Injury News

On January 18th, a new drug was accepted by the Food and Drug Administration to treat HIV symptoms, according to the news article found on Reuters.com. This drug, called Intelence, will aid for treatment of patients who have seen resistance to other medications that they have taken to treat HIV. So Intelence is definitely not a cure or a prevention of HIV but to help treat the symptoms once you have HIV in your system. The Reuters.com article stated, “Close to 40 million people are infected with HIV,” which creates a high demand for this type of a drug in the market. The article also says that there are already over two dozen medications available for the treatment of HIV.

Intelence was discovered by the company Johnson & Johnson. It is to be administered for HIV patients who have proven resistance to other therapies they have tried. The article reported the most common side effects were skin rashes and nausea, and if you notice a rash to immediately contact your doctor. The long term side effects are unknown at this point due to the newness of the drug. Stated in the article, “The drug, also known as TMC125 or etravirine, is a new member of the family of AIDS-fighting drugs called non-nucleoside reverse transcriptase inhibitors (NNRTI)… The new tablet is the first NNRTI to work for patients who have developed resistance to medicines in the same family.” So in response to the growing number of people seeing HIV symptoms, Intelence could be a positive alternative. And with all the medicines that are approved, hopefully the research will eventually lead to a cure of HIV, but until then we must rely on what the FDA has approved for public use.

Welcome to our new Injury News Blog. We will be bringing you the latest in Personal Injury news, and injury claim information. Thanks for visiting!

Primarily, we hope we get the vision across to our readers that there is help and a light at the end of the tunnel. Sometimes after a brutal accident occurs, many people may get discouraged. They may think there is no hope, no nope for justice. That is not true and we would like injury victims to feel a sense of relief by finding our website.

We will do our best to stay current with the health news and any kind of recall information published. You should be able to find it within our resources. It’s hard to stay on top of the news with so many beneficial medicines and approved drugs out there. The general public needs to have access to the FDA recalls, as well as side effects of a prescription. It will be our job to bring this news to your attention.

When you visit your doctor because of symptoms you may be feeling, make sure you also share with your doctor the medications you are currently taking. This is vital information for your doctor to know, as certain drugs have chemical reactions to other types of drugs. When they interact it could produce a risky side effect that you have no idea about. Make sure every doctor you see, whether it is a Family Practitioner, Gynecologist, Dermatologist, Gastrointestinal Doctor, Dentist, Physician, Orthodontist, or surgeon, is fully aware of the medications you are using at the time you visit them. They have knowledge about the chemical interactions between medicines and may be able to prevent certain side effects. Combinations of medications usually always present a risk with side effects. It is important that you know which side effects may be normal and which ones, if severe, may be life-threatening. If you are unsure, ask your doctor. A pharmacist can be very helpful with medicines as well; consult your pharmacist if you have questions about your medications.

Always take your medications for the prescribed amount of time. Many colds or negative symptoms could come back if you stop taking the medicine before the prescription allows for. Even if you don’t see any symptoms after taking the medicine for just two days but it’s prescribed for 7 days, continue the use of that medication. Follow any instructions you may receive from your doctor or pharmacist. Some drugs are better when taken along with food and some are not. These instructions are significant to you in order to help your symptoms to clear up. Take their advice seriously.

If you are concerned about a certain medicine, there’s no problem with doing some research on your own before taking it. Be aware that not all information found online may be completely accurate. Be sure that you are researching through a trusted source of information.

We hope that we will make your experience better for you, that you can manage your injury or illness a little easier, knowing there are people you can count on to get what you deserve. A personal injury attorney or lawyer may be exactly what you need to receive the benefits you are entitled to. And we will update our health-oriented blog with any recalls or news that you should be aware of. Again, thank you for visiting our site and we hope you benefit from our information.

Also, below are sources for other information you may be searching for.

By Marilynn Marchione, THE ASSOCIATED PRESS

Getting a headache trying to choose a painkiller?

The government’s advice is to take the lowest possible dose for the shortest possible time, and talk with your doctor about what’s best for you.

No medicine is without risk, but nonprescription pain pills appear safe when taken at the suggested dose for no longer than two weeks, officials said.

Some answers for consumers:

Q: Which drugs are off the market and why?

A:Merck & Co.’s Vioxx and Pfizer Inc.’s Bextra have been removed by their makers. Pfizer’s Celebrex still is being sold. Vioxx and Bextra raised the risk of heart disease and strokes and Bextra also has been linked to serious skin problems.

Q: Are problems limited to these two drugs?

A: No. FDA officials think all prescription drugs in a wider category called nonsteroidal anti-inflammatory drugs, or NSAIDs, may carry some risk of cardiovascular problems and should now carry warnings. They said Celebrex’s benefits appear to outweigh its risks “in properly selected and informed patients,” and that’s why it is allowed to remain on the market. There are a variety of other prescription NSAIDs.

