FDA warns of problems with injectable steroids produced by Tenn. compounding pharmacy

In an eerie echo of last year’s national fungal meningitis outbreak, the US Food and Drug Administration warned Friday that an injectable steroid produced by a compounding pharmacy in Tennessee has caused problems for at least seven people.

The patients received doses of methylprednisolone acetate — the same drug that caused the fatal outbreak last year. Used in treating pain and inflammation, the drug was produced by Main Street Family Pharmacy in Newbern, Tenn.

Five patients in Illinois developed abscesses after receiving the drug, and two more in North Carolina have been affected. The exact cause was still unclear, but at least one case appeared to be a fungal infection, the FDA said.


“Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided,’’ an agency press release said.

There have been no reports of meningitis or life-threatening infections, the Tennessee Department of Health has said.

The pharmacy was already on probation as a result of a recent inspection, according to the state release, and this week voluntarily recalled its sterile products. The agencies were contacting health officials in states where the drugs were shipped, including 13 identified so far, none in New England.

Tainted steroids produced at New England Compounding Center, a Framingham, Mass., compounding pharmacy, have sickened at least 741 people, 55 of whom have died.

Compounding pharmacies traditionally have been allowed to mix drugs for individual patients who need formulations or doses that are not widely available off the shelf. But last year’s outbreak highlighted the fact that some were acting more like manufacturers, producing large batches of drugs, including medications that must be made in controlled, sterile environments.

Lawmakers are still debating whether to tighten federal control of the facilities. Oversight of the compounders generally has been left to the states. Before last year’s outbreak, the Massachusetts pharmacy board did not conduct unannounced inspections of compounders.


Governor Deval Patrick ordered the board to make surprise visits after the trouble at New England Compounding. He proposed adding $1 million to the state budget to hire more inspectors.

The Senate’s proposed budget originally didn’t include that money. But about $600,000 was restored to the $34 billion plan passed by the Senate Thursday, under an amendment put forth by Senator John Keenan, a Quincy Democrat.

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