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June 3, 2009 - FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil(PTU) for the treatment of Graves’ disease. For more information, click here May 1, 2009 - FDA Warns Consumers to Stop Using Hydroxycut Products The dietary supplements have been linked to at least one death; pose risk of liver injury. For more information, click here March 31, 2009 – Caraco Pharmaceutical Announces a Nationwide Recall of Digoxin Tablets Due to Size Variability For more information, click here March 23, 2009 - Watson Pharmaceuticals Announces a Nationwide Recall of Propafenone HCL Tablets Due to Oversized Tablets For more information, click here March 4, 2009 – US Supreme Court Rejects Limits on Drug Lawsuits February 27, 2009 – Seroquel Maker, AstraZeneca, “buried” unfavorable studies, according to an internal e-mail unsealed as part of litigation over the medicine For more information, click here November 7, 2008 - ETHEX Corporation Issues Another Recall Due to Potentially Oversized Tablets ETHEX Corporation has again recalled specific lots of products that it markets. Earlier ETHEX recalls have occurred in June and October of this year. The specific lots for this latest recall have been recalled due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage. According to the recall notice, “overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.” For more information, click here October 26, 2008 – Thoratec Corporation Recalls Heart Pumps Thoratec Corp. has issued a recall of its “HeartMate II LVAS” mechanical heart pumps after receiving reports that 5 people have died while using the device and at least 27 reports of need for replacement. The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003. According to the recall notice on the FDA website, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead. For more information, click here October 15, 2008 - ETHEX Corporation Recalls Dextroamphetamine Sulfate 5mg Tablets The recall involves the possible distribution of oversized tablets. Oversized tablets may contain as much as twice the labeled amount of the active ingredient. According to the recall notice, the recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. For more information, click here September 4, 2008 – Medtronic’s "Infuse Bone Graft" Device Linked to Life-Threatening Complications - Click here August 14, 2008 – Boston Scientific Recalls NexStent Stents Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding this issue at: July 22, 2008 - Zimmer Halts Distribution of Its Duron Acetabular Hip Implant Components According to a Zimmer announcement, it was suspending sales of its Duron Acetabular Hip Implants after some doctors have complained that the device, a hip socket known as the Durom cup, was failing in their patients, who then had to undergo replacement surgery. Zimmer said that it is updating its product labeling with more detailed surgical implant instructions for surgeons and also will require surgeons to undergo a special training program. Capretz & Associates is investigating claims on behalf of patients who have experienced a failure of their Zimmer hip implant and required a revision surgery to correct the problem. If you experienced an early failure of your Zimmer hip implant that required you to undergo a revision surgery, please contact our office for a free legal consult at (800) 351-8588. June 19, 2008 - FDA Sued Relating to Risky Painkillers Darvon and Darvocet Consumer watchgroup Public Citizen sued the U.S. Food and Drug Administration (FDA) for failing to act on its petition to withdraw Darvon, Darvocet and all drugs containing propoxyphene gradually from the market as is now required in the United Kingdom (U.K.). Public Citizen’s complaint argues that the FDA is violating the law and putting patients at risk. In its 2006 petition, Public Citizen told the FDA that Propoxyphene is physically and psychologically addictive, is no more effective than safer alternatives and has been associated with more than 2,000 accidental deaths in America since 1981. June 13, 2008 - Ethex Corporation Recalls Morphine Sulfate Tablets The recall covers specific lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed under an “ETHEX” label between June 2006 and May 2008. The lot numbers involved in the recall are: Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284 Morphine Sulfate ER 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. The 60 mg product is a white oval tablet with “60” on one side, and “E” on the reverse. The 30 mg product is a pink oval tablet with “30” on one side, and “E” on the reverse. If you believe you have these recalled tablets, we recommend you call your physician, pharmacist or other health care provider. If you believe you may have been injured after ingesting tablets from any of the above-listed recalled lot numbers, you may contact our office for a free consultation. Call (800) 351-8588 or e-mail us by clicking here. Click here to see the FDA Recall Notice April 25, 2008 - Digitek (Digoxin) Tablets Recalled Actavis Totowa LLC initiated a Class I nationwide recall of Digitek oral tablets after it was discovered that the tablets may contain twice the approved level of active ingredient than is appropriate. Click here for more information. December 2006 - Capretz & Associates is pleased to report the December preliminary approval of a $40 million dollar settlement of a California class action lawsuit that it initiated against the City of San Diego on behalf of the residents of the city. The state court action was brought with a couple of notable San Diego law firms as the result of the residents having been allegedly overcharged for sewer assessment fees for a period of ten years. January 26, 2006 - Trasylol - Study Finds Risk of Kidney Failure, Heart Attack & Stroke A study published in the New England Journal of Medicine ("NEJM") found that Trasylol (aka "Aprotinin") doubles the risk of kidney damage, which it is estimated, could force approximately 10,000 patients onto dialysis each year. The study of about 4,400 patients also reported that Trasylol was found to increase the risk of heart attack by 48%, heart failure by 109% and stroke by 181%. The researchers concluded that the drug was not even necessary in most cases because there were two generic drugs that cost a tenth as much and were nearly as good at stopping bleeding yet produced no increased risk. January 20, 2006 - Ketek (telithromycin) - FDA Warns of Liver Toxicity The Food and Drug Administration (FDA) issued a Public Health Advisory warning of life threatening liver toxicity following an article in the Annals of Internal Medicine reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). The FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. November 10, 2005 - Ortho Evra Birth Control Patch - FDA Issues Stricter Warnings The Food and Drug Administration (FDA) today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. |
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