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Sort by date 1,437 pages found matching black box- Does New Warning For Ketek Go Far Enough?
Aug-8-07 Baltimore, MD At least four people have died and 37 others suffered liver damage after taking Ketek , an antibiotic made by Sanofi-Aventis. Now, many people are investigating the possibility of filing lawsuits after they suffered serious complications from taking the drug. The U.S. Food and Drug Administration (FDA) has responded by changing the labeling... - Saying 'No' to Avandia: Doctors are Taking no Chances
Aug-8-07 Eustis, FL While Avandia may still be viable for some patients in spite of possible increased risks for heart attack, stroke and kidney failure, most doctors are advocating a switch away from Avandia to an alternative drug therapy for their diabetic patients. While possible risk factors for the antidiabetic drug - made by GlaxoSmithKline - have been k... - Avandia Drug Maker's Stock Rises: FDA "Dropped the Ball" says Congressman
Aug-7-07 Gaithersburg, MD The International Herald Tribune reports that shares of GlaxoSmithKline, the maker of Avandia , rose the most in two years last week, after a U.S. FDA panel recommended that Avandia be kept on the market. The FDA panel was organized by U.S. Rep. Henry Waxman (D-California), who stated he believes the FDA may not be adequately requir... - Avandia Defended by Glaxo Despite Heart Attack Risk
Aug-2-07 Rockville, MD As part of the July 30th proceedings of a federal drug advisory committee that ultimately voted to keep Avandia on the market despite cardiovascular risk, Avandia maker GlaxoSmithKline defended its product as completely safe. Dr. Murray Stewart, A Vice President with the company, presented the findings of an examination of data from more... - FDA Internal Memo: Early "Black Box" Recommendation Ignored
Jul-14-07 Washington, DC A 2006 internal FDA memorandum suggests that the FDA recommended GlaxoSmithKline, the maker of Avandia , add a "black box" (the strongest warning) about congestive heart failure to the drug's label more than a year ago. As well, a warning about macular edema, which can lead to blindness, was also recommended. Even though the recommenda... - Liver Damage Warning Issued For Multaq
Washington, DC: Federal health officials have issued a warning to doctors and patients regarding the potential for liver damage associated with a recently launched drug for atrial fibrillation. According to a report by the Associated Press the Food and Drug Administration said it has received reports of liver damage in patients taking Multaq (d... - Doctors Weigh in on Permax Recall
May-17-07 Chapel Hill, NC On March 29, 2007, the FDA withdrew Permax (pergolide) from the market because it increases the risk of valvular heart disease. It was the right thing to do, according to leading research physicians. In a New England Journal of Medicine report, Permax, used to treat Parkinson's disease, can seriously damage heart valves. Some medical... - Elidel User went through "Living Hell"
May-11-07 Houston, TX The Rev. Johnny Henderson, interviewed in late April for a story by award-winning investigative reporter Jeremy Rogalski, of CBS Houston affiliate station KHOU-TV, describes what followed his Elidel treatment as "a living hell". The television report, which aired April 26, 2007, includes a number of photographs showing in stark detail the... - Black Box Warning Added To Epogen, Aranesp, and Procrit
Apr-12-07 Thousand Oaks, CA: A black box warning has been added to the labels of Epogen, Aranesp, and Procrit , a sign that the U.S. Food and Drug Administration (FDA) is concerned about the risks associated with using the anemia drugs. Doctors have also been warned that patients should be given the lowest possible dose in order to avoid blood transfusions. The... - Xolair could be a Lethal Injection
Mar-8-07 Los Angeles, CA: On February 21, 2007 the FDA called for a black box warning on Xolair , also known generically as omalizumab. The drug, which is injected, is used to treat patients with asthma that is related to allergies. The new warning alerts users that Xolair may cause anaphylaxis. Also, the FDA has asked Xolair's maker, Genentech, Inc., to revise t... - More Zyprexa Postcards From the Edge
Feb-18-07 Washington, DC: On February 13, 2007, Judge Jack Weinstein issued a permanent injunction, prohibiting attorney, Jim Gottstein, and Dr David Egilman, an expert witness in litigation involving Zyprexa , from further disseminating certain Eli Lilly documents that were sealed with a court order until Mr Gottstein released them to the media in December 2006... - Chantix Heart Attack - Chantix Heart Problems, Chantix Lawsuits
The US Food and Drug Administration (FDA) has issued a warning about a potential link between Chantix and heart problems , including heart attacks. The Chantix heart attack warning was issued after a clinical trial found a small increased risk of Chantix heart problems . Chantix and Heart Problems The FDA issued a warning on June 16, 2011,... - Wellbutrin Side Effects - Wellbutrin Birth Defects, Zyban Side Effects, Wellbutrin Lawsuit
Wellbutrin (known generically as bupropion hydrochloride) is approved to treat patients with major depressive disorder. Wellbutrin side effects may include serious health events, such as Wellbutrin birth defects in infants when taking Wellbutrin while pregnant . Those birth defects include potentially serious congenital heart defects. ... - Business Booming for SSRI Makers
Jan-8-07 Washington, DC: The market for antidepressants is the largest segment of the Central Nervous System drug sector with global sales of $16.2 billion in 2005. Depression costs the US economy an estimated $44 billion a year and the World Health Organization predicts depression will be the leading cause of disability by 2020, according to a report by Research a... - Victims of Elidel Mounting
Jan-5-07 Florida For some users of Elidel , the black box warning came too late. "I asked my doctor to prescribe Elidel for a skin condition but I would never have taken it had I known the side effects," says Ed Johnson. "About eight months after I was using Elidel on a regular basis, I was diagnosed with lymphoma," says Johnson (not his real name pending a law... - Experts Says Warn About Stents - FDA Says No
Dec-11-06 Washington, DC: What to do about the problematic over-use of drug-eluting stents has become a problem in itself. A recall is out of the question, because 3 million people in the US already have the devices implanted in their chests, according to USA today. Drug-eluting stents (DES) are mesh tubes used in patients with heart disease to keep their arter... - Mental Illness Epidemic Hits US
Dec-7-06 Washington, DC: In the run-up to the December 13, 2006, meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, to review the suicidality data from adult SSRI studies, a host of newly identified disorders have been popping up in the media, all treatable with SSRIs. The committee is expected to vote on whether the association between the sel... - More Adverse Effects linked to SSRI Celexa
Nov-14-06 Avalon, NJ: According to testimony at an inquest into the deaths of Roxanne Richardson, 30, and her children, Luke, 3, and Grace, 20 months, an autopsy revealed that at the time of their murders, husband and father-turned-killer, Michael Richardson, had Celexa in his system higher than prescribed which may have caused him to become agitated and irritable... - Unscientific Depression Screenings and Front Groups Boost SSRI Sales
Nov-10-06 USA: Prior to the arrival of the selective serotonin reuptake inhibitor antidepressants (SSRIs) on the market, depression was estimated to affect only 100 people per million. And those 100 people per million sought help from a medical professional trained in psychiatry and the treatment of depression. Since the introduction of SSRIs, rates for dep... - Big Pharma Bankrupting US Health Care System
Aug-29-06 ig Pharma is bankrupting the nation's health care system by convincing prescribing doctors to over-medicate patients with expensive psychiatric drugs and then send the bills to government programs like Medicaid and Medicare. The peddling of the new generation of psychiatric drugs that include the selective serotonin reuptake inhibitors antidepressants (S...