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Nearly a Third of Drugs Hit by Safety Issues After FDA Approval

Posted 10 May 2017 by

WEDNESDAY, May 10, 2017 – Safety problems emerge with nearly one in three prescription drugs after they've been approved by the U.S. Food and Drug Administration, a new study reveals. Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32 percent of the drugs had safety issues after approval. "That is very rarely a drug withdrawal, but more commonly a black-box warning or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined," said study leader Dr. Joseph Ross. He is an associate professor of medicine and public health at Yale University. Of 222 drugs approved by the agency during the study period, three were withdrawn, 61 received boxed warnings and 59 prompted safety communications, the findings showed. Drugs most likely to have ... Read more

Related support groups: Seroquel, Abilify, Latuda, Risperidone, Zyprexa, Quetiapine, Risperdal, Geodon, Saphris, Seroquel XR, Olanzapine, Rexulti, Invega, Clozapine, Aripiprazole, Arginine, Clozaril, Vraylar, L-Arginine, Paliperidone

Anemia Drugs May Not Boost Kidney Patients' Well-Being: Study

Posted 16 Feb 2016 by

MONDAY, Feb. 15, 2016 – The pricey anemia drugs often given to people with chronic kidney disease may make no difference in how they feel day to day, a new research review confirms. Researchers said the study results back up current guidelines on how to use the drugs, called erythropoietin-stimulating agents (ESAs). These include the injection drugs marketed under the names Procrit, Epogen and Aranesp. Patients may still benefit from the medications because they reduce the need for blood transfusions to treat severe anemia, said Dr. Navdeep Tangri, senior researcher on the study. "But this should close the book on the idea that these drugs help with exhaustion and improve patients' quality of life," said Tangri, an attending doctor at Seven Oaks General Hospital Renal Program in Manitoba, Canada. However, one expert argued that while on average, that is true, some patients do feel ... Read more

Related support groups: Anemia, Renal Failure, Chronic Kidney Disease, Peritoneal dialysis, Procrit, Epogen, Aranesp, Darbepoetin Alfa, Renal Osteodystrophy, Mircera, Anemia Associated with Chronic Disease, Epoetin Beta-Methoxy Polyethylene Glycol, Omontys, Peginesatide, Hyperphosphatemia of Renal Failure, Epoetin Alfa

Anemia Treatments Don't Boost Recovery From Brain Injury, Study Finds

Posted 1 Jul 2014 by

TUESDAY, July 1, 2014 – People who suffer a severe head injury often develop anemia, but aggressively treating the blood condition may do more harm than good, a new clinical trial suggests. Experts said the findings, reported July 2 in the Journal of the American Medical Association, were disappointing: Treating anemia with blood transfusions – and in some cases, the medication erythropoietin – did nothing to improve brain-injured patients' long-term recovery. And when transfusions were used more aggressively, the risk of blood clots increased. Lead researcher Dr. Claudia Robertson said the results "will probably change clinical practice." Anemia is a condition in which the body has too few oxygen-carrying red blood cells. It's common for people with serious traumatic injuries to develop anemia, because of internal and external bleeding and other damage to the body. In trauma victims ... Read more

Related support groups: Head Injury, Procrit, Epogen, Epoetin Alfa

Armstrong Confession Validates His Use of Performance-Enhancing Drugs

Posted 18 Jan 2013 by

THURSDAY, Jan. 17 – For over a decade, world-renowned cyclist Lance Armstrong has strongly denied use of performance-enhancing techniques to improve his athletic performance. Armstrong has now admitted in an interview with Oprah Winfrey that he used performance-enhancing drugs while conquering a record seven Tour de France championships. He said it was “not possible” to win without doping. Armstrong admitted to getting lost in the momentum of a perfect life – beating cancer, having a wonderful family and winning the Tours. He said would do anything at all costs to win. And then, Armstrong apologized. The confession, in a “no conditions” interview conducted by Winfrey appears to be the first step in Armstrong’s hope to lessen his lifetime ban, regain his ability to compete, and soften the blows of a damaged reputation. Prior to taping the episode on Monday, Armstrong also made an emo ... Read more

Related support groups: Prednisone, Testosterone, Methylprednisolone, Prednisolone, AndroGel, Hydrocortisone, Medrol, Cortisone, Triamcinolone, Dexamethasone, Testim, Betamethasone, Budesonide, Axiron, Entocort, Androderm, Decadron, Solu-Medrol, Entocort EC, Cortef

