Klausner drops push to increase penalties for illegal Viagra use

"Dr. Jeffrey Klausner, director of the San Francisco health department's STD prevention section, filed a citizen petition on August 5, 2004 with the Food and Drug Administration asking the agency to reclassify the medications, including Pfizer's Viagra, ISOC Inc.'s Cialis, and GlaxoSmithKline's Levitra, as Schedule III controlled substances. Under such classification, anyone in possession of the drugs could face local or state prosecution, and dealers of the substances, if caught, could be given up to five years in prison and a fine of $250,000 for a first offense." [Bay Area Reporter]

FDA Was Told of Viagra-Blindness Link Months Ago

"More than 13 months before a scientific journal reported that Viagra had been linked to a rare form of blindness in some men, a Food and Drug Administration safety officer made the same observation from monitoring adverse event reports and told her supervisors that doctors and patients should be warned of the findings." [Washington Post]

Impotence Drugs Under Attack

"CBS News correspondent Sharyl Attkisson reports that two reasons fueled Public Citizen's FDA request. First, studies show that people don't pay much attention to the type of warning that was added in July. They do pay attention to a Black Box warning, which is what Public Citizen is pushing for.

"Second, Attkisson adds, there's new information. Pfizer had claimed men weren't more likely to go blind if they take Viagra. But Public Citizen says in men with similar risk factors, Viagra users are much more likely to suffer a type of eye stroke called 'NAION.' And it's not just a question of eye stroke but other types of blindness." [CBS News]

Feds Eye Viagra-Blindness Reports

"Federal health investigators are looking into reports that some men who used Viagra may have suffered a new and very serious side effect -- blindness.

Twenty-three million men worldwide have used Viagra. A very small number of them are going blind after taking normal doses" [CBS News]

Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

"A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored. NAION is one of the most common causes of abrupt vision loss in older individuals." [NewsInferno.com]

Impotence drug such as Viagra may cause Vision Loss

"Impotence drugs such as Viagra use is linked to development of vision disorders. It is found that 19% of people with vision disorders have used Viagra medicines. It is found that it contains three phosphodiesterase 5 (PDE5) inhibitors which is found to cause risk of blindness." [MedIndia.com]

FDA Asked to Require ED-Blindness Label

"A prominent consumer advocacy group is calling for the government to add the most serious of warnings to the labels of Viagra and other impotence drugs, noting that some users have gone blind." [Herald News Daily]

Vioxx shows need for civil justice system

"I took columnist Michael Kinsley’s advice (“Taking Vioxx — for Plenty,” Aug. 28) and “googled” Vioxx. The first result was Merck’s own Vioxx Web site (www.vioxx.com), which complains that the drug giant did nothing wrong, that it was subjected to an unfair trial, and promises to continue its scorched-earth legal policy of forcing victims to trial.

"What I did not find were the facts. The truth is that David Graham, a scientist at the Food and Drug Administration, has estimated that Vioxx contributed to the deaths of as many as 55,000 Americans." [The State]

'85 adverse reports from Vioxx'

"The Irish Medicines Board has so far received 85 adverse events reports for the painkilling drug Vioxx, according to the Department of Health.

Health Minister Mary Harney, in a Dail reply this week, said that since Vioxx was authorised for use in November 1999, the board has received 85 adverse reaction reports relating to the drug, of which eight have been classified as cardiovascular in nature" [Irish Health]

Cardiologist testifies in Vioxx suit

"Two heart specialists testified Thursday that a man suing the maker of Vioxx over his heart attack had a healthy heart before being stricken, and that the painkiller may have been the cause.

"Humeston, a Boise, Idaho, postal worker, was a nonsmoker with no history of high blood pressure, heart disease, family history of heart trouble or diabetes when he had the heart attack in September 2001, Dr. David Sim testified on a videotape played for jurors in Humeston's product liability trial against Merck & Co." [Businessweek]

Pharma investors turn wary after huge Vioxx award

"International investors turned wary on pharmaceutical stocks on Monday after a $253 million award against Merck & Co. Inc. (MRK.N: Quote, Profile, Research) over its withdrawn painkiller Vioxx.

