The decision sounded reasonable. Pull 14 painkillers off the market because they had never received federal approval.
These drugs might be unsafe, ineffective or of poor quality, the Food and Drug Administration said. It ordered that manufacturing cease within 60 days. Patients could use other painkillers that were already approved instead, they said.
On Thursday, the FDA announced it had targeted one drug too many.
Officials changed their minds about a form of liquid morphine that is given to perhaps as many as 2 million people at the end of life and dying at home. For these people, no substitute is available, the FDA learned from protesting doctors and patients.
Just a few drops of the concentrated liquid, placed in the mouth of a patient who has trouble swallowing, lets a caregiver provide rapid pain relief.
The FDA's Dr. Douglas Throckmorton said the drug would remain on the market until it's replaced by an approved version or some equivalent therapy.
The reversal was welcomed by experts in hospice care and pain relief.
Dr. Diane Meier, director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine in New York, called Thursday's decision "fabulous.... It's incredibly refreshing and makes me hopeful about our government."
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research.
In interviews, experts said they didn't have firm numbers on how many patients use the concentrated liquid. But Meier estimated it may be at least 2 million Americans a year.
Caregivers can administer the concentrated solution at home, where morphine shots often aren't an option because of cost or limited abilities. Without the concentrated liquid, families could end up calling 911 to rush their loved ones to an emergency room for morphine shots, said Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine. That would be costly and against patient wishes, he said.
Storey called the FDA reversal "a really important step in the right direction," showing "an amazing level of responsiveness we're not used to seeing in our government officials."
But he said he is still concerned about the other painkillers ordered off the market, products containing morphine, hydromorphone or oxycodone.
There are approved medications with those ingredients, but opiate painkillers are in short supply, Storey said. So rather than removing the unapproved versions all at once, exacerbating the problem, he suggested the FDA proceed more slowly.
In a letter to the FDA earlier this week, Storey's organization said the unapproved painkillers "have been used safely and effectively for decades."
Throckmorton told The Associated Press in an interview the FDA was open to additional information on the other drugs still targeted and would discuss it with experts in hospice and palliative care.
But Storey said that in a later phone call with physicians and pharmacists, the FDA said that the order against those painkillers would stand.
Further shortfalls in painkiller supply could spell trouble for chronic pain patients such as 62-year-old Ora Chaikin in New York City, said her physician, Dr. R. Sean Morrison at Mount Sinai.
Chaikin takes an unapproved version of the drug Dilaudid — hydromorphone — when her joint pain flares, which is typically on most days. She said she needs that medication "just to be able to walk, to be able to do daily activities (like) putting a coat on."
Although approved versions of the drug are available, the FDA order makes Morrison worry about their supply.
"It's already hard to get them," he said.
On the Net:
FDA statement on original order
FDA background information