Lance Armstrong Stripped of Tour de France Titles

Posted 15 Jan 2013 by

MONDAY, Oct. 22 – Lance Armstrong has been stripped of his seven Tour de France titles and banned from cycling for life, the International Cycling Union announced Monday. The UCI decision comes after the recent release of a United States Anti-Doping Agency report that said Armstrong used doping to help win Tour de France titles from 1999 to 2005, and coerced his cycling teammates to do the same. The company that organizes the Tour de France will now remove Armstrong's name from its record books, The New York Times reported. "We've come too far in the fight against doping to go back to the past," UCI President Pat McQuaid said at a news conference on Monday in Switzerland. "Something like this must never happen again." He added that Armstrong "has no place in cycling." According to Christian Prudhomme, the race director for the Tour de France, the races in which Armstrong formerly ... Read more

Related support groups: Procrit, Epogen, Testicular Cancer, Epoetin Alfa

Lance Armstrong Says He Doped Before Cancer Diagnosis: Source

Posted 15 Jan 2013 by

TUESDAY, Jan. 15 – In his interview with Oprah Winfrey, disgraced American cyclist Lance Armstrong admitted that he began using performance-enhancing drugs in the mid-1990s, before he was diagnosed with cancer. That's what a person familiar with the interview told USA Today. The anonymous source also said that Armstrong intended to make a general confession about his doping to Winfrey, but without going into great detail. The interview was taped Monday and will be aired Thursday night. The source also revealed that Armstrong and his representatives have had discussions with the U.S. Anti-Doping Agency about a meeting in which Armstrong would be expected to "answer every question, give over records, telephone calls, test results, everything," USA Today reported. Read more

Related support groups: Procrit, Epogen, Epoetin Alfa

No Proof That 'Doping' With EPO Gives Athletes an Edge: Review

Posted 7 Dec 2012 by

FRIDAY, Dec. 7 – Erythropoietin, more commonly known as EPO, has been banned from sports due to a belief that it provides an unfair competitive advantage to users, but new research found there is no scientific evidence the blood-cell stimulating hormone actually enhances athletes' performance. EPO has been in the news recently because of its reported use by the American cyclist Lance Armstrong, who won the Tour de France a record-breaking seven times. He was stripped of those titles in October. While the scientists who conducted a systemic review of existing studies on EPO did not find proof of performance-enhancing benefits, they did find that possible harm from use of the hormone was well-documented. In their report, published in the Dec. 6 issue of the British Journal of Clinical Pharmacology, they warned that EPO doping thickens the blood and could increase a person's risk for ... Read more

Related support groups: Procrit, Epogen, Epoetin Alfa

As Armstrong Case Unfolds, Experts Describe Doping's Harms

Posted 11 Oct 2012 by

THURSDAY, Oct. 11 – In the wake of new allegations around Lance Armstrong's involvement in blood doping, experts are reminding the public of the devastating impact these substances can have on an athlete's health. The recent report by the United States Anti-Doping Agency accusing seven-time Tour de France winner Armstrong (he was recently stripped of those titles) of doping participation shows how deeply the practice is ingrained in cycling, but it's a big problem in others sports as well. So-called performance-enhancing drugs – such as erythropoietin, anabolic steroids and human growth hormone – may affect almost every system in the body, and have been linked to severe medical and psychiatric side effects. Add in diuretics to mask all the drugs, and athletes who use performance-enhancing drugs are risking their long-term health, experts say. One of the most common drugs is ... Read more

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Humatrope, Fortesta, Genotropin, Depo-Testosterone, Testopel, Procrit, Saizen, Nutropin, Epogen, Testopel Pellets, Testosterone Enanthate, Norditropin, Serostim, Nutropin AQ, Omnitrope

FDA Medwatch Alert: Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Posted 27 Jun 2011 by

Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke. BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce ... Read more

Related support groups: Procrit, Epogen, Aranesp, Darbepoetin Alfa, Epoetin Alfa

FDA Urges Reduced Doses for Anemia Drugs

Posted 25 Jun 2011 by

FRIDAY, June 24 – Doctors should use the anemia drugs Procrit, Epogen and Aranesp more cautiously in patients with chronic kidney disease, U.S. health officials said Friday. The new warning comes in response to data showing that patients on these drugs face a higher risk of cardiovascular problems such as heart attack, heart failure, stroke, blood clots and death, the U.S. Food and Drug Administration said. "FDA is recommending new, more conservative dosing recommendations for erythropoiesis-stimulating agents [ESAs] for patients with chronic kidney disease," Dr. Robert C. Kane, acting deputy director for safety in the division of hematology products, said during a news conference Friday. These recommendations are being added to the drug label's black box warning and sections of the package inserts, he said. This is not the first time health risks have been linked to these anemia ... Read more

Related support groups: Chronic Kidney Disease, Procrit, Epogen, Aranesp, Darbepoetin Alfa, Epoetin Alfa

