Elk River Clinic in Minnesota Announces Chickenpox Vaccine Recall

ANOKA, Minn. -- The RiverWay Clinic in Elk River

announced on March 3, 2004 that it is contacting approximately 1,200 patients who

received immunizations with varicella (chickenpox) vaccine at the clinic

between December 1998 and December 2003 to ensure that they are adequately protected

from the chickenpox.

An audit of vaccine freezers at the clinic in January found a temperature

variance in one freezer containing varicella (chickenpox) vaccine that may

have resulted in the loss of effectiveness of the vaccine stored inside.

RiverWay Clinics has conducted a review of vaccine storage procedures at

its three clinic locations and found no additional problems.

"We have no indication that any doses of varicella vaccine from the

freezer at the Elk River Clinic has failed," said Charles Lais, MD, RiverWay

Clinics' medical director. "However, we are concerned that we cannot determine

if patients who received vaccine stored in the affected freezer have immunity

to chickenpox. That is why we have mailed letters to all patients who received

vaccine from this freezer to give them information about the recall and

explain the steps we are taking to protect them from chickenpox. We're also

making a public statement to enlist the help of the media in reaching any

former patients who may have moved to new addresses that we do not have on

file."

RiverWay Clinics are asking patients or guardians of patients who received

the chickenpox vaccine at the RiverWay Elk River Clinic from December 1998 to December 2003 to call:

* 763-712-6400 for an appointment at the RiverWay Clinics-Elk River site

* 763-712-6500 for an appointment at the RiverWay Clinics-Andover site

* 763-712-6100 for an appointment at the RiverWay Clinics-Anoka site

* 952-967-6990 for an appointment at the HealthPartners Coon Rapids

Clinic

Patients should say that they need to make an appointment for the Elk

River RiverWay Clinic chickenpox vaccine recall. Patients may schedule an

appointment for anytime during regular clinic hours, evenings or weekends.

The clinic will offer patients the choice of being revaccinated or taking

a blood test to determine if they have immunity to the chickenpox. If the test

shows no immunity, they can then choose to be re-vaccinated. Other than the

possibility of some minor discomfort in an arm or leg, there are no medical

concerns related to receiving an additional vaccination. These services will

be available free of charge at any RiverWay Clinic.

RiverWay Clinics developed the following recommendations to help guide

patients or their guardians in making a decision between revaccination or a

blood test, however, they may choose either option.

For children ages 1 to 5, physicians recommend revaccination. This avoids

putting small children through the discomfort of a blood test and possibly

having to come in again for an injection if results show no immunity to

chickenpox. Other than the possibility of some minor discomfort in an arm or

leg, there are no medical concerns related to receiving an additional

vaccination.

For children ages 6 to 12, physicians recommend a blood test. Studies have

shown that a significant number of children in this age group are already

immune to chickenpox even though they have no history of the disease or

vaccination.

For children ages 13 and over physicians recommend a blood test. Research

has shown that many, if not most people in this age group are already immune

to chickenpox even though they have no history of the disease or vaccination.

For this age group, two vaccinations are also required to achieve adequate

immunization. Having a blood test may reduce additional trips to the clinic

and needle sticks.

"We sincerely apologize for any inconvenience this vaccine recall has

caused our patients," said Lais. "We have our patients health and welfare

in mind and want to make absolutely sure that our patients are protected from

the varicella virus."

Source: RiverWay Clinics