11/04/2009 - The U.S. Food and Drug Administration on Monday said it approved a new label for the diabetes treatment Byetta, made by Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN), amid reports the medicine may cause kidney problems. From April 2005 through October 2008, the FDA has received 78 reports of patients taking Byetta who have had altered kidney function, including renal failure, according to an alert the agency sent to doctors on Monday. The alert was posted to the FDA's Web site. The agency said it received 62 cases of acute renal failure and 16 cases of renal insufficiency in patients taking the medicine, which on Friday received FDA approval to be used as a stand-alone treatment for controlling sugar levels in patients with Type 2 diabetes. Previously, the drug had been approved only in patients who were also on other diabetes medications. << MORE >>

11/04/2009 - Results of a new study suggested that prescription of antipsychotic drugs for children could be a factor in their rapid weight gain and may raise the risk for diabetes and heart disease. The study showed that up to one-third of adolescents and children who took some of the common antipsychotic drugs for the first time became overweight or obese in as little as 11 weeks, which in turn raised their risk for diabetes and heart disease. Researchers said that doctors who prescribe these antipsychotics to children should carefully consider the benefits against the risk, and keep a close eye on the children who are taking these medications. << MORE >>

11/04/2009 - Refusing to accept the explanation of Toyota and the federal government, hundreds of Toyota owners are in rebellion after a series of accidents caused by what they call "runaway cars." Safety analysts found an estimated 2000 cases in which owners of Toyota cars including Camry, Prius and Lexus, reported that their cars surged without warning up to speeds of 100 miles per hour. Toyota says the incidents are caused by floor mats becoming stuck under gas pedals, but owners say that's not what happened to them. "I'm absolutely certain that in my situation, it was not the floor mats," Elizabeth James told ABC News. She was driving her Toyota Prius outside Denver, CO when she says it suddenly shot up to 90 miles an hour, even though her foot was on the brake and not the gas pedal. << MORE >>

11/02/2009 - The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. << MORE >>

11/01/2009 - Results from a retrospective study presented here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting suggest that use of isotretinoin is associated with the development of inflammatory bowel disease (IBD). "We performed a case control study looking at the connection between [isotretinoin] and inflammatory bowel disease," said lead investigator Seth Crockett, MD, University of North Carolina Medical School at Chapel Hill, Chapel Hill, North Carolina, on October 27. "We found that there did appear to be an association between prior [isotretinoin] use and subsequent development of ulcerative colitis. There appeared to be approximately a 4 times increased risk for those who had taken [isotretinoin] compared with those who had not." << MORE >>

11/01/2009 - It's been over a month since Madison County Circuit Judge David Hylla heard arguments in a case over the acne drug Accutane and, with the case's Oct. 19 trial date past, he is scheduled to hear more motions in the suit on Nov. 3. On the table is a move to bar an unpublished university study on the drug's effects on the digestive tract and other discovery matters. The case's trial has been postponed several times. Had it gone to trial on its original 2007 date, the case would have been the first Accutane trial in the United States. The case was last scheduled to open for a jury Oct. 19. Plaintiff Jason Peipert is suing his dermatologist, Dr. Daniel Goran and the makers of Accutane, Hoffman-La Roche Inc. and Roche laboratories. He claims that Goran negligently prescribed the drug in 1999 knowing that its effects are difficult to manage in patients. << MORE >>

10/27/2009 - Ennis & Ennis, P.A. announces today it is still investigating and accepting Accutane cases against the manufacturer of the drug Hoffman La-Roche. David Ennis states, "although Hoffman La-Roche announced in June 2009 that it will no longer sell Accutane due to generic competition and large legal costs defending the drug this does not absolve La-Roche from liability from patients who took the drug in the past and have suffered Inflammatory Bowel Disease (IBD), Ulcerative Colitis and Crohn’s Disease". Ennis went on to state 6 juries in New Jersey have ruled in favor of plaintiffs in excess of $33,000,000 in damages finding that the company did not adequately warn of the side effects associated with IBD, Ulcerative Colitis and Crohn's Disease. Ennis believes that there are thousands of patients who suffered from these side effects and are not aware it was due to Accutane use. << MORE >>