"Drug shares were the biggest fallers on European markets by mid-session as the verdict by a Texas jury set alarm bells ringing about product liability risk across the industry. [Reuters]

$365m Vioxx award buoys lawyer for NZ patients

"A $365 million award against a drug company over the discredited painkiller Vioxx is encouraging for New Zealanders planning to sue the company, a lawyer says." [NZ Herald]

Reuters Business Channel | Reuters.com

"Shares of Merck & Co. fell on Monday as investors assessed the liability the company must overcome after a $253 million jury award, the first of possibly thousands of lawsuits it faces over pain killer Vioxx.

"Merck was off 54 cents, or 1.92 percent, at $27.52 in afternoon trading on the New York Stock Exchange." [Reuters]

Texas jury finds Merck liable for Vioxx

"In a landmark decision for the drug industry, a Texas jury has found Merck & Co. liable in the sudden cardiac death of a man who had used the company's recalled drug Vioxx, awarding the man's widow $253.4 million in damages.

"In a statement released after the verdict, Merck said that it was 'disappointed' by the verdict and planned to appeal." [MarketWatch]

Chronology-Key events in the development of Vioxx

"A jury on Friday found Merck & Co. (MRK.N: Quote, Profile, Research) liable in the death of a Texas man, in the first civil trial against the company's popular painkiller Vioxx.

"A timeline of the drug's history follows:" [Reuters]

Merck shares fall after jury finds it liable in first Vioxx trial

"Shares of Merck & Co. fell Friday immediately after a Texas jury found the pharmaceutical giant liable in the first trial involving a death linked to its Vioxx painkiller. The man's widow was awarded $253.4 million in damages.

"Although Whitehouse Station-based Merck plans an appeal, the uncertainty from thousands of other cases pending around the nation will be a drag on share price, said analyst Jon LeCroy at Natexis Bleichroeder Inc." [Newsday.com]

Jury awards widow $253.4M in Vioxx trial

"A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country

"A seven-man, five-woman jury deliberated for 10 1/2 hours over two days before returning the verdict. Merck said it plans to appeal.

"Mrs. Ernst began to cry when the verdict was read while her attorneys jumped up and shouted, 'Amen!'" [BusinessWeek Online]

Merck Is Found Liable for Man's Death in Vioxx Trial

"Merck & Co. must pay more than $253 million to the family of a Texas man who died after taking the company's Vioxx painkiller, a jury ruled in the first personal-injury case over the drug to come to trial.

"Jurors awarded $24.4 million in actual damages and $229 million in punitive damages to the family of Robert Ernst. Merck will appeal, spokesman Kent Jarrell said. The company's shares fell as much as 6.8 percent." [Bloomberg]

Merck Loses First Vioxx Trial

"A jury ruled today against Merck on all major counts in the first trial relating to its withdrawn painkiller Vioxx, awarding a Texas widow $253.4 million in damages.

"The verdict is a blow to the once well-regarded drug giant, whose shares immediately plunged as much as 8%, to $28.07." [Forbes.com]

Jury Awards Widow $253.4M in Vioxx Trial

"A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country

"A seven-man, five-woman jury deliberated for 10 1/2 hours over two days before returning the verdict. Merck said it plans to appeal.

"Plaintiff Carol Ernst began to cry when the verdict was read while her attorneys jumped up and shouted, 'Amen!'" [USA Today]

SEC Asking Pfizer for Bextra, Celebrex Data

"Pfizer Inc. is responding to a request from the Securities and Exchange Commission for information and documents on its Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing." [Washington Post]

Patch watch - The Boston Globe

"OFTEN, THE Food and Drug Administration approves drugs after trials with a few thousand users only to see problems emerge later when the drug reaches the general market. It happened with the pain medication Vioxx, and it might be happening now with the hormonal patch for birth control, Ortho Evra. The FDA should require a large, rigorous controlled study of the patch to make sure that it is, at a minimum, no more likely to cause life-threatening blood clots than the birth control pill." [Boston Globe]

Lilly posts second-quarter loss on hefty Zyprexa settlement

"Eli Lilly & Co. posted a second-quarter loss Thursday after taking a one-time charge of $1.07 billion to cover a product liability case involving its top-selling drug, the anti-psychotic treatment Zyprexa." [Miami.com]

Who pays for recall surgery?

