Articles Posted in Defective Medicine

The food and drug administration (FDA) is adding new safety warnings about possible risks while taking statins, a class of drugs mainly used to help lower cholesterol levels. Increased cholesterol levels are commonly associated with heart problems, leading to several statins to be used in the prevention of cardiovascular diseases. However, research has shown a number of statins being linked to risks of memory loss and elevated blood sugar. Though none of the side effects have been reported as severe, several drugs will undergo label changes, including Lipitor, Crestor, and Zocor, all medication used to prevent heart-related problems associated with cholesterol.

The new labels will warn of these potential risks and will also include a warning about elevated blood sugar associated with diabetes. Studies show the risk between statins and type 2 diabetes is small, but should still be carefully monitored. Doctors want to continue to inform patients that though the benefits of statins still outweigh the risks, it is best to be cautious and double check with your doctor to see if the medications are best for your conditions. Doctors are encouraging all patients to talk to their doctor to discuss any possible side effects they may be affected by.

As the FDA takes a closer look into the potential risks of statins, they have also decided to remove a different warning on the medications labels. Statins previously had labels warning of liver damage and recommended routine testing of the liver enzymes, but will now change the recommendation to a single test when patients first begin taking the drug. The FDA has found that severe liver damage is rare, and continuous testing of the liver enzymes does not show to be efficient in finding liver damage.

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Pfizer, the worlds largest research based pharmaceutical company, issued a voluntary recall of its contraceptive pills that were found to have a manufacturing issue. Lo/Ovral-28 and its generic brands were recalled in late December after the company found a key mistake that could lead to several unintended pregnancies.

https://www.youtube.com/watch?v=zcLIbeVHGgY

Each packet of the birth control contains 28 pills, including 21 active pills, pills that prevent pregnancy, followed by seven placebo pills, pills that allow the body to have a period. Most active and placebo pills are differentiated by the color, allowing women to keep track of when they are taking an active or placebo pill. In order for the birth control to work effectively, the pills must be taken properly. Women are suppose to take them in the correct order at the same time everyday. If a pill is missed, her chances of becoming pregnant increase.

After the company received a call from a woman stating she found an active pill in the middle of her placebo pills, completely altering the order of her packet, Pfizer reviewed the manufacturing company. They realized there were a handful of packets that were put together incorrectly, mixing the order of active pills with placebo pills. The company immediately fixed the problem and later sent out a warning to the public addressing the issue. Pfizer recalled 1 million packets of Lo/Ovral-28 and its generic brands, though they believe only about 30 packets were defective. Though Lo/Ovral-28 is not one of the most used birth controls, the warning sent many women into a panic.

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Reports raise concern for a multiple sclerosis drug after 11 deaths were reported, all in which the patients had recently begun taking the drug. Novartis International AG, one of the largest multinational pharmaceutical companies based in Switzerland, came out with one of the first oral drugs used to help treat symptoms for multiple sclerosis. Gilenya, the oral medication, was approved in the U.S. and in Europe in 2010, but now, the drug is undergoing further safety testing.

Recent reports show the drug may have severe side effects on the heart, possibly leading to death. At this point, nothing has been confirmed but both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are reviewing the medication. According to an article in Business Week, concerns were sparked last November after a patient who had recently begun taking Gilenya died within 24 hours of starting his treatment. The article states, “ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to the disruption of heart rhythm, the London-based EMA said.” (read full article)

Novartis estimated around 30,000 patients are still being treated with Gilenya, Novartis and both agencies are notifying doctors about the possible side effects and have recommended all doctors to increase monitoring of patients’ hearts before beginning treatment and for at least six hours immediatly after beginning treatment. Though the drug has warning labels about the possibility of a slow heart rate and atrioventricular conduction block during your first treatment, it is still unclear whether or not the drug is the main cause of these deaths; the EMA and FDA hope to find out more information soon from continuous studies.

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A new diabetes drug has made it to the market after a long delay by the Food and Drug Administration (FDA). The FDA approved Amylin Pharmacuetical’s drug Bydureon just a few days ago. Bydureon is a once a week injection medication created to improve glycemic control in adults with type 2 diabetes in multiple settings. In 2010, the FDA rejected the drugs approval twice, requesting more studies be done, but Bydureon has finally been approved. Amylin is hoping with the new drugs convenient once a week use, it will gain an advantage over competitors. The company plans to sell the new diabetes drug in both the U.S. and Europe, they are expected to hit $1 billion in annual sales. (read full article)

According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes; it affects millions of Americans every day. With type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin, and insulin is necessary for the body to be able to use glucose for energy. Untreated patients with type 2 diabetes may experience constant fatigue, weight loss, blurred vision, increased thirst and several other serious side effects. Over the past few years, pharmaceutical companies have tried to find alternative options for diabetic patients when it comes to injections or oral medication and as of now, Amylin’s Bydureon is the only type two diabetic medication for adults with a once a week dose. The company has tested the drug for any side effects and has clearly posted all possibilities on the label.

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Johnson & Johnson, the world’s eighth-largest pharmaceuticals company, has made the news again, unfortunately, not for positive reasons. After the company had to recall their DePuy ASR™ XL Acetabular Hip System and the ASR™ Hip Resurfacing System in 2010, they faced hundreds of lawsuits involving failed medical devices and have continuously received more cases. Though, their most recent lawsuit was for something different.

