The painkiller, Darvon, a narcotic painkiller similar to morphine and oxycodone, and related brand, Darvocet (propoxyphene + acetaminophen), was reported to have been taken off the market as it is potentially linked to acquired dangerous/fatal cardiac dysrhythmia (by adversely altering electrical activity of the heart), suicide and accidental overdoes. The FDA has also ordered companies compounding drugs with the active ingredient for Darvon, propoxyphene, to be removed from shelves.
Despite acknowledgment of potential cardiac dangers from propoxyphene administration and shelf removal, the director of FDA's office of surveillance and epidemiology said patients should continue taking their Darvon prescription until their doctor prescribes an alternative pain reliever. Thoughts on this?
In 2009, the FDA rejected the notion to remove Darvon from shelves and decided to add a bolder warning label regarding overdose to the drug as an alternative.
Since the removal of the drug, drugmakers are working to compound alternative pain killers.
What do you guys think? Do you think the FDA's initial choice in slapping a "bolder" warning label on Darvon would lead to less overdoses? Personally, I do not find that alternative to be an efficient measure in preventing overdoses of consumers. There are warning labels on cigarettes and alcohol regarding birth defects yet people still continue to to smoke and drink while pregnant. If the drug is demonstrated to alter the electrical activity of the heart, it should be removed and an alternative drug should be administered instead. I like my electrical activity the way it is, thank you!
http://www.msnbc.msn.com/id/40274692/ns/40278426
Cardiac electrophysiology is a huge topic of debate in the pharma world. Beginning in 2005, the FDA has started requiring clinical QT interval studies to be conducted in conjunction with other clinical trial procedures for new molecules in first time human use.
ReplyDeleteIt is important to make sure that new drugs are not causing cardiac toxicities in patients, but the fear of not getting a drug approved based on QT prolongation is making investigational drugs out of reach for some patients, due to a prolonged QT interval before they start the drug (>450ms is considered abnormal for men and >480ms is abnormal for women).
Most clinical trials do not have different cutoffs for women than men, so it is not uncommon to see a man be allowed on a clinical trial with a borderline QT interval, while a woman with a borderline QT interval will not be allowed to take the new drug.
Also, QT (or QTc) intervals can be prolonged by other drugs, stress, or just about anything. It can also be shortened (sometimes intentionally) by other drugs, such as Mg++.
I can't even imaging how many ECGs must be taken to find any statistical significance in a clinical trial.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129357.pdf
In my opinion "bolder" warning labels are definitely not effective in usage and or overdose of dangerous things. I doubt anyone who forks up the money to buy a pack of cigarettes is not gonna smoke it because there's a label that says it can cause lung cancer. As far as prescription drugs, there are so many labels and things to read on the bottle I do not think people would even take an extra warning label seriously. Scary how little people know about some of the negatives of painkillers
ReplyDeleteIt certainly seems that more action than a bolder warning is needed. However, I think it is good for the FDA to warn against stopping medication before consulting a physician. In this case, by switching narcotics, they would be able to avoid the often painful withdrawl symptoms associated with opiates. In genral, I do like the idea of consulting a physician, because immediately stopping medications can potentially be just as dangerous as the negative side effects in question.
ReplyDeleteI totally agree! Slapping a bolder warning label on the medication is not exactly the type of proactivity I was looking for. I, too, think the FDA should pre-warn physicians about the adversities of Darvon so they can prescribe alternative narcotics to their patients off the bat. I cannot imagine it being the smartest thing to drop a medication cold turkey and start up a new one even if they are deemed similar.
ReplyDeleteThis drug should be completely taken off the market and anyone who is currently on it should talk to their physician IMMEDIATELY. The problem I have seen is that nurses administer Darvocet like candy. I recently had a grandparent who died in the hospital after a month straight on this drug. We do not know if it was the drug that killed him but it very well could have been. Anything this dangerous should be illegal or highly supervised by a licensed professional when taken.
ReplyDeleteI agree that it is dangerous to just stop taking it as quitting cold turkey from any narcotic is dangerous, but not switching to another one could not only prove to be dangerous but fatal.