Wednesday, July 1, 2009

Still Fuming at the FDA!

It should be noted that more people visit an ER and/or die, as a result of mishaps with cars, OR swimming pools, OR alcohol, OR tobacco, THEN AS A RESULT OF TAKING PERCOCET, VICODIN, OR OTHER TYLENOL CONTAINING PRODUCTS!!!



Rx Intern said...

What's the max dose now, 625mg? You know, it's not so much that the FDA lowering the max dose is "helping" patients, it's that patients just need to be more COMPLIANT with their bloody medications. No more, no less. I hear the phrase "well, I take it as needed", but I'm sure their PCP or specialist told them it's every 4-6 hours or something to that extent. Whatever happened to healthcare being a contract between practitioner and patient?! We fulfill our end, they have to fulfill theirs. Suckers.

A CancerDoc said...

I agree.

Our pharmacist thinks that they have a college intern working at the FDA whose project is to create havoc. Hmmmm.

Did you catch the proposal to ban Roxinol (oral morphine 20 mg/cc). That's is one of the main-stays for hospice/cancer pain care. Thankfully, that was re-instated after the national hospice organizations met with the FDA...afterwards, the FDA apparently acknowledged that they had not considered the ramifications of their proposal. Despite that, several companies were told to cease and desist the manufacture of long acting opiods. Given the week or two that Roxinol was not produced plus the cease and desist on the other opioids, we are currently have difficulty finding both roxinol and dilauded for our patients.

You gotta love the "transparency," no?

Reality Rounds said...

....and Big pillows.

Anonymous said...

Don't give them any more ideas you might. They don't understand sarcasm and might just give you what you ask for.

Grumpy, M.D. said...

I love the above post!

"Don't give them any more ideas you might."

I had no idea you were reading my blog, Master Yoda.

Idiot are they, the FDA, Young Skywalker!

Anonymous said...


Lipstick said...

Dr Grumpy, I have to offer a dissenting opinion...

Admittedly it is a little more from a taxpayer perspective than a pharmacy perspective but just hear me out.

All those idiots who are abusing Percocet, Lortab, etc and taking #24 tablets (and up) per day are the ones who are ending up in the ER with the liver failure and the resulting medical bills. {my state can't shut the rx mills down fast enough much less the online pharmacies}

Removing 500 mg (or 650 mg) from the oxycodone or hydrocodone will solve that problem at least.

Also Jim Plagakis had a good point...hydrocodone without tylenol is a schedule II narcotic.

LOL about the swimming pools, tobacco, etc!! excellent point the previous reader made about Roxanol 20 mg/mL and the FDA stupidity...that has been such a nightmare for our oncology pts. Supply is still an issue.

Thanks for listening.

Did you have to get tomatoes tonight?

Grumpy, M.D. said...

Very good points, Lipstick, thank you!

Agree, the shortage of immediate release oxycodone has been a problem for all of us.

No tomatoes tonight, but Local Grocery has Diet Coke for $1.99 a 12 pack! So I'm going!

Anonymous said...

What about the concern for terminal cancer patients OD'ing. We can't have that, now can we?

Anonymous said...

It's hard not to be suspicious. Today the patient tells me she has had 4 back surgeries (2002-2004) at Cleveland Clinic and says she was placed on Dilaudid SQ infusion pump, but says she had to have it removed earlier this year because it was too bulky. She's in for massive bruises sustained from running into furniture. She shows me her hand-typed list of drugs taken prior to admission which includes alprazolam, clonazepam, gabapentin, and oxycodone APAP 5/325 '1 or 2 every 4-6 hours as needed', and another note that she had a prescription for hydrocodone 7.5/325 mg but ran out, and a note that says she doesn't take that much oxycodone. So, I ask her, 'do you take oxycodone and generic Lortab and generic Percocet?' And, she says 'I only take oxycodone, no generic Percocet, and the hydrocodone was discontinued' so I point out that her note says such and such, and APAP is a shorthand for Tylenol, and she says 'I don't want to take that much Tylenol'. (Hmmm, so how much generic Percocet and generic Lortab do you take?)

