WhiteCoat

Warning Labels – Just Don’t Puke

nauseated-vomiting-manIn less than 24 hours, Phenergan will no longer be available in one of the largest teaching hospitals in our area. Because of the decision of 6 appointed justices in our US Supreme Court, the hospital is removing all of the Phenergan in the hospital’s stock.

Thus continues the assault on many of the antiemetic stalwarts that we have been using for decades.

Bendectin was the first antiemetic to go the way of the dodo bird after famous plaintiff attorney Melvin Belli sued Merrell Dow Pharmaceuticals. No credible evidence was ever found that Bendectin caused birth defects as the plaintiff attorneys alleged.
Droperidol was another great nausea medicine that got the FDA’s dreaded “black box.”
Then the FDA went after Tigan suppositories.
Compazine was next to get the dreaded “black box” kiss of death.
Just last week, Reglan joined the “black box” club due to a risk of tardive dyskinesia.

Now Phenergan is going to take a hit. After the publicity, many doctors and hospitals will be afraid to use it.

It’s just amazing that the medical profession has been poisoning patients with all of these medications for decades and just now we’re finding out about it.

Luckily, we still have Zofran and other 5-HT3 receptor antagonists – if patients can afford it.

I wrote a prescription for 12 Zofran ODT tablets for a patient who was vomiting last week. The pharmacist called me and said that the prescription would cost $260 and it wasn’t covered on the patient’s insurance. Could I change it to something else?

I wasn’t willing to take the chance if the patient had a bad outcome.

Defensive medicine strikes again. Avoid the bad outcome.

I wrote about the Wyeth case here and here. I’m by no means a staunch drug manufacturer supporter, but pretend that you’re running a manufacturing company. What are you supposed to do with your drug labels now? Overlawyered.com has a summary of opinions about the Supreme Court’s decision as well as a link to the published opinion.

The product labeling for Phenergan had the following language in it:

phenergan-warning1

I skimmed the 80 page US Supreme Court opinion and it appears that the majority believed that “Wyeth could have unilaterally added a stronger warning about IV-push administration.” Good thinking. Now you’ve just opened the legal floodgates to every Tom, Dick and Harry who has ever had a bad outcome from taking a medication. All they have to claim is that the warnings on the medication bottle “weren’t strong enough” and they’ve got the opinions of six Supreme Court justices to guide them on their quest for independent wealth at the expense of a drug manufacturer.

Extending the Supreme Court’s logic puts every pharmaceutical manufacturer on notice that they must discover each and every way someone could possibly misuse their product and specifically warn the public not to use the product in that manner.

Don’t pour Phenergan in electric sockets – it could start a fire and burn down your house
Don’t feed Phenergan to your goldfish – it could burn their scales off and give you emotional distress
Don’t gargle with Phenergan – it could cause caustic burns to your throat and you could get disfiguring burns and you could suffocate to death
Don’t mix Phenergan with Frosted Flakes – it could cause an exothermic reaction with the Frosted Flakes, resulting in nasal irritation if you breathe the fumes

Actually, I created a Supreme Court-approved label that all pharmaceutical companies could use when they decide to manufacture medications. I’ll bet that some companies will find it very helpful:

supreme-court-friendly-warning-label1

If this label makes you feel nauseous, be careful.

There aren’t that many antiemetics left that doctors will be willing to prescribe to you.

UPDATE MARCH 7, 2009
The ink wasn’t even dry on the opinion and firms are out looking for “mass tort” clients.
wyeth-mass-torts

47 Responses to “Warning Labels – Just Don’t Puke”

  1. [...] room blogger White Coat: should your condition grow so severe as to call for medical attention, the arsenal of antiemetic treatments available to doctors keeps dwindling under the legal [...]

  2. Rebecca says:

    Your hospital doesn’t use any meds with black-box warnings? You guys are pussies.

    • WhiteCoat says:

      I agree that many hospitals and doctors are risk adverse.
      In fact, I still prescribe Droperidol – one of the black box medications mentioned above. But I get a hassle every time I order it.
      At some point, the hassle factor and the chance that I will lose everything in a lawsuit like the Wyeth v. Levine case outweigh the usefulness of one drug over another.
      If there was a chance that you could lose your life savings and be pushed into bankruptcy for posting comments on a blog, would you continue to do so?

      • Matt says:

        “that I will lose everything in a lawsuit like the Wyeth v. Levine case ”

        Huh? How would you lose “everything” in a case about the warning label of a drug?

