LYMERIX

LYMERIX

What is Lymerix?

Lymerix is a vaccine to aid in the prevention of Lyme disease which is transmitted to people through the bites of ticks infected with the bacterium Borrelia burgdorferi. Lyme disease causes fatigue, fevers and joint pain that can persist for weeks. Some patients develop severe arthritis. If not treated with antibiotics, Lyme disease can severely damage the heart and nervous systems.

The vaccine was approved for use in people 15 to 70 years of age who live or work in grassy or wooded areas where these infected ticks are present. The vaccine’s effectiveness depended upon the patient receiving three doses over a one-year period.

What are the Concerns about Lymerix?

Instead of being an answer to lyme disease prevention, Lymerix was blamed for causing the kind of arthritic symptoms it was supposed to prevent. In its first two years on the market, the vaccine prompted 905 adverse-event reports, such as swelled joints and aching muscles. There are concerns regarding severe rheumatologic, neurologic, autoimmune and other adverse events and the use of Lymerix. Many of the patients may have had a prior exposure and infection which Lymerix was triggering, or reactivating the damage caused by old and presumably cured Lyme disease.

FDA Involvement:

In 1998, the FDA licensed Lymerix (distributed by SmithKline Beecham Pharmaceuticals) as the first vaccine to help prevent Lyme disease.

On January 22, 2002 in Bethesda, MD, the Lyme Disease Association (LDA) was able to get a private meeting with the FDA to discuss the concerns and complaints regarding the vaccine.

In February 2002, a month after meeting with FDA, LDA received written answers to its questions from FDA and also learned that Glaxo SmithKline had quietly pulled Lymerix from the market, citing "poor sales."

Precautions to Take to Help Prevent Lyme Disease

Lyme disease is spread by ticks that live in wooded and grassy areas nationwide, but it is especially common in certain areas of the country. Per the Center for Disease Control, from 2003-2005 over 90% of the cases in the country occurred in 10 endemic states: Connecticut, Delaware, Maryland, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Rhode Island, and Wisconsin.

To help prevent lyme disease:

--Check yourself and your children daily for ticks
--Wear long sleeves and pants tucked into socks or boots when venturing into tick-prone areas like unmowed grass or brush
--Use insect repellent that contains DEET to discourage ticks from moving into yards,
--Put a barrier, such as a layer of wood chips, between woods and grass.
--Remove leaves and brush, as ticks prefer dark, moist habitats.

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