Philadelphia Medical Malpractice Attorney Blog

A Food and Drug Administration panel voted 12-1 to recall Avastin's approval for use in breast cancer patients. The drug is still approved to fight colon, lung, kidney and brain cancer.

Avastin was approved in 2008 for breast cancer after a study showed that it delayed the progression of the cancer by five months. The approval was controversial because it did not show to extend patients' lives. In a caveat to approval, the manufacturer of Avastin, Roche, was obligated to conduct two follow up studies.

The results of the follow-up studies were not promising. When added to conventional chemotherapy, the drug no longer delayed the progression of cancer and had no impact on the lifespan of patients. Alarming side effects were also discovered in the study. Patients saw an increase in blood pressure and fatigue with an abnormal level of white blood cells.

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FDA panel: Withdraw Avastin for breast cancer

The advisory committee on the diabetes drug Avandia has voted to keep the drug on the market despite the increased risk of heart problems associated with the drug.

The advisory panel agreed that Avandia does in face increase the risk of heart problems; however the panel voted 20-12 to keep the drug on the market. A similar Food and Drug Administration committee voted 22-1 in 2007 to keep the dangerous drug on the market. The panel believed that the evidence was not strong enough and further studies would be needed to make a final decision on the diabetes medication.

Avandia was approved for use by the FDA in the 1990s based a relatively small study of several thousand patients. The small study showed the drug was effective in increasing the body's sensitivity to insulin and helping patients control blood sugar levels. The small study was not able to show the side effects associated with the drug. Now the FDA will only approve drugs based on larger groups of patients that contain those at higher risks. Currently the FDA and GlaskoSmithKlie are conducting such a study on Avandia.

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FDA panel: Avandia should stay on market

Report: Avandia Maker Hid Risks For 11 Years

A report has surfaced that the manufacturer of the controversial diabetes drug, Avandia, hid the dangerous side effects from the public for over a decade.

Internal e-mails from GlaskoSmithKline (GSK) the maker of Avandia, suggest that in 1999 the first comparative study was down between Avandia and its rival Actos. The results of that study suggested that Avandia increased the risk of heart problems in patients when compared with Actos. A top executive at GSK stated in an e-mail that the results of the study should remain internal.

Avandia is currently under heavy scrutiny from the Food and Drug Administration after numerous studies have linked the drug to an increased risk of heart problems. People suffering from diabetes are already at an increased risk of heart attacks and other serious heart problems.

In 2007, a warning label was added to the drug to inform doctors and patients of the serious heart risks associated with the medication. The FDA will convene next week to discuss the future of the drug. Some options to be considered include: pulling the drug from the market, limiting the type of physician that can prescribe the drug and/or adding more warning labels to the drug.

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Report: Avandia Maker Hid Risks For 11 Years

Another study has confirmed that Avandia increases the risk of heart problems, strokes, and death in older adults.

Researchers studied the health records of 230,000 patients who take Avandia or its competition, Actos. The average age of those in the study was 74. Results showed that 27% were more likely to suffer from a stroke, 25% more likely to have heart failure and 14% were more likely to die on Avandia when compared with Actos. Doctors in study believe that if 60 people are treated with Avandia over Actos there were be one unnecessary heart attack, stroke or death.

Avandia has been linked to heart problems since 2007. It has come under recent fire from the Food and Drug Administration and may be pulled from the market. It is estimated that 100,000 have unnecessary suffered from a heart attack, stroke, or death since 1999. Many health organizations have urged those suffering from diabetes to stop taking Avandia and the FDA has scheduled a hearing on the safety risks of the popular diabetes medication.

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Diabetes Drug Avandia Tied to Major Health Risks

The popular weight loss pills, alli and Xenical are under investigation by the Food and Drug Administration for any connections to cases of severe liver damage.

The FDA has received over a dozen instances of liver damage associated with the drugs and has placed warning labels on the drug informing doctors and patients of possible liver damage. It is unclear yet if there is a casual connection between liver damage and the drugs but the FDA is launching a formal investigation. Xenical is a prescription drug manufactured by Roche and alli is the generic form manufactured by GlaxoSmithKline. The FDA first asked for liver toxicity reports from the drug manufacturers two years ago.

For now the administration is urging all patients taking the pills and doctors prescribing the pills to be on the lookout for signs of liver injury. Patients taking the medication who are itching, losing their appetite or have yellow skin or eyes should immediately go see their doctor and have their liver examined.

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Liver damage warning to be on weight loss pills

The Food and Drug Administration may remove Avandia, a popular diabetes drug, from the market due to increasing concerns of heart risk.

After a study confirmed that Avandia increased the risk of heart attacks and heart failure in patients, the FDA placed a black box warning on the drug to inform doctors and patients of the drug's heart risks. The FDA then began a study comparing the drug to its top competitor, Actos but now may halt the study. The discontinuation of the study is leaving Avandia in serious risk of being pulled from the market.