By: Marilynn Marchione, Associated Press

ANAHEIM, Calif.

With prescription drugs Vioxx and Bextra already pulled from the market, a study has raised disturbing questions about the heart safety of long-term use of over-the-counter pain relievers such as Advil, Motrin and Aleve.

Smokers in Norway who took such drugs for at least six months had twice the risk of dying of a heart attack, stroke or other heart-related problem.

The findings came from a study of whether these pain relievers could prevent oral cancer. The drugs did, in fact, cut the risk of developing oral cancer in half, but the deaths that were prevented were offset by the increased risk of dying from cardiovascular disease, according to the study, reported Monday at an American Association for Cancer Research conference in Anaheim.

The study was relatively small — 908 people — and involved people prone to heart problems and cancer because they smoked. But specialists said it supports the Food and Drug Administration’s recent decision to warn about long-term use of all such painkillers except aspirin.

The findings add to the suspicion that the heart risk extends beyond the so-called cox-2 drugs — Bextra, Vioxx and Celebrex — to the larger family of medications known as non-steroidal anti-inflammatory drugs, or NSAIDs, which include naproxen, ibuprofen and virtually all other over-the-counter pain relievers except acetaminophen or Tylenol.

In recent months, many doctors have switched patients to these over-the-counter medications, believing them to be safer alternatives.

“To the best of our knowledge, these are the first data to support putting a box warning on NSAIDs, not just cox-2s,” said Dr. Andrew Dannenberg, a Cornell University scientist who helped do the Norway study.

Vioxx was pulled from the market last fall when a different study, testing whether it could prevent colon cancer, showed a higher heart disease risk. The FDA recently persuaded Pfizer to stop selling Bextra for safety reasons, but Pfizer’s Celebrex was allowed to remain. Some researchers from the new study in Norway have been Pfizer consultants.

Some results from the Norway study were presented in February hearings at the FDA, but consisted of only one summary slide and “nobody really picked up on it,” said Dr. Raymond DuBois, a Vanderbilt University cancer expert who had no role in the work.

The fresh information presented on Monday should persuade others to study these over-the-counter drugs in more depth, DuBois said.

Oral cancer is a deadly and disfiguring disease that is an especially big problem in Asia. Worldwide, about 275,000 cases and 127,000 deaths occur each year. In the United States, about 29,370 new cases and 7,320 deaths are expected this year.

Dr. Jon Sudbo of the Norwegian Radium Hospital in Oslo, who led the research, and others wanted to see if NSAIDs could prevent oral cancer, since studies showed they could help ward off other types of cancer. They chose more than 3,000 people at high risk for oral cancer because of their smoking habits from the Norwegian Cancer Registry, a database of more than 123,000 people.

Over 20 years, 454 of them developed oral cancer, and they were compared with 454 similar people who did not develop the disease. Of these 908 people, 263 had used NSAIDs daily for at least six months. They had a two-thirds lower risk of developing oral cancer, but scientists were puzzled because deaths were not lower.

A deeper look revealed that the NSAID users were dying at twice the rate of the others from heart-related problems. There were 42 cardiovascular deaths among the 263 painkiller users and 41 deaths among the much larger group of 562 people who had never taken such drugs.

Risk was highest among ibuprofen users, who were nearly three times more likely to die of cardiovascular disease than non-NSAID users. Aspirin was the only NSAID that did not seem to raise the risk, but the numbers of aspirin users in the study were small.

Asked what advice he would give smokers about using such painkillers, Sudbo replied: “If you think you need them use them, but you have to be careful.”

Doctors said the NSAID dose made no difference in risk, but others said this should be studied in future experiments.

“There are important uncertainties. One of them is the doses and one is what the effect would be in the larger population,” said Dr. Michael Thun, chief of epidemiology for the American Cancer Society, who had no role in the study.

Thun said he would propose a larger study on over-the-counter NSAIDs using the cancer society’s huge database, which contains information on more than 1.2 million Americans.

In other news at the conference, a large study suggested that cholesterol-lowering statin drugs might help prevent the most serious types of prostate cancer — those that kill or spread throughout the body.

Men who took statins had half the risk of advanced prostate cancer as men who did not take such drugs, reported Elizabeth Platz of Johns Hopkins University, who did the study with Harvard University researchers and the National Cancer Institute.

It involved 34,438 men in the Health Professionals Follow-up Study, which has been going on at Harvard since 1986. None of the men had prostate cancer at the start of this particular study in 1990, but 2,074 developed it over the next decade. Of these, 283 were advanced, including 206 that were fatal or had spread widely in the body.