  3. Jim says:

    I am waiting for a patient to sue the law firm which brought the phenergan case….when someone is unable to complete chemotherapy due to nausea (for instance) perhaps the firm could be sued for willfully acting in a way which it knew or should have known would restrict the availability of an FDA approved medication which would have allowed the individual to undergo lifesaving treatment!

  4. HyperAl says:

    Heck, that’s why we have Marijuana. Illinois, I believe just joined that bandwagon. Pass the joint Dude or (dood).

  5. shadowfax says:

    “Could I change it to something else?

    I wasn’t willing to take the chance if the patient had a bad outcome.”

    I call bullshit. Rant on, but this is just making shit up. If it’s true, my respect for you just went down substantially.

    • WhiteCoat says:

      When family members demand an admit for grandma who is on a slew of meds and who barfed a couple of times because she has the same bug that many other ED patients have, then threaten to go to administration when I discharge her, I’m not going to give them any type of extra opportunity to blame me for anything – lawsuit or no lawsuit.
      If you’re the type of doc that would just cave and admit grandma for no reason to avoid the confrontation with the family, you can keep your respect.

      • shadowfax says:

        Admit? What the hell are you talking about? You wrote about not changing zofran to phenergan — not about admitting someone. My point is that phenergan (PO) is still perfectly safe, as is reglan in low doses and for short periods, as are another dozen antiemetics. If the only oral antiemetic you are willing to prescribe is zofran, then that’s dumb, and that’s the inference I drew from your statement.

      • WhiteCoat says:

        You’re right about the “admit” thing. That was an unintentional straw man argument because I was pissed. I knew the presentation of the patient and why I “wasn’t willing to take the chance” – you didn’t. My bad. I was thinking about this all day and had planned to post an apology but you beat me back to the comments section.
        As for the medications – an angry patient or family member is halfway to a lawsuit. All you need is a bad outcome. If there is anything about a medication that can be used to bolster an angry or litigious patient’s claim that I recklessly prescribed some medication, I’m not going to take the chance. I still prescribe oral Phenergan as well, but have shifted toward using a lot more Zofran because it is “safer”. I won’t use Reglan.

    • cynic says:

      You can do what you want with your license. I agree with WC.

      These are your liberal judges that allowed this to happen. See if they are there to back you up when the shit hits the fan.

  6. Aaron In Florida says:

    Start prescribing ginger root. It works so well for the Chinese!

  7. Nurse K says:

    Whitecoat, I’m sure you know this, but ODT is way more expensive than just the plain ‘ol Zofran tabs that don’t dissolve. They’re both way, way, way more expensive than Reglan, however ($4 at Wally-World). There is a website run by the state in my state where you can check drug prices from different pharmacies in your area and, of the pharmacies that posted their prices, #20 of 8mg ondansetron tabs (generic) run anywhere from $28 to $1025, so IT PAYS TO SHOP AROUND.

  8. hashmd says:

    I’m with WC, shadowfax. You want to continue writing it, its your house, your source of income that you are risking.

    You are willing to go to court, sit in front of 12 non-doctor jurors, and say that you didn’t believe the black box warning, that you didn’t care that the hospital took it off their formulary due to safety concerns.

    You can’t claim you didn’t hear about the judgement against Wyeth either.

    In CA, if you even settle (not lose the case, just settle) above the $30,000 limit for the National Practitioner Databank, you are AUTOMATICALLY investigated by the Medical Board. That means the dominoes could all start falling one by one: Your license gets limited or suspended, you then lose the ability to contract with insurers, you lose your hospital privileges, you may lose your ability to see Medicare and Medicaid patients. It is NOT just a “slippery slope” argument. It happens automatically!!!!

    And you wonder why doctors are risk averse? You are just one bad outcome away from losing everything you have.

  9. pharmintern2010 says:

    The hospital I work at has just about all the antiemetics listed above except bendectin and tigan. Though the zofran was limited to the ER and inpatient cancer ward, all others had to get departmental approval from the head to get it available to them.

  10. Dr. Val says:

    I agree with you, White Coat. You might enjoy my follow up take on the verdict here: http://www.sciencebasedmedicine.org/?p=398

  11. Chuck says:

    In Fall of 2008 Michigan voters also voted to make medical use of marijuana legal. The state legislature is working out the details right now, like how many joints can you have on your person? In your house? Is a single 5 pound joint too much? Do you have to have the prescription in your person at all times? How many plants is considered “for medical use of one person”? Who gets sued if a medical marijuana user (MMU) steals some munchies? How much should they tax MM?