"Guidant, which recalled or issued alerts for about 50,000 devices in the past month, has offered to provide a replacement device for free and reimburse the patient for up to $2,500 in uncovered out-of-pocket expenses. While that is a significant offer, considering the ICDs run $20,000 to $25,000 each, it still leaves someone picking up the tab for doctors' fees and hospital charges, which average $23,000." [startribune.com]

FDA puts Guidant recall in Class 1

"On Friday, the Food and Drug Administration placed three models of the company's implantable cardioverter defibrillators (ICDs) in its highest risk category.

"The FDA's Class I ranking means users of the device could suffer death or serious injury if the device fails. Guidant advised physicians about the possibility of problems with the devices last week." [startribune.com]

Texas Joins Plaintiffs Suing Merck Over Vioxx

"The state of Texas on Thursday joined the thousands of individual plaintiffs suing Merck & Co. over its withdrawn painkiller Vioxx.

"Texas Attorney General Greg Abbott alleges that Merck 'falsely touted' Vioxx's safety, knowing it had higher heart risks, and still pushed for the drug to be on Texas' list of approved medicines for its Medicaid program." [REDNOVA.com]

Texas files suit against Merck over Vioxx - Yahoo! News

"Merck, already facing more than 3,800 lawsuits filed for patients allegedly killed or injured by its Vioxx painkiller, was hit with a new legal attack Thursday as the state of Texas accused the firm of covering up the drug's health risks." [Yahoo! News]

Guidant issues 2nd warning on defibrillators

"Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of the models because they could malfunction and may have to be recalled." [Chicago Tribune]

Lilly to Settle Zyprexa Claims

"Eli Lilly announced late Thursday that it will settle about three-quarters of the liability clams stemming from its Zyprexa schizophrenia drug.

"Lilly will establish a fund not to exceed $690 million for plaintiffs who agree to settle their claims. The number of claimants covered by the settlement is estimated to be 8,000, comprising about 75% of the claims." [ThsStreet.com]

Guidant issues warning on more defibrillator models

". . . [t]he latest concerns with Guidant defibrillators may force the Food and Drug Administration to put a 'recall' label on the devices. Last week, Guidant (GDT) said some of its older model defibrillators contained flaws, but those models are out of circulation. The new warning comes on devices that Guidant now is selling." [Investor's Business Daily]

Guidant's recall clouds merger status

"Guidant Corp.'s stock price sank 3 percent Monday as investor questions rose over the medical device maker's defibrillator recall and its impact on the pending takeover by Johnson & Johnson.

"Guidant's share price fell $2.16, to $70.30, its lowest price since the Indianapolis company agreed on Dec. 15 to be acquired by Johnson & Johnson." [Indystar.com]

Patients call doctors after Guidant recall

"Nervous patients called their doctors Monday to have potentially faulty implanted heart devices checked out after the company offered to replace thousands of them because of flaws.

For 44-year-old Alan Black, the potential for a short circuit in his defibrillator was enough to convince his doctor to schedule replacement surgery for June 30. The Lock Haven, Pa., resident got his device in 2002." [Seattle Post-Intelligencer]

Future of Bextra in doubt

"Pfizer Inc. wants to put its second-generation COX-2 drug Bextra back on the market but lawyers for patients who contend they were harmed by the drug warn it was approved too hastily in the first place.

[...]

