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Xanodyne Withdraws Darvon & Darvocet from the Market

Mike — Fri, 19 Nov 2010 13:00:47 +0000

FDA NEWS RELEASE

For Immediate Release: Nov. 19, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. 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.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid 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).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that 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 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.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.

Actavis Fentanyl Patch Recall

Toby — Thu, 04 Nov 2010 13:00:32 +0000

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

Actavis identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification. An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As part of the voluntary recall, all wholesalers and retailers were asked to return the product from the listed lots that they may still have on hand or in stock. Actavis also is encouraging consumers to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted by the recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Information also is available through the Actavis U.S. website at www.actavis.us by going to the “Fentanyl Recall Information” link on the front page.

LIFEPAK 15 Defibrillator Recall

Toby — Fri, 23 Apr 2010 13:00:38 +0000

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

Power Off then On by itself.
Power Off then NOT turn On.
Power Off by itself requiring the operator to turn it back On.
Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Operating Room System II Surgical Navigation System Recall

Toby — Wed, 09 Dec 2009 13:00:31 +0000

Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures and contains a computer workstation with the navigation System II software and various components necessary to run the system.The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product.

Cardiovascular Systems ViperSheath Sheath Introducer Recall

Toby — Fri, 04 Dec 2009 13:00:30 +0000

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.

In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

Ti Synex II Vertebral Body Replacement Recall

Toby — Thu, 12 Nov 2009 13:00:50 +0000

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

CardioVations EndoClamp Aortic Catheter Recall

Toby — Mon, 09 Nov 2009 13:00:52 +0000

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

Premie Pack and Meconium Pack Recall

Toby — Wed, 04 Nov 2009 13:00:09 +0000

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. These products were distributed from January 1, 2007 through September 22, 2009.

Pointe Scientific Liquid Glucose Hexokinase Reagent Recall

Toby — Fri, 30 Oct 2009 13:00:15 +0000

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.

American Regent Recalls Ketorolac Tromethamine Injection

Toby — Tue, 20 Oct 2009 13:00:40 +0000

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).