Archive for the 'Opioid' Category

FDA pulls Darvon, Darvocet from market

Monday, November 22nd, 2010

The popular painkillers Darvon and Darvocet (propoxyphene) have been pulled from the market because of their association with serious or even fatal heart rhythm abnormalities.

The US Food & Drug Administration (FDA) is also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.

Darvon and Darvocet are both made by Xanodyne Pharmaceuticals Inc. Propoxyphene is an opium-derivative used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

The US Food and Drug Administration has since reviewed the data from a recent study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death, the FDA said.

The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function, the agency said. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

Another Fentanyl Pain Patch Recall

Wednesday, August 20th, 2008

Watson Pharmaceutical is recalling more of their fentanyl pain patches because of their tendency to leak harmful fentanyl gel.

The manufacturer is recalling the 75mcg/hr fentanyl transdermal system patches sold in the US from wholesalers and pharmacies. These defective drug patches are used to manage persistent chronic pain that requires constant treatment with opioids.

The recalled patches in particular are from lot number 92461850 and have an expiration date of August 31, 2009. These patches were shipped to customers between January 30, 2008 and March 19, 2008.

According to Watson, some of the patches in this lot have been leaking fentanyl gel and exposing it to patients or caregivers. Fentanyl gel is a highly addictive opiate that is 80 times more potent than morphine. Direct exposure can cause serious effects such as trouble breathing, extreme tiredness, confusion, or death.

Canadian Morphine Tablets Recalled

Saturday, July 12th, 2008

Canadian drug makers, Health Canada, are recalling ratio-Morphine SR 15 milligram, 30 milligram and 60 milligram tablets. The tablets are being recalled due to possible overdose risks.

The recall was initiated after complaints were received by KV Pharmaceutical, a U.S. drug manufacturer.

Some morphine tablets may be oversized, containing more prescription medication than indicated on the label. This could lead to potential overdose.

According to defective drug attorneys, the symptoms of a morphine overdose are:

• Abnormal breathing
• Abnormally low blood pressure
• Abnormally low heart rate
• Dizziness

If untreated, a serious morphine overdose may also result in a cardiac arrest or fatality. If a drug overdose is suspected, defective drug lawyers agree that it is important to contact a qualified medical professional.

Morphine Tablet Recall Expanded

Tuesday, June 17th, 2008

Ethex Corporation has expanded its recall of morphine tablets on June 16, 2008. The recalled tablets potentially contain twice the dose of morphine that is on the prescription drug label.

Ethex Corporation originally recalled a single lot of morphine tablets on June 9, 2008. The recall has been expanded to include both 60 mg and 30 mg lots of extended release morphine tablets.

The recall expansion is being described as a precaution by Ethex Corporation. There have not been any reports of adverse reactions linked to the tablets.

Serious adverse reactions can develop due to an overdose of an opioid medication, like morphine. Symptoms of an opioid overdose include respiratory distress, low-blood pressure and hypotension.

The Food and Drug Administration (FDA) has listed the following recalled lots: 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284 and 60mg Tablet/NDC # 58177-330-04: Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

Defective drug attorneys are working to prevent the serious illnesses and injuries that can result from faulty prescription drugs.

Morphine Tablets Recalled

Saturday, June 14th, 2008

ETHEX Corporation is recalling one lot of 60 mg morphine sulfate tablets due to a risk of overdose. The tablets were manufactured with double the dose of morphine sulfate that is on the label, which could cause serious adverse reactions.

The lot affected by the recall is number 91762. No additional lots are being recalled.

The morphine tablets were released between April 15 and April 27, 2008. They are under the ETHEX label.

As with all opioid medication, the consequences of an overdose can be fatal. An overdose of morphine may result in difficulty breathing and lowered blood pressure.

To this date, the U.S. Food and Drug Administration (FDA) has not received any reports of adverse side effects.

Defective drug attorneys are working to help prevent serious consequences of faulty prescription medication by holding drug manufactures responsible for their negligence.

Prescription Drug Tracking Delayed in California

Wednesday, April 2nd, 2008

On March 25th, California regulators delayed the electronic tracking of prescription drugs for two years. The California State Board of Pharmacy voted 12-0 to allow prescription drug manufacturers, distributors and pharmacies an additional two years to begin electronically tracking prescription drugs from the manufacturer to the patient.The requirement was already delayed by the California State Legislation in 2007. Now, the pharmaceutical industry has until January 1, 2011. The delay is intended to allow the pharmaceutical industry time to set up computer systems that would comply with the first ever requirement to track prescriptions.

The requirement was instituted in California after a recall of fake Lipitor.

There are defective drug attorneys currently working on cases that involve the serious and fatal illnesses that result from defective drugs.

Shipments of Heparin Stopped at U.S. Border

Friday, March 21st, 2008

The United States Food and Drug Administration (FDA) announced on March 14th that it is taking action to stop the import of Heparin into the United States. The active ingredient of Heparin is manufactured by Scientific Protein Laboratories LLC., which has headquarters in both Wisconsin and China.

A major recall of Heparin was announced in January, 2008. Since then, hundreds of allergic reactions and at least 19 deaths have been reported in association with Heparin use.

A spokesperson for the FDA has announced that since the end of February, no new deaths have been reported due to adverse reactions to Heparin.