"The pharmaceutical giant voluntarily suspended sales of the $1 billion-a-year anti-inflammatory painkiller April 7, one day after a 19-page Food and Drug Administration memo raised concerns of possible health risks of COX-2 inhibitors, the class of painkillers touted as being easier on the stomach lining than aspirin. Bextra, Pfizer's second generation COX-2 after the success of Celebrex, was prescribed for treatment of arthritis, rheumatism and menstrual pain." [Science Daily]

E-mails Suggest Merck May Have Known of Vioxx's Risks: Report

"Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?

"The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack." [KLASTV.com]

News: Medical whistleblowers speak out

"The US Food and Drug Administration (FDA) was 'the single greatest obstacle to doing anything effective' about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

"In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, 'Nearly 60,000 people probably died from that drug. That's as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn't.'" [MyDNA.com]

Whether older NSAIDs like ibuprofen pose risks like Vioxx, Bextra still unknown DRUG Q & A RICHARD HARKNESS

"Reading news releases during the past months has been like watching an infection spread. First to get the cardiovascular risk bug was Vioxx. Next, Celebrex came down with it, then Bextra. Finally, the traditional NSAID naproxen appeared to catch it, causing suspicions to spread through the entire lot." [Times-Leader]

Tens of thousands of cases seen in Vioxx litigation

"A federal judge told dozens of lawyers crowded into a courtroom here Monday that there could ultimately be up to 100,000 cases filed against Merck (MRK) over its now-withdrawn pain reliever Vioxx, and that he could hear a case as early as the fall.

"There have been more than 2,000 cases filed against the Whitehouse Station, N.J.-based drugmaker so far. The pretrial issues for federal cases are being handled by U.S. District Court Judge Eldon Fallon, and lawyers from both sides met here for a monthly status conference." [USA Today]

FDA races to keep up with drug ads that go too far

"The TV commercial for the drug Enbrel was upbeat, engaging and, the Food and Drug Administration said, misleading.

"A young woman ran on a beach, flinging off her top to reveal her swimsuit and perfect skin. 'Want to get psoriasis off your back?' the voice-over asked." [USA Today]

New generation of robber barons

"CEOs can win big even when the company loses. Merck, for example, had to pull its Vioxx pain medication off the market because it increases stroke and heart attack risk, and Merck stock was down 28 percent last year, but CEO Ray Gilmartin got a supposedly performance-based bonus. His total 2004 compensation was $37.8 million and he received a new grant of 250,000 stock options." [NorthJersey.com]

Once-active man joins Vioxx attack

"John Honea went into semi-retirement at age 48, but now he's in full retirement after taking a drug called Vioxx.

"Honea, now 52, was a lieutenant colonel in the Air Force until 2000. He served 30 years. He had physicals every two years that he says showed none of the warnings signs of heart disease. His blood pressure and cholesterol were in check. He never smoked, and there was no family history of cardiac problems." [Denver Post]

News Feature

"Concerned by recently discovered dangers of relatively new arthritis and depression drugs, most Americans would prefer a drug that has been on the market at least a decade, according to a new survey.

'Seven out of 10 American consumers would prefer a drug that had been on the market for 10 years or more over newer drugs, even if the co-pays were equal,' according to the survey of 1,092 insured adults sponsored by pharmacy benefit manager Medco Health Solutions." [MaconDaily.com]

Senate panel passes bill to allow more Vioxx users to sue

"For some users of Vioxx and Bextra, known as Cox-2 inhibitors, the statute of limitations ran out before the drugs were found to increase the risk of heart disease and stroke, so the patients were unable to sue the drug's manufacturer, Merck & Co.

"The bill passed the Senate Judiciary Committee 4-3 with all Democrats voting in favor and all Republicans opposed. It will now go to a vote in the full Senate.

"The bill would extend the deadline for filing lawsuits to two years after the cause of injury was discovered. For Vioxx users, that would be two years from Sept. 30, 2004, the date the drug was pulled from the market." [OregonLive.com]

Citizens group pushes for end to drug company immunity

"A new citizens group wants to overturn Michigan's law protecting prescription drug companies from liability lawsuits.