I call her pharmacy, and find out that she gets part of her prescriptions there, and that she's had at least from that pharmacy a tidy sum of opiates in the last 3 months (generic Percocet, generic Lortab 7.5 and Lortab 5, Darvocet, and benzos, and then wonder...hmm, what does she have for liver function, and I wonder why the doc thinks she now has need for Pharmacy to go out and get a bottle of Provigil (~$1,000 for us to acquire) to start 200 mg Provigil every morning. Could it be that the patient is getting a little too snowed all by herself, been running into things and thinks it's because she's a little too groggy? Helllooo.. Maybe something entirely different, eh?

Carrie said...

Careful with those tomatoes, Dr. Grumpy, they're more likely to make you sick than the Percocet, et al. (

Soon-to-be-PharmD said...

Even if they drop the max dose to 3.25 grams (or whatever arbitrary number they decided) aren't all the practitioners going to be thinking, "But I know that I can go to a max dose of 4 grams.." Of course, barring liver failure or alcohol use; I know that's what I'd be thinking.

Phathead said...

Seriously, if it says do not take more than X number of tablets everyday, is it really that fucking hard not to take that many tablets a day?

If some dumbass decides to spill hot, fresh coffee on their lab do they go ahead and sue the company who... oh wait, this is America, they do never mind.

Honestly, if they're gonna go into liver failure because they're an idiot so be it. I do believe Darwin called that evolution, survival of the fittest.

That's just one less dumbass in the world in my opinion.

Liz RPh said...

This was the hot topic at work today - at least between me and my techs. I see lots of doctors writing for Vicodin 5/500 1-2 Q4-6H - which, if the patient takes 2 Q4H could lead to too much Tylenol. (above the daily recommended dose of 4g/day)

I'd be surprised if they removed *alll* of those drugs from the market, but I wouldn't be opposed to removing the drugs with higher amounts of Tylenol - i.e. the Hydrocodone 7.5/750 or 10/660 or Percocet 10/650. Perhaps they'd come out with new variations with different combinations - with a set maximum APAP dose of 325mg. (of course, then these new dosages would be brand-name only for awhile thanks to the joys of patent protection) I would also be completely fine with removing Darvocet N-100 since there's far too much Tylenol in there to be taken often enough to be effective for most patients.

I also think that there needs to be more patient/consumer education about the dangers of Tylenol overdose. It's commonly believed that Tylenol is "safe" because it's available without a prescription, and it is - to a point. But too many patients are completely unaware of the dangers of taking too much Tylenol.

Anonymous said...

Phathead, I agree! I personally know someone who gets regular Percocet prescription's for "back pain", but I dont think anyone has ever reevaluated him, he just keeps going back, with more aches and pains, and since he has been taking it so much, and so many- we have caught him crushing and snorting them instead, because he doesn't get the "relief" any more! Freakin idiots!

ShrinkingDoc said...

I'm just waiting for the influx of seekers/sellers coming to stock up before the ban. I might reconsider that coffee roasting job...

Anonymous said...

As others have said, the drug companies will just make the same narcotics minus the acetaminophen.
I've never bought into the idea that having 2 analgesics (hydrocodone/whatever + apap) had a synergistic effect.
So I'll take that oxycodone straight, no chaser.

Qex said...

Before using Stella Liebeck (the woman spilled coffee on her lap) as a symptom of all that's wrong with the legal system, consider that by its own admission, McD sold coffee at nearly boiling temperatures at the time. We expect coffee to be hot, but not scaldingly hot.

Consider also that the car was stopped at the time, so she could add cream and sugar to her cofee. Also, that 3rd degree burns are very painful, and that all Stella asked for was for them to cover her medical bills for the 2 years of treatment she needed; around $20K or so.

They refused, and the rest is history. If McD had done the right thing in the first place, it never would have gone to court. has a more detailed discussion.

Grumpy, M.D. said...

Okay, had no idea I'd spark this much.

I agree that APAP is a problem here- somewhat. The majority of the issue is patient overuse.

I don't however, have any problem with reducing the total APAP content content to 325mg/pill. I'm not sure how much it does, anyway.

Laura said...

Throwing a bone into the fray ...

Tylenol has a much higher incidence of causing rebound (ie the damn stuff CAUSES pain). If you NEED pain relief for whatever legitimate reason, why should you be force-fed another medication that 1) has been shown to cause liver damage and 2) has been implicated in the whole analgesic rebound equation.

