Date Published: May 18th, 2012
The FDA released a statement saying it is aware of the study published in the New England Journal of Medicine, Thursday that compared the risks of cardiovascular death in patients treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), and no antibacterial drug. The study reported a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of Zithromax (Z-Pak)compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
The FDA said it is reviewing the results from this study and will communicate any new information that results from the FDA review.
In the meantime, the agency said patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional.
It also advised healthcare professionals to be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering antibacterial drugs.
Zithromax belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. Prolongation of the QT interval can lead to torsades de pointes (TdP), an abnormal heart rhythm, which can be fatal. Zithromax was the only macrolide examined in the published study.
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Date Published: May 18th, 2012
A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize all federal product liability lawsuits filed over the da Vinci Surgical System, which is machine used during a variety of robotic surgery procedures.
There are currently four known da Vinci robotic surgery lawsuits filed in U.S. District Courts throughout the country, according to aboutlawsuits.com. The claims involve similar allegations that patients experienced internal injuries due to design defects, improper training and a failure to warn about the risk of complications following da Vinci surgery. More Motion Filed to Consolidat Da Vinci Surgical Robot Lawsuits
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Date Published: May 18th, 2012
A disturbing new report came out in regards to doctors’ lack of knowledge about chemo drugs. A new survey found that many primary care doctors are unaware of the long-term side effects of the chemotherapy treatments that cancer survivors under their care may have been given.
The good news is that most oncologists are familiar with the side effects of four common treatments used to treat breast and colon cancer, according to the results of the survey being presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. More Few Primary Care Docs Aware of Long-Term Chemo Side Effects
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Date Published: May 17th, 2012
Over 1000 patients have needed a second hip implant surgery to repair issues with a recalled DePuy ASR hip replacement device, according to new figures out of Australia.
The Australian federal government announced a crackdown on suspect joint prostheses after new results from a national orthopaedic registry reveal a cumulative failure rate for two related products of 25 per cent over seven years – about five times higher than average. More Hundreds of Australians Report Issues with DePuy ASR Hip Implants
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Date Published: May 17th, 2012
The popular antibiotic azithromycin may slightly increase the risk of death in patients with heart disease, a according to a new study.
Multiple antibiotics have been tied to an increased risk of sudden death among heart patients, and recent reports have suggested azithromycin (Zithromax or Z-Pak) might be part of that group, according to researchers from Vanderbilt University School of Medicine.
“For patients with elevated cardiovascular risk, the cardiovascular effects of azithromycin may be an important clinical consideration,” said study author Wayne Ray, a professor of preventive medicine at the school. “All antibiotics have risks and benefits, which must be considered in the prescribing decision.” More Z-Pak Antibiotic Found to Raise Death Risk in Heart Patients
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Date Published: May 17th, 2012
A nickel allergy affects over 10 percent of the population, but few options are given to those who have the allergy when it comes to knee replacements.
According to an article in the World of Orthopedics, the allergic reaction to this metal inside the body is drastically different than that of any type of piercing. If a person is allergic to nickel and it is implanted inside your body, several bad things happen. Your joint can swell up, become very painful and can become infected. If it is determined that these symptoms are caused by an allergic reaction to the metal, another surgery will be needed. More Planning Knee Replacement Surgery? Ask Doctor about Nickel Allergy
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Date Published: May 16th, 2012
Salem Community Hospital has issued safety guidelines for those who take acetaminophen, the active ingredient in Tylenol and other common over-the-counter drugs.
“People often think that acetaminophen is extremely safe because it is a familiar medication that is frequently used to treat pain. However, acetaminophen overdose is one of the most common drug poisonings in the world,” Salem Community Hospital’s Director of Pharmacy, Keith Meredith, Pharm D, told the Salem News. More Safety Guidelines Issued for Acetaminophen
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Date Published: May 16th, 2012
Certain chemicals that are used in sunscreens and other products because they protect against UV light are associated with an increased risk of developing the gynecological condition endometriosis, according to a new study.
However, Personal Care Products Council, a group that represents cosmetics manufacturers, called the study “weak” and “unconvincing” and said it shouldn’t scare people away from safe sun practices, according to a WebMD report. More Sunscreen Chemical Linked to Endometriosis
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Date Published: May 15th, 2012
Government advisers recommended approval on Thursday of the weight-loss drug lorcaserin, developed by Arena Pharmaceuticals.
An advisory committee to the FDA voted 18 to 4, with one abstention, that the benefits of the obesity drug outweighed the risks.
If the FDA approves the drug by its scheduled deadline of June 27, lorcaserin would be the first new prescription diet pill to reach the market in 13 years. The agency does not have to follow committee recommendations, although it often does. More FDA Panel Backing of Lorcaserin Weight Loss Drug Raises Questions
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Date Published: May 15th, 2012
The FDA issued a safety announcement regarding the multiple sclerosis drug Gilenya. The agency said Gilenya should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems.
The warning came after the FDA evaluated of a report concerning a patient who died within 24 hours after receiving the first dose of Gilenya. The agency also reviewed additional clinical trial and post-approval data for the drug, including reports of patients who died of cardiovascular or unknown causes, according to Health Day. More FDA Contraindicates Gilenya for Some Heart Patients
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