| |
Reporting issue
| Almost all reports turned out to involve questionable coding of published scientific report summarizing cases reported to the country’s poison control centers in 2006, and did not signal a new safety problem |
| |
Device problem
| Urgent alert to doctors that the catheter tubes that deliver the drug to the spine
were not being properly attached to the pump, leading to interruption of the drug
supply and severe withdrawal symptoms |
| |
Distant site paralysis
| Increasing reports that the nerve toxin was causing difficulty swallowing,
incontinence and breathing problems; along with misleading safety claims,
complicated names creating confusion, and extensive off-label use |
| |
Surge in Reports
| Within weeks of approval, the new drug surged to near the top of the adverse event rankings with reports of hemorrhage and blood clots |
| |
Walking problems
| This multiple sclerosis drug approved to increase walking speed was suspect in reports of seizures, impaired walking and altered mental states |
| |
Massive recall
| Recall of Actavis Group tablets because of the possibility that the strength of
tablets was greater than labeled and might provide a potentially lethal overdose |
| |
Reports rise sharply
| 1882 reports of serious injury, including 650 patient deaths due to patients taking
recalled medication from manufacturer Actavis Group |
| |
Severe liver damage/ventricular arrythmia
| New cases of reported serious injury, including new or worsened heart failure,
potentially lethal rhythm disruptions in the main pumping chamber of the heart, and kidney impairment and failure. Additionally, the manufacturer notified of a new reported si |
| |
Signal for 4 safety problems
| Increasing numbers of reports indicating the drug may cause or worsen heart
failure, trigger potentially lethal irregular heartbeats, interact with other drugs,
and impair kidney function |
| |
Deaths
| In 2009, fentanyl ranked 4th among all medications in causing death |
| |
Product problem
| 779 reports of serious injury, including 102 deaths, may be due to contamination of ingredients although drug association not confirmed |
| |
Reporting issue
| Increased reporting of patient deaths due to manufacturer outreach to elderly customers |
| |
Reporting issue
| Increase in reports apparently did not signal a new risk to patient safety; primarily
due to intensive company contact with patients on a monthly basis |
| |
Reporting issue
| Report volume was likely due to increased vigilance by the company and its
extensive direct contact with its patients, rather than a signal of a new safey
problem |
| |
Tendon/muscle injury
| Suspected in more reports than any other antibiotic; most cases involved tendon
rupture and other muscle, tendon and ligament injuries |
| |
Pancreatitis
| Early adverse event reporting revealed a marked signal for pancreatitis since approval in January 2010 |
| |
Psychiatric side
effects
| Increased incidence of psychiatric side effect reports due to Merck reporting a
small number of cases of suicidal behavior |
| |
Aggressive & suicidal
behavior
| Accounted for more possible cases of depression/suicidal behavior, hostillity/
aggression and psychosis than any other prescription drug |
| |
Irreversible injury
| Reported cases of diabetes, together with smaller numbers of reports of three
different types of movement disorders: dyskinesia, dystonia, and parkinsonism |
| |
Diabetes
| Mandatory medication guide warns of "high blood sugar" potentially minimizing
the diabetes risk associated with this drug |
| |
Reports rise sharply
| Increased awareness of risk associated with FDA's warnings, studies and publicity |
| |
Reported deaths
| More than 1000 deaths reported in three previous quarters. |
| |
Accidential exposure
| Adverse events among women and children associated with inappropriate off-label
use and accidental exposure |
| |
Suicidal behavior
| Manufacturer failed to submit propertly reports of serious psyciatric adverse events, including
150 cases of completed suicides |
| |
Safety signals grow
| Suspected in more possible cases of hostility-aggression, depression and psychosis
than any other monitored drug |
| |
Violence
| Increasing reports of violence to self and towards others associated with use |
| |
Psychiatric side
effects
| Identification of 30 possible cases reporting physical assault, 148 cases mentioning
homicidal thoughts and 331 cases of aggressive behavior |
| |
Serious injury/death
| Of 910 newly reported cases of serious injury and death, varenicline ranked 2nd only to digoxin (a high alert medication) among all prescription drugs |
| |
Accidental injury
| Toll included numerous cases of serious injury linked to traffic accidents/falls
which may be due to "blacking out" |
| |
Strong safety signal
| Many reports of numerous problems, including serious accidents & falls, potentially lethal cardiac rhythm
disturbances, severe skin reactions, acute myocardial infarction, seizures,
diabetes, psychosis, aggression and suicide |