Posted on January 09, 2015 in Defective Prescription Drugs

The product first hailed as a miracle weight-loss drug and subsequently pulled from the market when its dangers became apparent has resurfaced, albeit in another format. But the new drug has some of the same health concerns, and some new ones as well.

Fen-Phen

Fenfluramine was first introduced in the 1970s. Those who took it saw little or no results, so sales were quite weak until the early 1990s when it was combined with Phentermine. Its newfound success was short lived, however, as serious concerns about the link between Fen-Phen and primary pulmonary hypertension (PPH), one of the most serious heart-lung disorders, began to surface in the mid to late 1990s. The Food and Drug Administration recalled Fen-Phen in September 1997.

Qsymia

Fenfluramine was considered the more dangerous of the two drugs. Several years after the Fen-Phen recall, Vivus introduced a new drug pairing Phentermine with the anti-seizure drug Topiramate. The new anti-obesity drug, then known as Qnexa, initially faced some obstacles at the FDA because of its questionable heritage. But the agency eventually approved the drug for treatment of dangerously obese patients.

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 Posted on December 29, 2014 in Defective Prescription Drugs

Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

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 Posted on December 26, 2014 in Arlington Heights Defective Medical Device Attorney

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant designed to strengthen a weakened vaginal wall in the instance of POP or to reinforce the urethra to treat SUI. In 2011, the FDA issued a follow-up of its health notification from three years previous, which alerted people to the complications linked to transvaginal mesh when treating either of these medical conditions.

The updated safety alert identified additional concerns and growing numbers of reported difficulties involving surgical mesh devices. From the time between the initial communication in 2008 through to the end of 2010, the FDA recognized that complications were continuing at a high rate and were not considered a rare occurrence. More than 1,500 additional cases involving transvaginal mesh for POP repairs were documented and nearly 1,400 reports were linked to repairs for urinary continence.

According to The Harvard Medical School, over 1 in every 10 women will undergo prolapse surgery by the time they turn 80 years of age. Prolapse may be discovered during regular pelvic exams or carry symptoms including:

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 Posted on December 17, 2014 in Defective Prescription Drugs

The results from a new six year study may bring hope for those who have been forced to use dangerous drugs like statins to lower their cholesterol levels.

Whereas statins reduce LDL cholesterol by preventing it from being made, ezetimibe achieves the same result by preventing LDL cholesterol from being absorbed. The study, discussed at the annual meeting of theAmerican Heart Association, separated subjects into two groups – a group given statins and a group given the new drug ezetimibe. The statin group ended with an LDL of 69, while the ezetimibe group had an average LDL of 54. The second group also suffered 6.4 percent fewer cardiac incidents, such as heart attacks, strokes, and severe chest pain. One prominent observer called the outcome “fantastic” and “a truly spectacular result for patients.”

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 Posted on December 12, 2014 in Defective Prescription Drugs

Thrombosis, or blood clots as they are colloquially known, tend to manifest naturally in men more than women. Women, however, are at risk for blood clots primarily because of pregnancy, birth control, and other hormonal therapies men do not generally take, according to StopTheClot.org.

Birth control pills are the most common form of contraceptive used in the U.S., and carry a high risk of blood clotting. Women who take birth control pills are generally three to four times more likely of developing a blood clot than women who do not take the pill.

It should be noted that the chance of a woman developing a blood clot as a result of taking birth control pills is still relatively small. Only about one in 3,000 women develop a blood clot because of birth control, but if a woman has a history of thrombosis in her family, the risk increases significantly.

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 Posted on December 10, 2014 in Defective Prescription Drugs

Side effects of certain medication can put people at high risk for harm, increasing pain, and long-term medical conditions. It is the responsibility of drug manufacturers to make publicly known the severity of side effects its products may cause.

One of the highest-selling medications, Levaquin, secured record high sales in 2012 with $1.5 billion worth of prescriptions sold, according to Forbes. The antibiotic is prescribed to patients to treat conditions such as:

• urinary tract infections;
• pneumonia;
• acute bacterial sinusitis; and
• skin infections.

A little over a year ago, the U.S. Food and Drug Administration (FDA) issued a drug safety warning about the risks Levaquin carries. The administration required updates to drug labeling and medication guides to include a better description of one of the major side effects of taking the medication: peripheral neuropathy.

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 Posted on December 05, 2014 in Arlington Heights Defective Medical Device Attorney

With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

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 Posted on December 02, 2014 in Acetaminophen

A breakthrough in the medical community came for migraine sufferers this November, according to MedicalXPress.com. A study from Case Western Reserve School of Medicine found that nerves in the brains of patients who suffered migraines show abnormalities of the “myelin sheath that serves as insulation around nerve fibers,” MedicalXPress.com reports. The study involved observing 15 patients who underwent a surgical treatment that attempted to reduce the negative effects of serious migraines, and included electron microscopy that assessed the structure of cell nerves in patient's brains. The study also examined the presence and function of cranial proteins in migraine patients.

Ultimately, the study found that patients whose myelin sheath was damaged were more likely to suffer migraines. As a result, one doctor in the study “developed migraine surgery techniques after noticing that some migraine patients had reduced headache activity after cosmetic forehead-lifting.” This type of cosmetic surgery removes some of the muscle and vessel tissue surrounding cranial nerves.

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 Posted on November 28, 2014 in Defective Prescription Drugs

Pradaxa is a blood thinner, which was approved by the FDA in 2010, and prescribed to prevent blood clots in patients not suffering from a heart rhythm abnormality. Over a period of 11 months, an estimated 1.1 million prescriptions were written for the medication.

Since then, the FDA has issued multiple safety warnings about the potential of serious risks the use of Pradaxa carries for patients. Post-marketing reports have pointed to serious bleeding, some of which may lead to fatalities, occurring in patients taking the blood thinner.

The New York Times reported in 2012 that unlike warfarin, an older blood thinner, there is not an antidote to reverse the blood-thinning effects of Pradaxa and over 500 deaths had been linked to the drug. In the same month, the FDA issued an additional safety announcement stating that Pradaxa should not be used to prevent stroke or blood clot in patients with mechanical heart valves.

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 Posted on November 26, 2014 in Defective Prescription Drugs

A number of studies have linked certain SSRIs to birth defects when taken during pregnancy. Celexa is a SSRI typically prescribed as an antidepressant, but has been shown to carry risks when taken by women who are pregnant.

The FDA issued drug safety information alerting women of the risk Celexa poses when taken during pregnancy. Its warning was based on analysis of a published study identifying babies born to mothers taking SSRIs like Celexa as six times more likely to suffer from persistent pulmonary hypertension (PPHN) following the 20th week of pregnancy.

PPHN occurs when blood does not flow by the lungs in newborn babies. Symptoms of the condition include:

• rapid heart rate;
• blue tint to the skin; and
• rapid breathing or difficulty in breathing.

Five years after the FDA warning, the U.S. National Library of Medicine published a study linking prenatal exposure to Celexa to neural tube defects. Two of the most common neural tube defects, which can develop in the first month of pregnancy, are spina bifida and anencephaly. These types of birth defects can lead to paralysis or death shortly after birth, respectively. The study also found fetal alcohol disorders were 10 times more common in babies exposed to SSRIs during pregnancy than those who were not.

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