A compounding pharmacy that federal health officials linked to 15 fungal meningitis
deaths nationwide surrendered its Tennessee license Monday, nearly a
month after a Vanderbilt University doctor made the first connection
between her dying patient and a tainted epidural steroid.
The surrender came as the U.S. Food and Drug Administration linked infections in two heart transplant patients to drugs from New England Compounding Center.
Agency officials also said some of the compounding pharmacy's drugs
injected during eye surgery could cause infections, but they didn't name
The two heart transplant patients with Aspergillus
fumigatus infection -- one of two strains found in epidural steroids --
received cardioplegic solution from the New England Compounding Center
during surgery, the FDA said, noting that there could be other reasons
for the complication. It didn't say where the patients received their
Cardiac surgeons use cardioplegic solution to paralyze cardiac muscles during open-heart surgery.
After Monday's Tennessee Board of Pharmacy action,
the compounding pharmacy is banned permanently from doing business in
the state, where 53 have become sick and six have died of fungal
meningitis in recent weeks.
New England Compounding Center founder
Barry Cadden is licensed in Tennessee as the pharmacist in charge of
the business. He is preparing to surrender his right to practice in the
state, said John Smith, chief deputy general counsel for the Tennessee Department of Health.
Tennessee penalized the compounding pharmacy later than four other
states did, its action is more severe, Smith said. Tennessee follows New
Hampshire, Virginia, Massachusetts and North Carolina in taking
punitive action against the company.
"In each of those cases, the
license of NECC has been suspended, but there has been no revocation,"
Smith said. "We are the first board to actually revoke the license of
The state was able to take permanent action quicker by
allowing the firm to voluntarily surrender its license and still has the
option of assessing civil penalties or fines, he said.
Board members asked Smith whether they could pull Cadden's license before he signs a voluntary surrender agreement.
"Theoretically, he could come to Tennessee and go to work in Tennessee," said Kevin Eidson, a board member.
That's possible but unlikely, Smith responded.
he is in the middle of the storm. I think that everyone knows about Mr.
Cadden," he said. "The reality is that he has surrendered his license,
that he is not in Tennessee, that none of this product is being shipped,
and we will have a revocation of his license."
2nd steroid flagged
possible connection between epidural steroid injections from New
England Compounding Center's Framingham, Mass., facility and fungal
meningitis first came to light Sept. 18 when Dr. April Petit, a
Vanderbilt University Medical Center internist, reported the results of a
spinal tap to the Tennessee Department of Health.
Thomas Warren Rybinski, 55, of Smyrna, wasn't responding to treatment
for bacterial meningitis. Petit learned Rybinski had received a spinal
steroid injection of methylprednisolone acetate at Saint Thomas Outpatient Neurosurgery Center for his chronic back pain.
Rybinski died Sept. 29. The health department went public with the connection on Oct. 1.
FDA said Monday that a second steroid from New England Compounding
Center used for epidural injections -- triamcinolone acetonide -- has
been linked to a patient with possible fungal meningitis.
The company has recalled all of its products.
FDA also sent providers new guidance to warn patients who received
other injectable drugs distributed by New England Compounding Center
about the risk of infection. The two were ophthalmic drugs, commonly
used in eye surgery, plus the cardioplegic solution used during heart
"FDA is making this announcement out of an abundance of
caution in order to reduce any potential risk from possible contaminated
NECC products," FDA spokesman Steven Immergut said.
Carome, deputy director for Public Citizen, a consumer watchdog group in
Washington, D.C., said it's no surprise that other medicines
distributed by New England Compounding Center could have been
"If their manufacturing practices were deficient
enough to lead to contamination of what were supposed to be one set of
medication -- the first steroid that led to the big outbreak -- it's
certainly not surprising that others were contaminated," Carome said.
"It reflects obviously a significant failure in following appropriate
standards for manufacturing drugs."
Monday's announcement by the
FDA brought heightened concerns that patients with retinal problems who
received drugs distributed by NECC could be at risk for infections. The
FDA didn't say which states or surgery centers got those drugs.
Nashville ophthalmologist Chasidy Singleton said it is highly unlikely
that fungal meningitis could be contracted through the eye.
is no documentation of any fungal meningitis from any ophthalmic
medications that have been used in the past," she said. "The concern, if
you did use a medication that was contaminated, you would be
contracting an eye infection, not meningitis."
The FDA advised eye
doctors to warn their patients who received drugs purchased from or
produced by New England Compounding Center after May 21.
A statement from the center said it's reviewing and analyzing the FDA's announcement.
continue to cooperate with the FDA, as we are with the CDC and the
Board of Registration in Pharmacy of the Massachusetts Department of
Public Health. As we have said, we will respect those public agencies'
processes for investigations and will not comment while they are under
way," it read.
Last week, the Centers for Disease Control and
Prevention warned that people who got injections of the recalled lots of
steroid medicine, methylprednisolone acetate, in their knees and other
joints could develop septic arthritis.
Monday, the CDC said there
were 214 fungal meningitis cases nationwide, up from 205 Sunday. The FDA
said there were 17,676 vials in the recalled lot numbers.