Posted on July 24, 2014 in Defective Drugs & Treatments

Several forms of testosterone therapy have come under fire lately due to concerns for patient safety. According to WebMD, while the practice of prescribing hormonal therapy treatment to men with low testosterone has recently become more and more common, the long-term safety and side effects are not yet clear.

This year, the Food and Drug Administration (FDA) announced that it now requires such products to add a general warning about potential blood clots in the veins that are known to occur with certain testosterone therapies. Other therapies are known to result in negative side effects for the heart.

A study published by PLOS ONE has found “a twofold increase in risk of nonfatal heart attack shortly after initiation of testosterone therapy,” when used by men under the age of 65 who suffer from heart disease. However, it is noted that men, ranging in the millions, utilize testosterone as a lifestyle drug as a means to reverse the natural testosterone decrease men experience as they age.

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 Posted on July 21, 2014 in Defective Drugs & Treatments

Diabetes is one of the most common debilitating diseases in the U.S. today, and according to the National Diabetes Education Program (NDEP), an estimated 8.3 percent of the population suffers from diabetes, roughly 25.8 million Americans. However common, the disease is one of the least discussed conditions to affect so many people. In fact, the NDEP reports that an estimated 7 million people with the disease are not aware that they have it. Nearly 2 million people are diagnosed with the disease annually.

The two most common types of diabetes are Type 1 and 2. Type 1 was previously identified as early-onset or juvenile diabetes. Type 2 is by far the most common, and accounts for approximately 90 to 95 percent of all diagnoses. There is no cure for either type of diabetes, though studies have proven that regular exercise and weight loss can help prevent or delay the onset of the disease for many people. Despite these easy ways to help mitigate the effects of diabetes, the disease still costs the nation an estimated $116 billion in direct medical costs (such as hospitalizations, medical care, and treatments) every year. An additional $58 billion is spent annually on indirect costs associated with diabetes, according to NDEP, such as disability payments, time off work, and early death.

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 Posted on July 15, 2014 in Defective Drugs & Treatments

Since 1988, the first year in which such records were kept, there have been more than 15,000 claims filed in the United States for personal injury caused by vaccination. The year with the highest number of cases filed was 2003, in which nearly 3,000 claims – one-fifth of the aggregate total – were filed, followed by 2004. According to theHealth Resources and Services Administration (HRSA), a branch of the U.S. Department of Health and Human Services, the number of claims filed in 2013 (the most recent year for which complete data was available) was 503. As of March 2014, 218 claims had been filed. These types of claims cost the medical industry hundreds of millions of dollars each year. The most common types of injuries caused by vaccinations are temporary and not serious.

As reported by the History of Vaccines, an initiative of The College of Physicians of Philadelphia, side effects can generally include soreness, swelling, redness, fever, aching, or rash, especially at the site of the vaccine. More serious, life threatening risks of vaccinations are often a result of an allergic reaction.

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 Posted on July 08, 2014 in Birth Injuries

Several years ago reports were released regarding antidepressant medications and the link to birth defects. In 2009, noted by WebMD, a study reported that women who take antidepressants during pregnancy may risk that their baby will have a heart defect. And the risk of the baby being born with a defect is greater when the used antidepressant is a selective serotonin reuptake inhibitor (SSRI). The same goes for moms who switch to an SSRI antidepressant medication early in the pregnancy. Many women experience hormonal changes during pregnancy are prescribed antidepressants as a result. However, it was not clear in the study if all SSRI medications led to the increased risk of heart defect.

In 2005, the U.S. Food and Drug Administration (FDA) issued warnings about Paxil, an antidepressant similar to the more widely used Zoloft, Celexa, or Prozac. The study found no link between heart defects in babies whose mothers were taking Prozac or Paxil. But, it did find a correlation in mothers taking Celexa or Zoloft. That study, which examined more than 400,000 babies between 1996 an 2003, found that “septal heart defects occurred in 0.5 percent of children born to mothers who did not take antidepressants and 0.9 percent of children born to mothers who did.”

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 Posted on July 02, 2014 in Defective Drugs & Treatments

A recent Health Professional Follow-Up Study (HPFS) has found that erectile dysfunction drugs (such as Viagra) are linked to an increased risk of a dangerous type of cancer. The study showed that men who were taking Viagra were nearly 85 percent more likely to develop melanoma (a fatal type of skin cancer) than those who were not. Men who had previously taken Viagra and had ceased taking the drug were still twice as likely to develop melanoma than men who had never taken it.

