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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 |
| |
Angioedema
| This newer blood pressure drug triggered a signal for angioedema and other hypersensitivity reactions that could occur at any time during treatment |
| |
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 |
| |
Hemorrhage
| Dabigatran ranked first among all direct reports to the FDA in 2011, and ranked first among all regularly monitored drugs |
| |
Hemorrhage
| Hemorrhages reported for dabigatran were more likely to result in a fatal outcome than cases for two other anticoagulants, warfarin and rivaroxaban |
| |
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 |
| |
Withdrawal Symptoms
| Serious withdrawal symptoms were frequently reported for the antidepressant duloxetine. |
| |
Deaths
| In 2009, fentanyl ranked 4th among all medications in causing death |
| |
Persistent Sexual Side Effects
| Finasteride was associated with reports of possibly persistent sexual side effects, especially in its use for male pattern baldness |
| |
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 |
| |
Severe Liver injury
| With 159 cases reported in 2011, infliximab led all other drugs in reports of severe liver injury |
| |
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 |
| |
Severe Cutaneous
| Lamotrigine led all other regularly monitored drug in reports of severe cutaneous events in 2011 |
| |
Tendon/muscle injury
| Suspected in more reports than any other antibiotic; most cases involved tendon
rupture and other muscle, tendon and ligament injuries |
| |
Pancreatitis
| With 413 reports of pancreatitis, liraglutide led all other drugs in 2011 for this adverse event |
| |
Pancreatitis
| Early adverse event reporting revealed a marked signal for pancreatitis since approval in January 2010 |
| |
Patch product problems
| Problems with the protective liner spurred more than 1,000 reports in past year involving non-serious product quality complaints |
| |
Tardive dyskinesia
| Metoclopramide accounted for more reported cases related to legal claims (n=11,450) than any other drug in 2011 |
| |
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 |
| |
Bladder Cancer
| Pioglitazone was associated with reported bladder cancer, supporting findings in new epidemiological studies |
| |
Irreversible injury
| Reported cases of diabetes, together with smaller numbers of reports of three
different types of movement disorders: dyskinesia, dystonia, and parkinsonism |