Who was in bed with Tylenol when it 'had' to be added to potentiate opioids anyway? I think they've milked that cow dry and the consumers are paying for it on multiple levels.

w8ng2retireRPH said...

It's highly unlikely they will nix our beloved "Percocets" .. I mean 749s.. or 346s or whatever damn imprint the patient thinks works better or sells better.. or "vicodans". It would, in my perspective, be pretty nice if they got rid of at least some of the cough and cold products that contain APAP.
There are too many and they confuse the heck out of customers. Too many times I have someone show me a box of something that has your typical cough and cold trio in it, with tylenol. And they happen to already be taking acetaminophen for fever. If they hadn't asked me, they'd continue taking more. Not to mention the acetaminophen they are getting from their Vicoden ES or useless Darvocet that their physician wrote the max dose for. So if they listen (or take more which I know happens), they are already taking as much acetaminophen as they should get. Plus they have another Ultracet or something floating around from another prescriber/ER at another pharmacy that they are swallowing every now and then.

Most people assume over the counter products are safe and safe to take with whatever they are already taking. Thats where the trouble is.

You can hardly find a multi-symptom cough and cold tablet that doesn't have tylenol it in, and that there drives me crazy. I think the whole thing is ridiculous. Got a million cough and cold multisymptom products all with the same crap in them. Sure, hardly anyone is dying from the excess APAP but, hell lets just use it as an excuse to clear the shelves of cluttering me-too products.

Anonymous said... now share the Moron of the Day award WITH Stella!!

The old saw is correct---YOU CAN'T FIX STUPID!

Anonymous said...

Just a thought.

Since taking the acetaminophen out of the hydrocodone containing products means that they will become schedule II this also means that rather than having a prescription for a month's supply with 5 refills (6 months total as a CIII), the hydrocodone ONLY products would then require new RXs every fill. Pain to prescribers, patients, and pharmacists alike. Adding a dose-limiting product like acetaminophen may actually reduce the incidence of over-use of hydrocodone due to the risk of hepatotoxicity from the acetaminophen.

And anyway, who wants the currently Vicodin-dependent population banging down your door every month for a new RX?

Grumpy, M.D. said...

Frighteningly, there are some docs who will take advantage of this.

They'll make stable narc patients (now on C-II drugs that require written scripts every 30 days) to be seen every 30 days. Thus ripping off Medicare even more and driving costs up further.

RSDS said...

Here is the URL to a migraine forum thread where this topic is being discussed:

This shows what migrainers think of the FDA's plan.


Anonymous said...


3rd degree burns are painless. You are idiotic.

Anonymous said...

Ugh, migraineurs on narcotics.

Ugh, ugh, ugh. Good luck with that. I am of the opinion that narcotics make "migraines" and migraneurs worse. Nothing worse than a middle-aged migraine sufferer who likes Fiorinal and any narcotic, which invariably develops into a daily habit. Good God!

You know how hard it is to counsel a patient on how many tablets they can take when they take Darvocet for this, and Vicodin or Norco for that, and the doctor said they could take Tylenol instead if that works? How many tablets CAN they have? You almost need a grid! "Well it says not to exceed 6 tablets per day of Darvocet, which is good because I take Darvocet in the day, but at night I take Vicodin with my Tylenol PM." GAH! Oh, and Fiorinal, too, if I have a migraine.


Qex said...

To the two anonymous posters:

I post with a few facts concerning the McDonalds coffee case, and you attack me personally, instead of providing facts to refute my position. Great debate skills, there. You'd make great lawyers.

3rd degree burns may not be painful, but debridement and other treatments to help heal the burns are. And also, the edges of the burn aren't as badly damaged, and the nerve endings remain intact - and 2nd degreee burns are quite painful.

cynic said...


This is how our government now makes decisions. These antics now have trickled over to the FDA, who I never had faith in to begin with.

Fellow said...

Qex- you orginally said that third degree burns are painful, which is incorrect. I provided a fact, that they are not painful. That makes two things you have been incorrect about. You are an idiot.

-one of the anonymi

Qex said...

Yes, I now notice I grouped you in with the other anonymous without separating my messages clearly enough; you did only provide a fact.

