Re: FDA reversal OKs morphine painkiller for dying

Dear Lori,

It's a shame no one interviewed had at least one foot in reality. Depending
on the local ER for treatment of a cancer patients pain? What state do these
guys live in?

Must be a state of denial--og

"LoriB.o.B." <banjobabe@xxxxxxxxxxx> wrote in message
news:4e8d98db-67db-4eab-b3cb-224b11a886f7@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Thanks as always ((((((Tami))))), for the excellent info passed along
to us!!!!
Hope all is goin' well 4 U (& everyone else of course!!!!)!!!

The thought of ppl who have probs. swallowing, etc., not being allowed
to use a med. like the liquid form morphine (etc.) is absolutely wrong
wrong wrong (not to mention Unfair....ooops, mentioned it weg!) so
thankfully sounds like common sense was allowed in this case at
least!!! How rare!
Thanks again,
Kindly,
LoriBoB
(the sort of still out of it after my recent emerg. surgery where I
couldn't have swallowed reg. meds!!! Thankful for IV's & sharp eyes
to find tiny veins!)
*****************

On Apr 10, 9:19 am, Tami <tmst...@xxxxxxxxx> wrote:
FDA reversal OKs morphine painkiller for dying
By MALCOLM RITTER ? 17 hours ago

NEW YORK (AP) ? "A liquid morphine painkiller given by family
caregivers to dying patients can remain on the market, federal
regulators have 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.
One doctors group had told the FDA that last week's order would "cause
extreme suffering for many patients who are nearing the end of life."

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.

The agency said last week that the unapproved drugs might be unsafe,
ineffective or poor quality. The order gave manufacturers 60 days to
stop making those products.

The liquid morphine is highly concentrated. Other approved forms of
liquid morphine are more dilute, and Throckmorton said the FDA had
thought the other forms could take the place of the concentrated form.

But reaction from hospice experts and others "helped us understand"
that some patients need the unapproved version, Throckmorton said.

In interviews, experts said they didn't have firm numbers on how many
patients use the concentrated liquid. But Dr. Diane Meier, director of
the Center to Advance Palliative Care at the Mount Sinai School of
Medicine in New York, estimated that it may be at least 2 million
Americans a year.

She called Thursday's decision "fabulous.... It's incredibly
refreshing and makes me hopeful about our government."

The high morphine concentration is crucial, she and others said. It
allows caregivers to rapidly relieve pain by placing just a few drops
in the mouth of a person who has trouble swallowing, perhaps because
of confusion, lethargy or other conditions.

The more dilute morphine requires much more liquid, which could make
an impaired person choke or sputter, or refuse to take the medication,
experts say.

Caregivers can administer the concentrated solution at home, where
morphine shots often aren't a good option. Without the concentrated
liquid, families could end up calling 911 to rush their loved ones to
an emergency room for morphine shots, which would be expensive and
against patient wishes, said Dr. Porter Storey, executive vice
president of the American Academy of Hospice and Palliative Medicine.

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 Storey said he was still concerned about the other painkillers
ordered off the market, products containing morphine, hydromorphone or
oxycodone.

While approved medications with those ingredients remain on the
market, Storey noted that opiate painkillers are in short supply. 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 painkillers covered by last week's order "have been used safely
and effectively for decades."

Throckmorton said the FDA is open to getting additional information
about the other painkillers, and would discuss them 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 the other 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."

http://www.google.com/hostednews/ap/art? AD97F756O0

On the Net:
FDA statement on original
order:http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html
FDA background information:http://www.fda.gov/cder/drug/unapproved?
ticsQA.htm
FDA web page on unapproved drugs:http://www.fda.gov/cder/drug/unapproved
? efault.htm

Tami PRN


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