  12. cdy85 says:

    technically, the SCOTUS decision doesnt require a black box label or changing the label, it just says that state court failure-to-warn claims are not pre-empted under federal law therefore the previous decisions are upheld. All wyeth needs to do to avoid paying out similar claims in the future is contraindicate IV push administration, which shouldnt change the availability nor the effectiveness of phenergan

    • WhiteCoat says:

      “All Wyeth needs to do to avoid paying out similar claims in the future is contraindicate IV push administration”

      Until the next Tom, Dick, or Harry says that their rectal irritation was caused by Phenergan and if the warnings for supporitories was only stronger, they wouldn’t have developed colon cancer.
      Or the next Tom, Dick, or Harry states that Phenergan caused akathisia/dizziness (insert other side effect here) right as they started operating their car/climbing a tree/heading down the ski slope (insert other dangerous activity here), caused them to get into an accident and become paralyzed. Had Wyeth only had a stronger warning about akathisia on the product package, none of this ever would have happened.
      I could sit here all day and come up with other examples.
      Now the FDA is the floor. Where’s the ceiling?

      • Matt says:

        The FDA is not the floor. Again, did you read the ruling? You can make up hypotheticals like you’re in first year torts all day long, but I hope you don’t let hypotheticals that aren’t reality actually guide your thinking. It’s like never getting in the car because a semi could be coming down the road, and might lose its brakes, and maybe possibly not be able to swerve, and your car might stall and your door would stick and your passenger door lock didn’t work, and you might get hit.

  13. matt says:

    This post is a little unfair. The Court wasn’t able to look at the facts of whether the label was sufficient or not. A jury in Vermont already said that it was. (you can go blame Vermont) All the Supreme Court held was that states are allowed to impose higher (or lower) standards on the contents of the drug’s label than what was approved by the FDA. Given the amount of money being paid by drug manufacturers to gain capture over the FDA, you have to admit that’s not necessarily a bad thing.

    • WhiteCoat says:

      I agree that the Court couldn’t address the issue of whether the labeling in this case was sufficient.
      Of course the FDA has bias and PHRMA attempts to lobby the FDA just like any other special interest lobbies its oversight agency.
      However …
      It is very easy for someone to say how things “shouldn’t” be done.
      The Court established a floor, but not a ceiling, which may lead drug companies to go to ridiculous extremes to attempt to create a ceiling. With each new injury, there will be another lawsuit. With each successful lawsuit, there will be another ceiling set.
      Would you be willing to write a product insert for any medication that would pass muster in all 50 states plus any additional Supreme Court challenges?
      On the other hand, some drug companies may just do a risk/benefit ratio with certain drugs and stop producing them.
      Who benefits?
      You already know the answer.

      • Matt says:

        Again, you have yet to show that the Court actually established a floor, or at least a new one. Where is the support for that claim?

        Basically you’re just tossing out hypothetical scenarios to scare yourself and others.

  14. Matt says:

    cdy85 is right. Your anger at the US Supreme Court re: the warning label is misplaced. The Supremes were only addressing the pre-emption issue. Perhaps before you get too outraged about a ruling, you should do more than skim it.

  15. Matt says:

    “Defensive medicine strikes again. Avoid the bad outcome.”

    Interesting thought. When you made the decision, how much did you affect your chance of a bad outcome, and beyond that, a suit resulting from that outcome? If you don’t know, why take that course of action?

    • WhiteCoat says:

      Hmmm. Potentially risk getting sued if there is a bad outcome related to using a less expensive drug that caused injuries so horrific that the case was decided in the Supreme Court or give a more expensive and “safer” drug that doesn’t have the potential for side effects.
      With patients or family members who are already upset because they didn’t get the inappropriate treatment they demanded, the desire to “get even” goes up substantially. I’m prescribing the safest medication in that case.
      When things go wrong, no one thanks you for saving them money.

      • Matt says:

        Again, though, you don’t know if you really DID reduce your risk. And that case went to the Supreme Court on an issue that was brewing for years – FDA pre-emption.

        Interesting that you wouldn’t necessarily prescribe what you thought was best based on a risk you cannot quantify.

  16. Linda says:

    White Coat,

    You’ve been reading too much sensational press & not spending enough time with P&T committee minutes.

    For DECADES!!!! promethazine IV has been prohibited in doses of 50mg. That dose can only be given IM. For 25mg, the hospital standard of practice has been to give it slow IV push (over at least 1 minute) through a port in a running IV line. This pretty well assures it is not given in an artery. It is never given in a hep lock – only a running IV. I have no knowledge of this hospital or this situation, but the woman sued the deepest pocket – Wyeth. Hence, the black box warning. Obviously, some physicians, pharmacists & P&T committees need these becasue they DON’T READ THE WARNINGS WHICH ARE ALREADY THERE! This warning has been there for years – have you read it?

