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Warning Issued on Use of Crestor by Asians

The cholesterol drug Crestor is being relabeled to add a caution that starter doses should be reduced in Asian-Americans and some other patients. More >>

Biogen, Elan Confirm 2nd Tysabri-Related Infection

Drug makers Biogen Idec and Elan Corp. on March 10, 2005 said a rare and often fatal infection has been confirmed in a second patient receiving their multiple sclerosis drug Tysabri. More >>

FDA Warns AstraZeneca On Crestor Marketing

For the second time in four months, the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications (DDMAC) has warned AstraZeneca on advertisements promoting its cholesterol drug Crestor--calling suggestions that the drug is better that Pfizer's Lipitor "misleading." More >>

Crestor Warnings Too Weak, Group Says

Warnings added to anti-cholesterol drug Crestor last week sharply understate the drug's risk, the consumer group Public Citizen said Thursday in a letter to the FDA reiterating its request to have the drug pulled from the market. More >>

FDA to Create New Drug Safety Board

The U.S. Food and Drug Administration said on Tuesday it was creating a new drug safety board to improve the monitoring of medicines already in the marketplace, a response to charges the agency has failed to protect the public from dangerous side effects. More >>

New Study Links Painkillers Vioxx, Celebrex, Bextra to Increased Cardiovascular Problems

A new study has linked painkillers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs. More >>

Pain Drug Mobic Shows Increased Risk - FDA Scientist

A pain reliever called Mobic showed an "increased risk" for heart attacks in preliminary data, a veteran U.S. Food and Drug Administration scientist told an FDA advisory panel on Thursday, February 17, 2005. More >>

U.S. Says J&J Arthritis Drug Promotion Misleading

Johnson & Johnson promotion for rheumatoid arthritis drug Remicade is misleading because it makes unsupported claims about the drug's effectiveness and omits important information about risks, U.S. regulators said in a letter released on Monday. More >>

U.S. Official Says Crestor Should Be "Last Resort"

AstraZeneca's cholesterol-lowering drug Crestor should only be used after all other alternatives have failed, according to newspaper comments by a veteran U.S. Food and Drug Administration official. More >>

Amgen's Enbrel Ad Goes Too Far, FDA Says

An Amgen television ad for its psoriasis drug Enbrel is misleading and plays down the drug's very serious risks, the U.S. Food and Drug Administration said on Friday. More >>

Canada May Put Warnings on Cox-2 Inhibitors

Health Canada may follow Australia's lead and put special warnings and dosage limits on the painkillers that remain on the market from the now-controversial class of drugs known as Cox-2 inhibitors, Health Minister Ujjal Donsanjh said in February 2005. More >>

Kaiser Halts Prescriptions of Bextra

Kaiser Permanente, the nation's largest not-for-profit managed-care provider, has stopped prescribing Bextra until tests show whether the painkiller is safe. More >>

Spate of Recalls Spurs Pharmaceutical Companies to Err on Side of Caution

Got arthritis pain? How about severe headaches? If so, get ready for requests to take part in experimental drug testing. Heightened concerns about drug safety is about to boost the demand for patients willing to be guinea pigs. More >>

Doctors Say Avoid Pfizer's Bextra

Doctors writing in a prominent medical journal recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks. More >>

U.S. Group Says Crestor Risk Higher Than Others

The rate of serious muscle damage reported in patients who took AstraZeneca's cholesterol drug Crestor was six times higher than with similar medicines, a consumer group has said. More >>

Safety of Entire Family of Painkillers Questioned

The withdrawal of Vioxx from the market in September and more recent concerns about its cousin Bextra have raised safety questions about this entire class of painkillers: Are there one or two bad apples, or is the bunch spoiled? More >>

Merck Decided Against 2000 Vioxx Study

Top executives at pharmaceutical giant Merck & Co. Inc. decided in May 2000 against developing a study to test directly whether its Vioxx painkiller drug might pose a heart risk, The New York Times reported on Saturday. More >>

Abbott Adds Warnings to Arthritis Drug Label

Abbott Laboratories Inc. added several new warnings to the label for its rheumatoid arthritis drug Humira, according to a company letter released on Monday. More >>

AstraZeneca's Crestor, Other Medicines, Cited for Safety Risks

AstraZeneca Plc's Crestor for cholesterol and GlaxoSmithKline Plc's Serevent asthma drug head a list of five medicines that should get a closer safety review from the U.S. Food and Drug Administration, according to an agency staff member. More >>

