Posts Tagged ‘food and drug administration’

Qnexa- Not Yet

Wednesday, April 11th, 2012

FDA regulators will take another three months to make a decision on Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.

The Food and Drug Administration pushed back its target date t

o July 17, 2012 to consider a new drug safety plan submitted by the company. Previously the agency was scheduled to make a decision by April 17. Vivus said the three-month extension is standard when companies submit additional risk management information for a drug.

//finance.yahoo.com/news/fda-3-more-months-review-221936151.html

FDA Issues Warning to NY Drugmaker

Saturday, March 3rd, 2012

From a Buffalo news source:

APP Pharmaceuticals has received a warning letter from the Food and Drug Administration.

The letter notified the Staley Road manufacturer that the FDA expects it to “undertake a comprehensive and global assessmen

t” of its operations, particularly its “aseptic processing capabilities.”

The FDA inspected the plant in July, citing several “significant violations,” including insects found in vials of finished product, products with missing labels, a failure to follow quality- control procedures and improper investigating of customer complaints.

The latest letter says APP failed to properly address or correct the violations in its July response to the inspection. A statement from APP’s board of management said that the company has “full confidence” in its products’ quality and that it expects to respond satisfactorily to the FDA’s concerns.

The warning letter also said APP is manufacturing certain prescription drugs without an approved application. APP said the five drugs in question were “grandfathered,” or on the market long enough not to require FDA approval prior to 2006.

If you or anyone you know has been hurt by any APP Pharmaceutical products call us at: 877 882 0095

Source: //www.buffalonews.com/business/article744342.ece

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Monday, January 2nd, 2012

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The FDA renewed its focus on reusable medical devices after receiving reports that patients were exposed to infection when the instruments weren’t properly cleaned.

While the federal watchdog agency urged patients not to delay or forgo medical procedures for fear of infection, the risks have roused concerns over multiple-use medical devices.

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“Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there,” according to the FDA consumer update.

The risks result from improper “reprocessing,” the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.

Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.

The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.

Patients could become infected by other patients, or may suffer tissue irritation from chemical disinfectants or other reprocessing materials left on the device.

If you or anyone you know thinks that you have been hurt by any reused medical device, call us at: 877 882 0095

For original article see: //www.massdevice.com/news/fda-aims-reused-medical-devices

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Avastin Disappoints Against Ovarian Cancer Too

Thursday, December 29th, 2011

Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks disappointing against ovarian cancer, too. Two studies found it did not improve survival for most of these patients and kept their disease from worsening for only a few months, with more side effects.

The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, “we do not believe the data will support approval” although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.

Results of the studies are in Thursday’s New England Journal of Medicine.

If you or anyone you know has been hurt from taking Avastin, call us at: 877 882 0095
Read more: //healthland.time.com/2011/12/29/avastin-disappoints-against-ovarian-cancer-too/#ixzz1hw5xyf1U

December 2011, Conserve Hip Systems and possible failure?

Tuesday, December 27th, 2011

In 2009, the FDA approved the Conserve Hip Systems, made and sold by Wright Medical Technology, Inc.

Since 2009, there have been more than two hundred adverse reports where people claimed that the Conserve Hip Implant failed to do what it was promised to.

At year end, there is now a pending Petition for an MDL regarding those cases. The issues relate to the Conserve Plus Total Hip Replacement System and the Conserve Plus Resurfacing System. The total replacement system has four parts–  a metal femoral stem, metal femoral head, metal modular neck and the metal Conserve cup. The resurfacing system has two components: the metal femoral head cap and the Conserve Plus metal acetabular cup. Both systems are intended to be used as a hip-replacement implant when a patient’s hip joints are damaged or diseased as a result of fractures, osteoarthritis, rheumatoid arthritis and avascular necrosis.

The common component in both systems—and what is at the heart of the lawsuits—is the “Conserve cup”, which is a cast cobalt chromium molybdenum piece that holds the metal femoral head, mimicking the natural movement of a hip joint. It is that unlined cobalt part that is allegedly causing serious harmful effects to patients who receive the implant device. The problem is that these two metal components cause the release of metal particles around the hip joint and surrounding tissue. As a result, a high percentage of patients have developed metallosis and biologic toxicity and are experiencing a high and early failure rate of the device.

If you or anyone has been hurt by the conserve hip systems, call us at: 877 882 0095

FDA to investigate death of patient who was prescribed Gilenya?

Tuesday, December 27th, 2011

News today that follows the report earlier this month on Gilenya:

The FDA has received a report of a patient with MS who died within 24 hours of taking the first dose of Gilenya.

FDA has said it cannot conclude whether the drug resulted in the patient’s death, but was evaluating the case.

The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.

The drug’s maker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug.

If you or anyone you know has been hurt by Gilenya, call us at: 877 882 0095

Source: //news.yahoo.com/novartis-ends-study-drug-high-risk-patients-072623672.html

Vaginal Mesh Lawsuits May Be Centralized in West Virginia Court

Wednesday, December 21st, 2011

(openPR) – A number of plaintiffs who have filed lawsuits against the makers of vaginal mesh implants are seeking to consolidate the cases in a federal court. The push for consolidation comes as the first bellwether trials in the mesh litigation are scheduled to begin in November 2012.

The U.S. Panel on Multidistrict Litigation was presented with numerous motions to consolidate a number of cases filed against Johnson & Johnson, Boston Scientific and American Medical Systems with cases relating to the Bard Avaulta mesh system. If the panel approves the plaintiffs’ request, the cases would be heard by Chief Judge Joseph Goodwin in the U.S. District Court for the Southern District of West Virginia. Judge Goodwin has already been assigned to preside over a number of the Avaulta cases.