The group, called Drug Industry Immunity Must End, held a news conference Monday to express its support for bills expected to be introduced in the state Legislature this week. The legislation would repeal the state's 1996 law that shields drug makers from liability if their product was approved by the Food and Drug Administration" [Detroit Free Press]

You Stopped Taking Bextra, Now What

"Citing serious cardiovascular risks, the FDA recently pulled a whole class of drugs off the market including Bextra.

"Dr. Frederic Kahl, a cardiologist with Wake Forest University Baptist Medical Center says, 'The recent alerts by the FDA have covered the entire class of NSAID's, so that includes Celebrex, Bextra is off the market, Vioxx is off the market, and it includes all the prescription strength ibuprofen and naproxen.'" [WFMY News]

Company deceived doctors about Vioxx's safety, lawmaker says

"After a March 2000 study linked Merck's painkiller Vioxx to heart problems, Merck instructed its marketing force not to discuss the findings with physicians, according to company documents released Thursday by a congressional committee. Instead, Merck's sales staff provided doctors with different studies that suggested Vioxx was safe.

"Those actions, along with a multimillion-dollar ad campaign, helped make Vioxx a success for Merck. It reached $2 billion in annual sales faster than any of the company's other drugs, said Rep. Henry Waxman, D-Calif. But Vioxx may also have been a factor in thousands of heart attacks and strokes in patients who would have been better served with another medication, according to medical experts." [Kansas City Star]

Panel Finds Merck Went on 'Offense' in Promoting Vioxx

"Merck & Co. sales personnel, using projects code-named 'Offense' and 'XXceleration,' took extensive measures to boost sales of the painkiller Vioxx amid brewing safety concerns.

Documents released Thursday at a congressional hearing detail how a sales army of 3,000 turned the drug into a multibillion-dollar blockbuster before it was pulled from the market last fall because of an increased risk of heart attack and stroke." [NewsFactor.com]

Frontline - Pfizer Suspends Marketing of Bextra

"In answering FDA's request of last week to voluntarily remove Bextra (valdecoxib) from the market, pharmaceutical giant Pfizer efficiently set in motion the requisite actions, all the while disagreeing with FDA's conclusions about the prescription anti-inflammatory drug.

'Pfizer has not yet decided to recall, but rather has agreed to suspend marketing,' according to a Food & Drug Administration spokesperson. FDA defines recall as the 'removal or correction of a product actually in the distribution chain.'" [FrontLineToday.com]

DRUG ADS SHOW 'BEXTRA' CAUTION

"The withdrawal of two once-heralded painkillers within months is putting pressure on Big Pharma to take a hard look at its marketing tactics.

"In one prominent example, Johnson & Johnson has altered the tone of a recent campaign for its Ortho Evra birth-control patch to focus on potential medical concerns. One ad shows a doctor warning a young woman about the dangers of a stroke from smoking while on the patch." [New York Post]

FDA Public Health Advisory FDA Announces Important Changes and Additional Warnings for COX-2 Selective�and Non-Selective Non-Steroidal Anti-Inflammato

"Today, the Food and Drug Administration (FDA) is announcing that it has asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide." [FDA Repost @ Alexanderlaw.com]

Pfizer Pulls the Pin on Bextra

"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.

"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]

Pfizer Pulls the Pin on Bextra

"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.

"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]

Pfizer Pulls the Pin on Bextra

"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.

"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]

Sanford Bernstein Analyst: Return Of Bextra Unlikely >PFE | newratings.com

"Pfizer Inc.'s (PFE.NYS) withdrawal of its painkiller Bextra was not a total surprise and it is unlikely Bextra will return to the market, said Richard Evans, pharmaceuticals analyst at Sanford Bernstein.

'I think this should be the expected outcome,' Evans told CNBC Thursday.