Study Suggests How COX Drugs Cause Heart Disease

Painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries, researchers proposed on Thursday. The drugs, known as COX-2 inhibitors, include Merck and Co.'s Vioxx, which earned the company $2.55 billion a year but was pulled off the market on Sept. 30 after a study showed it doubled the risk of heart attack and stroke. More >>

Pfizer Hit With Bextra Lawsuit

Pfizer was hit by a lawsuit alleging its arthritis and pain reliever drug Bextra was responsible for the death of a 46-year-old New Jersey man who used the drug for nine months. More >>

Newer Arthritis Drugs Linked to Skin Disorder

Newer drugs like Enbrel and Remicade have been a boon to many arthritis sufferers, but researchers now report that such drugs may lead to the development of an inflammatory disorder of blood vessels, usually affecting the skin. More >>

FDA to boost safety reviews. In-house warnings after drug releases went unheeded, critics say.

The Food and Drug Administration -- reacting to claims that it lets dangerous drugs stay on the market despite warnings from its own scientists -- said Thursday it will bolster its safety oversight division. The action came as a prestigious medical journal accused the FDA of tolerating "lethal weaknesses" in its method of tracking serious side effects that can surface as newly approved drugs move into wider use. More >>

Pfizer Says FDA Warning Likely For Bextra

Bextra, a Pfizer pain drug that received a sales boost when Merck's Vioxx was pulled from the market, will probably be tagged with the most prominent type of safety warning used by the Food and Drug Administration. According to Pfizer, Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered. More >>

Arthritis Drug Has Blood Cancer Risk

Johnson & Johnson is warning doctors that patients taking its rheumatoid arthritis drug Remicade may have a higher risk of lymphoma, a blood cancer, the company said on Friday. More >>

Newer Arthritis Drugs Linked to Skin Disorder

Newer drugs like Enbrel and Remicade have been a boon to many arthritis sufferers, but researchers now report that such drugs may lead to the development of an inflammatory disorder of blood vessels, usually affecting the skin. More >>

FDA Downplayed Vioxx Doubts

The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday. More >>

Centocor Warns of Remicade-Lymphoma Risk

10/7/04 - Patients taking Remicade for rheumatoid arthritis suffered a type of cancer, lymphoma, at three times the rate of the general public, manufacturer Centocor warned doctors on Thursday. More >>

FDA Accused of Silencing Vioxx Warnings

The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday. More >>

Arthritis Drug Recall Sparks Criticism of FDA

U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes. Merck & Co. Inc.'s withdrawal of Vioxx Thursday raised inevitable questions about whether the prescription drug taken by millions should have come off pharmacy shelves sooner, or at least carried stronger warnings. More >>

AstraZeneca's Crestor May Harm Kidneys

Twenty-nine patients who took AstraZeneca Plc's anti-cholesterol drug Crestor have developed kidney damage, a U.S. consumer group said on Friday as it called again for a ban on the medicine. More >>

Report: Merck Tried to Bury Vioxx Concerns for Years

Internal e-mails and other documents from Merck & Co. show the company fought for years to keep safety concerns from undermining the drug's commercial prospects, the Wall Street Journal reported on Monday. More >>

Cholesterol Pills and Grapefruit Don't Mix

Taking certain cholesterol-lowering drugs at the same time as grapefruit juice can increase the risk of potentially life-threatening muscle toxicity, British regulators warned. More >>

Merck Should Have Pulled Vioxx in 2000, Study Says

Merck & Co.'s Vioxx painkiller showed heart risk in studies four years before the drug was recalled, and it should have been pulled from the market then, according to a study published in the medical journal Lancet. More >>

Pfizer Hikes Warning on Bextra Skin Risk

Pfizer Inc. on Friday said two clinical trials showed patients taking its anti-inflammatory drug Bextra had a higher risk of cardiovascular events during high-risk coronary bypass surgery. More >>

Pfizer Criticised Over Delay in Admitting Drug's Problems

Pfizer delayed announcing negative data about its painkiller valdecoxib (Bextra), Curt Furberg, a member of the US Food and Drug Administration's Data Safety and Risk Management Advisory Committee, told the BMJ this week. When the company eventually presented its data to the FDA, it also left out important details, Dr Furberg alleges. More >>

Vioxx Withdrawal Causes Concern About FDA

Americans should feel reasonably safe taking government-approved prescription drugs - with a few caveats - even after a popular arthritis medication was pulled from the market, medical experts say. But the problems with Vioxx raise questions about the Food and Drug Administration's safety review process and the length of time it took Merck to pull the drug, observers say. More >>

European Medicines Agency to Review Drugs in Same Class as Vioxx

The European Medicines Agency is to review all drugs in the same class as Vioxx after US pharmaceutical giant Merck withdrew the arthritis drug. More >>