10/24/2009 - Medications for Type 2 (adult-onset) diabetes are very effective at controlling blood sugar levels. You'd think, then, that the drugs would also be very effective at controlling complications of the disease related to those spikes in blood sugar: cardiovascular disease, kidney failure, blindness, nerve damage and amputation of limbs. Surprisingly, though, that has not turned out to be the case for cardiovascular events such as heart attacks and strokes. One study, in fact, hints that too-tight control may even cause patients harm.<< MORE >>

10/23/2009 - Given the current worldwide type 2 diabetes epidemic, it’s hard for drug developers to ignore the huge potential for new, better, and safer oral drugs. The U.S. market alone has reached $5 billion annually, and the prevalence of type 2 diabetes continues to rise across the globe. Approximately 250 million people worldwide have diabetes, and type 2 accounts for up to 95% of all diabetes cases in the developed world. Serious side effects continue to surface for existing drugs, though, forcing the FDA to revise the guidelines: All new drugs under developed will have to show that they do not increase the risk of cardiovascular events. The various glucose-lowering therapies currently under development will face tougher safety requirements. Drugs already on the market have stronger safety warnings, meaning that clinicians have fewer safe options. Additionally, recent evidence seems to point away from the use of treatments too aggressively. << MORE >>

10/23/2009 - A 39-year-old Newark woman has filed a lawsuit this week against Bayer Corp., blaming its popular birth control product Yaz for causing her stroke and other related health issues. Susan Galinis, the mother of 3-year-old twin girls, took the prescription-only product for four weeks in the summer of 2008, and wound up suffering a stroke that caused her to be hospitalized for six months, said her attorney. << MORE >>

10/22/2009 - While all birth control pills have side effects, Yaz and its sister pill, Yasmin (which contains less estrogen) seems to be taking the cake for increasing lawsuits for its effect on women. Courthouse News reports that Bayer faces 125 lawsuits against the Yasmin birth control pill. According to a recent complaint by Alishia Dianne Seagraves, "Yasmin and Yaz create 'unique and dangerous risks' for women because they contain a diuretic that has never been marketed in the U.S. and is unlike other progestins." The complaint also states that the FDA warned Bayer multiple times about falsely portraying Yasmin/Yaz in commercials, downplaying how serious the risks were of the product. << MORE >>

10/22/2009 - Back in 2008, pharmaceutical maker Bayer released a series of ads for Yaz, a birth control pill. The ads claimed that Yaz can treat various premenstrual symptoms and help clear up acne on skin. But oops-they weren't supposed to say that. The FDAsaid that these ads made claims that it hadn't approved, and they didn't adequately disclose the health risks associated with Yaz. << MORE >>

10/21/2009 - A hormone in some birth control pills made by Bayer may cause dangerous blood clots, studies have found. The pills have been linked to several recent deaths, but a ban is considered unlikely. Birth control pills containing certain hormones like drospirenone are twice as likely to cause blood clots - or thrombosis - than older pills, according to two recent studies published in the British Medical Journal. In Switzerland, a 21-year-old girl died in September after taking a drospirenone-containing contraceptive from Bayer's Yasmin line. In Germany, 25-year old Felicitas Rohrer collapsed in July with three thromboses in her lung. Since 2001, seven women in Germany have died while taking a contraceptive from the Yasmin family. << MORE >>

10/21/2009 - What would have been Madison County's first trial involving acne medicine Accutane has been put off again as discovery in the case continues. Plaintiff Jason Peipert filed notice of another deposition Oct. 13 as the defendants in the case have attempted to bar an unpublished study by the University of North Carolina. Dr. Daniel Goran filed Oct. 9 to join his fellow defendants, Hoffman La Roche Inc. and Roche Laboratories, in opposing the inclusion of the study at trial. Peipert deposed Dr. Paul Waymack in Washington D.C. on Oct. 6. The trial had been set to open before Circuit Judge David Hylla Monday. Peipert is suing Goran and the drug makers on negligence claims. He alleges that the drug, prescribed by Goran in 1999, caused him to develop bowel disease. << MORE >>

