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FDA Medwatch Alert: The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

Posted 8 days ago by Drugs.com

ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection. The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers. BACKGROUND: The FDA is basing this warning on a recent inspection of The Compounding Shop. The in ... Read more

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Study Supports Broader Access to Lap-Band Weight-Loss Surgery

Posted 15 days ago by Drugs.com

THURSDAY, May 2 – The Lap-Band weight-loss procedure should not be restricted only to patients who are very severely obese, a new study suggests. Still, some experts disagreed, saying further research will be needed before the procedure is used in a wider range of patients. The Lap-Band is a strategy in which an adjustable band is placed around the upper part of the stomach in order to create a pouch. The newly-created pouch restricts how much food a patient can eat at one time and helps reduce appetite. In 2001, the U.S. Food and Drug Administration approved the Lap-Band for use in patients who are very severely obese (a body-mass index of 40 or higher) and for patients who are severely obese (BMI of 35 to 39.9) with an obesity-related condition such as high blood pressure or diabetes. BMI is a measurement of body fat based on a ratio of weight to height. Obesity is typically defined ... Read more

Related support groups: Surgery, Obesity

FDA Medwatch Alert: Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

Posted 2 Apr 2013 by Drugs.com

ISSUE: Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. The affected lot number is 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015. Hospira is investigating to determine the root cause. The brass particulate was identified as containing copper, zinc and lead. If administered, solution containing brass particulate may result in occlusion of small blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. BACKGROUND: The product is ... Read more

Related support groups: Surgery, Sodium Chloride, Hyper-Sal, NebuSal, Thermoject

Experimental Staph Vaccine Fails to Work, Study Finds

Posted 2 Apr 2013 by Drugs.com

TUESDAY, April 2 – An experimental vaccine does not reduce the risk of staph infections in patients who have had heart or chest surgery, a large new study finds. The study included more than 7,000 thousand adult cardiothoracic patients. About half of them received an injection of the "V710" vaccine 14 to 60 days before their surgery, while the others received a placebo. At 90 days after surgery, Staphylococcus aureus infections showed up in 22 of 3,528 vaccinated patients and in 27 of 3,517 patients who received the placebo. No significant differences in effectiveness were ever seen between the vaccine and placebo groups during the study. The researchers also found that patients who received the vaccine had more negative side effects in the 14 days after vaccination than those who received the placebo (31 percent vs. 22 percent), including serious problems (1.7 percent vs. 1.3 ... Read more

Related support groups: Surgery, Bacterial Infection

New Method Quickly Spots Kidney Damage After Surgery

Posted 15 Mar 2013 by Drugs.com

FRIDAY, March 15 – A potential early indicator of acute kidney injury has been identified by researchers. Acute kidney injury is a common and serious complication of hospitalization. It affects about 6 percent of all hospitalized patients and 30 percent to 40 percent of adults and children who undergo cardiopulmonary (heart-lung) bypass surgery, according to the researchers from the Medical College of Georgia. They also noted that 10 percent to 15 percent of acute kidney injuries lead to chronic kidney disease or failure that may require dialysis or a kidney transplant. In animal and human studies, the researchers found that a significant amount of the protein semaphorin 3A is detectable in the urine within a few hours after acute kidney injury. The protein is not usually measurable in urine, but it was rapidly detected in a group of 60 children after they had heart-lung bypass ... Read more

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Angioplasty Safe in Hospitals Without On-Site Heart Surgery Services

Posted 11 Mar 2013 by Drugs.com

MONDAY, March 11 – Non-emergency coronary angioplasty is as safe and effective at hospitals with no on-site heart surgery services as it is at hospitals that have such services, according to a new study. Coronary angioplasty is a procedure to clear blocked or narrowed heart arteries to restore blood flow to the heart. Researchers compared outcomes among thousands of patients who underwent non-emergency angioplasty at 10 hospitals in Massachusetts without on-site heart surgery services and seven hospitals with on-site heart surgery services. Rates of major heart-related problems – including repeat angioplasty, heart attack, stroke and death – were assessed at one month and one year after angioplasty. Rates at 30 days were 9.5 percent for hospitals without on-site heart surgery and 9.4 percent at hospitals with on-site heart surgery. Rates at one year were 17.3 percent for hospitals ... Read more