The active ingredient, or clinical name for Viagra, is sildenafil. The drug, researchers found, "affects cell pathways that allow melanoma to spread (metastasize) to other parts of the body," reports Drugwatch.com. This type of skin cancer is responsible for nearly 10,000 deaths annually in the U.S., and an estimated 76,000 cases of melanoma are diagnosed in the same time period.

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 Posted on June 29, 2014 in Defective Drugs & Treatments

In June, the Food and Drug Administration (FDA) issued a statement requiring drug-makers who manufacture testosterone to issue a warning label on the drug regarding the potential risk for venous blood clots.

Testosterone replacement drugs are a medicinal therapy for men with erectile dysfunction, though according to WebMD, "inadequate production of testosterone is not a common cause of ED."

The natural decline of testosterone in a man's body begins after age 30, but there are several causes of lack of testosterone production. Reasons for inadequate testosterone production include (but are not limited to):

• Injury or infection of the testes;
• Genetic abnormalities;
• Chronic illness or kidney failure;
• Liver cirrhosis;
• Alcoholism;
• Inflammatory diseases;
• Chemotherapy or radiation; and
• Obesity.

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 Posted on June 27, 2014 in Defective Drugs & Treatments

The Food and Drug Administration (FDA) recently announced that it is conducting a pilot program to expedite drug recall notifications in an effort to quickly and efficiently relay important information to the public. The Agency, according to the FDA, currently issues a weekly Enforcement Report for consumers to be informed about the risks posed by products on the market. And in April, the Agency released a report on how to increase public access to such enforcement reports to ensure public access.

To do this, the FDA appointed eight focus groups, as detailed in the 2014 Transparency Report, with each group representing a center of the Agency to ensure that no significant function was left unwatched. One such initiative to come out of the focus groups was the decision that all agency groups will now, and moving forward, submit information electronically, and keep all electronic information stored in one place. This thus establishes "a single authoritative source for facility identifying information" and ultimately makes it easier for consumers to know where to look to check on product recalls, and also where to submit information. The FDA relies on consumer reports to stay on top of all the different products and services it regulates. Ensuring that consumers know where to go, as well as an ease to report faulty products, makes it easier for the FDA to do its job.

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 Posted on June 19, 2014 in Defective Medical Devices

Arthritis can turn into a debilitating disease, no matter the age of the sufferer. However, arthritis patients can be medically treated to help continue with the performance of daily activities. One such arthritic treatment method is a hip replacement implant known as A.S.R. or the “articular surface replacement,” and it is manufactured by DePuy, a subsidiary of Johnson & Johnson.

The A.S.R. product launched in 2003, yet it is noted that clinical trials were not performed before the A.S.R. product was released. During a period of six years, 93,000 patients received the implants. One-third of those patients were from the United States. However, doctors began to see issues shortly after the product launched. Several called for the product to be taken off the market but sales continued into 2009. In 2010, the A.S.R. product was removed from the market after a worldwide recall was issued.

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 Posted on June 17, 2014 in Defective Drugs & Treatments

A recent study, published by AdverseEvents.com, has found that a new class of diabetes treatment drugs may have serious side effects and are not necessarily being touted by the drug manufacturer or the doctors administering them. In April, AdverseEvents suggested a comparable safety research (CSR) study to offer a counterpoint to the report issued by the drug manufacturer. AdverseEvents released a publication using the proposed CSR framework regarding Type 2 Diabetes medication and found that while the drugs can be effective, they may have highly adverse and narrowly published side effects.

The drugs included in the study are GLP–1 Agonists, DPP–4 Inhibitors, and SGLT–2 Inhibitors. All drugs are manufactured by industry heavy-hitters, and while each has been tested in the lab for adverse side effects, none were formally analyzed by the drug company once they were dispersed for wide use. AdverseEvents CEO, Brian Overstreet, told DrugWatch.com that the only way to truly track the potential negative side effects of a drug is to monitor its effect on real patients in the real world.

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 Posted on June 05, 2014 in Defective Products

Sometimes the most common household items can be the most dangerous products, often made even more so because information regarding their dangers is not widespread or readily available. One of these is talcum powder—commonly known as baby powder.

In the 1970s the first report on the dangers of talcum powder was published. The report found a link between talc particles and ovarian cancer, according to The Huffington Post. Not surprisingly, the medical director for Johnson & Johnson (a leading talcum powder manufacturer) vehemently contested these findings.

For years, The Huffington Post reports, women were encouraged to put talcum powder on themselves as a way to "mask alleged genital odors." It was not until 1992 that a report in Obstetrics & Gynecology stated that a woman's risk of ovarian cancer was increased three times if she frequently used talcum powder. Since then, more than a dozen other reports have substantiated these findings.

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