FDA Issues Warning About Drugs in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia

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By The Associated Press

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 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, S.C., may be dangerous.

Urgent Care recalled one of its injectable drugs, the steroid methylprednisolone, in September after it was linked to four cases of meningitis caused by a rare fungus. 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 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. The pharmacy could not be reached for comment Friday. Its founder has said he didn't believe his company was responsible for the contamination linked to the meningitis outbreak.

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.

Baclofen

Betamethasone

Bimix 30:1 (Phentolamine mesylate/papaverine)

Clonidine

Estradiol

Hydromorphone HCl

Fentanyl

Methylprednisolone acetate

Morphine Sulfate/Bupivacaine

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 phone at 1-800-FDA-1088 or online at http://www.fda.gov/medwatch/how.htm.

-- Anonymous, November 20, 2002


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