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Before Deciding on Breast Implants, Consider FDA Precautions

Posted 27 Feb 2013 by Drugs.com

WEDNESDAY, Feb. 27 – If you're thinking about getting breast implants, there are some things you need to know before you make your decision, according to the U.S. Food and Drug Administration. In the United States, two types of breast implants are approved for sale: saline-filled implants (those filled with a saltwater solution) and silicone gel-filled implants. Both have a silicone outer shell and vary in size, shell thickness and shape. The implants are used for increasing breast size, for reconstruction after breast cancer surgery or injury, and to correct developmental defects. Women need to understand that breast implants are not lifetime devices. The longer a woman has breast implants, the greater the chances that she will develop complications, some of which will require surgery, according to the FDA. "The life of these devices varies according to the individual," Gretchen ... Read more

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Breast Reconstruction Using Women's Own Tissue Appears Safe: Study

Posted 22 Feb 2013 by Drugs.com

FRIDAY, Feb. 22 – Women who have breast reconstruction surgery using a transplanted flap of their own tissue have a low rate of short-term complications, a new study says. Tissue expansion with an implant is the most common type of breast reconstruction for breast cancer patients who have undergone mastectomy (breast removal), the study authors said. But many women prefer the more natural results when their own tissue is used for the procedure, a process called autologous breast reconstruction. However, it hasn't been known which autologous breast reconstruction technique provides the best results and has the lowest risk of post-surgical complications. In this study, researchers analyzed data from nearly 3,300 women in the United States who underwent three different types of autologous breast reconstruction and found that the overall rate of complications in the 30 days after surgery ... Read more

Related support groups: Surgery, Breast Cancer

Codeine Risky for Kids After Certain Surgeries, FDA Says

Posted 21 Feb 2013 by Drugs.com

THURSDAY, Feb. 21 – Children who are given codeine for pain relief after surgery to remove tonsils or adenoids are at risk for overdose and death, U.S. health officials said Thursday. The U.S. Food and Drug Administration said a new boxed warning – the agency's strongest caution – will be added to the labels of codeine-containing products to warn about this danger. The FDA strongly recommends against the use of codeine to manage pain in children after surgery to remove tonsils or adenoids, and suggests that doctors use an alternate pain reliever. The agency also said parents and caregivers need to be aware of the risks and ask for a different pain medicine if their children are prescribed codeine after having their tonsils or adenoids removed. Codeine is an opioid (narcotic) medication used to treat mild to moderate pain and is often prescribed to children after tonsil or adenoid ... Read more

FDA Medwatch Alert: Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death

Posted 20 Feb 2013 by Drugs.com

[UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). A new BOXED WARNING, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy. A Contraindication, which is a formal means for FDA to make a strong recommendation against use of a drug in certain patients, will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated. Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are ... Read more

Fluorescent Tracer 'Lights Up' Brain Tumor for Surgery

Posted 19 Feb 2013 by Drugs.com

TUESDAY, Feb. 19 – Neurosurgeons report that they harnessed the power of fluorescent light to illuminate a brain tumor so the entire growth could be removed. A report describes a case in which a patient with glioblastoma swallowed a pill, called 5-ALA, and was taken to surgery about four hours later. The medication attached itself to tumor cells, causing them to glow brightly. Once the skull was opened, the doctors focused a blue light on the tumor, which gave the cancerous cells a pink glow, so the surgeons could differentiate malignant tissue from healthy tissue. "This is a very, very good thing," said study author Mitchel Berger, chairman of neurosurgery at the University of California, San Francisco. "In this case, we just happened to notice we could see evidence of the tumor spreading along the way of the ventricles [a communicating network of brain cavities], which showed we ... Read more

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When It Comes to Spine Surgery, There Is No 'July Effect': Study

