When the FDA announced that it was recalling Darvon and Darvocet, two popular prescription pain killers in the US because of clinical studies showing that it can cause heart-related medical problems and other fatal cardiac abnormalities even at recommended doses, many people realized that they or their loved ones suffered a great injury or even death from these drugs. Many lawsuits have followed. Here is what has happened and what is happening with these claims:Long History that Lead to Darvon/Darvocet Recall and Lawsuits
This is not the first time that the FDA has questioned Darvocet over safety concerns. Consumer advocates have requested that Darvocet be pulled off the market since 1978. This battle in the 70s included Ralph Nadar and Sidney Wolfe. As retro as it seems, Nadar and Wolfe were at the forefront of this battle when the recall was finally issued this year for Darvon and Darvocet. Regrettably, it is 32 years too late for many.
Since the 70s, hundreds of millions of Americans have been prescribed Darvon and Darvocet as a pain reliever. However, medical studies show that heart abnormalities have been seen even in people who take prescribed dosages of the drug. The FDA has since instructed doctors not to prescribe Darvon and Darvocet after the recall. The government agency has also instructed that all drugs containing Propoxyphene be pulled off the market.
Darvocet and Darvon are classified as narcotic pain relievers. Its formula lists acetaminophen and Propoxyphene as its two major active ingredients.
Darvocet contains a combination of propoxyphene and acetaminophen. Propoxyphene is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever and a fever reducer that increases the effects of propoxyphene.
Darvocet is used to provide some relief for mild to moderate pain. Darvocet, like any pain reliever, gives these patients relief from pain by altering how the brain perceives pain. The combination of Propoxyphene and acetaminophen makes this drug a more potent analgesic. Acetaminophen increases the potency of Propoxyphene when the two are combined.Problems with Darvocet/Darvin
Propoxyphene and Acetaminophen
The first type of medical complication associated with Darvocet use is liver toxicity which results from taking in large amounts of the drug. This is an issue that did not get early attention with Darvocet but is likely to be a big subject in Darvocet lawsuits.
The liver is the organ that is responsible for breaking down drugs into forms which can be eliminated from the body. Because Darvocet is taken as a pain reliever, people are at risk of taking huge amounts of acetaminophen just to provide pain relief. When this happens, the liver is unable to cope with large amounts of the drug leading to liver damage.
Dependence is also a constant danger with continued use of Darvocet. Darvocet falls under narcotic and opioid analgesics and prolonged use may lead to habit-formation or addiction. Large doses of Darvocet can lead to Central Nervous System and respiratory depression.Heart-related complications
Although both previous medical complications discussed above are normally seen in many prescription drugs that are abused the real danger seen in Darvocet can be seen in its other main ingredient which is Propoxyphene. Studies have shown that even when Darvocet was used at recommended doses, it caused arrhythmias and cardiovascular problems associated with Propoxyphene poisoning.
There are now a great number of medical studies showing that Propoxyphene which forms the metabolite Norpropoxyphene is responsible for the various heart complications seen with Darvocet use. Cardiac complications include decreased heart rate and irregular heartbeats. Darvocet lawsuits are going to claim that the evidence was there from the beginning and Darvocet’s manufacturer chose to ignore those studies because it was making a fortune off of Darvocet. The sad truth is that whatever the outcome of the Darvocet lawsuits, so much money was made over the years on Darvocet and Darvon that it will still, in the final analysis, be a profitable venture. There was just too much profit to be lost in issuing a recall, regardless of how this drug was impacting consumers.Treating Darvocet Withdrawal and Overdose
Darvocet withdrawal is a real issue that is going to get more attention with this recall. Darvocet is a prescription synthetic narcotic drug or opioid that alters brain functioning to produce feelings of well-being. Long term use of the drug can cause physical and psychological dependence which may later turn into addiction. Patients who have been taking Darvocet continuously are advised to consult with their doctor before they stop taking the drug.
