February 1

CHANTIX Linked to Highest # Reports–Hostility-Aggression, Psychosis

The latest January 2011 QuarterWatch (analyzing FDA’s MedWatch adverse effect reports for Quarter 2 of 2010) found that despite prominent label warnings, the stop-smoking drug varenicline (CHANTIX) continues to pose serious life-threatening risks. 

A year after FDA required a prominent boxed warning, a mandatory Medication Guide for every patient and declining use, CHANTIX continued to account for the largest numbers of reported serious psychiatric side effects that pose serious risks of harm. The case reports involving CHANTIX, primarily of hostility-aggression, depression and psychosis, pose serious risks–not only to those who use it–but also to others who may be victimized by consumers of the drug who become psychotic or aggressive.

For this reason, the Federal Aviation Administration has banned varenicline for pilots and air traffic controllers; the Department of Transportation has limited its use among truck drivers; and the Department of Defense has banned it for use by some military personnel, including pilots and missile crews.

The evidence shows that irresponsible physicians prescribe dangerous drugs under the influence of the drugs’ manufacturers?

QuarterWatch reports: 

"In the second quarter OF 2010, CHANTIX accounted for 130 possible cases of clinical depression, 112 possible cases of hostility-aggression, and 70 cases of psychosis or losing touch with reality. Case reports of these serious side effects outstripped those from the most powerful antipsychotic and antidepressant drugs which are used more directly in vulnerable patient populations with mental disorders."

Overall,CHANTIX accounted for 378 serious adverse drug events of all types in the quarter.

So, why has the FDA has failed to protect the public at large? The FDA has a public responsibility to remove a drug whose benefit is not justified by the serious risks it poses. In the case of the CHANTIX, the drug poses life-threatening risks of violence to self and others, whereas smoking cessation is accomplished by non-pharmacological means.

The time has come for the FDA use its regulatory authority to withdraw CHANTIX from the market to protect the public at large–including children, families, neighbors–from drug-induced violence.

Other findings by QuarterWatch:

  • Although antibiotics rank among the safest drugs, levofloxacin (LEVAQUIN) had more reports of serious injury than other antibiotics. Most cases involved tendon rupture and other muscle, tendon and ligament injuries.
  • Maladministration of Fentanyl Patches (DURAGESIC), a synthetic opioid that is approximately 100 times more potent than morphine, had more than 400 reported cases of problems that can lead to overdose and opioid withdrawal symptoms.
  • The antipsychotic, qetiapine (SEROQUEL) ranked among the most frequently reported safety issues associated with drug-induced diabetes. 


Vera Hassner Sharav



QuarterWatch: 2010 Quarter 2

Monitoring MedWatch Reports

January 27, 2011
Signals for Varenicline, Levofloxacin and Fentanyl

Executive Summary

The safety signals observed in the second quarter of 2010 included the following:
a large number of psychiatric side effects reported for the stop-smoking drug varenicline
(CHANTIX); numerous reports of tendon injury or rupture for the antibiotic levofloxacin
(LEVAQUIN); and serious injuries resulting from maladministration of fentanyl patches.

Overall in the quarter, the Food and Drug Administration received 33,068
domestic reports of serious injury, disability or death associated with drug therapy. This
was an increase of 12% from the same quarter one year ago and little changed from the
previous quarter. Trends were different for the two primary sources for adverse event
reports. Cases reported directly to the FDA’s MedWatch program by consumers and
health professionals declined compared to both the previous quarter and the same quarter
in 2009. However, this decline was offset by gains in reports originated by drug

Varenicline (CHANTIX) Safety Problems Continue espite a prominent boxed warning,
a mandatory Medication Guide for every atient and declining use, the stop-smoking drug
varenicline (CHANTIX) continued to ccount for large numbers of reported serious psychiatric
side effects. In the second uarter the drug was suspect in more possible cases of hostility-
aggression, depression nd psychosis than any other monitored drug.