A Mingo County couple is suing a physician and the makers of a drug used to treat reflux, alleging the companies concealed the risk of side effects and the physician failed to recognize the wife was suffering from two of them. Shirlean and Elmer Meade filed a lawsuit in Mingo Circuit Court Feb. 25 against Dr. Deidre E. Parsley; Wyeth, Inc.; Schwarz Pharma; PLIVA, Inc.; Teva Pharmaceuticals; and six unnamed defendants. Shirlean says she can no longer control her facial expressions, mouth, tongue and jaw because she used a generic version of the drug Reglan for more than 12 months to treat her reflux. The conditions the woman is suffering from are called Tardive Dyskinesia and Akathisia, according to the complaint. Elmer claims he's lost the consortium of his wife, according to the couple's 14-count complaint. << MORE >>

A federal judge has handed four generic manufacturers of the heartburn medication Reglan another loss in their request to dismiss a product liability suit in Vermont. The ruling by Judge William Sessions of the U.S. District Court for the District of Vermont will not allow Actavis Elizabeth, Teva Pharmaceuticals USA, Pliva and Barr Pharmaceuticals to appeal a ruling that denied their motions for summary judgment and a stay of the proceedings in Ethel Kellogg v. Wyeth, et al., in which they are named among the defendents. Reglan (metoclopramide) is prescribed for treatment of gastrointestinal disorders, and is only supposed to be used for under 12 weeks. However, it is often taken for extended periods of time. When used for extended periods of time or at high doses, Reglan side effects have been linked to an increased risk tardive dyskinesia. This condition causes repeated movements of the extremities and the face muscles. Some symptoms of tardive dyskinesia are lip smacking, tongue protrusions and rapid eye blinking. << MORE >>

It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects? I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide") prescribed over a year ago for a digestive disorder. I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia", a permanent condition that's untreatable. TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways --the drug can also cause face jerking or involuntary body movements, including: << MORE >>

After a year of taking a drug to combat a medical condition involving paralysis of stomach muscles, an Arkansas resident started exhibiting abnormal muscle movements throughout her body. Kecia Neal has filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., the manufacturers of the drug Reglan and its generic equivalent metoclopramide. The product liability suit was filed on May 27, 2009, in the El Dorado Division of the Western District of Arkansas. The drug Reglan is used to treat gastrointestinal disorders but has been linked to an increase risk of tardive dyskinesia, a condition that results in involuntary and repetitive movements of the body. Currently, there is no known treatment for tardive dyskinesia. In some patients, the syndrome's symptoms may be reduced in the weeks or months following the cessation of the drug. << MORE >>

10/14/2009 - Swissmedic, the medical regulatory agency in Switzerland, is looking into the death of a young woman who suffered a pulmonary embolism that appears to be a side effect of her birth control medication. According to the agency, the woman had been using Yaz, an oral medication made by Bayer Pharmaceuticals, for about 10 months when her death occurred in mid-September. The cause of death was ruled pulmonary embolism, a blood clot that travels from another area of the body and blocks the main artery of the lung. The most common sources of the embolism are the lower extremities, which produce deep venous thrombosis (DVT’s). All estrogen-containing oral contraceptives carry an increased risk of the formation of DVT’s. << MORE >>

10/14/2009 - It was mid-August, 2008, when 24-year-old Tanya Hayes began to experience breathlessness and what her family described as a “nasty, hard cough.” A busy student, Tanya ignored the symptoms until one afternoon when she collapsed in a car park in her hometown of Melbourne, Australia. Five hours later, she was pronounced dead of a pulmonary embolism. According to the head of the emergency room that treated Ms. Hayes, her death was the result of “blood clotting caused by factors related to taking the oral contraceptive pill.” What her heartbroken family did not discover until later is that the fine print on the package of pills she was taking, known as Yasmin, lists “breathlessness” as a "very rare . . . very serious side effect.” << MORE >>

10/14/2009 - Ford Motor Co. is recalling 4.5 million vehicles due to a faulty switch that can overheat and catch fire. It’s the automaker’s eighth recall in a decade involving the same switch, which has now resulted in the recall of more than 14 million vehicles. Ford is recalling 1.1 million Ford Windstar minivans, model years 1995 through 2003, that could have the problem. The automaker also is recalling 3.4 million additional vehicles that have the switch, including Ford Excursions, Explorers and Rangers of various model years, going back as far as 1992. << MORE >>