"Earlier, Pfizer confirmed the U.S. Food and Drug Administration asked it to pull Bextra from the market amid worries of increased cardiovascular risk and to add so-called 'black box' warnings to another painkiller, Celebrex." [NewsRatings.com]

Bloomberg.com: Top Worldwide

"Pfizer Inc., the world's largest drugmaker, dropped after the company suspended sales of its Bextra painkiller." [Bloomberg.com]

FDA tells Pfizer to pull Bextra off market

"Food and Drug Administration officials Thursday told Pfizer Inc. to take its COX-2 drug Bextra off the U.S. market and put a warning on Celebrex." [Scient Daily]

Scotsman.com News - Latest News - Bextra Painkiller Sales Suspended in Europe

"Drugs company Pfizer today agreed to suspend sales of its pain-killing drug Bextra across Europe.

"The announcement is the latest to affect the class of drugs known as COX-2 inhibitors following the withdrawal of Vioxx last year due to concerns over an increased risk of heart attack and stroke." [Scotsman News]

Pfizer Yanks Bextra off Market

"Pfizer withdrew Bextra from the market Thursday after U.S. and European regulators said the arthritis drug’s risks may outweigh its benefits.

"The U.S. Food and Drug Administration also asked the company to put a so-called “black box” warning on its painkiller Celebrex, which is a strong cautionary notice on its use.

"Pfizer said it disagrees with the findings, but would comply with both requests as it pursues further discussions with the FDA. The agency previously advised U.S. physicians to limit prescriptions of both drugs due to evidence they might increase the risk of heart problems and stroke." [Red Herring]

Pfizer takes painkiller Bextra off market

"The painkiller Bextra was taken off the market Thursday, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them." [BusinessWeek.com]

Group Claims Merck Failed to Warn Hispanics in Spanish About Vioxx Cardio Risks

"As embattled pharmaceutical giant Merck attempts to recover over the fallout of its pain reliever Vioxx, Consejo de Latinos Unidos, a national non-profit organization which educates and assists Latinos and others, will release an investigative study conducted in Puerto Rico that shows that Hispanics patients and physicians appear to have never been informed in Spanish about the cardiovascular risks of Vioxx" [PRNewswire]

Times Argus

"Barbara Birmingham faced a busy weekend recently, so she went into her medicine cabinet for a fix: a couple of doses of a medication that had been pulled from the market for safety reasons. Her leftover supply of the drug enabled her to get through the weekend. When she told her doctor what she had done, she says, he scolded her."

Merck Updates Vioxx Legal Saga

"As the number of Vioxx-related cases mounts, Merck (MRK:NYSE - commentary - research) is discovering that some of its insurers don't want to pay for the company's defense against the lawsuits. Merck says it will fight the insurers' efforts to reduce or eliminate coverage." [TheStreet.com]

Consumer Confusion Persists on Painkillers' Safety

"Following months of public wrangling over the safety of cox-2 inhibitors and even with a federal advisory panel's endorsement to keep them on the market, consumers are still as confused as ever about these powerful painkillers." [Forbes.com]

Bush Fills Long-Standing Vacancy at FDA

"President Bush said Monday he will nominate Lester M. Crawford to be commissioner of the Food and Drug Administration, filling a position that has been vacant for nearly a year amid rising concerns about the safety of drugs on the market." [AP Wire]

More Bad News For Merck Over Vioxx Article?

"An article published in the Wall Street Journal today questions when Merck knew their pain drug Vioxx caused patients to experience an increase in the risk of suffering heart problems.

"The article indicated a Merck panel looking at the safety of the arthritis pain drug had information that Vioxx increased the risk of heart problems after four months of patient use.

"The information appears to conflict with a statement Merck made when the drug maker pulled Vioxx off the market in September." [Health Talk]

RedNova News - Merck Says It Decided Against Vioxx Study Three Years Ago

"Merck & Co. three years ago proposed, but ultimately decided against, a study of its withdrawn painkiller Vioxx that would have specifically looked at the drug's cardiovascular risks.

