FDA: More than 30 Maine health groups used pharmacy in meningitis outbreak

Federal agents investigate the offices of New England Compounding Center in Framingham, Mass., Tuesday, Oct. 16, 2012. The company's steroid medication has been linked to a deadly meningitis outbreak.
Barry Chin | The Boston Globe | AP
Federal agents investigate the offices of New England Compounding Center in Framingham, Mass., Tuesday, Oct. 16, 2012. The company's steroid medication has been linked to a deadly meningitis outbreak.
Posted Oct. 24, 2012, at 1:07 p.m.
Last modified Oct. 25, 2012, at 8:34 a.m.

The number of Maine health organizations that received products from a Massachusetts pharmacy implicated in a deadly fungal meningitis outbreak has widened to more than 30.

The U.S. Food and Drug Administration on Wednesday released an updated list of about 3,000 hospitals, physician offices, health clinics and other organizations that were customers of the New England Compounding Center, the Framingham, Mass., pharmacy at the center of the multistate outbreak. The FDA withdrew its original list, which cited 14 medical facilities in Maine, after discovering inaccuracies.

The updated list contains 34 facilities in Maine, though some are named twice. Two health organizations that were included on the original list — Coastal Health and Skin Center in Ellsworth and the Well Woman Clinic in Freeport — were omitted from the revised list.

While health facilities in the state have purchased products from the New England Compounding Center, the injectable steroid blamed in the meningitis outbreak was not used in Maine. The state has recorded no cases of fungal meningitis, though health officials are monitoring 74 Maine residents who were treated in New Hampshire with the injections.

Other drugs made by the pharmacy have not been linked to illnesses. But the FDA has recommended that patients who received the products be notified about the potential risk of infection.

“It is clear this is being done with an abundance of caution and there is no defined disease with these other products,” said Dr. Stephen Sears, state epidemiologist.

Approximately 14,000 patients may have been injected with the potentially tainted steroid. More than 300 people have been sickened, and 24 have died. Health officials consider the risk in Maine to be low.

Meningitis is a potentially deadly inflammation of the lining around the brain and spinal cord. Fungal meningitis is a rare form of the condition that usually results from fungus spreading through blood to the spinal cord. Unlike bacterial meningitis, fungal meningitis is not contagious.

The patients who face the highest risk of meningitis received spinal injections for back pain, while others received less risky shots in their knees and shoulders.

Health officials also are investigating whether medications used in eye and heart surgeries are connected to the outbreak.

The FDA’s updated list released Wednesday covers purchases made from New England Compounding Center since May 21, which are believed to carry the greatest possibility of contamination. The FDA also released a second list detailing which products were shipped to each facility.

The Maine facilities named as NECC customers include 14 hospitals throughout the state, as well as eye centers, pain consultants and cosmetic surgery practices. Even a Portland salon, Akari, was included for receiving a drug used in treating varicose veins. The salon’s “medi spa” employs several doctors.

Maine Eye Center in Portland has notified about a dozen patients who received antibiotics and topical treatments made by NECC, said CEO Richard McArdle. No patients have experienced symptoms of infection, and likely would have by now if the products, which aren’t implicated in the outbreak, posed a risk, he said.

“We don’t think there’s any danger at all,” McArdle said.

The Cosmetic Enhancement Center of New England in Portland is reaching out to 12 patients who were treated with an injectable fat removal product manufactured by NECC, said owner Dr. Maria Atkins. No problems have been reported with the product, she said.

At St. Joseph Hospital in Bangor, less than 6 percent of patients, or about 1,500 people, may have received NECC products during the time period in question. All will receive a notification letter this week, which will explain that none of the products has been linked to the outbreak, the hospital said.

Most of the products were injectables used to treat nausea, pain and fluid retention, but no steroid injections were used or received by the hospital.

St. Joseph has set up a hotline for its patients who have been notified about the NECC products. The hotline can be reached at 907-3441 or toll-free at 855-298-7064. Medical professionals will be available to answer questions 24 hours a day through Sunday, Oct. 28, and from 7 a.m. to 5 p.m. through Friday, Nov. 2.

Patients who received an injection or other product made by NECC after May 21 are advised to look for symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and changed mental status. Symptoms of other infections can include fever, swelling and pain and redness at the injection site.

Symptoms of fungal meningitis may take from four to six weeks to appear.

NECC has suspended operations and all of its products have been recalled. The outbreak has stirred calls for stricter regulation of compounding pharmacies, which step in to manufacture medicines when drugs from pharmaceutical companies become unavailable or when patients need custom-made formulations.

The industry is loosely regulated by the FDA and state pharmacy boards.

NECC is being investigated for its role in the meningitis outbreak, and Massachusetts health regulators said the pharmacy has repeatedly failed to follow safety and quality procedures.

For information on the fungal meningitis outbreak, visit www.fda.gov.

Reuters contributed to this report.

 

Similar articles:

ADVERTISEMENT | Grow your business
ADVERTISEMENT | Grow your business