While statins cut the chances of this, they made no difference in the risk of developing cancer that remains confined to the prostate. Although several large other studies have concluded statins may cut the risk of cancer, specialists say there is still not enough evidence yet to recommend them for this purpose.

The FDA has ordered a new warning to be put on Zyprexa, as well as other antipsychotic drugs like Symbyax, Seroquel, Risperdal, Clozaril, Geodon and Abilify.

The FDA is alerting physicians to a higher death rate when the medicines are prescribed for atypical use of treating dementia in elderly patients. The agency said it has asked the Zyprexa manufacturer, as well as the other affected drugmakers, to add boxed warnings to the labels describing the increased risks and noting the drugs are not approved to treat symptoms of dementia in the elderly.

According to the FDA, the death rate for elderly patients on the medication were 1.6 to 1.7 times greater than those on a placebo, and most of the deaths were either heart related or from infections. Since the agency believes, after reviewing 17 studies of four drugs in the class, that the health risks are a class effect, it has ordered Zyprexa and other antipsychotic drug manufacturers to add the new warning labels.

An Eli Lilly spokeswoman said the Zyprexa label has carried a warning with data on increased mortality risk in elderly dementia patients since May 2004. In addition, the spokeswoman said the company notified physicians of the Zyprexa risk since January 2004.

The FDA has been the object of great criticism in recent months. Some influential members of Congress, including Senate Finance Committee Chairman Charles E. Grassley (R-Iowa), have been pushing for a more independent drug safety office within the FDA.

The FDA, according to some critics, has been ineffective in protecting public safety from dangerous drugs in part because of its very close relationship the agency has formed with the companies it is supposed to be regulating. Criticism of the FDA multiplied after last September’s announcement that Merck & Co.’s blockbuster drug Vioxx was being recalled from the market.

Vioxx was removed after studies indicated the drug caused risks of heart attacks and strokes among patients, and alongside the recall announcement came questions regarding the entire class of drugs Vioxx belonged to called COX-2 inhibitors. The popular class of drugs also included Pfizer Inc.’s Celebrex and Bextra.

In January, Public Citizen consumer group petitioned the FDA, requesting Pfizer’s Celebrex and Bextra be immediately banned from the market. Because of all the safety questions surrounding COX-2 drugs, an advisory panel to the FDA met for three days in February to discuss the drug concerns. In a narrow margin, the panel voted to allow Bextra to remain on the market, though most members agreed it carried serious risks for heart attacks and strokes.

In addition to the cardiovascular risks Bextra presents, the drug is also linked to a potentially deadly skin disease. Against the panel’s recommendations, the FDA said Bextra’s benefits do not outweigh its risks, leading the agency to ask Pfizer to remove Bextra from the market. Pfizer said it disagreed with the agency’s request, though the company halted sales in both the United States and the European Union in response to requests by regulators.

Some FDA critics are encouraged by the FDA’s latest decision, believing the Bextra withdrawal displays the agency’s desires to show it can respond aggressively to safety concerns. Others believe the FDA actions are too little too late.

Public Citizen still wants Celebrex removed from the market, especially considering sales of the drug was nearly two times as popular as Bextra last year and both drugs fail to protect the gastrointestinal tract as drugmakers claim, and Consumers Union asks why the unsafe drugs were allowed to be sold in the first place. Other critics of the regulatory agency hope that after some of the pressure and scrutiny is lifted that the interests of the general public in regards to unsafe drugs will continue to remain as the top priority.

Source: PR Newswire

Three Bextra lawsuits were filed against Pfizer Inc. on behalf of three individuals who allegedly were injured by the pain relief drug, Bextra, the Philadelphia law firm Kline & Specter, P.C. announced Monday in a statement.

Two of the plaintiffs suffered heart attacks and one sustained a stroke after taking Bextra, attorneys for the plaintiffs stated.

Pfizer, the world’s largest drug maker, suspended sales of Bextra in the United States and the European Union on Thursday after the Food and Drug Administration concluded that its overall risk versus benefit profile is “unfavorable.”

Bextra belongs to a class of drugs called Cox-2 inhibitors, including Celebrex, another Pfizer drug, and Vioxx, made by Merck & Company. All three painkillers have been amid controversy since September 2004, after Merck pulled Vioxx from the market because it was found to increase a patients’ risk of heart attack and stroke after 18 months of use.

But unlike Vioxx, Bextra was taken off the market because of its potential to cause a rare but serious skin reaction, which is already disclosed on its label, Pfizer said.

The Bextra lawsuits, filed in the Supreme Court of the State of New York on Friday, claim Pfizer failed to adequately and properly test Bextra, and failed to warn doctors, patients and others about its potential risks.

Source: Business Wire

A class action lawsuit was filed against Pfizer Inc., on behalf of all persons who died or were injured by the pain relief drug, Bextra, the Chicago law firm Kenneth B. Moll & Associates, Ltd. announced Monday.

