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FDA Expands Recall List of Drugs Implicated in Meningitis Outbreak

2012-10-05 16:13

The US Food and Drug Administration (FDA) is working closely with the Centers for Disease Control and Prevention (CDC) to investigate potentially contaminated injectable drugs which have been implicated in at least 47 cases of meningitis in seven states. Today, they expanded the list of recalled medications to 34 different drugs that include steroids, epidural anesthetics, and saline solutions compounded to make different medicines.

Yesterday, Emaxhealth reported that a rare but deadly type of meningitis had killed four individuals and sickened more than two dozen in five states. As expected, the number of cases has grown to 47 people in Tennessee, Maryland, Virginia, North Carolina, Florida, Indiana, and Michigan. Tennessee has been the hardest hit with 29 cases and three deaths.

Meningitis refers to inflammation of the protective membranes covering the brain and spinal cord. The inflammation is usually caused by a bacterial, viral or fungal infection. The type of pathogen determines the potential severity of illness and the treatment.

Tests are still underway to identify the exact type of fungus that is linked to this current outbreak. The fungus was found in a sealed vial of the steroid Methylprednisolone Acetate manufactured at the New England Compounding Center in Framingham, Massachusetts. The NECC voluntarily shut down operations on Wednesday, October 3rd and surrendered its license to the Massachusetts Board of Registration in Pharmacy.

The Centers for Disease Control and FDA have asked the clinics, doctors offices and hospitals in 23 states that have received shipments of medications from NECC to stop using them immediately. In addition to the seven states listed above, those that have received the implicated products include California, Connecticut, Georgia, Idaho, Illinois, Minnesota, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, and West Virginia

Anyone who has received epidural injections since July 1 should watch for symptoms of meningitis. Health officials say the most common symptoms are worsening headache, fever, stiff neck, trouble walking or falling and progressing back pain. Many of these patients have suffered strokes.

Users should notify the 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 on line at www.fda.gov/medwatch/report.htm.

List of Recalled Products Related to Fungal Meningitis Outbreak

Methylprednisolone Acetate (original recall)

Medication Strength Lot Number
Methylprednisolone Acetate 80 mg/ml PF 05212012@68
06292012@26
08102012@51

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Expansion of Methylprednisolone Acetate recall

Medication Strength Lot Number

Methylprednisolone Acetate 40 mg/ml PF 05012012@74
06082012@63
07052012@34
08132012@38

Methylprednisolone Acetate 40 mg/ml P 04242012@91
06272012@7
08082012@103

Methylprednisolone Acetate 80 mg/ml PF 04162012@108
05012012@74
06082012@63
07052012@34
08132012@38

Methylprednisolone Acetate 80 mg/ml P 04062012@44
05222012@13
07302012@72

Sterile intrathecal products recall by NECC

Medication Strength Lot Numbers

Betamethasone repository 6 mg/ml PF ALL LOTS
Betamethasone repository 6 mg/ml p ALL LOTS
Betamethasone sodium phosphate 6 mg/ml PF ALL LOTS
Betamethasone sodium phosphate 6 mg/ml p ALL LOTS
Betamethasone sodium phosphate 8 mg/ml PF ALL LOTS
Betamethasone sodium phosphate 12 mg/ml PF ALL LOTS
Bupivicaine 0.25% ALL LOTS
Bupivicaine 0.5% ALL LOTS
Bupivicaine 0.75% ALL LOTS
Clonidine 100 mcg/ml ALL LOTS
Dexamethasone sodium phosphate 4 mg/ml PF ALL LOTS
Dexamethasone sodium phosphate 6 mg/ml PF ALL LOTS
Dexamethasone sodium phosphate 8 mg/ml• PF ALL LOTS
Dexamethasone sodium phosphate 10 mg/ml PF ALL LOTS
Glycerin 100% ALL LOTS
Hyaluronidase 150 u/ml PF ALL LOTS
lsovue 200 mg/ml PF ALL LOTS
lsovue 300 mg/ml PF ALL LOTS
Lidocaine/Dextrose 5%/7.5% PF ALL LOTS
Lidocaine 1% PF ALL LOTS
Lidocaine 2% PF ALL LOTS
Lidocaine 4% PF ALL LOTS
Omnipaque 240mg/ml PF ALL LOTS
Omnipaque 300mg/ml PF ALL LOTS
Saline 10% PF ALL LOTS
Saline 3% PF ALL LOTS
Triamcinolone 10 mg/ml p ALL LOTS
Triamcinolone 40 mg/ml PF ALL LOTS
Triamcinolone 40 mg/ml p ALL LOTS
Triamcinolone 80 mg/ml PF ALL LOTS

Source Reference: US Food and Drug Administration, Centers for Disease Control and Prevention

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