Diabetes Drugs Avandia and Actos Linked to Vision Problems

Posted June 14, 2012 by HarmfulDrugInfoCenter
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(June 13, 2012) – A recent study published on June 11th in the Archives of Internal Medicine suggests that use of thiazolidinediones (TZDs), a class of drug used to treat Type 2 diabetes, which includes Avandia and Actos, may include the risk of vision problems. The study followed 103,000 people for ten years and found that:

 

–       Participants taking one of the medications were two-to-three times more at risk of developing macular edema, a swelling in the central part of the retina, which can lead to blindness (although the likelihood of developing the disease was small).

 

–       1.3 percent of participants taking one of the medications developed macular edema, compared to a rate of 0.2 percent among participants not taking either medication.

 

–       Combining the drugs with insulin further increased the risk.

 

Dr. Iskander Idris, one of the study’s authors and a consultant in diabetes and endocrinology at Sherwood Forest Hospitals Foundation Trust in England, speculated one reason the drugs may cause damage to the retina is because of greater sodium and fluid retention or changes in the blood vessels.  Dr. Idris suggests that people who take one of these drugs should have their vision checked regularly, especially if they are also taking insulin or have a history of visual issues.

 

Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye, which is an area on the retina, and causes it to thicken and swell, causing distortion of vision.

 

This is not the first time Avandia and Actos have been scrutinized. Recent studies have confirmed links between Actos usage and bladder cancer. Avandia usage has been linked to an increase in heart attacks.  Consumer Reports says Actos, made by Takeda Pharmaceuticals, is linked to congestive heart failure, bone fractures, and bladder cancer and is a danger to all patients. If you are taking these drugs for diabetes, the publication suggests you ask your doctor if there are safer drugs that would do the same job such as metformin, glipizide or glimepiride, which have been around longer and have fewer consumer complaints.

 

Unfortunately, the risks diabetic drug users are faced with as a result of their prescription medications, continues to grow.

 

Many of the people affected by this have said that if they had just been told about the complications and risks, they would have saved their lives and their vision and taken some of the older, more reliable diabetic medications.

 

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Woman Files Lawsuit Against Former Broncos Cornerback, Current Broncos Receiver

Posted June 11, 2012 by HarmfulDrugInfoCenter
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(June 11, 2012) Yesterday, a woman filed a lawsuit seeking unspecified damages against former Denver Broncos cornerback Perrish Cox for sexual assault, and current wide receiver Demaryius Thomas.

 

Cox was acquitted of all charges by a jury in March, and he went on to sign a two year contract with the San Francisco 49ers.

 

The woman claims that she became pregnant in September 2010, after visiting Cox’s apartment, only a day after partying the night before.

 

Prosecutors put on evidence that she did not remember having sex, did not consent to it, and even showed DNA tests proving that Cox was the father. During Cox’s criminal trial, well-known allegations that she became overly intoxicated, possibly drugged after drinking lemon shots at the club, were presented. Cox’s attorney put on evidence that neither the woman, as well as Cox, did not remember having sex.

 

The lawsuit states that “the prosecution at the criminal trial declined to pursue any claim that a rape drug had been used and instructed its witnesses that they were not to volunteer testimony about such drugging or suspected drugging,” for unknown strategic reasons.

 

Demaryius Thomas expressed a romantic interest in this woman, and was also at the apartment the night she became pregnant.

 

This lawsuit alleges battery, sexual assault and battery, aiding and abetting tortious conduct, conspiracy, outrageous conduct, as well as negligence, which include failing to ensure the woman’s safety.

 

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Packaging Flaw Leads to Recall of Contraceptives

Posted June 10, 2012 by HarmfulDrugInfoCenter
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introvale

 

(June 10, 2012) – The U.S. Food and Drug Administration (FDA) notified healthcare professionals about a voluntary manufacturer recall of their contraceptive levonorgestrel and ethinyl estradiol tables (Introvale, Sandoz) due to a packaging flaw which could very well result in unplanned pregnancy.

 

The manufacturer, Sandoz, notified the public that is was issuing a voluntary recall of ten lots of its generic oral contraceptive, which was circulating in the United States following a recent report of a packaging flaw.

 

The following lot numbers in the recall, which were distributed between January 2011 the May 2012 (only in the U.S.) are:   LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01262C.