Risperdal, an anti-psychotic medication, also known as an “atypical anti-psychotic,” is used to treat schizophrenia and symptoms of bipolar disorder. It may also be used to treat symptoms of irritability for autistic children. Risperdal was created by Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, and has been on the market for several years. After years of patient use, complaints began to pile up claiming Janssen Pharmaceuticals Inc. made false or misleading statements about the safety, cost and effectiveness of the expensive drug. Patients also worried that the pharmaceutical company had been improperly influencing doctors to market the drug. Risperdal is not a cheap drug and has earned Johnson & Johnson close to a billion in profit.

Just last year a South Carolina jury found Johnson & Johnson guilty of overstating the safety and effectiveness of Risperdal, settling the case at $327 million. Shortly after, a Louisiana jury found the company guilty for violating that state’s Medicaid fraud act settling the case at $258 million. When a Texas attorney general heard of the two cases he added up all the money the state’s Medicaid program has spent on Risperdal, the attorney proposed Johnson & Johnson pay $579 million to the state’s Medicaid program and another $500 million in penalties. On January 19th Johnson & Johnson reached a settlement of $158 million in a Medicaid fraud lawsuit for the state of Texas. For the company, this settlement was considered a win compared to their previous settlements and also considering the fact that the company has made billions from Risperdal. Though Johnson & Johnson lawyers took this case as a win, the company’s continuous appearance in the news has negatively impacted their sales and reputation.

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A falsely advertised Yaz commercial sparks possible health concerns for the birth control pill. Yaz, a product of Bayer Healthcare Pharmaceuticals, has received thousands of complaints from women across the U.S. about unsatisfying results after taking the pill for several months. In 2007 Yaz launched an advertisement that promoted the pill to treat severe premenstrual symptoms and mild acne, making the pill extremely desirable for most women. After the ad hit the air, millions of women switched to the pill expecting to see a positive outcome. Just two years after the launch of Yaz, their sales had jumped to 2 billion, making Yaz one of the leading birth control pills on the market and one of Bayer’s top products. However, a positive outcome wasn’t true for everyone. Many women prescribed to Yaz felt as if the advertisement was extremely misleading. Premenstrual symptoms were still happening and women with mild acne were not seeing huge improvements like the ad had emphasized.

https://www.youtube.com/watch?v=DVy-uDadBx4

As more complaints were filed the FDA, Food and Drug Administration, took a closer look at the advertisement and results of the pill. After studies found that Yaz was never actually proven to treat severe PMS symptoms, Bayer launched a corrected ad that reinstated the pill should be used “for the treatment of premenstrual dysphonic disorder, or PMDD, and moderate acne, not for the treatment of PMS or mild acne.” Though Bayer had corrected their misleading ad, the FDA still had concerns about the pill. While looking over studies the FDA noted that Yaz, unlike most birth control pills, contains the use of drospirenone, a synthetic progestin that helps prevent ovulation. Though drospirenone works well for preventing pregnancy, the FDA has shown concern that the synthetic progestin may lead to a higher risk of blood clots.

In 2008, a 24-year-old woman taking Yaz for just three months suffered from a nearly fatal blood clot that she believes also might be the cause of her blindness. The woman began taking Yaz after seeing the convincing commercial that Yaz would treat all severe PMS and mild acne symptoms. After a few months on the pill she began to feel aching pain in her legs, assuming it was simply exhaustion. Shortly after, she suffered from severe blood clots the next evening. The clots had traveled from her legs up to her lungs causing a double pulmonary embolism. As she was rushed to the hospital her heart stopped and she slipped into a coma. The 24-year-old awakened about two weeks later to realize she no longer had her vision. Doctors are not positive what exactly lead to the blood clots and the loss of vision but the woman believes it had to do with the drospirenone in the pill. (read full story)

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The debate over the increased risk of bladder cancer while taking Actos remains consistent. As Actos bladder cancer lawsuits increase across the U.S., diabetic patients are continuously warned about the higher risk of bladder cancer while taking the prescription drug Actos (pioglitazone) for a long period of time. Actos is a once a day pill used to improve blood sugar control for patients with type 2 diabetes. In June 2011, the Food and Drug Administration (FDA) warned doctors and patients in the U.S. about the increased risk of bladder cancer while taking the medicine for over a year. The FDA issued this warning just two days after the drug was pulled off the shelves in France and Germany.

Based off of data collected from the first five years of a 10-year study taken by Takeda, the makers of Actos and the largest pharmaceutical company based in Japan, results showed that “patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk for bladder cancer”(European Medicine Agency – EMA). Though not all patients qualify in this category, this is still a very serious side effect for many.

Today, more and more Actos lawsuits are piling up. Takeda has suffered a severe loss in sales as the warning continues to spread across the U.S. Doctors are encouraged to prescribe other medications for their patients unless all other medications have failed. The FDA is still seeking more results from the study and will continue to update the public.

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In June of 2011 the Food and Drug Administration (FDA) issued a safety warning to all patients taking Propecia (finasteride). Propecia, a 5-alpha reductace inhibitor, “is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area” (PROPECIA). While taking Propecia, the drug begins to increase the number of scalp hairs with the intention to fill in most balding spots, however, studies may show the side effects to be far more dangerous than intended.

According to the Washington Post, the FDA based their safety warning off of two large studies. The studies showed that Propecia actually reduced the overall risk of getting prostate cancer, but increased the risk of developing high-grade tumors. Some doctors have reported that the drug is helping them find these serious tumors, while others are reporting that the drug is the reason for the tumors. Another serious side effect while taking Propecia is that it can affect the results of a Prostate-Specific Antigen (PSA) test, a blood test used to screen for prostate cancer. Propecia can actually lower your PSA levels and while several men think that a hair treatment drug is not anything serious, studies have shown otherwise. As the debate continues doctors seek for more results to determine the severity of Propecia’s side effects. (read full story)

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