The Heparin that is being stopped at the borders is manufactured by Baxter International, Inc. of Wisconsin. Baxter reports that they have not isolated the contamination, so it cannot determine if the contaminated Heparin was manufactured in their Chinese facility.

Defective drug attorneys are currently at work to help those who have faced devastating consequences due to contaminated Heparin.

Third Fentanyl Pain Patch Recall

Friday, March 14th, 2008

On March 1, 2008, the U.S. Food and Drug Administration announced a third major recall of Fentanyl Pain Patches.

Actavis South Atlantic LLC, which sells generic versions of Duragesic fentanyl pain patches, voluntarily recalled all lots of fentanyl transdermal system CII pain patches on the market with expiration dates between May 2009 and December 2009.

This third recall of Fentanyl pain patches is an expansion of an initial recall of Actavis Fentanyl pain patches that occurred on February 17th. The original recall only affected fourteen lots.

Actavis states that this third recall is a voluntary measure to prevent any exposure to Fentanyl gel that may result from damaged pain patches that were not already recalled. The Fentanyl pain patches in question have a fold-over defect, which could potentially cause Fentanyl gel to leak.

The only Fentanyl patches that are not affected by this recall are those sold by Actavis in Europe.

Exposure to Fentanyl gel is very dangerous and can result in serious adverse and fatal effects, such as respiratory depression and overdose. Fentanyl is a potent opioid and should only be prescribed to those suffering from chronic pain and who are in need of around the clock narcotic medication.

Do not use damaged Fentanyl pain patches under any circumstance. If exposure to Fentanyl gel does occur, do not use soap, but thoroughly rise the site with water.

Actavis South Atlantic LLC was previously known as Abrika Pharmaceuticals Inc. Some of the recalled patches may still be labeled Abrika Pharmaceuticals Inc., although the outer carton does have the Actavis logo.

If you or a loved one has suffered serious or fatal illness due to damaged Duragesic or Fentanyl pain patches, you may be entitled to compensation. Contact a Duragesic attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced Fentanyl attorney will be able to evaluate if you are eligible to seek compensation.

The Misuse of Fentanyl is Deadly

Friday, February 29th, 2008

Fentanyl is a medication that is prescribed to those with intense pain due to chronic or fatal illnesses. The composition of Fentanyl is similar to morphine and heroin, as it contains a synthetic opiate.

An overdose of Fentanyl will cause symptoms of respiratory depression and eventually respiratory arrest.

In February, the U.S. Food and Drug Association (FDA) issued it’s second warning regarding the misuse of Fentanyl since 2005.

Both patient and doctor error have lead to numerous fatalities through the misuse of Fentanyl. The FDA has only approved the use of Fentanyl for those with chronic pain, who are already accustomed to the use of opioids.

In order for the patient to be accustomed to an opioid, they must have consistently used the medication 24-hours a day for a week or more.

The FDA has been alerted to physicians prescribing Fentanyl to patients with non-chronic pain. Doctors have prescribed Fentanyl to patients suffering from post-surgery pain, migraine headaches and those that have never taken an opioid medication.

Accidental overdoses of Fentanyl have also been linked to frequent application of the pain patches. Another common misuse is from allowing the Fentanyl pain patch to become hot, which increases the delivery of Fentanyl through the skin.

If you or a loved one has suffered serious or fatal illness from misuse of Duragesic or Fentanyl pain patches, you may be entitled to compensation. Contact a Duragesic attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced Fentanyl attorney will be able to evaluate if you are eligible to seek compensation.

Fentanyl Pain Patch Recalled a Second Time

Tuesday, February 26th, 2008

A second voluntary recall has been issued for Fentanyl pain relief patches. 14 lots of Actavis generic Fentanyl CII were recalled because of a fold-over defect that could possibly expose patients and caregivers to Fentanyl gel.

Exposure to Fentanyl gel may result in serious or fatal adverse effects, such as respiratory depression and overdose.

The Actavis recall follows the recall of all 25 microgram/hour PriCara and Sandoz Fentanyl patches. The PriCara and Sandoz Fentanyl patches were recalled because of a cut along the side of the Fentanyl gel reservoir, possibly causing exposure to the Fentanyl gel.

The lots affected by the recall include 25-, 50-, 75-, and 100-microgram/hour strengths. The lot numbers are:

  • 27261 (expiration date 5/09)
  • 27317 (expiration date 5/09)
  • 27318 (expiration date 6/09)
  • 27319 (expiration date 6/09)
  • 27391 (expiration date 6/09)
  • 27409 (expiration date 6/09)
  • 27475 (expiration date 7/09)
  • 27476 (expiration date 6/09)
  • 27488 (expiration date 6/09)
  • 27514 (expiration date 7/09)
  • 27536 (expiration date 7/09)
  • 27537 (expiration date 8/09)
  • 27538 (expiration date 8/09)
  • 27545 (expiration date 7/09)

Damaged patches should not be used under any circumstances. Damaged or cut fentanyl patches should be stored in a safe, tightly-sealed container, out of reach of children. To avoid exposure to the fentanyl gel, do not handle the patch directly. Do not re-use a container in which you stored damaged or cut fentanyl patches.

If you or a loved one has suffered serious illness or death due to exposure to Fentanyl, contact a Fentanyl pain patch attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced Fentanyl pain patch lawyer will be able to evaluate if you are eligible to seek compensation.