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QuarterWatch Database

 
Searches generic and brand names only

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Generic: Acetaminophen, butalbital and caffeine; Brand: FIORICET

  Reporting issue Almost all reports turned out to involve questionable coding of published scientific report summarizing cases reported to the country‚Äôs poison control centers in 2006, and did not signal a new safety problem

Generic: Aliskiren; Brand: TEKTURNA

  Angioedema This newer blood pressure drug triggered a signal for angioedema and other hypersensitivity reactions that could occur at any time during treatment

Generic: Baclofen; Brand: LIORESAL INTRATHECAL

  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

Generic: Botulinum nerve toxins; Brand: BOTOX, MYOBLOC

  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

Generic: Dabigatran; Brand: Pradaxa

  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

Generic: Dalfampridine; Brand: Ampyra

  Walking problems This multiple sclerosis drug approved to increase walking speed was suspect in reports of seizures, impaired walking and altered mental states

Generic: Digoxin; Brand: DIGITEK

  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

Generic: Dronedarone; Brand: MULTAQ

  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

Generic: Duloxetine; Brand: CYMBALTA

  Withdrawal Symptoms Serious withdrawal symptoms were frequently reported for the antidepressant duloxetine.

Generic: Fentanyl; Brand: DURAGESIC, FENTORA,ACTIQ

  Deaths In 2009, fentanyl ranked 4th among all medications in causing death

Generic: Finasteride; Brand: PROPECIA

  Persistent Sexual Side Effects Finasteride was associated with reports of possibly persistent sexual side effects, especially in its use for male pattern baldness

Generic: Heparin; Brand: HEP-LOCK

  Product problem 779 reports of serious injury, including 102 deaths, may be due to contamination of ingredients although drug association not confirmed

Generic: Ibandronate; Brand: BONIVA

  Reporting issue Increased reporting of patient deaths due to manufacturer outreach to elderly customers

Generic: Infliximab; Brand: Remicade

  Severe Liver injury With 159 cases reported in 2011, infliximab led all other drugs in reports of severe liver injury

Generic: Interferon beta; Brand: AVONEX

  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

Generic: Kidney dialysis solution; Brand: DIANEAL

  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

Generic: Lamotrigine; Brand: LAMICTAL

  Severe Cutaneous Lamotrigine led all other regularly monitored drug in reports of severe cutaneous events in 2011

Generic: Levofloxacin; Brand: LEVAQUIN

  Tendon/muscle injury Suspected in more reports than any other antibiotic; most cases involved tendon rupture and other muscle, tendon and ligament injuries

Generic: Liraglutide; Brand: VICTOZA

  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

Generic: Methylphenidate; Brand: DATRANA

  Patch product problems Problems with the protective liner spurred more than 1,000 reports in past year involving non-serious product quality complaints

Generic: Metoclopramide; Brand: REGLAN

  Tardive dyskinesia Metoclopramide accounted for more reported cases related to legal claims (n=11,450) than any other drug in 2011

Generic: Montelukast; Brand: SINGULAIR

  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

Generic: Pioglitazone; Brand: ACTOS

  Bladder Cancer Pioglitazone was associated with reported bladder cancer, supporting findings in new epidemiological studies

Generic: Quetiapine; Brand: SEROQUEL (Showing 1 of 3 items. Group continues on the next page.)

  Irreversible injury Reported cases of diabetes, together with smaller numbers of reports of three different types of movement disorders: dyskinesia, dystonia, and parkinsonism

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