FDA reverses its decision on painkiller

? A liquid morphine painkiller given by family caregivers to dying patients can remain on the market, federal regulators decided after hearing protests over their decision to remove it.

The Food and Drug Administration had announced last week that it was ordering manufacturers to stop making 14 medications including the liquid morphine.

All were developed so long ago they had never received FDA approval.

But on Thursday, the FDA’s Dr. Douglas Throckmorton told The Associated Press the morphine liquid will 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.

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.”