Tuesday, November 24, 2009

Diabetes

Health Buzz: Supreme Court Phenergan Ruling and Other Health News

Posted March 5, 2009

Reader Comments

lay off phenergan

My fiancé has leukemia and has been checked in to the hospital for the last 3 months awaiting a stem cell transplant. He is nauseous 24/7 and has access to a multitude of IV antiemetics on request, phenergan being the most effective for him. He has pic lines in both arms and that is the only way the drug has been administered.

After 90 days of getting phenergan every 6 hours there have never been any negative side effects, even while using the full dose of 25mg. As of today he no longer has access to it.

I don't know if this lawsuit has anything to do with it, the nurses say the FDA sent out a warning that it should not be used intravenously, but after the research I've been doing for the safety of my loved one, I think the drug is perfectly acceptable. Maybe the people that administer it should be more educated but don't blame the drug. It doesn't seem right that a handful of incompetent people have managed to attach a bad name to an effective drug.

look what i find

Use fruit sugar? &rdquo

Phenergan is not to blame

ALL THINGS ARE POISON, IT IS THE DOSE THAT MAKES IT THERAPEUTIC. That is the first thing we learned in pharmacology. This unfortunate accident is not the fault of the FDA or Wyeth. There is NO way a drug company can possibly no all of the potential complications of a drug, especially when they arent given properly. Phenergan is an irritant to blood vessels, so care must be made to dilute AND ensure that it is NOT given in an artery. This is just another example of why there are 43 million Americans that cant afford health insurance. Phenergan WORKS it is one of the best antiemetics on the market (that is anti nausea to you non-medical folks). The woman already sued the "provider" for the mistake, now lets get more from the deeper pockets. If you are one of the people that believe in these "stupid" lawsuits, that is fine; just dont complain when it costs you 1000.00 dollars to treat a cold.

I almost lost my baby because of Phenergan

I was given Phenergan after experiencing nausea from a epidural...Almost immediately after the phenergan was injected I started having treamors and heart palpitations and my child went into fetal distress. The doctors had to do an emergency Cesaren. Of course the doctors deneyed that phenergan was the cause (they didnt give me a cause) but I know my body is very sensitive to chemicals. This drug is very dangerous and should be taken off the market before more people die! I guess the almighty dollar is more important than people! How sad!

Patients getting their health back

Let's give patients their health back. How about tackling kidney disease as well? http://www.thelatestmedicaltreatment.com (Dr. David Moskowitz of GenoMed, Inc.) offers a treatment option that applies to 90% of diabetes type II patients and can prevent an untimely death. Why the NIH keeps ignoring solid scientific evidence and practical results is beyond me. Let's give patients their health back!

great day for lawyers everywhere

It seems a majority of posts believe that the nurse should have been sued for not giving the drug correctly. If I am remembering correctly, the victim has already sued the nurse and won a multimillion dollar suit. Since the lawyers commonly take 30 -40 % of these awards and the drug companies have very deep pockets, the lawyers can greatly increase their take with little additional effort.

And as many of you pointed out, you will be paying for this with every visit to your doctor and pharmacy.

Important fact

Read a few other news reports to find this:

The label warned doctors to use extreme caution in injecting the drug but did not tell them it should never be injected. The court said the company was on notice of the danger - citing at least 20 similar reports of amputations since the 1960s - and could be sued for not adding such a warning on its own.

The patient didn't know this, the doctor didn't know this. Wytth knew this but, apparently, believed they were shielded by the FDA's approval of the warning label.

Phenergan

My mother had a stent placed in a heart artery, and had severe nausea while still in the operating room. She was given an injection of Phenergan and immediately stopped breathing. She was intubated (I was not told other details) and placed on a respirator for 48 hours. Thank the Good Lord she survived.

I have many severe side effects from drugs and have asked to place Phenergan on my list of "allergic" drugs, but have been denied.

Phenergan story

There are two issues here. One is whether the labeling was appropriate. Having just looked up the FDA-required labeling for phenergan, in my opinion the instructions are crystal clear regarding the importance of avoiding arterial injections and the likely consequences if it is accidentally injected into an artery. However, this is not what the Supreme Court ruled on.

The other issue, which the Court did rule on, is whether a company can be held liable for inappropriate labeling. Since the companies are prohibited by law from deviating from the FDA-approved labeling, the Court's ruling leaves companies in an impossible position. If they change the labeling they violate the law, but if the labeling is ruled to be inappropriate, then they are liable. This leaves the companies without a means to protect themselves, except for removing the product from the market. Such a move would protect the company, but it would leave many patients without access to an important medicine.

I think without guidance from the Court on what steps a reasonable company should take to protect themselves from liability, the current ruling by the Court is irresponsible and is simply driven by sympathy for the patient who was harmed by the mistake of the nurse who injected the drug in an incorrect manner.

Phenergan award by Court

The drug "Phenergan" and its warnings: I will have to agree with the Supreme Court that the warnings are not plainly written and could have better clarity. Warnings are scattered over eleven pages on the PDF file, the one that I read. The sheet prepared by the FDA looks like it was put together by an FDA committee with typical government obscure wordage. Hazards about the drug are not clearly spelled out, or buried in several places. The lawsuit against the maker of the drug, Wyeth, should have been directed against both the FDA and Wyeth. Initially the sheet probably had enough warnings, but over the past years, several cases of gangrene had been noted as a possible adverse reaction. Nothing was done to update the clarity of the "drug sheet" that comes with the medication. This is at least partly Wyeth's fault. I believe Wyeth should rely on FDA versions, but with the recent history of possible gangrene complications from this drug's use, Wyeth had some responsibility to nudge the FDA to revise its warnings about use of Phenergan, and to do it quickly. The lawsuit should make both Wyeth and FDA responsible partners, not only Wyeth. Drug manufacturers should rely on the FDA to write the "drug sheet hazards". In this case with the growing understanding of the possibility of gangrene complications, both Wyeth and FDA should be held responsible. An assistant administered the drug. Responsibility of possible hazards involved by prescribing this drug should come directly from the doctor treating the patient. They should not be left to the assistant. That is why the patient is given the "drug sheet" for the drug to be used. The possibility of gangrene setting in should stand out clearly and if the patient had seen this, she might have opted to not accept the treatment. A good reason for the use of clear English.

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