Health Risks Force Vioxx Recall

Vioxx, the blockbuster arthritis drug heavily promoted on TV and taken by tens of millions of people, was pulled from the market by its maker Thursday after a study found it doubled the risk of heart attacks and strokes. Experts advised patients to immediately stop taking Vioxx and talk to their doctors about alternatives. More >>

Drug Makers Create Database for Trial Results

The drug industry, fighting off criticism for hiding data from negative studies, unveiled on Tuesday a database for firms to voluntarily provide summarized results of most clinical trials of medicines sold in the United States. The Web-based clearinghouse will contain summaries of findings, both positive and negative, of studies completed since October 2002, according to the Pharmaceutical Research and Manufacturers of America, the drug industry's lobbying group known as PhRMA. More >>

FDA Nod Won't Guarantee Drug Safety

A 60-year-old woman with degenerative disk disease recently came into Dr. Allen Lebovits' Manhattan office with a complaint. This time, the grievance wasn't about the pain but about news reports linking Vioxx, her pain reliever, with an increased risk of heart attacks and sudden cardiac deaths. She didn't want to take it anymore. More >>

Blood, Nervous System Ailments Tied to Remicade Use, FDA Says

The Food and Drug Administration and manufacturer Centocor are warning doctors that patients receiving the drug Remicade to treat rheumatoid arthritis and Crohn's disease have suffered sometimes fatal blood and central nervous system disorders. Centocor, a subsidiary of health care product manufacturer Johnson & Johnson, said the FDA has been told of 580 adverse reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Forty-four reports were most worrisome because they involved significant blood disorders. At least 12 patients taking Remicade - in combination with other drugs - died worldwide. More >>

Vioxx Study Suggests Heart Risks; Kaiser to Review

Patients taking Merck & Co. Inc.'s Vioxx arthritis drug had a 50 percent greater chance of heart attacks and sudden cardiac death than individuals using Pfizer Inc.'s rival Celebrex medicine, according to a large study financed by the U.S. Food and Drug Administration. More >>

Settlement Sets New Standard for Release of Drug Information

Attorney General Eliot Spitzer today announced an agreement that resolves charges that a leading pharmaceutical company concealed information about the safety and effectiveness of one of its drugs. As part of the agreement, GlaxoSmithKline (GSK) will become the first major drug manufacturer to publicly disclose information on clinical studies of its drugs. More >>

Etanercept Appears to Increase TB Risk

The use of the tumor necrosis factor (TNF) alpha antagonist etanercept may increase the possibility of patients developing tuberculosis, according to a study published in the August 1st issue of Clinical Infectious Diseases. More >>

Inappropriate Drugs Commonly Prescribed to Elderly

Potentially inappropriate drugs are commonly prescribed to elderly patients, according to a report in the August 9/23 issue of the Archives of Internal Medicine. "Suboptimal prescribing has been an important issue in the elderly population for some time," Dr. Lesley H. Curtis from Duke Clinical Research Institute, Durham, North Carolina told Reuters Health. "Concerns over the costs of inappropriate prescribing are appropriate, but the costs of adverse events related to these medications are even more concerning." More >>

Tuberculosis Linked to Arthritis Drugs: Doctors Should Screen for TB Before Prescribing Drugs That Suppress Immune System

Several cases of tuberculosis (TB) have been linked to drugs commonly prescribed for arthritis, the CDC reports. Doctors who prescribe potent immune-suppressing drugs for their rheumatoid arthritis patients should screen them for TB exposure and infection before prescribing these drugs, the CDC says. The arthritis drugs are all in a class called tumor necrosis factor-alpha (TNF-a) antagonist drugs and include Remicade, Enbrel, and Humira. More >>

Study: Seniors Get Wrong Drugs

A warning for senior citizens who take prescription drugs: A new study, published by the Archives for Internal Medicine, finds that inappropriate drug prescription for people over 65 is still a major problem, with potentially deadly consequences. More >>

J&J Adds Warning to Arthritis Drug Label

Johnson & Johnson added a new warning to the label for rheumatoid arthritis drug Remicade about blood disorders that sometimes were fatal, U.S. regulators announced on Tuesday. More >>

AstraZeneca Battles Patient Concerns to Increase Crestor Sales

Nigel Jones quit canoeing shortly after taking up the sport last year because his shoulders ached so badly. When the pain persisted, the Welsh businessman stopped taking Crestor, AstraZeneca Plc's new cholesterol-reducing drug. Jones, 47, said he read on Crestor's label that muscle pain was a possible side effect, and an Internet search showed the drug had been linked to rhabdomyolosis, a rare and sometimes fatal condition that causes severe muscle weakness. Though Jones never saw a doctor about his pain, he's sure Crestor was the cause. More >>