 

Each of the recalled ten lots contains approximately 4300 units. According to the head of global medial relations for Sandoz, Maria Mandic, only about 1 percent of the affected lot has been distributed to the market, or 48 units. “Across the ten lots, there were approximately 31,800 units distributed between January 2011 and May 2012 with an estimated 3700 units remaining in distribution channels (unused),” Mandic said.

 

“Each unit consists of three 3-month cards,” she told Medscape Medical News. “Those units that have been distributed have been on the market for nearly 2 months. This is the only reported complaint for the lot, and we have not received any related adverse event reports, and the remaining 4245 units of the impacted lot have not been distributed,” she said.

 

The way this was discovered was a consumer reported that the white placebo tablets were mistakenly placed in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”).  Each 3-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.

 

The purpose of having different colored pills in each packet is to distinguish them from one another. While the white placebo tablets can be easily identified from the peach-colored active tablets, the risk of an unintended pregnancy in a patient who takes the wrong tablet over a period of a few days cannot be excluded.

 

The FDA recommends that if a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), she should immediately begin using a non-hormonal form of contraception and contact her healthcare professional.

 

It is important to be aware of the medications you take. You should be familiar with the color of your contraceptive and which day you are supposed to take which pill. If you are not cognizant of what you put into your body, you may wind up taking the wrong medicine, or even discover that you are pregnant.

 

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FDA Approves Breast Cancer Medicine

Posted June 9, 2012 by HarmfulDrugInfoCenter
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(June 9, 2012) The U.S. Food and Drug Administration (FDA) approved a new anti-HER2 therapy, called Perjeta (pertuzumab) to treat patients with HER2-positive late-stage (metastatic) breast cancer.  Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.

 

HER2 is a protein involved in normal cell growth, and is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. The increased amount of HER2 protein in these HER2-positive breast cancers contributes to cancer cell growth., as well as survival.

 

Perjeta is intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy.

 

Perjeta is administered through an IV, and is a humanized monoclonal antibody, manufactured through biotechnology methods.

 

Currently, breast cancer is the second leading cause of cancer-related death among women. In fact, an estimated 226,870 women will be diagnosed this year, and 39,510 will die from the disease.

 

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said,  “given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply.”

 

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug and Research, said, “since trastuzumab was first approved more than a decade ago, continued research has allowed us to better understand the role HER2 plays in breast cancer. This research provided the background to combine two targeted drugs – trastuzuman and Perjeta with docetaxel to slow disease progression in breast cancer.”

 

In a study designed to measure the length of time a patient lived without the cancer progressing, progession-free survival (PFS), those treated with the combination containing Perjeta had a median PFS of 18.5 months, whereas those treated with the combination containing placebo had a median PFS of 12.4.

 

Common side effects are diarrhea, hair loss,  a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage.

Smoking Hookah May Be More Harmful Than Smoking Cigarettes

Posted June 8, 2012 by HarmfulDrugInfoCenter
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Hookah

 

(June 7, 2012) One in three college students has smoked hookah. The hookah is a beautiful, decorative piece of polished brass. It is used for smoking when friends get together, and to relax and socialize.

 

Hookah is also known as narghile, shisha, and goza. It is a water pipe with a smoke chamber, a bowl, a pipe, and a hose. Specifically-made tobacco is heated, and the smoke passes through water and is then drawn through a rubber hose to a mouthpiece. The tobacco is no less toxic in a hookah pipe, and the water in the hookah does not filter out the toxic ingredients in the tobacco smoke. Hookah smokers may actually inhale more tobacco smoke than cigarette smokers do because of the large volume of smoke they inhale in one smoking session, which can last as long as 60 minutes.

 

Hookah bars have become popular around the country for the last decade. “It usually attracts 18-20 year olds”, says Lance Freeman, of The Egyptian Café and Hooka Bar in Indianapolis, Indiana. “We are a place to come for people who can’t go to bars.”

 

The problem is that smoking hookah is still dangerous because it delivers the same chemical compounds as smoking cigarettes. One session (from 45-60 minutes) delivers about 100 times the smoke as a single cigarette, with 40 times the tar and 10 times the carbon monoxide. While research about hookah smoking is still emerging, evidence shows that it poses many dangers.

 

Hookah smoke contains high levels of toxic compounds, including tar, carbon monoxide, heavy metals, and cancer-causing chemicals (carcinogens). In fact, hookah smokers are exposed to more carbon monoxide and smoke than are cigarette smokers.

 

As with cigarette smoking, hookah smoking is linked to lung and oral cancers, heart disease, and other serious illnesses.