However, it is the very rare patient with 3rd degree burns that doesn't also have 2nd or 1st degree burns as well, and I'm sure you will agree that those kinds can be quite painful.

I still stand by my first post: If you are hurt by a company's product, when the company knows this type of injury will happen and has done nothing to eliminate (or at least reduce) the danger, that company should pay for medical care resulting from that injury.

Anonymous said...

So what about my PCP, who used to give me 5mg oxycodone without incident for about a year and a half, and then one day when I called in for my monthly Rx found -- much to my horror-- that my dr was on vacation for the entire week and the dr covering for him refused to fill the Rx. Of course I was madder than hell at this whole situation (which naturally is interpreted as 'drug seeking behavior') so my dr's brilliant idea has been to give me an Rx for #360 percocet/APAP 5/325 -- told me I could take 12 a day so I'm getting the same dose as oxy as before his little freak-out. 4000mg/day of APAP is borderline WRONG. Now guess what: I just had two areas on my legs biopsied last week due to a strange rash that started around the time he put me on percs: guess what it is? Acetaminophen-induced progressive pigmentary purpura (Schamberg's disease) Yay smart doctor for fucking up my life just because I got angry with you.

Phathead said...

Anon - So because you, one person, had an adverse reaction, that justifies a redefinition of an entire drug?

People respond differently to all medications. There is no way to accurately predict what may happen. In your instance, something did occur, but that does not mean there was not an underlying condition which merely exacberated the problem.

If you were only on Perc for one month (which I am assuming you were until your regular doc came back) you are missing the point entirely as the danger lies mainly with liver functionality.

And if you hadn't been 'madder at hell' at the situation, you most Drs would have no issue regarding your situation. It's not their fault the doc was out of town. You shouldn't have over-reacted in such a way. Thus one could almost infer it is your fault you were on the Perc to begin with.

Anonymous said...

phathead, you apparently have misunderstood my post and are part of the dillweed idiots out there who make it so difficult for people who DON'T abuse their pain meds to be treated as non-junkies. Because of the fact that my dr didn't anticipate my upcoming monthly rx would coincide with his vacation and therefore left it up to the dr covering for him (who refused to write ANY rx for me) I was basically forced to go through withdrawal AND endure my usual pain on top of that. I had every right to let my dr know I was angry with him. I have a hard time believing that if you were put in my situation and forced to withdraw from opiates and suffer in pain for a week only to have your dr basically penalize you for being angry at him for the whole situation and then changing your meds for no reason other than to be an asshole, you wouldn't be pissed off, too.

Anonymous said...

As a footnote to my previous post: I wanted to make it clear that my dr switched me from 60mg oxycodone/day, which he had been prescribing for me for over a year without incident, ie, no 'lost pills' or early refills on my part , to 12# percocet 5/325 a day, which he's kept me on for a year now. This was obviously done on his part because he was mad at me for pointing out his error (which he did apologize for), however because of his anger (and I can only assume, his fear of the Mighty Sword of the DEA) he used my (justified) anger at him to switch me to a drug he no doubt felt was less of a hassle for him to prescribe, yet has caused me needless harm.

I noticed you're in school to become a pharmacist. I can only hope you don't automatically pre-judge people by the scripts they need filled. Yes, there are losers out there who ruin it for the rest of us who take narcs for legitimate reasons, but you need to learn to make that distinction between the two and not just lump everyone into the same boat. Who knows, maybe one day you'll have a surgery go wrong and end up having to live with constant pain.

Phathead said...

It was unneeded to call me names and classify myself in such away considering I did not do such a thing to you.

In my experience it is not up just the Dr to rely on ensuring all Rx's are done prior to a vacation. I do agree with you, in this case, that he should have had a contingency plan on hand for this situation.

But here's the deal, and you have to look at it from our end.

If a patient comes up to you screaming that you need you pain meds and you've been without them and yada yada yada, 95% of the time it's a junkie.

That 5% of the time, which you fell under, are burned because of the inconsiderate actions of the majority of others. It is not fair by any means, but when presented with this situation you have to respond like you normally would. It is better to do so than to get burned once and lose your license due to a junkie.