This fall has been tough for Toyota, which had already been suffering from a strong yen amid the global financial crisis. On Sept. 30 the Japanese automaker recalled 3.8 million Lexus and Toyota cars sold in the U.S. since 2004 because of potentially deadly floor mats. It is the largest ever recall in the company's 72-year history. The removable driver's-side mats were responsible for a series of accidents when they slipped forward and jammed accelerator pedals. Industry experts say that changing the mats will cost Toyota some W50 billion (US$1=W1,174), but perhaps even more serious is that the problem has sullied Toyota's reputation as a top-drawer automaker. The company has been blasted by the U.S. media for having been aware of the flawed mats for two years before deciding on the recall. << MORE >>

10/07/2009 - One week ago today, owners of eight Toyota and Lexus models got an urgent plea from the U.S. Department of Transportation, delivered via the media: Remove your driver's side floor mat immediately, and don't replace it until you've taken your car to the dealer. With much of the coverage calling it a recall of 3.8 million vehicles, Toyota issued a cautious statement the next day saying that it wasn't yet a recall but a "safety advisory." Well, it's a recall now. The company will send letters to customers before the end of the month--and it left open the possibility that the list vehicles being recalled might expand beyond those already identified. << MORE >>

Avandia is marketed by GlaxoSmithKline for the treatment of Type 2 diabetes. Recently however, studies have shown that Avandia significantly increases the risk of heart attack and heart related deaths. Earlier this month Toronto researchers for the Canadian study found that patients taking the controversial diabetes drug Avandia (Rosiglitazone) had an increased risk of heart failure. The study and its findings haves been published in the British Medical Journal for the month of September. This has not been the first study to come to this conclusion. Avandia's scrutiny began in 2007 when 42 clinical trials published by the Cleveland Clinic showed a 43 percent higher risk of having a heart attack. << MORE >>

09/30/2009 - Toyota Motor Corp. will recall more than 3.8 million Lexus and Toyota vehicles, its largest ever U.S. safety recall, after drivers reported that floor mats slid forward and in some cases jammed the accelerator pedal, the company and the U.S. government said Tuesday. Transportation Secretary Ray LaHood and Toyota officials urged owners of seven vehicle lines, including Toyota's best-selling Camry sedan, its Tundra truck and three premium Lexus models, to immediately remove driver-side floor mats, particularly if they are not secured. << MORE >>

09/30/2009 - Toyota is launching its biggest recall ever to prevent sliding floor mats from jamming accelerator pedals, a problem that may have killed four in the crash of a runaway Lexus. The automaker on Tuesday warned the owners of 3.8 million late-model Toyota and Lexus vehicles to immediately remove any driver's side floor mat. Official notice will go out to owners next week. << MORE >>

09/29/2009 – The mainstream media has finally woken up to Bayer’s problems on its Yaz contraceptive brands. The New York Times published a story over the weekend about the 74 lawsuits against the company alleging that the pills cause potentially fatal embolisms in users. A close look at recent events at Bayer indicate that the company seems to see the world one way, even though everyone else sees it another. BNET readers have known since June that Yaz was the focus of concerns that it causes more blood clots in users than older safer pills. Reuters reported another death Friday. << MORE >>

RV Refrigerator Fire Recalll : Dometic and Norcold have recalled several models of refrigerators due to the risk of fire. These defective refrigerators were installed in travel trailers, motorhomes, RVs, 5th wheel trailers, luxury recreational vehicles, fifth wheelers, horse trailers and other conversion vehicles manufactured between June 1, 2003 and April 30, 2007. << MORE >>

A man and woman have filed a suit against Bayer, alleging they were not warned of possible side effects in a drug used to control bleeding in coronary artery bypass grafting. Don Juan Brown and Jean N. Snyder claim their use of Trasylol led to renal damage, renal insufficiency and multi-system organ failure. Trasylol, which was approved by the FDA in 1993, is usually supplied as a colorless, sterile isotomic solution that is administered through an IV during coronary artery bypass grafting, according to the complaint filed Aug. 20 in St. Clair County Circuit Court. "Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of CABG procedures," the suit states. "The effects of Trasylol use in cardiopulmonary bypass surgery involve a reduction in inflammatory response, which translates into a decreased need for allogenic blood transfusions and reduced bleeding." << MORE >>

The U.S. Food and Drug Administration advises consumers to stop using three Zicam products marketed as cold remedies. The products are associated with the loss of sense of smell (anosmia), a condition the federal agency warns could be long-lasting or permanent. The three products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. << MORE >>

