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.

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.

Paxil is an antidepressant drug that has been under a lot of critical target ever since an FDA warning was issued in December 2003. As the number of people diagnosed with depression continues to increase, with figures tripling since the 1980s, the competition between drug companies trying to capitalize on the growing market has also increased. Despite the fact that over half the drug company studies through the 1990s showed no more effectiveness than a sugar pill, the use of antidepressants like Paxil continued to flourish.

In the summer of 2003, British regulators issued a warning to doctors to avoid prescribing Paxil to children due to the new data linking the antidepressant to suicide attempts. The statement released by the British equivalence to the U.S.’s FDA was that “it has become clear that the benefits (of Paxil) in children for the treatment of depressive illness do not outweigh these risks.” In the U.S., the FDA did not issue a Paxil warning until nine days later.

For thousands of parents learning that a threefold increase of suicide existed because of the use of Paxil, the news was frightening and upsetting. Other parents that had already seen their children’s ill response to Paxil, in addition to some researchers and lawyers, finally felt like progress was being made in their long pursuit to get Paxil restricted or banned. Paxil has been linked to deadly side effects that some people claim was allowed to continue because the company manipulated data to diminish the appearance of suicide risk amongst patients and the FDA.

Thousands of products are recalled every year. Unfortunately, most recalls are made after serious injury or death has occurred. If you or a loved one has been injured by a recalled product, you may be entitled to monetary awards for your injury.

Tamoxifen is a drug that has been used for many years to treat women with invasive breast cancer. Even though Tamoxifen has important benefits, the drug can have some serious negative side effects. The use of Tamoxifen increases the risk of several life-threatening diseases, including endometrial cancer, stroke, and pulmonary embolism. New data now indicates that Tamoxifen may also increase the risk of uterine sarcoma, a rare and life-threatening cancer of the uterus.

Cisapride (Propulsid) is a drug that is commonly used in the treatment of heartburn in patients with gastroesophageal reflux disease (GERD), also known as acute nighttime heartburn. It has been on the market in the U.S. since 1993, and has now been found to be the cause of dangerous heart irregularities, ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation.

Meridia, a diet drug, was first approved by the FDA in 1997, one year after the advisory committee voted 5-4 that the benefits of Meridia did not outweigh the risks. Meridia had received a review from an FDA medical officer concluding that a non-approval was recommended due to the significant increase in blood pressure and heart rate in many people. Meridia has now been associated with 29 deaths, including 19 due to adverse cardiovascular effects.

Meridia is found in 70 countries and has been used by 8.5 million people worldwide. But the sales success of Meridia has turned into a safety question. After two cardiovascular deaths occurred in Italy, the use of Meridia was suspended so that a safety review could be performed. This Meridia suspension in Italy was the first country movement to investigate the safety of the weight loss pill that led to a Europe-wide review of the drug. France and Great Britain have also banned the drug due to its adverse cardiovascular effects.

Pemoline is a stimulant used to treat attention-deficit disorder. Pemoline may be prescribed for other conditions as well. Pemoline (Cylert) has been known to cause rare cases of liver damage, some serious enough to be fatal. Children taking Cylert should have their liver function tested every two weeks. If the child develops any signs of liver damage, call your doctor immediately. Warning signs include fatigue, loss of appetite, digestive problems, yellow skin or eyes, and pain in the upper right section of the abdomen.

Ephedra is a stimulant found in many diet pills and sports drinks that has been linked to a high number of serious adverse effects but has not been able to be regulated. Ephedra is an herbal stimulant taken from an evergreen plant found in Central Asia and is classified as a food so the FDA has been unable to regulate it despite the reports of chest pain, myocardial infarction, hepatitis, stroke, seizures, psychosis, and death. Despite the inability to regulate ephedra- containing products, the FDA has been collecting reports on the supplement attributed to over 100 deaths.

Consumer group Public Citizen has been actively trying to have ephedra banned from consumer use since September 2001. Despite support from consumer advocates, healthcare professionals, and the FDA to ban ephedra-containing products, ephedra has remained popular, selling three billion servings every year. Recently, the U.S.’s largest selling ephedra-containing product Metabolife was put under criminal investigation for lying to the FDA about adverse health effects the company had received reports of.

The FDA’s 1996 amendment to the Federal Food, Drug, and Cosmetic Act required that the agency show evidence that a marketed product like ephedra is unsafe instead of the company showing it is safe to receive FDA approval first. When company’s selling ephedra-containing products, such as Metabolife International, do not provide the FDA with adverse effects reports the FDA is unable to have evidence to remove dangerous products from the market. In 1995, a pharmacologist that was hired by the FDA to analyze the sudden increase in death and heart problems with teenagers that had used ephedra-containing products expressed his surprise that the FDA did not quickly restrict ephedra following the study.

Evidence of deadly and serious ephedra side effects has been noted as far back as 1994. Finally, in June 2002, the Health and Human Services announced the Rand Corporation would perform all scientific reports on ephedra’s safety and a decision would be made following the results. Ephedra is a popular ingredient in sports drinks and diet supplements because of the stimulant effects it has, including a low appetite and high alertness.

When the FDA approved a new drug called Serevent (almeterol xinafoate) for the treatment of asthma in 1994, they were unaware of the problems to come. Serevent, manufactured by GlaxoSmithKline, later had its FDA-approved use extended to include treatment of chronic obstructive pulmonary heart disease. Used daily, Serevent controls the symptoms of asthma and is considered a long-acting bronchodilator. According to Serevent marketing material, the medication provides up to twelve hours of relief from chest tightness and wheezing related to asthma and other chest conditions. While Serevent enjoys great popularity with asthma victims, many users remain unaware that a recent study showed that users of Serevent are three times more likely to die asthma-related deaths as users of other asthma medications.

In 1996, Serevent was the subject of a study conducted by GlaxoSmithKline (due to FDA concerns). During the Serevent study, a number of participants suffered fatal asthma attacks, leading to the cancellation of the study. In all, 36 participants in the Serevent study experienced life-threatening asthma episodes, including several who died. Some of the Serevent users had such severe difficulty breathing that they were intubated to re-open their airways. African-Americans who use Serevent are at a higher risk for these problems than users of other ethnic backgrounds, and patients who do not use Serevent in combination with another drug to fight inflammation also have increased odds of complications. A safety monitoring board shut down the Serevent study, and the FDA required GlaxoSmithKline to place a black box warning (the highest level of warning) on all Serevent product packaging and marketing materials. As of December 2003, no such warning existed on any Serevent material, and there is no known target date for a warning to appear.

Patients who are currently taking Serevent should consult a physician before altering or ceasing treatment. Many individuals have benefited from the use of Serevent, but it is important to discuss all potential side effects with your doctor, to determine whether or not Serevent is the best option for controlling your asthma. If you or a loved one has suffered adverse effects or death as a result of using Serevent, GlaxoSmithKline may be liable, and you could be entitled to recover all costs associated with medical treatment, hospital and/or funeral expenses, lost wages, pain and suffering, and punitive damages.