Yes your Dr was in the wrong, and probably is an ass, but you have to understand their side of it.

Phathead said...

Anon - I'm not actually in pharmacy school yet, hope to be soon though.

I don't automatically judge someone based upon what they take until they give me a reason to. That does not apply in all cases, but if you are cordial and respectful, I have no ill will towards you in anyway.

If you had pulled that kind stunt in my pharmacy, you would almost immediately peg yourself with a red flag. Maybe not so much due to the medication you are, but that you may be a volatile customer that should be handled carefully.

Has horrible as it sounds, its better in many ways to have a pessimistic outlook on things. I would hate to lose my license and profession over the fact that I misplaced my trust in someone.

Did that make any sense or am I just rambling?

Anonymous said...

Again, I don't feel my letting my dr know I was angry with him for what he had put me through would be viewed in the same negative way if it had been another med that I needed. Once you're prescribed an opiod you're pretty much at the mercy of your dr's (and pharmacist's) whims, and expressing anger -- even when justified -- is viewed as drug seeking behavior. I doubt had this been, say, a seizure med there wouldn't have been an issue at alI. What angers me the most is that it's a form of coercion and discrimination, as you're presumed to be guilty from just having that script.
I admit your comment that "it was [my] fault for being on the percs in the first place" just struck a nerve in me. To an extent you're correct in that I wasn't 'forced' to take the percocet, however what choice did I have? It was the only option my dr was giving me (enter the coercion). Why don't I just find another dr who is comfortable with prescribing opiates? Because they DON'T EXIST (although I have heard rumor of the occasional dr brave enough to treat pain despite the DEA breathing down everyone's necks). If I attempted to get a new PCP I would more than likely be accused of doctor shopping, the dr would be suspicious of my need for the pain meds in the first place and think I was simply another drug seeker, as you implied, and would more than likely not agree to give me an Rx which worked sufficiently to control my pain.
BTW, I never stated in my original post that I agreed with the FDA changing the amount of APAP in certain meds. My point was that many drs, such as mine, don't know enough about pain management (and/or are afraid of the DEA's wrath) to bother with it. So I'm stuck with having to take an absurd amount of percocet/APAP for the time being until he receives my biopsy results and realizes I can't take APAP anymore.
Here is an interesting site which explains the horrid way pain patients are being treated (or more accurately NOT being treated because of drs' fears of the government's ill-conceived "war on drugs":
Read through some of the blogs written by people in severe pain who can't find a dr willing to treat them, and pharmacists unwilling to prescribe certain meds (again, the innocent are being unfairly judged and punished because of the actions of some miscreants who choose to abuse medications meant to relieve pain). I luckily have a great pharmacist who owns a small pharmacy with a few staff who all know me, so I'm not treated like a criminal when I bring in my Rx. each month.
My apologies for rambling on, but this issue just hits too close to home for me. Oh, and you might be interested to know that my husband is a dr and offered to write me an Rx so I wouldn't have to suffer opiate withdrawal and pain in my dr's absence, but I didn't want him to risk his career over it. He did write me an rx for a non-scheduled med which was supposed to take the edge off the withdrawal symptoms, but unfortunately it didn't help much. Now do you understand where my anger at my dr stems from?

Phathead said...

Have you ever considered going to a pain management clinic? Obviously, and I'm not sure what your underlying condition is, but it is a recurring problem and usually, in my area, they are referred to the pain management clinic. The reasons for this are exactly what you have just described. Sure, you don't get to see your PCP, but judging from what you have said I don't think that would be any loss.

There are Docs who will prescribe this type of med when needed. ER Docs and PCPs are generally the most skeptical because they get most of the seekers out there. Thus, most of our chronic pain patients go through the local pain management center which is always quite courteous and understanding.

Like I said, I just want you to understand the position we're in. No one wins due to this situation. We have to watch our ass as much as we watch yours. There is a very very fine line and being able to tell the difference between a seeker and an actual chronic pain patient. And, at this time, I'm afraid there's really no way around it.

Anonymous said...

I'd posted a reply earlier, but I guess it didn't make the cut. Basically yes, I did try a pain clinic and didn't like that they treated their patients as criminals, having mug shot-like photos taken, assuming you're going to lie to them, and basically just thought the whole business rather degrading. So that's why I chose to stay with my PCP.

