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Food and Drug Administration 233 articles

Recovery more likely after shoulder surgery than in years past

Many athletes who rely on their throwing motion for their livelihood consider the torn shoulder labrum one of the most fearsome injuries. In many cases, it can ruin a career or at the very least, leave them benched for weeks if not months. The labrum is a cartilage found in the shoulder’s ball-and-socket joint where the arm meets the body. It serves to deepen the socket so that the ball stays in place and helps stabilize the arm. When the labrum is torn due to injury, the ball may slide part or all of the way out of the socket. ... Read More

Note to Chantix flunkees: there’s still hope even after the magic pill fails

“It’s my mind-set this time,” Eric Wolbert told the St. Louis Post-Dispatch. “This time I’m going into it celebrating that I’m quitting rather than worrying about not being able to and how hard it was.” Wolbert, who has been a non-smoker for 30 days, attributes his success to seven-week group therapy session at Washington University’s Siteman Cancer Center. Like many others who have tried to quit smoking, Wolbert used Chantix unsuccessfully in his previous attempts to quit. I can relate to Wolbert’s experience. I also used Chantix unsuccessfully for months, spending well over $400 for the drug. After a couple ... Read More

Colon cleansing products may be hazardous to your health

Companies who push sales of colon cleansing products are quick to make claims that the products will rid the body of toxic sludge that weighs us down and makes us feel fatigued, bloated and sick overall. But do colon cleansing products really do us good? Joan Endyke with GateHouse New Service says buyer beware. Many colon cleansing products claim to produce rapid weight loss, but studies have shown that the weight loss from colon cleansing is from fasting and water loss, not the melting away of fat that would be most beneficial. Along with water loss, Endyke says, “is a ... Read More

FDA reviews possible link between ADHD meds, sudden cardiac death

The Food and Drug Administration (FDA) has issued a Safety Communication about an ongoing review of stimulant medication used in children with attention-deficit hyperactivity disorder (ADHD) because of reports of sudden cardiac death in healthy children. The events are part of a study published in the American Journal of Psychiatry. Because of the study’s limitations, the FDA urges parents not to stop a child’s stimulant medication based on the study and to discuss concerns about the use of these medications with the health care professional who prescribed the medications. The study, which is funded by the FDA and the National ... Read More

FDA issues Class I recall for faulty pacemakers

The Food and Drug Administration (FDA) has issued an alert to patients just two weeks after Medtronic, Inc. sent separate letters to health care professionals and patients worldwide warning that thousands of its pacemakers could have faulty wiring that can cause the medical devices to work improperly or not work at all. This defect could have potentially deadly consequences for patients with the devices. The Class I recall involves nearly 37,000 of Medtronic’s Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002. Class I recalls are the most serious type of recall and involve situations in which ... Read More

FDA warns of contaminated skin sanitizers, protectants

The Food and Drug Administration (FDA) has announced that Clarcon Biological Chemistry Laboratory, based in Roy, Utah, is recalling several of its over-the-counter topical skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. An FDA inspection analysis of product samples revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of the bacteria can cause infections of the skin and underlying tissues and may require medical or surgical attention and could result in permanent damage. Of heightened concern is that these products are promoted as antimicrobial agents for the treatment ... Read More

Congressional hearings continue on Medical Device Safety Act

The House Energy and Commerce Health Subcommittee continues to debate the Medical Device Safety Act of 2009, with the announcement of a June 18 hearing on the matter. The bill proposes to overturn the Supreme Court ruling of Riegel v. Medtronic, Inc., which prevents consumers who have been hurt by defective medical devices to sue the device’s maker if the devices have been approved by the Food and Drug Administration (FDA). The class includes medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, coronary artery stents and pre-filled syringes. According to an internal FDA document, senior officials with the ... Read More

Watchdog group pressures FDA about contaminated syringes

Watchdog group Project on Government Oversight (POGO) is asking the Food and Drug Administration (FDA) inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products. POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. ... Read More

Magic’s Nelson plays just months after shoulder surgery

Last February, experts thought Orlando Magic point guard Jameer Nelson was done for the season when he underwent surgery to repair a torn labrum in his right shoulder. Recovery usually takes about six months, and over the past four months the Magic began inching toward the Finals. Now it seems, just four months post surgery, Nelson has stepped back into the game to help his team fight for the title against the Los Angeles Lakers. Labrum repair surgery requires months to heal because the fibrocartilage has a poor blood supply. During surgery, the labrum is stitched together and anchored to ... Read More

FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died. Investigators now know that the pre-filled heparin and saline syringe Fullerton used was ... Read More