A Maryland company's recall of an automatic injector widely used to treat severe allergic reactions has triggered a run on replacements, wiping out supplies at pharmacies for what could be several more weeks.
The shortages are persisting nearly two weeks after Columbia-based Meridian Medical Technologies Inc.'s May 8 recall and despite a sharp increase in production at its Ohio plant, where it has instituted a 24-hour, seven-day-a-week schedule. The company has promised free replacements for the roughly 1 million epinephrine-loaded EpiPen and EpiPen Jr. injectors involved.
"We are shipping an awful lot of product to meet demand," James H. Miller, Meridian's chairman and chief executive officer, said yesterday.
Miller said the company expected to catch up with demand by the first week in June.
The recall also has depleted pharmacists' shelves of the Ana Kit, a competing product made by Bayer AG, the German consumer products giant.
The situation has left allergy sufferers and asthmatics increasingly anxious, said pharmacists and food allergy experts.
"Some people are getting very angry, particularly parents who have kids with food allergies. It's understandable that they are alarmed. It really is not a good situation," said Arnold Davidov, a pharmacist at Tuxedo Pharmacy, which operates stores in Roland Park and Lutherville.
Like many other pharmacies, Davidov said, Tuxedo had called customers who had purchased the auto-injectors to alert them to the recall.
"That was a Friday [May 8]. By Monday we were cleaned out," said Davidov.
"When we contacted the wholesaler to order more, we were told they were out, too. At this point we're telling people to hold onto the pens until more stock comes in. You're better off with some protection instead of none."
Anne Munoz Furlong, founder and president of the Food Allergy Network, an Alexandria, Va.-based nonprofit group, said the organization has been flooded with calls from people who have not been able to get replacements.
"There is a lot of confusion out there over how the pens are being distributed and when they will be available," she said.
"Supply seems to be trickling in to local pharmacies. We are getting a lot of calls from people angry and confused," said Munoz Furlong.
Miller said that since the voluntary recall began, Meridian has shipped about 600,000 injectors. With the increased production, the company estimates it is making 100,000 injectors weekly.
"Our entire company is focused on getting these pens replaced as quickly as possible and ensuring this never happens again," the executive said.
The company estimated that about 10 percent of the recalled units are actually defective, but said it needed to test all injectors in the 47 recalled lots to find those with defects.
Meridian issued the recall after a routine inspection revealed a defect in the injectors' spring activation that could prevent them from delivering the full dose of epinephrine.
Miller said consumers can call Meridian's toll-free number, 800-240-5788, for help in finding a retailer with replacement stock.
Colleen Mansbach of Columbia said she was able to get two replacement pens for her 6-year-old daughter, who is allergic to peanuts, after about a week-long wait.
Like many parents with children who have severe food and insect allergies, the Mansbachs store injectors at multiple locations so treatment is available no matter where their daughter is.
"You feel less secure about handling an emergency with less than two pens available, particularly if you are in a remote area," said Mansbach.
A syringe kit marketed by Bayer, Meridian's only competitor in the allergy self-treatment market, is also flying off the shelves.
"We are seeing three times the normal demand for our product," said William Bauernschmidt, director of marketing for Bayer's allergy products division.
As a result, Bayer increased production of its Ana Kits this week and expects to ship 250,000 Ana Kits to retailers in the next two months to meet demand. That's about as many kits as the company normally ships in a year, said Bauernschmidt.
Bauernschmidt anticipated that Bayer would be able to capture 5 percent of Meridian's customers as a result.
Ivy Kupec, a spokeswoman for the Food and Drug Administration, said the agency was advising consumers who can't get EpiPen replacements to contact their doctor about alternatives and to be especially vigilant in avoiding whatever triggers reactions.
Munoz Furlong at the Food Allergy Network advised food allergy sufferers to avoid dining in restaurants or trying new foods until they get replacement pens.
Allergy experts said anyone who has a recalled pen and experiences the onset of an allergic reaction or severe asthma attack should go to an emergency room for treatment.
The recall also has taken its toll on Meridian's stock, which was trading at around $14 before May 8.
Yesterday it closed at $11.125, up 68.75 cents.
Pub Date: 5/21/98