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VO L . 4 2 , N O. 3 T he Leading Inde p endent Ne wspaper for the Inter nist—Since 1968 F E B R UA RY 1 , 2 0 0 9
INSIDE
Breast Cancer
Decline Linked to
M EDICINE
OF
A GAPITO S ANCHEZ J R ./B AYLOR C OLLEGE
HT Cessation
New WHI data affirm hormonal link.
Self-Harm BY BRUCE JANCIN breast cancer risk imparted by
Some abused teens may Denver Bureau hormone therapy rises sooner
deliberately embed foreign and more steeply than previ-
objects into soft tissues. S A N A N T O N I O — Two new ously recognized, and it swiftly
Dr. Rachelle Doody says the phase II trial of bapineuzumab ‘at statistical analyses of Women’s declines after HT is discontin-
PAGE 10
least had some signal’ that the agent is safe and effective. Health Initiative data persua- ued, Dr. Rowan T. Chlebowski
sively indicate that the recent said at the San Antonio Breast
abrupt decline in breast cancer Cancer Symposium.
Amyloid Theory Genetics in Your
Practice
incidence in the United States is
attributable to a dramatic drop
in the use of estrogen-plus-prog-
“The good news for women
here is that the risk rapidly dis-
sipated in just a year or year and
Sputters for AD Dr. Matthew R.G. Taylor
looks at genome-wide
association studies.
estin menopausal hormone
therapy, and not—as skeptics
have argued—to less utilization
a half,” said Dr. Chlebowski, a
medical oncologist at the Los
Angeles Biomedical Research
B Y M I C H E L E G. caused early-onset Alzheimer’s, PAGE 28 of mammography. Institute in Torrance, Calif.
S U L L I VA N coupled with the association of Academic fencing over causal- The WHI was a very large
Mid-Atlantic Bureau plaque deposition and early ity aside, the practical take- National Institutes of Health–
Alzheimer’s in Down syndrome home message from the latest sponsored study on the preven-
he amyloid hypothesis patients, added weight to the Women’s Health Initiative tion of cardiovascular disease
T physicians to inform patients taking anticon- psychiatric patients (8.5 suicidality reports per 1,000 pa-
vulsant medications that the drugs have the po- tients receiving antiepileptic medications, compared with
tential to increase suicidal thoughts and behavior. 5.7 per 1,000 for psychiatric patients taking placebo).
Although physicians were encouraged to discuss the
risks and benefits of continuing treatment, they were
also urged to warn patients and families against stop-
Families and caregivers should also be notified of this Among epilepsy patients, 3.4 events per 1,000 were re- ping medications abruptly. ■
risk so that they can be attuned to changes in behavior ported for those receiving antiepileptic medications,
in patients receiving antiepileptic medications, accord- compared with 1.0 for those assigned to receive placebo. The FDA’s health care alert is available at www.fda.gov/
ing to the FDA’s alert for health care professionals. Four patients randomized to receive antiepileptic cder/drug/InfoSheets/HCP/antiepileptics200812.htm.
Based on an agency review of nearly 200 clinical tri- drugs committed suicide during the trials that were ex-
als of 11 antiepileptic drugs, the directive coincided with amined by the FDA, while no patient assigned to place-
an FDA announcement that manufacturers of any bo took his or her own life. However, those numbers
medication in the class will be required to add warn- were not high enough to justify a warning of suicide
Drugs to Receive New
ings about suicidal thoughts or behavior in on drug labeling, the press release stated. Suicidality Labeling
prescribing information or labeling and to “The biological reasons for the increase in
develop medication guides for patients.
