USA Today: Avandia safety debate shows flaws in FDA drug monitoring. USA Today (7/9) editorializes, “Since 2005, evidence has mounted that the blockbuster diabetes drug Avandia [rosiglitazone maleate] might increase the risk of cardiovascular complications — including heart attacks, one of the major causes of death among diabetics.” Yet, “the drug is still on the market, and scientists still are battling over its safety.” This “prolonged battle leaves nervous patients in the lurch — and renews questions about whether America’s medication safety watchdog, the Food and Drug Administration, is effectively monitoring drugs after they’ve been approved for sale. As with Vioxx [rofecoxib], the popular painkiller pulled off the market in 2004, the FDA has lagged several steps behind independent researchers.”
Healthcare experts and federal regulators knew that the use of Avandia created a greater risk of heart attacks by as much as 43% way back in 2007, but recommended to the FDA that it stay on the market. Why?
When it comes to drug safety, they say, you can’t make an omelet without breaking a few eggs.
One key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety. “Only the grossest, most commonly occurring things will show up in clinical trials designed to determine efficacy,” said Sydney Wolfe, director of health research for the advocacy group Public Citizen.
Suppose a drug saves 3 people and kills 1 person… is that a good reason to keep it on the market?
AstraZeneca faces its first trial over a Seroquel-diabetes link. Vietnam War veteran, Ted Baker, contended he developed diabetes after taking Seroquel to deal with lingering symptoms of post- traumatic stress disorder. However, AstraZeneca claims that they knew of the risk and that the drug’s label was adequate. Baker’s case is the first to go to trial of about 26,000 such claims over Seroquel. If you or a close family member has developed diabetes after using Seroquel,we may be able to help you be compensated for your injuries.
Read the Bloomberg article: http://www.bloomberg.com/apps/news?pid=newsarchive&sid=avtv2jf6sRy8 .
In an op-ed in the Boston Globe (1/24) Paula J. Caplan, a clinical and research psychologist at Harvard University, wrote that an “overlooked” primary cause of “America’s obesity epidemic” is the increased use of psychiatric medicines, as many of them “cause weight gain — often of the rapid and massive sort.” Caplan suggests that this link is not well known possibly due to the power of the pharmaceutical industry or clinicians not knowing other treatments.
Caplan argues against listing obesity as a mental illness, as it can be caused by “physical problems that are often undiagnosed.” Caplan also says that doctors should “explore other non-drug ways to treat emotional problems.” What happens when the drug you are taking causes serious side-effects? Are there legal remedies for dangerous drugs?
The AP (1/22, Perrone) reports that the FDA “on Thursday added new warnings to weight loss pill Meridia [silbutramine] about the increased risk of heart attack and stroke in patients with a history of heart problems.” The new label “states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.”
European regulators call for sibutramine ban. The Wall Street Journal (1/22, Favole) reports that the European Medicines Agency on Thursday said the sale of sibutramine should be suspended because of the risks of stroke and heart attack. The European Commission will now review the agency’s advice. The Journal also notes that both the FDA and EMA announcements come following a study of 10,000 patients that showed 11.4 percent of those who took sibutramine had a cardiovascular event, compared with 10 percent of patients who received a placebo.
The AP (1/13, Perrone) reports that the FDA “issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon for making inaccurate or incomplete statements while promoting their drugs.” The agency’s “letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain, and the pain ailment fibromyalgia.” The FDA indicated that Lilly’s ad fails to “adequately display information about the drug’s side effects.” Dow Jones Newswire (1/13, Favole) reports that the FDA said Amylin and Lilly representatives overstated diabetes drug Byetta’s weight loss benefits, and that Bayer’s promotional material for the birth-control drug Mirena does not adequately warn women of the risk of losing their baby if they become pregnant while taking the drug.
Meanwhile, the FDA’s letter to Cephalon said the drugmaker did not include important risk information on a dosing card for its lymphoma treatment Treanda, Reuters (1/13, Heavey) reports. The FDA asked that the drugmakers halt use of the advertisements and promotional materials immediately.
Bloomberg News (1/7, Waters) reports that the agency “will convene an advisory committee to re-evaluate the use of” Amgen’s Aranesp and Epogen and J&J’s Procrit following studies that showed “high amounts boost the risk of heart attacks, blood clots, and stroke.” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, noted that the trials were intended “to show that using” the drugs “to raise hemoglobin concentration…improves clinical outcomes,” but “all results have suggested the opposite.”
Agency officials said lower doses of the drugs and monitoring blood hemoglobin more frequently may improve clinical outcomes, Dow Jones Newswire (1/7, Dooren) reports. According to a spokeswoman for the FDA, the advisory panel will address target levels for blood hemoglobin. Aranesp and Procrit are also currently approved for anemia in certain cancer patients who undergo chemotherapy. Reuters (1/7) also covered the story.
In a column at Portfolio.com (1/4), Ed Silverman writes that critics say sales of atypical antipsychotics have been spurred in part by “an epidemic of off-label marketing. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters.” Another side effect “is even more disturbing-unnecessary deaths among elderly patients, who shouldn’t receive these medicines if they suffer from dementia.” Robert Rosenheck, a Yale University professor of psychiatry and epidemiology and director of the Division of Mental Health Services and Outcomes Research, said, “The general public and the patients may not be better off. There’s evidence the drugs aren’t always effective, may be harmful, and can cost a good deal of money, but there’s nothing we can do about it, because we’re committed to the principal that doctors should be able to choose whatever treatments are best for their patients.”
The New York Times (12/13, BU1, Singer, Wilson) reported that “more than 13,000 people…have sued Wyeth over the last seven years,” alleging “that its menopause drugs” Premarin and Prempro “caused breast cancer and other problems.” Plaintiffs also contend that “Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.”
According to Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School who has written about the subject in the Journal of the American Medical Association, “the cases demonstrate the importance of litigation in detailing exactly how drugmakers operate their businesses.”
The court documents also “illustrate a pattern in the history of hormone therapy. First, many doctors enthusiastically prescribe hormone therapy drugs. Then a few researchers publish studies cautioning about risks, causing sales to fall. And finally, some doctors start prescribing a new iteration of hormone drugs.
And while big pharma continues to use deceptive practices to help market their drugs, consumers in Florida are limited to legal protection by earlier tort reform. Fl 768.1256 Government Rules Defense has been interpreted by some courts to mean that a Florida resident injured by a pharmaceutical drug, does not have the same legal rights as another person injured by the same drug, in the same way, who happens to be from another state.
(formerly Crews) v. Novartis Pharmaceuticals Corporation, 3:06-cv-00659 (M.D. Tenn.) currently pending resolution in the sixth circuit
American Association for Justice | 777 6th Street, NW | Washington, DC 20001 provides briefings.
The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement. Now, federal regulators are demanding changes to labels on the devices.
The Companies making pain pumps have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to an FDA spokeswoman.
“The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals,” the FDA said in a notice to doctors and other health care professionals Nov. 13.
APP, Stryker and Hospira all make the pain pumps. The anesthetics in the FDA’s alert include bupivacaine, marketed as Sensorcaine or Marcaine, and lidocaine. These anesthetics, the FDA noted, have been used safely in single injections for many years without any reports of cartilage decay.
Reports about decaying cartilage after shoulder surgery, when the pumps were involved, began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. If you have suffered severe cartiledge damage as a result of these pumps, contact a Jacksonville Personal InjuryAttorney.