The Bextra lawsuit accuses pharmaceutical giant Pfizer of failing to properly research the known risks of Bextra, warn consumers of the fatal side effects, and withdraw the drug from the market even when the dangers became widely known.

Pfizer suspended sales of Bextra in the United States and the European Union on Thursday after the Food and Drug Administration concluded that its overall risk versus benefit profile is “unfavorable.”

Bextra belongs to a class of drugs called Cox-2 inhibitors, including Celebrex, another Pfizer drug, and Vioxx, made by Merck & Company. All three painkillers have been amid controversy since September 2004, after Merck pulled Vioxx from the market because it was found to increase a patients’ risk of heart attack and stroke after 18 months of use.

But unlike Vioxx, Bextra was taken off the market because of its potential to cause a rare but serious skin reaction, which is already disclosed on its label, Pfizer said.

The Bextra lawsuit, filed in the Federal District Court for the Northern District of Illinois, seeks compensation for those who have died and been injured as a result of their use of Bextra.

Source: U.S. Food and Drug Administration
Published: April 08, 2005

Celebrex, a pain relief drug from Pfizer Inc., will include a boxed warning, highlighting the potential for increased risk of heart problems and the serious, potential life-threatening gastrointestinal (GI) bleeding associated with its use, the Food and Drug Administration said Thursday in a statement.

The agency is asking manufacturers of all prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Cox-2 selective drugs, to revise the labeling for their products to included this boxed warning.

Concerns about the safety of COX-2 inhibitors, like Celebrex and Bextra, another drug made by Pfizer Inc., increased when Vioxx was pulled from the market by Merck & Company in September 2004, after a study found that it increases a patients’ risk of heart attack and stroke.

Manufactures of non-prescription (over-the-counter) NSAIDS, including Motrin and Advil (ibuprofen) and Aleve (naproxen), are also being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products. In addition, the FDA is asking that the labels for Motrin, Advil and Eleve to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

FDA asked Pfizer to remove Bextra (valdecoxib) from the market on Thursday because the overall risk versus benefit profile for the drug is unfavorable.

After six months of questions regarding the COX-2 inhibitor class of drugs, including Merck & Co.’s Vioxx and Pfizer Inc.’s Celebrex and Bextra, the FDA has asked Pfizer to remove Bextra from the market.

Though Pfizer said it disagreed with the FDA’s request to withdraw Bextra, the company has stopped sales of its $1.3 billion in sales a year drug in the United States and the European Union. The safety of COX-2 drugs has been under scrutiny following last September’s Vioxx recall because of a study that linked the drug to heart attacks and strokes.

Vioxx, Bextra and Celebrex were said to limit gastric upset and bleeding caused by other anti-inflammatory drugs, but questions about the actual benefits of the drug class was raised when Vioxx was taken off the market. Because of the public controversy the Vioxx recall helped set off about the safety of Celebrex and Bextra, in addition to questions about the FDA’s ability to adequately protect the public from dangerous drugs, an advisory panel met in February for three days to discuss the drugs’ dangers.

The panel barely voted in favor of allowing Bextra to remain on the market, though it did recommend it carry the agency’s strongest drug warning indicating the risks of heart attacks and strokes it presented. Bextra already carried a black box warning for the risks of a potentially fatal skin disease called Stevens Johnson syndrome.

Because of the panel’s vote, Pfizer officials contend the government went against advice from an FDA panel of doctors and scientist. Even though the FDA usually follows its panel’s recommendations, the agency is not required to do so.

The vote narrowly favoring Bextra resulted in the FDA rejecting the advisory panel’s recommendation, stating the potential benefits to patients from Bextra carried less weight than the potential risks, especially because a similar drug with fewer risks was still on the market - Pfizer’s Celebrex. Along with the announcement that Bextra was being taken off the market, the FDA issued its strongest black box warnings for Celebrex and 19 prescription and over-the-counter products, including Advil, Aleve and Motrin.

The Public Citizen consumer group petitioned the FDA in January to have Bextra and Celebrex removed from the market because they raise the risk of heart attacks, and while the group agreed with the FDA’s actions for stronger warnings, it also continues to support a ban on Celebrex. Last year, according to the group, there were 23.9 million prescriptions sold for Celebrex compared with 12.9 million for Bextra.

In a statement issued on the day of the Bextra recall announcement, the group said, “neither Bextra nor Celebrex protects the gastrointestinal tract as drugmakers claim.” COX-2 drugs were believed superior over older drugs because they were thought to limit gastric upset and bleeding caused by other anti-inflammatory drugs, but the real benefit of the drugs has been questioned in recent months.

Pfizer currently ranks as the world’s largest drug maker.