    This has nothing to do with po or pr phenergan or compazine. They are all still available & the only black box associated with those is age related (so pediatricians don’t give promethazine syrup to a 2 yo & mom finds the child not breathing hours later). The fact that trimethobenzamide (Tigan) has been removed from the market is because it wasn’t a very good antiemetic & sales went down far enough that it was productive to produce. (It rarely gave a cost price break so it was off the formulary when we already had 2 other adequate antiemetics (before Zofran). Ondanseton ODT is a marketing ploy & you got sucked into it. The ONLY advantage it has over ondansetron oral (which is MUCH, MUCH cheaper) is for migraine headaches. For chemo, GI bugs, etc – use the oral.

    No – hospitals are not removing promethazine or even IV promethazine. Just restricting how its being given & they should have been doing this for years. It has been the standard of practice for the 30 years I’ve worked in hospital pharmacy.

  17. Max Kennerly says:

    What a crock.

    Why would this “teaching hospital” revoke a medicine in response to a ruling on manufacturer liability? The ruling changed nothing at all relating to their liability. Do they also dispose of their vehicles every time the car manufacturers are held liable?

    The law is the same as it has been for decades: manufacturers remain responsible for appropriate warning labels.

    That’s it. The big “loss” today is that they weren’t granted a special immunity that neither Congress nor the FDA saw fit to grant them.

    • WhiteCoat says:

      Why?
      Because apparently the teaching hospital in question is risk-adverse.
      I don’t blame them.
      Why take the chance of another provider in the hospital accidentally giving the medication intra-arterially with a similar outcome – only this time with such a well-publicized decision from the Supreme Court?
      Besides, removing such a dangerous medication from hospital formularies enhances patient safety. Isn’t that what all you “AAJ” folk clamor for?
      Can’t have it both ways, Max.
      By the way, love the phrase “appropriate warning labels.” Can you define the term “appropriate” in a prospective fashion for us?

      • Matt says:

        “Why take the chance of another provider in the hospital accidentally giving the medication intra-arterially with a similar outcome – only this time with such a well-publicized decision from the Supreme Court?”

        Why would another provider do that now that they know it’s not to be given in that manner? No one said it’s dangerous per se. Again, you’re not sticking to the ruling, just making guesses. Have you read it yet?

      • Max Kennerly says:

        So what you’re saying is that the hospital will stop using it not because it is a “dangerous medication,” but because it’s worried about negative publicity about the drug in an unrelated field?

        That’s just terrible.

        No, I can’t define “appropriate” in a prospective fashion any more than you can prescribe the medicine in a prospective fashion.

        Act reasonably. Put patient safety first. Don’t keep using “dangerous medications,” regardless of whether a court tells you to or not.

  18. Matt says:

    “an angry patient or family member is halfway to a lawsuit. All you need is a bad outcome.”

    That’s incredibly laughable. You should stick with opinions on medicine, which you have experience in. Not the steps involved in bringing a malpractice suit. If you think the above is true, you clearly don’t know what you’re talking about.

    • WhiteCoat says:

      Funny. That’s what our malpractice insurer tells us and they have a few lawyers on their staff.
      Maybe they haven’t read the “World According To Matt” yet.
      Here’s a random article stating the obvious, too:
      http://www.sentinel-event.com/ptdrdialog.php
      You wouldn’t have a citation to your assertion that patient anger and lawsuits are unrelated, would you?
      Didn’t think so.

      • Matt says:

        I didn’t say they weren’t related. I said that you’re a far cry from halfway. Studies show that those physicians who treat their patients the most politely are less likely to have claims.

        But simply being angry and having a bad outcome doesn’t mean you’re anywhere near filing a lawsuit. You have to find an attorney willing to spend the money to take the case, and there is a long vetting process for most attorneys who specialize in that area. I used to work with attorneys who handled these cases. But you heard something from your carrier, so you’re probably right.

  19. scalpel says:

    I still use all of them in certain situations. Under age 2, all I will use is Zofran, although I see reglan used sometimes by PCPs. I won’t prescribe phenergan in the elderly either, so if a pharmacist calls, I’m not substituting for the zofran either. Phenergan and all the phenothiazines are much more likely to cause sometimes really horrible side effects in the elderly, even at low doses.

  20. scalpel says:

    Hah, nobody’s feeding the troll today. Good.