 

Hookah smoke delivers about the same amount of nicotine as cigarette smoking does, possibly leading to tobacco dependence. Hookah smoke poses dangers associated with second hand smoke. Hookah smoking by pregnant women can result in low birth weight babies.

 

Hookah pipes used in hookah bars and cafes may not be cleaned properly, risking the spread of infectious diseases.

 

Dr. Brian Primack conducted a study which was published in the June issue of the journal Nicotine and Tobacco Research, which found that 1 in 3 current college students has smoked hookah at some point; more than 50% of those students were not cigarette smokers.

 

Primack said that while he was giving a lecture on the dangers of smoking at the University of Pittsburgh School of Medicine, a student interrupted him. “He said, ‘No offense, but nobody really smokes anymore – we all do this hookah thing instead.’” That very moment started Primack’s research into the hookah world. “It’s a very interesting public health puzzle. The same chemicals – in one form are reviled by many people; but the same people will go across the street and take it in this difficult format.”

 

Better education is needed, Primack has said, to show similarities between hookah smoking and cigarette smoking. In a previous study, the research found 92% of videos on You Tube showed hookah in a positive light, compared to just 24% of cigarette videos. The population that participates in hookah smoking tends to be younger, male and white, but is found across all characters.

 

The researchers do not know yet if hookah is addictive. Smokers inhale twice the amount of nicotine in one hookah session as they do with a single cigarette, but long-term studies need to be done to see if it interferes with their life in the same way.

Plague Medication Approved by the FDA

Posted June 7, 2012 by HarmfulDrugInfoCenter
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(June 7, 2012) At the end of May, the U.S. Food and Drug Administration (FDA) approved a drug to treat patients with plague, a rare and potentially life-threatening bacterial infection.

 

In addition, Levaquin (levofloxacin) was also approved to reduce the risk of getting plague after exposure to a bacterium, which causes the disease, known as Yersinia pestis.

 

Although plague is extremely rare in most parts of the world (only 1,000 to 2,000 cases per year), and is primarily an animal disease, plague may be spread to humans from an infected flea, contact with infected animals, or laboratory exposure.

 

The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).

 

The Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, Edward Cox, M.D., M.P.H., said that this “approval broadens the available therapeutic treatments for plague. It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible.”

 

The agency approved Levaquin under the Animal Efficacy Rule, which allows research on animals in cases where it is not feasible or ethical to conduct trials in humans, so long as the studies are adequate and well-controlled.

 

The study was conducted on African green monkeys infected with the plague bacterium in a lab setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. 94 percent of the 17 monkeys (roughly 16) treated with Levaquin survived, but none of the seven monkeys treated with the placebo survived.

 

Common side effects of Levaquin, reported in more than three percent of patients, were nausea, headache, diarrhea, insomnia, constipation, and dizziness. In addition, such rare but serious side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.

 

As always, when dealing with these FDA-approved drugs, is to determine if taking this medicine is worth it in your situation, and decide if the risks in not taking the medication outweigh the benefits that the medication provides. Since plague is a very serious, potentially deadly condition, it would almost always seem that taking Levaquin outweighs any risk of its side effects.

 

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Most School Districts Reject “Pink Slime” For Lunch Programs

Posted June 6, 2012 by HarmfulDrugInfoCenter
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(June 6, 2012) – The nation’s school districts are pulling the plug on “pink slime,” the beef product that was all over the news earlier this year.

 

The U.S. Department of Agriculture (USDA) says that the vast majority of states that participate in its National School Lunch Program have opted to order ground beef that does not contain the product, known in the industry as ‘lean finely textured beef.’  Only three states – Iowa, Nebraska, and South Dakota — chose to order ground beef, which may contain the product.

 

The product has been used for many decades, and federal regulators claim that it is perfectly safe to eat. However, it has become the center of national attention after the nickname “pink slime” was quoted in a New York Times article regarding the safety of meat processing, especially since it is being served to our children in school lunches. The filler is made of fatty bits of beef that are heated to remove much of the fat, then treated with a puff of ammonia to kill any bacteria.

 

In response to the public’s outcry over it’s use, the USDA said in March that for the first time, it would offer schools the choice to purchase beef without filler for the 2012-2013 school year. The Department has continued to affirm that lean finely textured beef is a safe, affordable, and nutritious product, which reduces overall fat content.

 

As of May 18, 2012, the Agency says States ordered more than 20 million pounds of ground beef products, which do not contain finely textured beef. Orders for beef that may contain the filler came to approximately one million pounds.

