New Warnings Required on Possible Overdose in using Darvon and Darvocet
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On July 7, 2009, the Food and Drug Administration (FDA) requested the manufacturers of pain relievers that contain propoxyphene, such as Darvon and Darvocet, to increase the warning level on their product packages.
There has been growing evidence that has shown an increase in exceeding the dosage of propoxyphene and an increase in overdose of the medications. The FDA is also requesting the manufacturers of the medications to pursue further studies regarding the use of these medications and the effects that they have on the heart at increased levels.
Physicians and medical professionals are urged to take a patient’s medical history into consideration when prescribing Darvon or Darvocet. The potential for an overdose has presented a serious and potentially life threatening risk in using propoxyphene as a pain medication.
The FDA’s Center for Drug Evaluation and Research urges medical professionals to be aware of the consequences that may arise if a patient were to take a higher dose of Darvon or Darvocet. The effect that these drugs have on a patient has not been addressed at higher levels than have been prescribed. But with the growing tendency of overdosing or taking the medications at higher levels than have been prescribed these effects need to be addressed so that patients can be warned in advance of the risks involved in taking propoxyphene.
In addition, the FDA is working closely with the Centers for Medicare and Medicaid Services as well as the Veterans Health Administration to monitor the effects that propoxyphene has on elderly patients and if a better course of action for pain relief should be considered.
A public interest group called Public Citizen has called for a phased withdrawal of the use of propoxyphene but the request was denied by the FDA. At this time the FDA feels that the benefits of using the drug in the correctly prescribed dose outweighs the risks involved in taking too much of the medication.
Propoxyphene was approved by the FDA in 1957 and has been used for decades as a form of pain relief in the mild to moderate level. It is a form of opioid and in its regular dose and use the side effects are mild ranging from dizziness, nausea, lightheadedness and vomiting.
The FDA is monitoring this situation and will continue to review the tendency to exceed the prescribed amount of propoxyphene as a pain reliever. If you have used propoxyphene through a prescription of Darvon or Darvocet and found yourself using more than the prescribed amount you should contact your physician and consider an alternative pain reliever.
If you or a family member has suffered as a result of the use of propoxyphene you may want to consult any member of our legal team at Napoli Bern Ripka LLP who specialize in the side effects that come about as a result of FDA approved medications. Our attorneys have experience in dealing with these types of cases and could help you and your family receive compensation for suffering the side effects of these drugs. Call for a free consultation at 1-888-LAW-IN-NY.