According to a study released by the U.S. Senate, Avandia is responsible for 500 heart attacks and 300 heart failures a month and users are at a 43% greater risk of having a heart attack. Those in the healthy community have recommended continuing taking the drug until you can meet with your primary care doctor and formulate a new plan to control your blood sugar.

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FDA Mulls Killing Avandia Safety Study: Report

According to the Food and Drug Administration, Philadelphia men and women looking for a quick way to lose weight should not consider lipodissolve which is being marketed as "fat-melting injections."

Lipodissolve injections are offered to patients as a less evasive alternative to liposuction and used to "melt" fat in the limbs and stomach but this treatment has not been approved by the FDA. Lipodissolve injections use, phosphatidylcholine, or PC, and sodium dioxycholate, or DC, chemicals which naturally occur in the body. Our metabolism uses these chemicals to break down fat but the chemicals are never meant to be extracted, or injected into the body. The injections are mixed with other ingredients at health spas by individuals with little or no medical training and currently should not be considered a safe alternative to liposuction.

So far patients have experienced permanent scarring, hard lumps and dark spots on their skin after receiving the therapy but long term effects of the dangerous procedure are still unknown. The FDA has issued letters to spas known to use to treatment and ordered them to stop marketing it as an alternative to liposuction because it has not yet found to be safe or effective. The agency is cautioning patients to think twice before trying an unproven, potentially unsafe, and expensive procedure.

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FDA Cracking Down On Fat-Melting Injections

Thousands of women in Philadelphia and millions in the United States are on medications to control their osteoporosis. There is now anecdotal evidence that these drugs can actually cause bones to become brittle and break very easily.

The osteoporosis drug Fosamax has been linked to severe musculoskeletal pain and a serious jaw disease called osteonecrosis and now it is linked to reports that it is causing bones especially the femur to severely fracture or break. Reports have surfaced that women on the drug for five years or longer have suffered severe and spontaneous bone fractures. In some cases women were engaging in normal activities such as walking down the stairs. The femur is one of the strongest bones in the body but it seems to be the most common bone broken in women who are on this popular bisphosphonate.

Women suffering from osteoporosis lose their ability to remodel and regenerate bone and are most susceptible to hip and spine fractures that can become fatal. Fosamax works to help women re-grow bones but prolonged use seems to make bones brittle and more likely to break. The Food and Drug Administration along with the drug manufacture Merck so far have done nothing to affirm or refute the claims of bone fractures despite pressure from many in the health community. Doctors and patients need to be informed that prolonged use can cause bone breakage to adequately weigh the risk of taking Fosamax and other drugs like it.

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Fosamax: Is Long Term Use of Bone Strengthening Drug Linked to Fractures?

The Food and Drug Administration is in the process of approving a new transplant drug manufactured by Bristol Myers Squibb. The drug works by suppressing the body's immune system to boost chances the body will not reject a new organ. The drug is marketed exclusively for kidney transplants. Similar drugs have been used in the past for a variety of different organ transplants with the most notable side effects being liver toxicity.

The drug has shown a significant increase in patients surviving after a transplant when compared with other drugs but it has also shown some dangerous side effects. Higher rates of severe kidney rejection where noted when compared with other drugs. There is also a chance of developing a rare but fatal neurological disease called multifocal leukoencephalopathy. The disease attacks the brain and central nervous system with patients losing vision, memory and coordination. Multifocal leukoencephalopathy is usually fatal.

The FDA has sent the reports to an outside advisory panel to weigh in on its safety. The panel will also assess the risk management plan for the drug. The drug manufacturer will be required to inform doctors and patients of the severe risks associated with the drug.

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FDA has concerns with Bristol transplant drug

Thousands of Philadelphia residents and millions of Americans take the popular medicine Avandia to aid in their struggle with diabetes; however, a study from the Senate is again raising concern for the defective drug. Avandia works by increasing the body's sensitivity to insulin and unfortunately it also increases the body's sensitivity to coronary problems.

According to a report from the U.S. Senate Avandia is known to increase the chances of a heart attack when prescribed to diabetes patients. In 2007, the Food and Drug Administration forced Avandia to place a warning on its box informing users of the serious heart problems associated with the drug and now after a two year study Congress came within one vote of recommending a withdrawal of the dangerous and defective drug.

From 1999 to 2007 over 80,000 patients on Avandia reported having a heart attack and the Senate report alleges that the manufacturer, GlaskoSmithKline downplayed the reports and the FDA did nothing to stop clinical trials of the drug. Patients suffering from diabetes are at a higher risk of suffering a heart attack and it is the duty of GlaskoSmithKline to report any and all information to the public. Instead the manufacturer downplayed reports of Avandia and tried to downplay reports that a rival drug decreased the chance of a heart attack in patients.

In 2007, The New England Journal of Medicine published a report that Avandia increased the chance of a heart attack by 43%. That report and other information about the drug finally surfacing had the profit for Avandia drop from $2.2 billion in 2006 to $1.2 billion.

Since the forced warning label, the FDA has made no other recommendations to GlaskoSmithKline or the public on the problems associated with Avandia.

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Report: Avandia maker knew of cardiac risks