FDA Approves Azilsartan, Another ARB, for

Hypertension
Michael O'Riordan
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February 25, 2011 (Silver Spring, Maryland) — The Food and Drug Administration (FDA)
today approved a new angiotensin-receptor blocker (ARB), known as azilsartan medoxomil
(Erdarbi, Takeda Pharmaceutical), for the treatment of hypertension in adults [1]. The drug will
be available in 80 mg and 40 mg doses, although 80 mg is the recommended dose. The 40-mg
dose is available for clinicians who wish to combine the drug in patients treated with high-dose
diuretic therapy.
In phase 3 studies, first reported by heartwire at the American Society of Hypertension (ASH)
meeting in 2010, azilsartan at its highest dose was more effective in lowering 24-hour blood
pressure than two of its ARB rivals, olmesartan (Benicar, Daiichi Sankyo) and valsartan
(Diovan, Novartis).
Earlier this week, Takeda also submitted a New Drug Application (NDA) to the FDA for a tablet
that combines azilsartan with chlorthalidone, a thiazide-like diuretic. In a trial also presented
last year at ASH, the azilsartan-chlorthalidone combination had better antihypertensive effects
than azilsartan and hydrochlorothiazide (HCTZ).
Azilsartan contains a boxed warning stating that it should be avoided in pregnant women as it
can cause injury to the developing fetus if taken by the mother in her second or third trimester. If
a women taking azilsartan becomes pregnant, the drug should be stopped.
References

Coadministration of Flu, Pneumococcal

Vaccines Linked to Febrile Seizures
Emma Hitt, PhD
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February 25, 2011 — Trivalent inactivated flu vaccine (TIV) administered concurrently with the
13-valent pneumococcal conjugate vaccine (PCV13) appears to be associated with an increased
risk for febrile seizure in children age 6 months to 23 months, according to the US Centers for
Disease Control and Prevention (CDC).
Frank DeStefano, MD, MPH, from the CDC's Immunization Safety Office, and Grace M. Lee,
MD, MPH, from Harvard Medical School, in Boston, Massachusetts, presented data and
discussed the issue at the Advisory Committee on Immunization Practices (ACIP) meeting held
here in Atlanta, Georgia, on Wednesday and Thursday this week.
According to Dr. DeStefano, fever after vaccination is a common event and can potentially
increase the risk for febrile seizures.
Vaccines associated with febrile seizures include whole-cell pertussis vaccines, measles-
containing vaccines, and the 2010 TIV for the southern hemisphere, specifically the brand
manufactured by CSL Biotherapies (Fluvax and Fluvax Juniors, used in Australia and New
Zealand only).
Preliminary results from the Vaccine Safety Datalink suggest that the 2010/2011 TIV used in the
United States is not associated with an increased risk for febrile seizure in children 6 months to
23 months of age, unless administered at the same time as PCV13.
Dr. DeStefano estimates that TIV and PCV13 coadministration may account for about 60
seizures per 100,000 children and that such seizures typically occur the day after vaccination.
"Febrile seizures associated with vaccine administration are associated with a good prognosis,
although they can scare parents and caregivers," he said.
ACIP also cast a final vote regarding the use of a booster vaccine against Japanese encephalitis
virus. A purified, inactivated vaccine derived from an attenuated strain of Japanese encephalitis
virus vaccine, Ixiaro, was licensed for use as a booster in October 2010 after its initial approval
in 2009.
The vaccine requires a 2-dose series, but guidelines for a booster dose had not been established;
ACIP voted that a booster dose before potential exposure to the virus should be given if the
primary series of Ixiaro was administered more than a year ago.
The vaccine is recommended for travelers who may be exposed to endemic Japanese encephalitis
virus for more than a month as well as laboratory workers.
[CLOSE WINDOW]

Authors and Disclosures

Journalist

Emma Hitt, PhD

Emma Hitt is a freelance editor and writer for Medscape.

Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships.

Dr. Hitt does not intend to discuss off-label uses of drugs, mechanical devices,
biologics, or diagnostics not approved by the FDA for use in the United States.
Dr. Hitt does not intend to discuss investigational drugs, mechanical devices,
biologics, or diagnostics not approved by the FDA for use in the United States.