Several lawsuits have been filed against Bayer due to serous side effects associated with Yasmin / Yaz. Here we discuss the implications such a lawsuit would have on a potential recall. Both the drugs are oral contraceptives that contain synthetic versions of the hormones estrogen and progestin, and are associated with side effects including stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder problems, and kidney problems. Some strongly suspect that Yasmin / Yaz will be recalled in the near future because of the attention now being brought to the serious risks involved in taking them. << MORE >>

Folks inside the Yaz brand management team at Bayer have another pill-induced headache this month in the form of a BMJ study that indicates the progesterone ingredient of Yaz is more risky than those in other contraceptives. Conversely, the study will be greeted with joy by the lawyers suing Bayer, who believe that Yaz causes a greater-then-usual number of blood clots compared to older pills because of its new progesterone ingredient. << MORE >>

09/17/2009 - As if the makers of Yasmin / Yaz didn’t have enough to worry about with pending lawsuits related to major side-effects, now they’ve been served a warning letter from the FDA for quality control problems at a plant in Germany that manufactures one of the ingredients in the drug. FDA inspectors discovered the problems during an inspection in March, 2009, and informed Bayer. Bayer claims that the quality of the drug was not affected. << MORE >>

09/11/2009 - A judge declared a mistrial Friday in a closely watched case involving Merck & Co.'s osteoporosis drug Fosamax after a jury failed to reach a verdict amid tense jury deliberations. The mistrial came two days after U.S. District Judge John F. Keenan in Manhattan called for a daylong "cooling off" period as one juror claimed in a note to have been the subject of physical threats and that a chair was thrown in the jury room. The judge declared a mistrial Friday after the jury's forewoman indicated the jury remained deadlocked and a lawyer for Shirley Boles, a 71-year-old Florida woman who sued Merck, again asked for a mistrial. Merck opposed the mistrial motion. << MORE >>

09/17/2009 -Q. A dear friend was put on Reglan for acid stomach and left on the drug for nine years. The therapy is only supposed to last a few weeks. She now has tardive dyskinesia. Her tongue is enlarged, and she can no longer speak properly. The side effects did not go away when the drug was stopped. Is there anything that can help her? Please warn your readers about Reglan. << MORE >>

09/18/2009 - Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony. After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury. << MORE >>

08/27/2009 - Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. << MORE >>

Infant Warmer Recall: In July 2009 Draeger Medical and the FDA notified healthcare professionals of a class 1 recall and recommended the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. << MORE >>

08/26/2009 - Maytag Corp. is expanding its recall of Maytag, Magic Chef, Performa by Maytag and Crosley brand refrigerators. An electrical failure in the relay, the component that turns on the refrigerator’s compressor, can cause overheating and pose a serious fire hazard. The latest recall is for 46,000 refrigerators. About 1.6 million units were recalled in March 2009. Maytag has received 23 additional reports of refrigerator relay ignition, including 4 reports of property damage ranging from smoke damage to extensive kitchen damage. The refrigerators were sold at department and appliance stores and by homebuilders nationwide from September 2000 through May 2004 for between about $350 and $1,600. They were made in the U.S. << MORE >>

Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements. “In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it’s the first information about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University in New York and an expert on civil procedure. Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said. << MORE >>

Exclusive CBS News Investigation Finds 59 Deaths, Hundreds Of Injuries Linked To Yamaha's Off-Road Vehicle. In the swath of Kentucky called the Land Between The Lakes, the Turkey Bay Off-Highway Vehicle Area is a rugged expanse of hills and woodlands crisscrossed by 100 miles of trails. Test drivers came here in July, 2002, to try out the Yamaha Rhino, a new breed of off-road vehicle then in development, and had a mishap that would resonate years later. << MORE >>

08/04/2009 - In a post-Ephedra market, consumers by now should be well aware that products on drugstore shelves can be harmful. But the fact that your supplement isn't approved by the government doesn't mean it's unsafe. The U.S. Food and Drug Administration does not approve dietary supplements before they come to the market but rather may become involved after they are on shelves. Within the past 12 months over 86 weight loss supplements have been flagged by the FDA as unsafe. Over 70 products tested positive for potentially harmful prescription drugs and chemicals that were not declared by their manufacturers. Fourteen Hydroxycut products were also recently recalled after the FDA reported possible liver damaging side effects. << MORE >>

