Posted on June 27,2014 in FDA

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 Drugs

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 10,2014 in FDA

Crohn's disease is an inflammatory bowel disease and can affect any portion of the gastrointestinal tract from the mouth to the anus. If this is left untreated, a patient can suffer from diarrhea, vomiting, weight loss, skin rashes, abdominal pain, lack of concentration, tiredness, eye inflammation, and even arthritis. As a result of the pain and discomfort experienced by many Crohn's patients, the search for a medical treatment has been widespread. However, a new medical treatment is on the horizon.

A press release from the FDA has announced that the agency has approved a new treatment method for both Crohn's disease and ulcerative colitis. Ulcerative colitis is another type of inflammatory bowel disease that causes the formation of ulcers in the bowels and is common to Crohn's disease.

The new medical treatment method for Crohn's and ulcerative colitis is that of Entyvio, which is an injection for adults who have moderate to severe cases of these illnesses. This new treatment has been approved to treat cases where primary methods have not helped relieve symptoms in patients.

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 Posted on June 05,2014 in Illinois Defective Medical Products Lawyer

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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 Posted on June 03,2014 in Defective Medical Devices

Morcellation devices are used to remove uterine fibroid growths that are common in women. They are non-cancerous growths that appear in the smooth muscle tissue in the uterus. If these fibroid growths are not removed, they can cause serious health issues for the affected women.

Uterine tissue is divided into smaller segments so it can be removed through an incision in the abdominal area of the body. A morcellation device is small enough to go into the body to perform this work. This medical device has recently been recalled by the FDA because it has been linked to the spread of undiagnosed cancer throughout the body.

FDA Warning

The FDA found that one in 350 women who receive myomectomy procedures for uterine fibroids also have an undetected cancer of the uterus known as uterine sarcoma. The FDA warned against the use of the morcellation device due to the increased risk of cancer spreading throughout the body.

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 Posted on May 30,2014 in Defective Medical Devices

Boston Scientific (BSX) recently announced that it received a subpoena on May 5 from the Department of Health and Human Services. The subpoena asked the company for information about the performance of its implanted defibrillators. Defibrillator devices are used to shock racing hearts back into a normal rhythm during cardiac emergencies, some of which may injure patients.

The subpoena requested information from 2008, when Boston Scientific released two different types of implanted cardiac defibrillators. The documents also asked for information regarding the performance of these two devices when used between 2007 to 2009. The defibrillators are sold using the names Teligen and Cognis and are implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

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 Posted on May 28,2014 in FDA

Men across the country are subjected to television and radio ads selling drugs that treat Low-T levels in the body. Men are told that their low libido, lack of energy, and inability to play sports can be fixed with testosterone drugs. Now, the FDA is examining issues that include an increased risk of heart attacks in men who receive testosterone treatments for their Low-T.

Testosterone treatments have been approved by the FDA, but in a recent press release, the agency said that it has opened an investigation into the side effects of the drugs.

“At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death,” the FDA announced in its press release. “Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

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 Posted on May 21,2014 in Defective Medical Devices

There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.

The reason for this action is to lower the number of recalls and reduce injury to patients. Postmarket surveillance is important because most drugs are approved based on clinical trials of the products. Clinical trials apply to a small control group that are selected by the manufacturer. This control usually does not have other medical ailments besides the one that the drug is designed to treat. Yet this will not be true of the general populous.

Postmarket surveillance then continues to monitor the performance and safety of the drug or product once it is released to the general populous who may have addition and varied medical conditions. Information is gathered through various databases, event monitoring for prescriptions, and patient registries. It is then gathered and compared through data mining and will be further be reviewed to uncover any potentially dangerous safety concerns.

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 Posted on May 15,2014 in Defective Medical Devices

Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA. With increased scrutiny surrounding defective medical devices and treatments amidst reports of heart problems from patients who have undergone the therapy, the FDA stands poised to evaluate the manufacturing companies.

Two studies about such therapies have already found that the treatment increases the risk of heart attack, stroke, and death. A patient contemplating receiving the therapy should fully investigate the claims from other patients and really consider whether it is worth taking on such a major risk.

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