Since 2008, the FDA has received thousands of complaints from women who complained of severe pain, infection, scarring, blood vessel damage and other complications after receiving a vaginal mesh implant. The FDA issued updated safety warnings for the devices to better inform women of the potential health risks associated with the implants.

It’s estimated that there are approximately 4,000 lawsuits pending against vaginal mesh manufacturers in state and federal courts across the country. With an estimated 300,000 women receiving mesh implants each year, that figure is expected to increase substantially. Centralization of some or all of these cases could streamline the process and substantially reduce costs for all parties involved.

If you or anyone you know has been hurt by a vaginal mesh, call us at: 877 882 0095

For original article see: //www.openpr.com/news/204343/Vaginal-Mesh-Lawsuits-May-Be-Centralized-in-West-Virginia-Court.html

FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY)

Wednesday, December 21st, 2011

FOR IMMEDIATE RELEASE – December 14, 2011 – St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.

The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the Physician Advisory Letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.

St. Jude Medical reiterates that all leads with an externalized conductor, with or without an associated electrical abnormality, be reported to the company’s Technical Services Department at 1-800-722-3774. The company strongly encourages that any experience with screening of Riata leads for externalized conductors be shared with the company, including information regarding a lead or leads in which externalized conductors are not present. If a lead has been removed from the patient, St. Jude Medical requests that it be returned to the company, at company expense, for failure analysis to further understand this particular failure mechanism. All reports and returns received by St. Jude Medical of Riata leads exhibiting externalized conductors, irrespective of whether there is an associated electrical abnormality, are reported to FDA as a Medical Device Report (MDR). Any adverse reactions experienced with the use of this product, and/or quality problems also should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

If you or anyone you know has been hurt by the riata defibrillator, call us at: 877 882 0095

For original article see: //www.fda.gov/Safety/Recalls/ucm283879.htm

King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager

Monday, December 19th, 2011

Recall Class: Class I

Date Recall Initiated: August 30, 2011

Product: ShoulderFlex Deep-kneading Shiatsu Massager, Model # SH61

This product was manufactured from June 1, 2003 through January 27, 2011 and distributed from October 18, 2003 through April 19, 2011.

See related Safety Communication and Firm Press Release under Additional Links below.

Use: The ShoulderFlex massager is a personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder, and back while the user lies on a flat surface.

Recalling Firm:

King International LLC
16286 SW Horseshoe Way
Beaverton, OR 97007

Reason for Recall: The FDA became aware of one death and one near strangulation associated with the use of the ShoulderFlex massager. Additionally, the FDA was informed of two other reported incidents involving clothing and hair becoming caught in the device.

Public Contact: Customers may contact King International LLC at 1-503-524-7046, through its website (www.shoulderflex.com), or by writing to King International at P.O. Box 2384, Beaverton, OR 97075.

FDA District: Seattle

FDA Comments: King International LLC sent customers a letter notifying them about the product recall. In addition to the consumer information below, the letter informed customers to complete and return the enclosed postage-paid card to King International to confirm receipt of the recall letter.

Consumers:

Do NOT use the ShoulderFlex massager. Users of the device should dispose of the device components separately so that the massager cannot be reassembled and used by throwing away the power supply separately and removing the massage “fingers” to dispose of them separately.

Health Care Providers:

Advise your patients NOT to use the ShoulderFlex massager.

Summary of Recall: On August 25, 2011 the FDA published a Safety Communication on the FDA website and updated it on September 6, 2011. On August 31, 2011, the company issued a press release notifying the public about the recall of its Shoulder Flex massager.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

If you or anyone you know has been hurt by the ShoulderFlex Deep-kneading Shiatsu Massager, call us at: 877 882 0095

For original article see: //www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm280135.htm

CooperVision AVAIRA Toric and Sphere Soft Contact Lenses

Thursday, December 15th, 2011

Recall Class: Class I

Date Recall Initiated: August 19, 2011; expanded on November 15, 2011

Product(s): AVAIRA (enfilcon A) TORIC and SPHERE soft (Hydrophilic) Contact Lenses

The Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses.

Go to the CooperVision recall web page at www.coopervision.com/international-recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737.

The recalled Avaira Toric Soft Contact Lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.

The recalled Avaira Sphere Soft Contact Lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011.

Use: For the correction of nearsightedness or farsightedness, with or without astigmatism, in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters, and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single-use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Recalling Firm:

CooperVision Inc.
180 Thruway Park Dr.
W. Henrietta, New York 14586-9798

Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Public Contact:

Consumers may contact CooperVision on their toll-free hotline at 1-855-526-6737.

FDA District: New York

FDA Comments:

Based on a conversation with the firm, the FDA has agreed that the Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses.

On August 19, 2011, the firm sent a recall notification letter to the Avaira Toric Contact Lens worldwide distributors and health care practitioners. On November 19, 2011, the firm sent a recall notification letter to the Avaira Sphere Contact Lens worldwide distributors and health care practitioners.

Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice. Avaira contact lens wearers should check CooperVision’s recall web site www.coopervision.com/international-recall to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Alternatively, consumers can contact CooperVision’s toll-free consumer hotline at 1-855-526-6737 (M-F, 9:00 am – 5:00 pm EST). If you discover your lenses are among the recalled lots, return them to the point of purchase or to your eye care practitioner.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

If you or anyone you know has been hurt by any Cooper Vision products, call us at: 877 882 0095

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