Re the position you say you're in, I understand it all too well. As I've stated previously, I'm married to a dr and have heard his horror stories re having to deal with drug seekers. After being in practice for many years, however, his radar is more finely tuned so he doesn't feel the need to treat ALL of his pain patients as drug seekers.

Grumpy, M.D. said...

Anon- I have not deleted or blocked publication of ANY comments on this thread that I'm aware of. I'm sorry if one of yours is missing. If I deleted it then it was an accident. I am not trying to censor viewpoints on this important subject.

Anonymous said...

I'm sorry -- I didn't mean to imply you had censored my post, Doc Grumpy. I just assumed it had gotten lost in the ether.
Thanks for the clarification, though!

Hey, one quick med opinion: provigil: scam or not?

Grumpy, M.D. said...

I think Provigil is a perfectly good drug when used for it's FDA indications.

Anonymous said...

Right now it's only been approved for two conditions, right? I've heard that Cephalon, the manufacturer, has gone out of their way to make the drug hard to go generic (it was supposed to in '07 but they managed to extend the patent until '12 I think) and its successor, Nuvigil, won't be off patent until 2023 or '25.

So you don't think it could be used successfully for treatment of other conditions? I'm just curious as a friend of mine was given an Rx for it from her PCP and her insurance company wouldn't cover it. She would need to pay roughly $430.00/month out-of-pocket if she wants to try it out.

Grumpy, M.D. said...

It may work for other conditions, it's just not approved for them.

danielle said...

I'm sorry but I think Vicodin should be taken off the market...and not because of the tylenol in it either. Because of the amt of vicodin that is prescribed thru out pregnancy - and then we in the NICU's are stuck dealing with those babies...and yes OB's, the babies are negatively affected by the vicodin that the preggo's get and you keep renewing thru out their pregnancy...

ProvigilSavedMe said...

Just caught this thread and the question about Provigil.

Just wanted to say that it has been a life-changing drug for me. I have MS fatigue that otherwise renders me completely useless (either asleep or in a hangover-esque state) from at least 3pm-6pm daily (if not longer). Very sleepy and mentally tired other times of day as well. I lived like that for *years* because I thought I was overworked, not fatigued.

Finally, after I moved and had to see a new neurologist, he told me that what I was going through was fatigue, and put me on Provigil. Provigil made me remember what it was like to be more normal. I still get tired if I have a big lunch, but that's *normal*. I still get tired if I overwork, but that's *normal*. I don't have my abnormal daily crashes.

At one point I switched to amantadine because I found out (after taking it for years!) that there's a conflict between Provigil and birth control... but amantadine didn't do anything for me. I got an IUD just so that I could go back to taking Provigil.

I normally take 150mg/day. If I can't get to sleep at night, I go down to 100mg. If I start getting sleepy during the day, I go up to 200mg for a little while. I self-regulate -- my prescription is 100-200mg/day, so I can be flexible.

Oh, and in regards to Vicodin - if anyone who hasn't had children ever is going to get an IUD, make them give you the Vicodin prescription **BEFORE** the procedure not after. Holy f'ing s**t. I would have been happy to come in to sign the release form the day before so that I would not be "legally incapacitated" by the level of Vicodin I should have been on. But that's a side note. If I can prevent one woman from having to feel what I felt where I felt it, I'll be happy.

Dr. Tonya said...

Also late to the party but I also wented to comment on Provigil. It also "saved" my life as well. I have many neurological problems and my neuro put me on it for chronic fatigue after doing a sleep study. I take 200mg in the morning and 100mg at lunch. Like the poster above, it just makes me feel "normal" and allows me to get thru the day. I could literally sleep for 14 hours per day if allowed without the Provigil. My insurance company needed extra paperwork from my neuro before they approved it - he said it was essential for my functioning and it went thru. We need to repeat the process every 6 months, but it is totally worth it to me. Amantadine, which I took prior to the provigil, did absolutely nothing for me either. Neither did getting frequent B12 shots. I have no side effects at all - no shakes or anything - and I still drink my Diet Coke with it. For someone with extreme fatigue, it is definitely worth the money and the insurance hassle.

Just my 2 cents.

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