The company that recalled a million units of its emergency allergy-fighting injections last week has failed to deliver on its promise to provide quick replacements, leaving millions of Americans without medication they might need to stop life-threatening allergic reactions to food and insect bites.
The self-injecting devices with the drug epinephrine were recalled last week because the maker, Meridian Medical Technologies of Columbia, discovered that certain lots were not potent enough to stop reactions that can lead to swelling, suffocation, blood pressure loss and shock.
At the time of the recall, the company said consumers could get replacements with adequate doses of epinephrine at no cost at their pharmacies.
The sudden shortage of the devices has caused consternation among the 10 million Americans who are sensitive to bee stings and the 5 million more who are sensitive to foods, although not all carry the devices, called EpiPens, to protect themselves. Each year, 1 million Americans experience severe allergic reactions.
Yesterday, Thomas Handel, Meridian's executive director of business development, acknowledged that the firm cannot keep up with demand for replacements even though it has stepped up production to 24 hours a day, seven days a week.
Handel said Meridian hopes that current orders for replacement devices can be met within two to four weeks. He said the company, which has made EpiPens for nearly 18 years, hopes to provide drugstores with a generous stock of EpiPens within four weeks.
Handel said the company tried to act responsibly, by announcing the recall soon after discovering the problem with the potency of 47 lots of EpiPens.
He said it was impossible to have enough replacement EpiPens right away. "No one could have anticipated this," he said.
Since the recall, the Food Allergy Network, a nonprofit allergy education organization in Fairfax, Va., has been swamped with phone calls from consumers complaining that they cannot find replacement EpiPens at drugstores.
Pub Date: 5/14/98