Anemia Drug May Worsen Heart Attacks

Posted 10 May 2011 by

TUESDAY, May 10 – People given a drug known as erythropoietin alfa after a heart attack may experience new heart problems and even greater cardiac damage from the attack, a new study finds. The drug, which stimulates red blood cells, has been used in some heart attack patients because certain studies suggested it might reduce the extent of heart attack damage and improve heart function, the researchers explained. The study was published in the May 11 issue of the Journal of the American Medical Association. "This study shows that erythropoietin should only be used with caution in patients with recent heart attacks," said Dr. Deepak L. Bhatt, chief of cardiology at the VA Boston Healthcare System, who was not involved in the study. In fact, "there are hints in this study that the use of erythropoietin might have adverse cardiac effects," said Bhatt, who is also an associate professor of ... Read more

Related support groups: Procrit, Epogen, Epoetin Alfa

Use Anemia Drugs for Cancer Patients With Caution, Experts Say

Posted 26 Oct 2010 by

TUESDAY, Oct. 26 – Physicians need to use caution when giving a class of drugs called erythropoiesis-stimulating agents (ESAs) to cancer patients who have anemia caused by chemotherapy, according to new medical guidelines. And with rare exceptions, ESAs should not be given to cancer patients who are not receiving chemotherapy, according to joint guidelines issued by the American Society of Hematology and the American Society of Clinical Oncology. ESAs (marketed as Procrit, Epogen and Aranesp) stimulate the bone marrow to produce more red blood cells but are associated with shorter survival and increased risk of blood clots and tumor progression, the guidelines noted. However, ESAs reduce the need for red blood cell transfusions, which carry a risk of serious infection and adverse reactions in the immune system. The guidelines offer specific recommendations on the use of ESAs. Among ... Read more

Related support groups: Procrit, Epogen, Aranesp, Darbepoetin Alfa, Mircera, Epoetin Beta-Methoxy Polyethylene Glycol, Anemia - Chemotherapy Induced, Epoetin Alfa

FDA Advisers Back Anemia Drugs for Kidney Patients

Posted 19 Oct 2010 by

TUESDAY, Oct. 19 – Kidney-failure patients can continue taking a group of widely used anemia drugs, even though a recent study showed they can increase the risk of stroke, U.S. health advisers said Monday. A panel of U.S. Food and Drug Administration advisers voted 15-1, with one abstention, to maintain use of the drugs for patients with chronic kidney disease who aren't yet in need of dialysis, the Associated Press reported. The FDA is not required to follow the advice of its advisory panels, but typically does so. The drugs – Procrit, Aranesp and Epogen, a class of medications known as erythropoiesis-stimulating agents (ESAs) – boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten ... Read more

Related support groups: Chronic Kidney Disease, Procrit, Epogen, Aranesp

Anemia Drugs Could Pose Threat to Some Kidney Patients

Posted 15 Sep 2010 by

WEDNESDAY, Sept. 15 – When people with chronic kidney disease and type 2 diabetes take certain anemia drugs, the level of hemoglobin cells in their blood should go up. But a new study finds that if those levels don't increase by much, these "poor responders" experience a significantly increased risk of heart problems and death. Reporting in the Sept. 16 issue of the New England Journal of Medicine, a team of international researchers says that those who had the worst response to erythropoiesis-stimulating agents (ESAs) – drugs that include Aranesp, Epogen and Procrit – had a 31 percent rise in the risk of cardiovascular complications and a 41 percent increased risk of death. "For people who have chronic kidney disease, I think this is further evidence that we have to be extremely cautious when we use ESAs. There is a potential for harm. The patients who respond poorly are the ones ... Read more

Related support groups: Procrit, Epogen, Aranesp, Darbepoetin Alfa, Epoetin Alfa

Anemia Drugs Hold Dangers for Kidney Patients

Posted 5 May 2010 by

WEDNESDAY, May 5 – The powerful drugs used to fight anemia caused by kidney failure increase the risk for cardiovascular problems such as heart attack, a major study has found. A meta-analysis of 27 trials, which included more than 10,000 people who were given the drugs, known as erythropoiesis-stimulating agents (ESAs), found that those who took the drugs at the highest dosages had a 51 percent increased risk for stroke and a 33 percent increased risk for thrombosis, or blockage of an artery. The study, by an international group of experts, was published online May 3 in Annals of Internal Medicine. The increased risk for death (9 percent) and serious cardiovascular events such as heart attacks (15 percent) did not reach statistical significance, the analysis found. The U.S. Food and Drug Administration has acted to control the use of ESAs marketed as Epogen, Procrit and Aranesp, which ... Read more

Related support groups: Procrit, Epogen, Aranesp, Darbepoetin Alfa, Mircera, Epoetin Beta-Methoxy Polyethylene Glycol, Epoetin Alfa

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