Levofloxacin (LEVAQUIN) Cases Lead Antibiotics
While antibiotics rank among the safest drugs we monitor, levofloxacin
(LEVAQUIN) was suspect in more reports of serious injury than any other antibiotic.
Most cases involved tendon rupture and other muscle, tendon and ligament injuries. Case
reports of this problem substantially outnumbered those for two chemically similar
drugs—ciprofloxacin (CIPRO), with greater volume of prescriptions, and moxifloxacin
(AVELOX), with somewhat less frequent medical use.

Dronedarone (MULTAQ) Update
Safety signals continued for this relatively new drug for patients with irregular
heart rhythms in the atria, or upper pumping chambers of the heart, a condition called
atrial fibrillation or flutter. We identified 134 new cases of reported serious injury,
including new or worsened heart failure, potentially lethal rhythm disruptions in the main
pumping chamber of the heart (ventricular tachycardia), and kidney impairment and
failure. In addition, sanofi-aventis, manufacturer of dronedarone, notified doctors and
regulatory agencies of a major new reported side effect: severe and potentially life
threatening injury to the liver.

With nine different contraindications and numerous interactions with other drugs,
we saw additional evidence of serious injury associated with apparent medication errors.
Since approval we identified a total of 39 cases (including 4 deaths) in which patients
received another antiarrhythmic drug in addition to dronedarone, a practice explicitly not
recommended, 16 cases of off-label use, 12 cases of drug interactions, and 15 reports of
dosing or administration error. Cases could fall into more than one category.

Johnson & Johnson OTC Recalls
More than a year after Johnson & Johnson’s McNeil Consumer Healthcare began
a long series of drug recalls of its over-the-counter products, reports of serious injuries
associated with the Johnson & Johnson recalls continued to dominate all new case reports
indicating a product problem. This quarter’s cases primarily involved McNeil ibuprofen
and acetaminophen products for infants and children that were recalled starting in May
2010. Evidence available was insufficient either to establish or to rule out a direct
connection between more than 700 reported injuries and any identifiable form of product
contamination or other defect.

Drug Safety Perspectives
We used new statistical tools to identify and select specific drug safety issues that
were reported in large numbers in the quarter and were clinically significant. We describe
the new program in the full report. The drugs and issues involved were:

• Maladministration of Fentanyl Patches (DURAGESIC, generics). This synthetic
opioid is approximately 100 times more potent than morphine and had more than 400
reported cases of problems administering it. This included patches that fell off or
failed to adhere, that were applied incorrectly, or that were applied on the wrong
schedule. These problems can lead to overdose or opioid withdrawal symptoms.

• Diabetes and Quetiapine (SEROQUEL). While most newer antipsychotic drugs
carry warnings about diabetes, reports of diabetes associated with quetiapine ranked
among the most frequently reported safety issues in the second quarter (191 cases).

• Skin Cancer and Infliximab (REMICADE). This immunosuppressant drug for
rheumatoid arthritis and other disorders linked to the immune system accounted for
© Institute for Safe Medication Practices 2010 Q 2 QuarterWatch – 3
154 reports of non-melanoma skin cancer. The drug carries a boxed warning about
increased risk of infection and certain other cancers.

• Limb Fractures and Alendronate (FOSAMAX, generics). While alendronate came
into widespread use to preserve bone density in post-menopausal women with
osteoporosis, new reports associate the drug with the possibility that leg bones
(femur) also might become more brittle and subject to fractures (126 cases).
Alendronate was also associated with 53 case reports of osteonecrosis of the jaw.

• Inflamed Pancreas and Exenatide (BYETTA).This drug, injected twice daily for
the treatment of Type 2 diabetes, accounted for a disproportionate share of a medical
disorder called pancreatitis, or inflammation of the pancreas. Symptoms include
abdominal pain, nausea and vomiting. All these cases were rated as serious by the
reporters or manufacturers (118 cases).


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