On July 28, 2009 Abbott conducted a voluntary recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.<< MORE >>

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK IN RE: MASTER FILE FOSAMAX PRODUCTS LIABILITY LITIGATION 1:06-MD-1789 (JFK) This Document Relates To All Actions OPINION & ORDER APPEARANCES: FOR THE PLAINTIFF’S STEERING COMMITTEE: Timothy M. O’Brien, Esq. Meghan Tans, Esq. Ned McWilliams, Esq. LEVAN PAPNATONIO THOMAS MITCHELL ECHSNER & PROCTOR, P.A. Michelle Parfitt, Esq. James Green, Esq. ASHCRAFT & GEREL FOR DEFENDANT MERCK & CO, INC.: Norman C. Kleinberg, Esq. William J. Beausoleil, Esq. HUGHES HUBBARD & REED LLP Paul F. Strain, Esq. David J. Heubeck, Esq. Stephen Marshall, Esq. VENABLE LLP Christy D. Jones, Esq. BUTLER SNOW O’MARA STEVENS & CANNADA PLLC JOHN F. KEENAN, United States District Judge: Click Here To Continue Reading Entire Doccument >>> << MORE >>

07/30/2009 - AstraZeneca said its Seroquel litigation costs have exceeded $593 million, and that it has tapped out the extent of its liability insurance. With no more insurance available to cover its bills, the company said it will take charges on its income statement in upcoming quarters. The news comes as AstraZeneca also gave an update on the scale of the litigation filed against it: 10,381 cases are pending. << MORE >>

07/15/2009 - The Food and Drug Administration (FDA) has caught itself in a trap of precedent and logic that should force it, finally, to regulate homeopathic products. FDA regulations require that drugs and treatments be “scientifically proven safe and effective.” Homeopathic remedies, except when people rely on them to treat serious conditions, are usually safe as water—which they actually are. Some homeopaths claim that shaking and serial dilutions—even to the point that not one molecule of the “active” ingredient remains—create a “memory” of the long-gone ingredient. So far, though, the FDA has ignored the multi-million dollar fraud. After all, what’s the harm? Well, one harm, according to hundreds of people and dozens of lawsuits, is that some of Matrixx Initiatives’ homeopathic Zicam cold “treatments” cause anosmia—the loss of smell, a sense necessary both to enjoy a summer day and to detect gas leaks, fires and spoiled food. << MORE >>

07/21/2009 - If you use denture cream, you might want to sit down while you read this. Remember the old saying, “What you don't know won't hurt you?” That's not the case with some denture creams. Glaxo Smith Kline, the maker of PoliGrip and Super PoliGrip, and Proctor & Gamble, the makers of Fixodent, are being sued because their products contain zinc, a potentially harmful element when taken in high doses. Doctors say too much zinc drives down copper levels in the body, affects the spinal cord and makes it hard for people to walk. In a 2008 study published by the Journal of Neurology, the authors said long-term denture cream overuse caused zinc poisoning in four patients, which resulted in neurological problems for all of them. << MORE >>

07/15/2009 - If you are taking either Yaz or Yasmin birth control pills, be aware that there could be some severe effects on your health. Those who have elevated blood potassium should not take these pills, because they can raise your blood potassium. A high potassium level in the body can cause...<< MORE >>

07/08/2009 - A drug - Phospho-soda - that could cause severe kidney injury, especially in seniors, is still being sold over the counter in Jamaica, six months after its US manufacturer yanked it off American shelves. The United States Food and Drug Administration (FDA) has frowned on Phospho-soda, an over-the-counter (OTC), bowel-cleansing drug, saying it could have "serious, adverse" effects on users and should be sold by prescription only. In a December 2008 letter posted on its website, C B Fleet said it was doing a voluntary recall of its products Fleet Phospho-soda and Fleet Phospho-soda EZ Prep in accordance with an FDA recommendation that oral sodium phosphate preparations (OSPs) be prescribed. << MORE >>

Last year, C.B. Fleet Company voluntarily recalled its over-the-counter products Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System after the U.S. Food and Drug Administration (FDA) issued a safety alert stating that oral sodium-phosphates bowel-cleansing solutions should be available by prescription only. However, the News & Advance is reporting that C.B. Fleet says its products are safe and has collected thousands of cases of the products and is considering ways to put the drugs back on the market. << MORE >>