- Runny nose
- Muscle pain
Those going cold turkey may experience the worst symptoms of Darvocet withdrawal during the first two days. Stating the obvious: you need to talk to your doctor immediately if you were taking Darvocet now that there has been a recall. Medical supervision during this period is highly recommended and the patient is instructed to undergo bed rest for a few days to a month depending on the severity of the condition. Patients may experience episodes of muscle pain, chills, nausea and vomiting and care is needed to treat these symptoms.
A less stressful method of treating Darvocet dependence is done by gradually decreasing the dosage while replacing it with small amounts of similarly acting drugs. Commonly used drugs for replacing Darvocet are Buprenorphine and Suboxone. This allows patients to be treated with little supervision allowing them to continue with their normal daily routines.
The danger with any type of addiction is the sudden return to drug use. Overdose is highly possible because patients who have just undergone withdrawal treatment are likely to suffer overdose from much smaller doses than they used to take.
Darvocet is a mind altering drug. Not that this is necessarily a bad thing, but obviously there are risks that accompany this. Activities which require concentration like driving or working with precision instruments is highly discouraged. You should also advise your physician if you are taking in any cold, pain or sleep medications. Acetaminophen is an active ingredient in many of these medications and could lead to overdose when used together with Darvocet. Alcohol should also be avoided as this increases the likelihood of developing liver damage during treatment.Darvon, Darvocet Alternatives
The simplest way to say it is that for a drug that had so many risks, it was not that good anyway. There are just oo many alternatives that undoubtedly have risk, but not nearly as much as Darvocet and Darvon. The list includes narcotic drugs such as oxycodone, codeine and hydrocodone based medications. Aspirin and non-aspirin analgesics like Tylenol (acetaminophen) and NSAIDS such as Advil and Motrin (ibuprofen) are some of the suggested alternatives.These drugs too are probably overprescribed and harmful to some people. But for some, the balancing test leans in favor of using the drug over not using the drug. With Darvocet and Darvon, there is a good argument no one ever should have been taking the drug.Darvon, Darvocet Recall
The use of Darvocet and Propoxyphene based analgesics has been banned in many European countries because medical studies have concluded that continued use of the drug has been shown to produce cardiac abnormalities. Certainly, Darvon and Darvocet lawsuits are going to underscore the obvious: why were these drugs not recalled here in the U.S.?
In fact, this is not the first time that the FDA has acknowledged the medical risks posed by Darvocet. It has decided in the past that the benefits of Darvocet use far outweigh the risks posed to patients. Previous actions taken by the FDA include the strengthening of warning labels on the drug advising consumers about the possible risks of taking in the drug.
The FDA has since ordered all Darvon and Darvocet be pulled from the U.S. drug market and advised doctors to stop prescribing these drugs. However, this action by the FDA has gotten mixed reactions from patients who have been using/abusing Darvocet. But this recent announcement by the U.S. FDA is a final nail to the coffin ending its role as a pain reliever in the U.S. drug market.Darvocet Lawsuit Settlements
Getting a settlement in any mass tort lawsuit is difficult and it can be a long road. Arguably, settlement of the Darvon/Darvocet lawsuits will be easier because the drug is off the market. Companies sometimes - repeat sometimes - are less likely to defend a case to the end after a recall because the drug in no longer earning them profits that make it "worth their while" to leave the drug on the market, earning the cash and then some to defend the lawsuits.
2014 Update: Our law firm is no longer handling these cases.Darvocet News
These case are proceeding forward. There have been some struggles. On April 18, 2012, the judge who is overseeing all federal Darvocet cases centralized in Kentucky in a nationwide MDL/class action, has dismissed two critical defendants - Endo Pharmaceuticals Holdings, Inc. and Endo Pharmaceuticals, Inc. - because the court believed it did not have jurisdiction over these defendants.
The judge also dismissed plaintiffs’ claims with respect to the manufacturers of the generic form of these drugs, finding that they are preempted by the court decision in another case.