Roxanol being pulled from the market by FDA

Published

Also MSIR, Oxyfast....

Please notify your administrators. Get in touch with your legislators and start a campaign. If this happens, this will have a huge impact on our patients care. The only way to obtain the strength needed for our pt's will be to compound. If anyone has contact at NHPCO, contact them.

http://www.medpagetoday.com/ProductAlert/Prescriptions/13526

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Oh for Petes sake!

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It's been the law for a very long time, and certainly no secret, that you can't sell drugs that aren't FDA approved in the US. As I understand the brouhaha, no one is saying there's anything wrong with the drugs themselves, just that the manufacturers haven't gone through the required process to get FDA approval. Why should the standard for these drugs be different than the standard for any other drug? If it was some honest mistake that the manufacturers didn't realize they needed to go through the FDA process (very hard to imagine!!), they can fix that now -- better late than never.

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Specializes in Cardiac, Hospice.

Our medical director is just switching everyone to oxyfast....just have to use 1/2 the dose because it's twice as strong.

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that explains a whooole lot. Getting pharmacy and even hospice to fill roxanol orders recently has been as hard as pulling teeth. It has been so scarce and hard to find. I kept thinking there must be more to the story and I guess there was. We keep being told it's going to take 2-3weeks to fill these orders. Yeah the patients can wait that long in pain....

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Our medical director is just switching everyone to oxyfast....just have to use 1/2 the dose because it's twice as strong.

and probably twice the cost, i guess i have my answer about "were does the money trail" go to......

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It's been the law for a very long time, and certainly no secret, that you can't sell drugs that aren't FDA approved in the US. As I understand the brouhaha, no one is saying there's anything wrong with the drugs themselves, just that the manufacturers haven't gone through the required process to get FDA approval. Why should the standard for these drugs be different than the standard for any other drug? If it was some honest mistake that the manufacturers didn't realize they needed to go through the FDA process (very hard to imagine!!), they can fix that now -- better late than never.

If this was aimed at only one or two manufacturers, I would think that perhaps they were just negligent about filing. But when it's nine companies, then I think there's something else going on.

At least with the majority of actively dying Pts I see, capsules or 20mg/5ml concentrations are a long way from being good substitutes.

Interesting, too, that the FDA had a lawyer commenting on what are good substitutes for the pulled meds.

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Redheadedvixon his it on the nose - follow the money trail.

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Specializes in Hospice.

Even if it turns out that no-one manufactures 20:1 morphine concentrate, the solution is simple ... take the ordered dosage in morphine IR pill, crush and suspend in 1/2 - 1 cc of hot water. What's the emergency?

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MSIR and oxyfast are being pulled, as well.

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I take that back...it doesn't list oxyfast in the approved or unapproved column

List of Approved Narcotics Drug Products:

Morphine Sulfate Tablets and Solutions

Drug NDC #* NDA# Manufacturer Morphine Sulfate Tablets 15 & 30 mg 00054 22207 Roxane Morphine Sulfate Oral Solutions

10mg/5 ml &

20mg/5ml 00054

00054 22195 Roxane Morphine Sulfate Extended Release Tablets 00406 76412 Mallinckrodt Morphine Sulfate Tablets Extended Release 60951 75295 Endo/Skyepharma Hydromorphone Immediate Release Tablets

Drug NDC #* NDA# Manufacturer Hydromorphone immediate release tablets - 2, 4, AND 8 mg 00074

00406 19892

78273 Abbott

Mallinckrodt Oxycodone

Drug NDC #* NDA# Manufacturer Oxycodone immediate release tablets - 5, 10, 15, and 30 mg 00406 76758 Mallinckrodt Oxycodone immediate release tablets, 5, 15, and 30 mg 00254 77-712 Vintage Oxycodone Extended Release Tablets, 10 mg 59011 20-553

75923 Purdue

Endo Oxycodone Extended Release Tablets, 15 mg 59011 20553 Purdue Oxycodone Extended Release Tablets, 20 and 40 mg 59011 20553 Purdue * 5-digit Labeler Code of the NDC number

List of Unapproved Narcotics Drug Products Subject to Warning Letters

Firms Products Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml Boehringer Ingelheim Roxane Inc. Roxanol Oral Solution, 20 mg/ml;

Roxicodone Tablets, 5 mg Roxane Laboratories, Inc. Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg Glenmark Generics Inc.

Morphine Sulfate Tablets, 15 mg & 30 mg;

Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml;

Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml Lannett Company, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml;

Hydromorphone HCl Tablets, 2mg and 4mg Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg;

Morphine Sulfate Solution Concentrate, 20 mg/ml Physicians Total Care, Inc. Morphine Sulfate Immediate Release Tablets, 30 mg;

Hydromorphone Tablets, 2 mg;

Hydromorphone Hydrochloride Tablets 4 mg Xanodyne Pharmaceuticals Inc. Roxanol Oral Solution, 20 mg/ml;

Roxicodone Tablets, 5 mg Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml * 5-digit Labeler Code of the NDC number

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Even if it turns out that no-one manufactures 20:1 morphine concentrate, the solution is simple ... take the ordered dosage in morphine IR pill, crush and suspend in 1/2 - 1 cc of hot water. What's the emergency?

Not sure that families in the home, where many Pts prefer to remain, are going to love this idea.

And I still can't help but wonder why the FDA suddenly has this twist in their shorts. Call me cynical, but it rather sounds like some bureaucratic power trip.

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