  21. ERP says:

    I use them all too – although only Zofran under two. Also, when I discharge people I always just write for 5 Zofran since that is often all then need if they have a day or two of gastroenteritis. That is usually affordable by most people. I have heard prices as low as 20 bucks. Otherwise, oral phenergan or reglan are fine. I very rarely gave Phenergan IV anyway – but I do give lots of Reglan – mostly for migraines.
    And as for the “liberal judges” argument, I would not call Thomas and Souter liberal at all. I wonder if they all thought of the potential wide-reaching ramifications of this judgement in terms of how we practise.

  22. B.RAD says:

    “Why would another provider do that now that they know it’s not to be given in that manner?”

    Matt, to answer your question, no provider would KNOWINGLY give the medicine in an artery, but by leaving in on the formulary, the hospital is risking the chance that someone could inadvertently inject it in the wrong vessel. Distinguishing between artery and vein, although most of the time is easy, is not 100%. So it’s easier to just pull it off.

    The only thing that will come from this is that sick people will have lesser choices of medicines available to them.

    • Matt says:

      If they do it unknowingly and accidentally shouldn’t they still be liable for the resulting harm? I wouldn’t knowingly run a red light but if I accidentally do and hit you in the crosswalk aren’t you going to hold me responsible?

      Knowing that chance is there do you still cross the street?

  23. William the Coroner says:

    The thing is, the lawyers talk of “reasonably for-seeable outcomes.” So, it’s foreseeable. Someone F*ed up and did it. Now, they shouldn’t have. Their actions merit severe punishment. The patient SHOULD be compensated for their problem

    But if the hospitals leave it in formulary, and it gets misused, the hospitals and the pharmaceutical companies get shafted. They have the deep pockets, not the idiot tech. It hasn’t happened with other drugs, but there are fewer and fewer out there.

    It’s like airport security. Flying loaded airplanes into buildings? Done that already. But TSA is busily locking the barn door, and the horse is over the horizon. The next attack will be something different. And the risk managers and the lawyers can ALWAYS second-guess the practicioners. There is no way not to be at risk from SOMEONE who wants a legal piece of you.

  24. Strong One says:

    Defensive medicine = micromanaged healthcare
    The ones calling the shots don’t even work in the clinical setting… hhmm.

  25. B. RAD says:

    “If they do it unknowingly and accidentally shouldn’t they still be liable for the resulting harm? ”

    Matt, you’re totally missing the point. Yes, someone should be liable if harm is done and it satisfies malpractice criteria. But in this case, the drug company? Given that they already had a warning about intrarterial injection, how are they liable for a misadministration of the drug by an individual, especially when it’s been known for years not to give it in an artery. It makes no sense. Deep pockets is the only reason I can think of.

    The point is that the hospital response will be to pull the drug because they don’t want to take that very small chance of someone screwing up.

    The harm to a tiny few takes precedent over huge benefit to the masses.

  26. Matt says:

    I have no idea since the facts of the underlying case aren’t laid out in the opinion since the Supreme Court opinion wasn’t about the issue of malpractice. It wasn’t really ever a malpractice case against the drug company at all.

    We’re simply guessing about the facts of the Vermont case beyond the sketchy summary. This is a case about FDA preemption. THAT is the point of this case. The rest of the posts about other issues that might result from this cases are simply guesses and idle speculation, primarily from people who clearly haven’t read the case.

    You can say deep pockets, and to an extent you’re probably right. But that’s kind of a silly statement, since it’s not like the drug industry, and the medical industry in general, isn’t about profit. Profit is why drug companies exist. And most are quite good at creating it.

  27. B. RAD says:

    I guess all I can say now is, as WC already said, “just don’t puke”.

  28. KAR says:

    In my experience, many insurances won’t cover Zofran — but maybe now with all the black box warnings on the other anti-emetics, they’ll be forced to.

    Zofran 4mg tabs are available in generic form for a lot less if you go to the right pharmacy in your area. We prescribe Zofran for kids all the time — the trick is to tell parents which pharmacies charge the lesser amount.

    Here in AZ, Fry’s, Walmart and Target pharmacies have all agreed to only charge between $5-6 per tab. Because many of the kids I prescribe it for take only 1-2mg doses, I ask the pharmacist to halve or quarter the ODT tabs. Works really well.

    — Peds EM doc

  29. Linda says:

    If you halve or quarter the ODT tablet, the rest becomes unusable. It absorbs water from the air & not only disintegrates, it becomes ineffective.

    Nonsense! Prescribe the kid the oral tablet, have the parent cut it (we’ll tell them how & tell them how to mix it in something the kid can tolerate) & you won’t waste the rest.

    When those drug reps come calling at least ask how the dissolution factors work!

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