Posted 29 Jan 2013 by Drugs.com

TUESDAY, Jan. 29 – There's no proof to support the widely held belief that July is the worst time of year to have spinal surgery, according to a new study. Researchers from the Mayo Clinic in Rochester, Minn., looked at whether there was any evidence of the so-called "July Effect," which is the notion that the arrival of new residents and fellows at teaching hospitals each July makes it the worst time of year to be a patient. The investigators examined data on nearly 1 million patients who had spinal surgery from 2001 to 2008 and found that the month in which they had surgery had little effect on their outcomes. Incidents of all negative outcomes studied were slightly higher in teaching hospitals than in non-teaching hospitals. In the teaching hospitals, there were minimally higher rates of infection after surgery, and patient discharge to a long-term care facility in July compared ... Read more

Related support groups: Back Pain, Surgery

Quitting Smoking Before Cancer Surgery Best, Study Finds

Posted 25 Jan 2013 by Drugs.com

FRIDAY, Jan. 25 – Cancer patients who smoked up until their surgery were more likely to take up the habit again compared to those who quit earlier, a new study finds. The study from the Moffitt Cancer Center in Tampa, Fla., included lung cancer and head and neck cancer patients who quit smoking before or immediately after surgery. They were followed for a year after the surgery. "Sixty percent of patients who smoked during the week prior to surgery resumed smoking afterward, contrasted with a 13 percent relapse rate for those who had quit smoking prior to surgery," study corresponding author Vani Nath Simmons said in a Moffitt news release. The significantly lower smoking relapse rate for those who quit smoking before surgery shows the need to encourage patients to quit smoking when they're diagnosed with cancer, the researchers said. The investigators also noted that most of the ... Read more

Related support groups: Surgery, Cancer, Smoking, Smoking Cessation

Wound Infections From Colon Surgery May Raise Risk for Blood Clots

Posted 18 Jan 2013 by Drugs.com

FRIDAY, Jan. 18 – Colorectal surgery patients who develop surgical-site infections are at increased risk for potentially deadly blood clots, a new study says. Researchers examined the medical records of 615 adults who had colorectal surgery and found that 25 of them (4 percent) developed blood clots known as venous thromboembolisms within one month after surgery. Fourteen (56 percent) of those patients also had surgical-site infections, compared with 168 of patients (28.5 percent) without venous thromboembolism. In nine of the 14 patients with those blood clots (64 percent), the surgical site infection occurred before or on the same day. Patients with a surgical-site infection were four times more likely than infection-free patients to develop either a blood clot in the legs called deep-vein thrombosis or a potentially deadly pulmonary embolism, which occurs when a blood clot in ... Read more

Related support groups: Surgery, Gastrointestinal Surgery

Surgery May Not Be Needed for Ruptured Achilles Tendon

Posted 28 Dec 2012 by Drugs.com

FRIDAY, Dec. 28 – In the long run, patients who rupture their Achilles tendon fare equally well following nonsurgical treatment as they do with surgery, a new Canadian research review shows. The catch: Nonsurgical patients can only expect to see results on par with surgery patients if they simultaneously engage in so-called functional rehabilitation, a bracing process that offers patients the opportunity to quickly engage in range-of-motion exercises to promote tendon healing. And even so, nonsurgical patients will experience a slower speed of recovery than surgery patients. "[But] if you rupture your Achilles you need to consider nonoperative treatment, because it's safer than surgical treatment," said study co-author Dr. Mark Glazebrook. "What this means is that if you have nonoperative treatment with functional rehabilitation you will have an outcome just as good as surgery and you ... Read more

Related support groups: Surgery, Muscle Pain

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Surgical Prophylaxis, Ophthalmic Surgery, Orthopedic Surgery, Head & Neck Surgery, Cardiothoracic Surgery, Gastrointestinal Surgery, Neurosurgery, Vascular Surgery, Genitourinary Surgical and Other Conditions, Postoperative Albumin Loss, Biliary Tract Surgery