2016.  Key findings are described below.

The types of injuries reported in 2016 affected every body system and include severe damage to the kidneys and liver, fatal cardiac events, cancer, potentially life-threating allergic reactions, as well neuropsychiatric effects such as depression, suicidal thoughts, and aggressive and violent acts. Although these largely voluntary reports capture only a fraction of the severe injuries that occur, the therapeutic use of drugs constitutes a major public health risk of the same order of magnitude as illicit use of drugs or violent crime. Two notable drug risks are examined in these 2016 data.

Exposure of the U.S. population to therapeutic drugs is extensive. In 2016, a total of 4.5 billion outpatient prescriptions were dispensed, a 1.9% increase over 2015, according to QuintilesIMS. Of that total, 89.5% were for generic drugs, the remainder for brand name drugs.

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April 2017
DEPRESSION AND SUICIDAL BEHAVIORS
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
PERSPECTIVES FROM nEW aDVERSE eVENT rEPORTS
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
PROBLEMS WITH A PATCH AND A SELF-INJECTION PEN
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
ANNUAL REPORT ISSUE
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
SAFETY PERSPECTIVES IN THIS ISSUE
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
NEW SAFETY PERSPECTIVES
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
ANNUAL REPORT ISSUE
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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