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Published Date: 2002-11-17 23:50:00
Subject: PRO> Fungal meningitis, contaminated drug - USA: alert (02)
Archive Number: 20021117.5831

FUNGAL MENINGITIS, CONTAMINATED DRUG - USA: ALERT (02)
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[1]
Date: 16 Nov 2002
From: ProMED-mail <promed@promedmail.org>
Source: AP Online 16 Nov 2002 09:36 EST (edited)

FDA issues warning on injected drugs
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WASHINGTON (AP): Pain clinics and other health facilities should
immediately quit using all injectable drugs made by a South Carolina
pharmacy after one of that company's drugs was linked to deadly meningitis,
the [United States] government said on Friday, 15 Nov 2002.
The Food and Drug Administration () issued a nationwide alert warning
health workers that injectable antibiotics, pain medications and hormones
made by Urgent Care Pharmacy of Spartanburg, SC, may be dangerous. Urgent
Care recalled one of its injectable drugs, the synthetic corticosteroid
methylprednisolone, in September 2002 after it was linked to 4 cases of
meningitis caused by a rare fungus [_Wangiella dematitidis_ - Mod.LL]. One
of the patients died.
Injected drugs must be sterile, or they can cause deadly infections in
their users. The FDA said its inspections found the Spartanburg pharmacy
ill-equipped to ensure sterility in any of the injected drugs it makes, and
Urgent Care wasn't properly testing the drugs for sterility before shipping
them to pain clinics and other customers. Urgent Care refused to recall any
other drugs, the FDA said. So the government told health workers on Friday
to avoid using any of the following injected drugs made by Urgent Care:
baclofen, betamethasone, Bimix 30:1, clonidine, estradiol, hydromorphone,
fentanyl, morphine, papaverine, Super Trimix, mesylate/prostaglandin, and
testosterone.
The FDA said the drugs were sold in Connecticut, Illinois, Indiana,
Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North
Carolina, South Carolina, and Virginia. Also, the South Carolina pharmacy
board recently ordered a halt to further sales by Urgent Care, the FDA said.
Urgent Care is not a pharmaceutical company. Pharmaceutical companies
manufacture injected drugs under conditions designed to guarantee
sterility. Instead, Urgent Care "compounded" drugs, brewing prescription
medicines to fit a doctor or clinic's special order instead of simply
dispensing a drug made by a pharmaceutical company. Compounding is a common
practice -- pharmacists routinely flavor medicines for children, for
example, or remove an allergy-causing ingredient from common drug brands.
But the FDA is investigating whether Urgent Care compounded drugs legally.
******
[2]
Date November 15, 2002
From: ProMED-mail <promed@promedmail.org>
Source: FDA Talk Paper T02-44
<http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01171.html>

Nationwide alert on injectable drugs prepared by Urgent Care Pharmacy
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The Food and Drug Administration (FDA) is announcing a nationwide alert
concerning all injectable drugs prepared by Urgent Care Pharmacy of
Spartanburg, South Carolina, based on the lack of assurance that their
products are sterile. Non-sterility of injectable products can represent a
serious hazard to health that could lead to life-threatening injuries and
death. FDA inspection of Urgent Care's facility revealed the firm failed to
have adequate controls to ensure necessary sterility, including the absence
of appropriate testing for potency and sterility prior to distribution.
On September 16, 2002, Urgent Care recalled all lots of its injectable
methylprednisolone acetate based on reports of 4 patients who developed a
rare fungal (wangiella) meningitis after use of their product. These
patients were treated at 3 different North Carolina hospitals/clinics.
Spinal fluid from all of these patients tested positive for a fungus
consistent with that found in the Urgent Care product analyzed by both the
FDA and Centers for Disease Control and Prevention (CDC). One patient later
died despite antifungal therapy.
Urgent Care has refused to voluntarily recall any other injectable products
they prepared and refused to provide FDA with a complete list of products
they distributed. FDA is working to identify the recipients of these
products so that the agency can directly alert them to the serious risks
involved. FDA is continuing to work with CDC, along with officials from
both North Carolina and South Carolina, and will take whatever additional
action is needed.
In the meantime, the South Carolina Board of Pharmacy has issued a Cease
and Desist order to halt further sale of products from Urgent Care. At the
present time, based on limited information, FDA is aware that Urgent Care
has distributed the following injectable drugs to physicians, hospitals,
clinics and consumers in Connecticut, Illinois, Indiana, Kentucky,
Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South
Carolina and Virginia:
Baclofen
Betamethasone
Bimix 30:1 (phentolamine mesylate/papaverine)
Clonidine
Estradiol
Hydromorphone HCl
Fentanyl
Methylprednisole acetate
Morphine Sulfate/Bupivacaine
Papaverine HCl
Super Trimix (papaverine HCl/phentolamine mesylate/prostaglandin)
Testosterone cypionate
Testosterone/Estradiol
Urgent Care injectables are labeled as URGENT CARE PHARMACY 2500 WINCHESTER
PLACE , STE. 106, SPARTANBURG, SC 29301, 800-692-8982. Consumers,
physicians, and health care workers are urged to examine their drug
supplies for any Urgent Care injectable products and immediately
discontinue their use. Users should also notify FDA of any complaints or
problems associated with these products.
These reports may be made to MedWatch, the FDA's voluntary reporting
program, by telephone at 1-800-FDA-1088 or online at
<http://www.fda.gov/medwatch/how.htm>.
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