See related the risk for suicidal thoughts and behavior ob- he Food and Drug Administration called for
Revised labeling or an explanation “why
they do not believe such labeling changes are
commentary served in patients being treated with
on page 9. antiepileptic drugs are unknown,” according
T new labeling for these drugs, some of which
also are available in generic form:
necessary” must be submitted to the agency to the FDA. Carbamazepine (marketed as Cabatrol, Equetro,
within 30 days. A review article about suicidality and Tegretol, Tegretol XR)
Jack Cox, a spokesman for Pfizer Inc., said in a tele- antiepileptic drugs noted that the baseline suicide rate Clonazepam (marketed as Klonopin)
phone interview his firm will comply with the order. among patients with epilepsy is 5 times higher than that Clorazepate (marketed as Tranxene)
“Pfizer will work closely with the FDA to update the la- seen in the general population, and higher still (25-fold) Divalproex sodium (marketed as Depakote,
beling of our antiepileptic medications Lyrica [prega- in patients with temporal lobe epilepsy and complex Depakote ER, Depakene)
balin] and Neurontin [gabapentin], in a timely manner.” partial seizures (Drug Saf. 2007;30:123-42). Ethosuximide (marketed as Zarontin)
“We have not heard directly from the FDA, but we Although that article commented on antiepileptic Ethotoin (marketed as Peganone)
will work to address any of the agency’s concerns,” said medications’ disparate mechanisms of action and vary- Felbamate (marketed as Felbatol)
Tricia Geoghegan, a spokesperson for Ortho-McNeil ing effects on serotonin metabolism (a hypothesized Gabapentin (marketed as Neurontin)
Neurologics, makers of topiramate. Ms. Geoghegan link to suicidality), the FDA report found that the risk Lamotrigine (marketed as Lamictal)
noted that the label for Topamax (topiramate) has al- for suicidal thought or behavior was “generally consis- Lacosamide (marketed as Vimpat)
ways included “content about this topic,” but added that tent” among the 11 drugs studied. Levetiracetam (marketed as Keppra)
revisions will be made should the FDA request them. As the name implies, antiepileptic drugs were intro- Mephenytoin (marketed as Mesantoin)
The agency’s decision drew on data from placebo- duced and approved for the treatment of seizures. Methosuximide (marketed as Celontin)
controlled clinical trials that enrolled a total of 43,892 However, they are prescribed for conditions, including Oxcarbazepine (marketed as Trileptal)
patients aged 5 and older taking the medications for bipolar disorder, depression, anxiety, neuropathic and Phenytoin (marketed as Dilantin Suspension)
epilepsy, psychiatric disorders, and other conditions. chronic pain, and migraine, among others. Pregabalin (marketed as Lyrica)
The FDA meta-analytic review of 199 trials deter- “Patients being treated with antiepileptic drugs for Primidone (marketed as Mysoline)
mined that patients receiving antiepileptic drugs were at any indication should be monitored for the emer- Tiagabine (marketed as Gabitril)
a twofold risk of suicidal behavior or thoughts (0.43%), gence of worsening of depression, suicidal thoughts, Topiramate (marketed as Topamax)
compared with patients receiving placebo (0.24%). The or behavior, or any unusual changes in mood or be- Trimethadione (marketed as Tridione)
difference translates to 1 additional case of suicidality per havior,” said Dr. Russell Katz, director of the division Zonisamide (marketed as Zonegran)
530 patients treated with antiepileptic drugs. of neurology products in the FDA’s Center for
33%
these patients may not be referred for white (90% vs. 86%).
evaluation of their cytopenias. Further- Among patients with MDS, comor- 1.8%
more, if referred, they may not undergo bidities were more common in patients re- Kidney complications
diagnostic bone marrows, or if they un- ceiving blood transfusions. Of patients 0.4%
dergo a diagnostic bone marrow, it may receiving transfusions, 80% had cardiac Note: Based on an analysis of data from a random sample of 1.7 million
be done in primary care, and not re- complications, vs. 69% of the others. This Medicare patients.
ferred to the tumor registry. Thus, we was also true of new cases of diabetes Source: Dr. Goldberg
think that the myelodysplastic syn- (48% vs. 32%) and dyspnea (62% vs. 41%).