Lyme Disease Still a Threat to Many States This Summer
Since its FDA approval in 1998, nearly 1,000 complaints from patients have been recorded; about 70 of those cite arthritis-like side effects.
While the adverse reactions continue to be reported, "there have been no clear patterns," says Lenore Gelb, spokesperson for the FDA. "We'll continue to do surveillance. [The reports] could point to something very rare," like a genetic predisposition to having problems with the vaccine.
"Everybody feels that more study is needed," Gelb tells WebMD. "We are concerned about it, yet it's difficult because some of these arthritis symptoms are very common and hard to pin down. It's not like a specific, unusual side effect. And it was nothing we saw in clinical trials with thousands of people."
At this point, hypersensitivity reactions -- similar to allergic reactions -- are the only changes that might be made to the vaccine's physician labeling, says Gelb.
"We know there is a controversy out there," says Carmel Hogan, spokesperson for Glaxo SmithKline. "But all our surveillance data and evidence from our clinical trials establishes LYMErix to be safe and effective. Our position hasn't changed."
The company is embarking on a phase IV, or postmarketing, clinical trial of the vaccine, to comply with all FDA requirements, Hogan tells WebMD. Thus far, 4,000 people have been identified with a goal of enrolling 15,000.
"We continue to monitor this," says Hogan. "But we currently have no scientific evidence to suggest that any [serious side effects] exist beyond those which has already been included on the label."
While investigations continue on the vaccine front, it's a good idea to be sure you are up on the features of Lyme disease.
A bull's-eye rash is most characteristic, followed a few months later by arthritis as well as brief bouts of pain and swelling in one or more large joints, especially the knees. Lyme disease is not fatal, but it can have long-term effects including destruction of joints and nervous system disorders. However, with early diagnosis and treatment, serious consequences can be kept at bay.
High-risk areas include those where deer and white-footed mice and ticks are abundant, Hayes says. That includes brushy and wooded habitats, especially those where forest edges meet lawns and meadows.