"Instead, the drug maker, which detailed its decision in a filing posted Friday on the Web site of the Food and Drug Administration, decided to gather data of Vioxx's heart effects through other studies evaluating its impact on various cancers. Data from one of those trials led Merck to withdraw the drug from the market Sept. 30 because of increased risks of heart attack and stroke.

"In an article Tuesday, The New York Times cited other company documents that said the canceled Vioxx study could have provided answers to Vioxx's risks in March of last year or earlier." [RedNova News]

Merck's Successor To Vioxx Has Heart Aches

"Arcoxia, Merck's successor to Vioxx appears to be worse than other painkillers when it comes to cardiovascular problems and deaths, according to documents released Friday by U.S. Food and Drug Administration staff reviewers." [Health Talk]

FDA to Weigh Fate of Bextra, Celebrex, Similar Drugs

"When it debuted in 1999, Vioxx was hailed as a wonder drug, even though its advantage lay not in better pain relief but in fewer side effects.

"Soon, the drug and others like it in the same class of cox-2 inhibitors became widely prescribed, particularly to arthritis sufferers, thanks to heavy advertising by manufacturers.

"Now, the drugs face intense scrutiny over heart risks posed by the medicines. Starting Wednesday, a U.S. Food and Drug Administration (FDA) advisory panel will meet for three days to debate the future of the cox-2s and perhaps even their predecessors, the cox-1s." [Forbes.com]

How Much Bad News Can Merck Sustain?

"First it was the Vioxx disaster, and now a challenge by Teva Pharmaceutical (TEVA) has unhinged its patent for Fosamax, its second top selling drug. The timing couldn't be worse. In 2006 it will lose it number one drug, Zocor, to generic competitors. Zocor is a statin, in a similar class with Pfizer's (PFE) Lipitor and Pravachol from Bristol-Myers-Squibb (BMS)." [Investors.com]

Vioxx was over-prescribed and under-regulated

"A study of the arthritis drug Vioxx has shown that it may have caused up to 140,000 cases of heart disease in the United States before it was withdrawn from sale. A separate study finds that many of the victims may have received the drug unnecessarily.

The estimate comes from David Graham, a researcher at the US Food and Drug Administration (FDA) in Rockville, Maryland, and his colleagues. The painkiller rofecoxib, sold under the name Vioxx by New Jersey-based manufacturer Merck, was pulled from the market in September 2004. The decision was made after a study of Vioxx’s effect on colorectal cancer revealed that it increased patients’ risk of heart attacks." [The Manila Times]

NBC11.com - Health - Kaiser Stops Dispensing Bextra

"The nation's largest not-for-profit managed-care provider has stopped prescribing Bextra until tests show whether the painkiller is safe.

"According to a company memo, Kaiser Permanente's decision came amid compelling evidence of heightened heart risks associated with Bextra and a similar drug called Vioxx." [NBC11.com]

MercuryNews.com | 01/29/2005 | Kaiser bans prescription painkiller Bextra over concerns about safety

"Citing safety concerns over heart attacks and strokes, health care giant Kaiser Permanente will no longer prescribe Bextra -- a popular painkiller similar to the recently pulled-off-the-market Vioxx -- for its millions of patients." [MercuryNews.com]

E-Commerce News: News: Consumer Advocates Urge Pulling Two Drugs off Market

"The Food and Drug Administration should immediately yank Celebrex and Bextra from the market to protect Americans from the drugs' heart risks, according to a petition filed with the agency yesterday by Public Citizen. The petition also requests that the FDA freeze applications for Arcoxia and Prexige -- two painkillers under development -- for the same reason." [Ecommerce Times]

BBC NEWS | Business | Vioxx drug ban hits Merck profits

"Profits at US pharmaceutical giant Merck fell 21%, after the firm was forced to withdraw its Vioxx painkiller last year" [BBC]

Vioxx Overuse Blamed On Aggressive Advertising

"Cox-2 inhibitors like Merck's Vioxx, and Pfizer's Celebrex were aggressively promoted directly to consumers, leading to their overuse, according to a new study." [Health Talk]

FDA: Painkiller Ads Misleading |

"Pfizer Inc. ads for the painkillers Celebrex and Bextra mislead consumers and fail to properly disclose the drugs' side-effects, the U.S. Food and Drug Administration (FDA) told the pharmaceutical company." [JoinTogether.org]

Consumer Group Lists 'Worst Pills'

"In the wake of the health dangers linked to the prescription medications Vioxx and Celebrex, a consumer group has come out with a list of some 180 other government-approved drugs it says may do more harm than good.

