Forget the Palladone

[stand4hope]

Some of you probably heard me mention the new pain medicine they gave my husband for his hip pain that worked so well, and I even recommended that TAnn tell her onc about it. Well, forget it! It's been suspended. Here's the article about it:

http://www.medscape.com/viewarticle/508364

Medscape Alert

Palladone Suspended Because of Alcohol Interaction

July 14, 2005 — The U.S. Food and Drug Administration (FDA) and Purdue Pharma LP have announced the immediate suspension from the market of hydromorphone HCl extended-release capsules (Palladone) because of the potential for severe adverse reactions with concurrent use of alcohol, according to a public health advisory released today.

New pharmacokinetic data from a company-sponsored study indicate that coingestion of alcohol damages the extended-release mechanism of the capsules, resulting in dangerous increases in the peak plasma concentration (Cmax) of hydromorphone that may be lethal even in opioid-tolerant patients.

Results of the study showed that coadministration of the lowest-dose capsule (12 mg) with 8 oz of 40% alcohol rather than water caused a mean 5.5-fold increase in Cmax.

Although the effect is generally more pronounced with increasing concentrations of alcohol and a fasted state, lesser amounts of alcohol can also have potentially serious adverse effects in some individuals.

In the study, ingestion of the 12-mg dose with a mixed drink (20% alcohol) or 8 oz of 4% alcohol (about two thirds of a typical serving of beer) resulted in approximately doubled hydromorphone Cmax in some subjects.

While there have been no reports of serious problems thus far, the FDA notes that since its launch in February 2005, the extended-release opioid has only been used in a relatively small number of patients.

The agency has expressed concerns regarding the product's safety with increasing use and has judged the overall risk of serious and potentially fatal adverse events to be greater than can be effectively managed by label warnings and a risk management plan.

Healthcare providers who have prescribed hydromorphone HCl extended-release capsules are advised to contact affected patients to discuss proper use of any remaining drug and to prescribe an appropriate substitute.

Hydromorphone HCl extended-release capsules are indicated for once-daily use in the management of persistent, moderate to severe chronic pain in opioid-tolerant patients requiring continuous, 24-hour analgesia with a high potency opioid for an extended period.

Adverse events related to the use of hydromorphone HCl extended-release capsules should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

[tnmynatt]

Peggy,

Bummer...I am so sorry to hear this for Don. Praying he can get a good replacement drug strategy. Take care.

[bunny]

I'm sorry for that disappointment. hopefully, there's something else out there for him.

xoxo

amie

[stand4hope]

LOL! Thanks, my friends, but he hasn't taken it for about two weeks because he isn't having any pain since radiation to his hip. Well, he just started having some new knee pain, but it's nothing real bad right now. Anyway, I just wanted to be sure that after I promoted it as being so effective that nobody else had it on their list to ask their doctors about it.

Thanks again! You're the best!

Love,

Peggy

[SJAS]

Peggy,

It's such a roller coaster ride with the meds isn't it. One moment you think you've got the answer, then the next thing you know the rug gets jerked out. So happy to hear that Don didn't even need it at this point - that really brightened my day which was a much needed lift. Hurrah for Don (and Peggy too, of course - ((((Don & Peggy))))