FDA Issues Recall for Implantable Infusion

Pumps
John Otrompke
Authors and Disclosures
Posted: 02/24/2011
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February 24, 2011 — The US Food and Drug Administration (FDA) has issued a Class I recall
for certain lots of implantable infusion pumps manufactured by Medtronic, which are used in
patients undergoing therapy that requires the constant delivery of drugs or fluids.
The Class I recall, which was initiated January 14, is the most serious type of recall, and involves
situations in which there is a reasonable probability that the use of these products will cause
serious adverse health consequences or death.
However, the company is not retrieving the product from the field or recommending the removal
of the product.
The recall was issued for Medtronic SynchroMed II (model number 8637) and SynchroMed EL
Implantable Infusion Pump (model numbers 8626 and 8627) and Refill Kits (model numbers
8551, 8555, 8561, 8562, 8564, 8565, and 8566).
The recall did not include Medtronic's MiniMed Infusion Pumps or external insulin pumps for
diabetes, according to the FDA. The devices included in the recall were distributed beginning in
April 1999.
The problem with the devices is the potential for "pocket fills" to occur, in which the drug is
injected into the pump pocket (the area under the skin where the pump is placed) instead of the
pump. Between 1996 and 2010, 8 deaths and 270 events requiring medical intervention were
reported related to the occurrence of pocket fills, according to the FDA. The rate of occurrence
per refill opportunity is at least 1 in 10,000. However, Medtronic determined that the problem
could be addressed with updated product labeling and instructions to physicians.
To ensure safe and correct use of the device, it is essential that the needle be inserted through the
refill septum until it has reached the needle stop in the pump reservoir. Pocket fills can occur
because the physician relies heavily on tactile feedback to determine if the needle is correctly
positioned in the pump reservoir during drug refill.
Additionally, providers can adopt a number of strategies to watch for pocket fills. They can
check for a discrepancy between the volume of drug in the pump and the expected volume.
Providers can also look for swelling at the injection site or watch for an unusual reaction in the
patient, such as burning or stinging, at the time of the injection.

Fatal Adverse Events With Bevacizumab

Alok A. Khorana, MD
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Posted: 02/24/2011
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Treatment-Related Mortality With Bevacizumab in Cancer Patients: A

Meta-analysis
Ranpura V, Hapani S, Wu S
JAMA. 2011;305:487-494
Study Summary
Although bevacizumab has been shown to improve survival in patients with a variety of solid
tumors when added to conventional chemotherapy, it has also been associated with life-
threatening and fatal adverse events (FAEs), including bleeding, thromboembolism, and
perforation. This improvement in survival has led to the assumption that FAEs are rare and do
not significantly affect patients who are receiving treatment. In this large meta-analysis, Ranpura
and colleagues identified 10,217 patients with various solid tumors from 16 randomized studies,
as follows:
• Colorectal cancer (5 studies);
• Non-small cell lung cancer (4 studies);
• Breast cancer (3 studies);
• Renal cell cancer (2 studies);
• Pancreatic cancer (1 study); and
• Prostate cancer (1 study).
A clear increase in FAEs was evident in patients who received bevacizumab compared with
those who received standard chemotherapy alone (2.5% vs 1.7%; relative risk [RR] 1.46; P = .
01). This association varied with chemotherapy agents but not with tumor type. In particular,
FAEs occurred in patients receiving taxanes or platinum agents (RR 3.49; 3.3% vs 1%) but not
with other specific agents. Types of FAEs included bleeding (23.5%), gastrointestinal perforation
(7.1%), and pulmonary embolism and stroke (5.1% each). Most fatal bleeding events were
pulmonary or gastrointestinal in origin.
Viewpoint
The benefit of bevacizumab is under increased scrutiny given the latest data in patients with
metastatic breast cancer. In this large meta-analysis, Ranpura and colleagues documented a clear
increase in the rate of FAEs (2.5%) in patients receiving bevacizumab and identified
taxane-/platinum-based regimens as being largely responsible for this increase. Of note, patients
enrolled in clinical trials typically have fewer comorbidities than patients not enrolled in trials; in
bevacizumab studies specifically, patients with recent history of stroke or myocardial infarction
were excluded. Therefore, risks for FAEs may be greater in the real-world setting than reported
here. The bottom line is: Exercise caution when selecting patients for treatment with
bevacizumab, keeping in mind both improvement in survival and risk for FAEs.
Abstract