New Anti-Inflammatory Drugs Increase TB Risk

Recently developed drugs called TNF-blockers have brought relief to many people with inflammatory conditions such as rheumatoid arthritis or the intestinal disorder, Crohn's disease. However, the drugs do carry a risk. In a report released on Thursday, federal health officials at the Centers for Disease Control and Prevention in Atlanta point out that patients taking TNF-alpha antagonists, such as Remicade (infliximab), Enbrel (etanercept), and Humira (adalimumab) have an increased risk of tuberculosis. More >>

Watchdog Group, AstraZeneca Face Off Over Cholesterol Drug

7/23/04 - It is an unusual skirmish for the pharmaceutical industry, and one potentially significant for consumers. In one corner, is London-based AstraZeneca, the world's fifth-largest drug maker with $18 billion in sales last year. In the other, is Public Citizen's Health Research Group, a nonprofit advocacy organization in Washington with a staff of six full-timers and two part-timers. More >>

FDA: Most Drug Makers Skip Study Listings

The drug industry is largely ignoring a federal law requiring that thousands of medical studies be listed on a government database, federal research suggests. The Internet-based database, ClinicalTrials.gov, opened in 2000. An FDA check against its own internal research lists shows that in 2002, just 48 percent of industry-funded studies for cancer therapies alone were reported to the public database. More >>

Portsmouth Man's Case Cited As Reason For Concern Over Cholesterol Drug Crestor

There is controversy brewing over a cholesterol lowering drug called Crestor. A Washington D.C. watchdog group is calling for a ban on the drug after one woman died and 16 others - including a Portsmouth man - had serious side effects after taking it. Unlike other cholesterol lowering drugs - called statins - Crestor has been linked to potentially fatal muscle destroying conditions and kidney abnormalities. More >>

Consumer Group Urges Ban of Cholesterol Drug: Concern Over Side Effects of Crestor Grows

In a letter published Thursday in the medical journal The Lancet, a consumer advocacy group warns that the danger of such life-threatening side effects is unacceptably high with Crestor, a statin that was approved by the Food and Drug Administration last August. More >>

FDA Adds Warning to Serzone

June 23, 2004 -- The FDA issued a warning today for the antidepressant Serzone, saying that those who take the drug are at increased risk of liver failure. More >>

Glaxo to Publish Drug Trial Results Online

GlaxoSmithKline will publish clinical trial results for marketed medicines on the Internet, the London-based firm said on Friday, as it seeks to fight back from a lawsuit claiming it suppressed negative data on one of its drugs. More >>

AstraZeneca Changes Crestor Label at Agency Request

AstraZeneca Plc, the U.K.'s second- largest drugmaker, changed the European label of its Crestor cholesterol treatment because of safety concerns. European doctors will get letters telling them to start patients on the lowest dose of the drug, the London-based company said. The majority of the cases of rhabdomyolysis, a muscle weakness that affects the kidneys and can be fatal, have been in patients who started on higher doses, AstraZeneca said. More >>

FDA Public Health Advisory for Crestor (rosuvastatin)

Astra-Zeneca Pharmaceuticals today released a revised package insert for Crestor (rosuvastatin) for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to postmarketing spontaneous adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. More >>

Manufacturer Halts U.S. Sales Of Controversial Antidepressant

Sidestepping the safety issue, Bristol-Myers Squibb pulls Serzone from the U.S. market, citing decreased sales and generic competition. Critics of the drug are only partly pleased, however. Bristol-Myers Squibb (BMS) announced that this month it would stop manufacturing and shipping its Serzone brand of the combined serotonin-norepinephrine reuptake inhibitor and 5-HT2 antagonist nefazodone. The announcement brings to a close a rocky nine-and-a-half-year run for the antidepressant, which has been tied to serious adverse effects on the liver and played a part in documented medication errors, due to name confusion. With a voluntary removal, BMS is protected from the impact of an official FDA determination that the drug was removed from the market for safety reasons. Generic formulations of nefazodone are available from nine manufacturers, and at press time there was no immediate indication of any similar action by any of the nine companies. More >>

FDA Public Health Advisory for Crestor (rosuvastatin)

Astra-Zeneca Pharmaceuticals today released a revised package insert for Crestor (rosuvastatin) for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to postmarketing spontaneous adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. More >>

