No warning on new Lyme disease vaccine downside

Thursday, 9 March 2000 16:25 (ET)

NEW YORK, March 9 (UPI) -- The new vaccine for Lyme disease has caused 298 adverse reactions, including chronic arthritis, according to reports obtained by Newsday, but there's no warning on the drug's label that this could happen.

Newsday said Thursday it obtained the reports from the Food and Drug Administration under the Freedom of Information Act.

Some 600,000 people took the drug, produce by SmithKline Beecham Pharmaceuticals of Philadelphia as LYMErix, the newspaper said, so the number of adverse reactions is small. However, the reports said apart from the arthritis, which is similar to rheumatoid arthritis, most reactions were allergic reactions. About one-third of the patients taking the drug who experienced the bad reactions ended up in the emergency room.

Spokespeople for the FDA and SmithKline say the reports did not reliably link the drug to subsequent complications.

However, lawsuits have been filed against the drug maker, including a class action suit in Philadelphia, charging that SmithKline failed to warn doctors and the public that the vaccine puts certain people with specific genetic traits "to the risk of a chronic, degenerative and incurable autoimmune disease which is much greater than the risk posed to these individuals by an ordinary Lyme-carrier tick bite."

The suits are asking that the company re-label its warning on the vaccine, that it advise doctors to screen patients for potential risk and pay for blood screening for those who have taken the drug, to see if they are still at risk.

LYMErix causes the immune system to produce antibodies to a protein on the surface of the Lyme disease bacterium B. burgdorferi, but researchers found that part of surface protein called OspA, could possibly cause a reaction in certain individuals with a specific gene, the HLA-DR4 gene.

Karen Vanderhoof-Forschner, chairwoman of the board of directors of the nonprofit Lyme Disease Foundation in Hartford, Conn., told Newsday: "I'm stunned. Looking at these data, I'm highly concerned by the number of the reactions and the severity of the reactions. ... This is a voluntary reporting system, so this is probably the tip of the iceberg. How is the public supposed to evaluate this data?" -- Copyright 2000 by United Press International. All rights reserved.