 

Because schools were not given a choice last year, all states may have previously received beef with the product. The Agency is still accepting orders for the upcoming school year.

 

Beef Products, Inc., the South Dakota company that makes LFTB, has announced that it will close three of its four plants as a result of a drop in orders from fast-food chains, supermarkets, and schools. It has set up a website, beefisbeef.com, to combat what it says are myths about the product.

 

The USDA does not buy lean finely textured beef directly, but buys products from beef vendors who must meet the Agency’s specifications; ground beef can include no more than 15% of the product.

 

The USDA’s National School Lunch Program buys about 20% of the products that are served in schools across the country. The remainder of the beef purchased for schools is directly from private vendors.

 

The percentage of beef that schools get through the USDA tends to be higher, however, because beef is expensive, and schools have such tremendous budget cuts, they like to take advantage of favorable prices, which the government can negotiate.

 

Pink Slime & Ammonia: Two Main Ingredients in Some Ground Beef

 

Beef Products, Inc. of South Dakota (BPI) allegedly transforms trimmings into something they call “boneless lean beef.” In huge factories, the company liquefies the trimmings and uses a spinning centrifuge to separate the sinews and fats from the meat, leaving a mash that has been described as “pink slime,” which is then frozen into small squares and sold as a low-cost additive to hamburger.

 

BPI produces more than 7 million pounds of the mash per week, making it the world’s largest manufacturer of this frozen product. BPI explains that its product is mixed into most of the ground beef sold in the U.S. – at major fast-food restaurants, supermarkets, and school lunch programs. The problem is, when you turn garbage bits of animal carcasses into “pink slime” to be sold as a food product, is there is an issue with pathogens, such as E. coli.  When samples of the pink slime were tested, the tests came back showing that the slime was rampant with harmful bacteria.  So, BPI started disinfecting the slime with ammonia. What’s even more bizarre, they somehow convinced the U.S. Food and Drug Administration to allow them to list the ammonia as a “processing ingredient” so that we wouldn’t know we were eating ammonia.

 

The term “pink slime” was coined by former USDA scientist Gerald Zirnstein and used in a 2009 interview by the NY Times on the safety of beef processing. In 2011, the product was featured on a segment of Jamie Oliver’s Food Revolution.

 

The widespread use of LFTB really caught the public’s attention in March 2012, when food columnist and mother Bettina Siegel launched a petition to ban it from the National School Lunch Program. Within a few days, it received over 250,000 signatures. LFTB does not have to be labeled and it is estimated that it can be found in 70% of conventional ground beef (it has never been allowed in organic meat). Due to public outcry, the USDA agreed to let schools opt out and many supermarket and fast-food chains including McDonald’s and Taco Bell also discontinued selling meat with filler.

 

The meat industry has been hit hard by the rejection of “pink slime.” South Dakota based-Beef Products, Inc. (BPI) the largest producer of LFTB, has announced that it is closing three of its plants (located in Texas, Kansas and Iowa) at a loss of about 650 jobs.  This week, the vast majority of school districts have been able to buy non-LFTB beef for their kids.

 

LFTB is a filler made of fatty bits of beef that are then heated and treated with ammonia to kill bacteria. The USDA maintains that the product is safe to eat and reduces the overall fat content of beef products.

 

Fast-food chains were the first to reject the LFTB in its hamburgers, McDonald’s, Burger King, and Taco Bell all dropped it after initial medial reports. Wendy’s eventually took out ads in newspapers saying it never used “pink slime.” Later, grocery store chains, including Whole Foods, Publix, and Costco would tell ABC News they have never sold products containing LFTB. Grocery giant Safeway told ABC News in March they will no longer be carrying beef products containing LFTB. Others followed, and BPI has closed all but one of its factories! Under pressure from the public for better labeling practices, the USDA also announced in April that they will approve requests from ground beef producers to voluntarily label their product containing LFTB. Labels could read: “contains Lean Finely Textured Beef” or “contains Lean Beef Derived from Beef Trimmings.”

 

It is bad enough that these companies would try to sell bacteria-laden animal carcasses to the American public, but to serve it to our children in their school lunches? How can our government allow this to go on? They try to control how much sugar our children eat with their lunches, and teach them to eat a nutritious, healthy lunch and choose fruits instead of candy, but then they serve them bacteria soaked in ammonia for lunch??  Would you eat this for lunch? Would you be happy knowing your children were being served this type of lunch in school?

 

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