Health Canada Advises MDs to Take Care in Prescribing Anti-Cholesterol Drug

Health Canada has issued a warning about a potentially dangerous condition linked to Crestor, one of the "statin" drugs used to lower cholesterol. The medication, when taken by patients with certain other health problems, can cause a condition in which muscle cells break down, leading in some cases to kidney failure and even death, says an advisory letter issued to physicians. More >>

Bristol-Myers Discontinues Antidepressant Serzone

Bristol-Myers Squibb (BMY) said on Wednesday it would no longer make or sell its antidepressant Serzone, which has been linked to life-threatening liver problems. More >>

Bristol-Myers Squibb to Pull Serzone from the Market

5/20/04 - The maker of Serzone will pull the controversial antidepressant off the U.S. market next month, blaming a decline in sales rather than concern about a risk of liver failure. The end to U.S. sales comes after Serzone was pulled off the market in many other countries, and as maker Bristol-Myers Squibb was under mounting pressure from lawsuits. Serzone has been linked to dozens of cases of liver failure and injury, including at least 20 deaths. More >>

Anti-Depressant Taken Off Market

Serzone was already off the market in Europe, Australia, New Zealand and Canada. In the case of Canada, Bristol-Myers acknowledged the reason was "adverse events including liver failure." However, the company continued to sell the drug in the U.S. "For commercial reasons we're discontinuing sales and manufacture of Serzone effective June 14, A Bristol-Meyers spokesman told Attkisson today. The company denies adverse events played any role in the withdrawal, even though the company acknowledged that was the case in the Canada withdrawal. This will not quite end the controversy, as generic versions of the drug are still on the market and Public Citizen will continue to sue the FDA over this issue if the generics aren't also pulled. Serzone, the brand name for "nefazodone," is linked to dozens of liver failures including at least 21 deaths in the U.S., reports Attkisson. Hundreds of patients who may have been affected are suing Bristol-Meyers. Last month, Attkisson reported on one of those possible victims, Cassie Geisenhof, who was just 15 when a doctor prescribed Serzone for her depression. More >>

Public Citizen Sues FDA for Failing to Ban Serzone

US Consumer Group Public Citizen sued the US FDA in an effort to get the agency to ban the antidepressant Serzone, which has been linked to liver damage. More >>

Consumer Group Public Citizen Warns Against New Statin Drug Crestor: Cholesterol Drug Potentially More Dangerous Than Baycol; FDA Should Not Have Allowed on Market

"It was irresponsible of the FDA to approve this drug without requiring routine urine testing for protein and blood to monitor for the early signs of kidney damage, " said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. "This drug is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after ‘enough’ people have been injured or killed, that it will have to be pulled from the market." More >>

Cholesterol-Lowering Drugs Can Cause Complications

Complications associated with cholesterol lowering drugs include rhabdomyolysis, muscle pain, kidney and liver conditions, and cognitive problems. As more people take statins, the number of side effects has grown. Some doctors now say they suspect the incidence of side effects is much higher than what has been shown in various clinical trials, including several funded by the drug makers. More >>

New Concerns Over Antidepressant Serzone

Nineteen year old Cassie Geisenhof died earlier this week in a Minneapolis hospital, adding to the Serzone linked deaths and to the reasons critics want the drug banned. More >>

Cholesterol-Buster Raises Safety Concerns

3/12/04 - It emerged this week that MedCo, which manages the prescription drug insurance benefits of 60 million Americans, has opted to leave Crestor off its list of recommended drugs, directing patients instead towards Pfizer's Lipitor, or Merck's Zocor. More >>

Consumer Group Says Ban Cholesterol Drug

A consumer group on Thursday asked the U.S. government to ban an AstraZeneca cholesterol drug approved only months ago, citing reports of dangerous reactions and one death. The prescription drug, Crestor, was introduced in Canada in February 2003 and in Europe in March 2003. The drug hit the U.S. market last September. More >>

FDA Center for Drug Evaluation and Research Releases Drug Database

Searchable database of FDA approved drugs, tentatively approved prescription, over-the-counter, and discontinued drugs, drug approval letters, labels, and review packages. Go to FDA Drug Database >>

Prescription Drugs that Kill: Another Kind of Drug Problem

A medical report in 1998 estimated that adverse reactions to prescription drugs are killing about 106,000 Americans each year -- roughly three times as many as are killed by automobiles. This makes prescription drugs the fourth leading killer in the U.S., after heart disease, cancer, and stroke. More >>

One in 12 Older People are Prescribed the Wrong Drug

Americans aged over 65 stand an 8% chance of being prescribed inappropriate drugs when they visit their doctor’s surgery or a hospital outpatient department, a new study has found. The risk is twice as high for women and may be worse among patients in nursing homes, and the finding probably underestimates the problem. More >>


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