'There are 180 government-approved pills on a list called 'The Worst Pills.'" [KIROtv.com]

Dizzy from drugs' side effects

"I kind of miss seeing Dorothy Hamill glide across the surface of those Vioxx commercials on her silver blades. The Olympic gold medalist reminded me of the old joke about the man who asks his surgeon if he'll be able to play the piano after the operation. When the doctor says yes, the man says, 'That's funny, I couldn't play it before.'" [IndyStar.com - Opinion]

Pfizer Falls on FDA Move

"Pfizer shares fell Thursday following a Food and Drug Administration warning about company advertising for two controversial pain drugs.

"The FDA sent a letter to the New York drugmaker stating that television and print ads for the drugs Bextra and Celebrex were misleading. The letter said the ads did not fully disclose side effects while also making 'unsubstantiated effectiveness claims.'" [TheStreet.com]

HoustonChronicle.com - Pharmacy: What is a safe drug?

"In 2005, it is quite possible that we are less safe from medication mishaps than we were in 1975. It's not that medications have become more toxic, but our attitudes have changed. Americans have become far more cavalier about the pills we pop.

"Part of that is due to advertising. If you watch a 30-second commercial on TV for Viagra, Lipitor or Nexium (the Purple Pill), you might start to think of potent prescription drugs as if they were consumer products like shampoo or beer." [Houston Chronicle]

News on pain relievers enough to cause headache

"Read the fine print of any medication, and you might hesitate to take it.

"In recent weeks, it's not fine print but news headlines that are confusing and scaring folks who take pain relievers.

"First it was the prescription drug Vioxx, pulled from the market in September because of studies linking it with heart disease. Then in December, the Food and Drug Administration issued a public health advisory about similar drugs, Celebrex and Bextra." [Syracuse Post-Standard]

You get relief. You also get some health risk. This is the deal you cut . . .

"In the past few weeks, both Celebrex and Bextra--which belong to a popular class of pain relievers known as Cox-2 inhibitors--and the widely used over-the-counter pain reliever naproxen, sold as Aleve, have been linked to an increase in heart attacks and strokes." [USNWR]

Another Vioxx Headache for Merck

"Food and Drug Administration researcher Dr. David Graham is reportedly ready to publish research that suggests up to 139,000 Americans have died or have been seriously injured as a result of taking the drug.

"The research would be published in The Lancelet, a leading British medical journal, according to a Monday report in the Financial Times." [TheStreet.com]

Merck slides on Vioxx report

"David Graham, a leading researcher for the Food and Drug Administration, said in an interview with the Financial Times that he now estimates Vioxx may have harmed as many as 139,000 users. He had said previously that he thought the number might only be 28,000." [CBS MarketWatch]

RedNova News - Vioxx, Celebrex Furor Tops Health News for '04

"For years, Americans turned to the blockbuster drugs Vioxx and Celebrex for relief from chronic pain. But as 2004 ends, Vioxx is no longer on the market and the future of Celebrex remains unclear.

"The tattered reputation of the cox-2 inhibitor class of analgesics not only left millions without their preferred method of pain relief, it also prompted criticism of the role -- even the integrity -- of the U.S. Food and Drug Administration, making the drug debacle the year's top health news story." [RedNova.com]

Forbes.com: Vioxx: More Debate, More Data

"As doctors struggle to come to grips with what the withdrawal of Vioxx means for drug safety, the letters pages of the normally sedate New England Journal of Medicine have turned into a battleground." [Forbes.com]