Missouri Accident Lawyer Blog

The U.S. Food and Drug Administration has suggested that makers of propoxyphene voluntarily withdraw the product from stores due to the medicine's potentially dangerous side effects.

Data has shown that propoxyphene users are at risk for developing arrhythmia, a condition of irregular heartbeats that can cause serious health problems including sudden death.

Propoxyphene is prescribed as a mild pain reliever to treat chronic pain resulting from conditions like arthritis. It is sold under the brand names Darvocet and Darvon, but also a number of generic names. It is one of the top 40 most used drugs with millions of prescriptions being filled each year.

The FDA says that considering the risks, the limited benefits do not justify the use of the drug.

Propoxyphene has been under scrutiny for years, with some groups advocating its removal from the market over concerns about unintentional overdose. The United Kingdom withdrew it from the market in 2005 and a European-wide withdrawal began last year.

One of the FDA's goals is to protect consumers from dangerous defective drugs. Other recent examples of drugs that have come under heavy scrutiny are Prempro, Avandia and Trasylol. If you feel that you or a loved one have been injured by unexpected side effects of a certain medication and you want to discuss your legal rights, consult a St. Louis personal injury attorney with dangerous drug litigation experience.

A couple weeks ago, we commented on a Harvard study that concluded that malpractice insurance and defensive medicine make up a small percentage of overall healthcare costs. Those wanting to cut costs significantly will have to find another way besides tort reform. Another recent study shows that the really costly aspect of our system is the medical errors that malpractice suits and defensive medicine are meant to prevent. Here are some of the major findings:

-According to the Agency for Healthcare Research and Quality, nearly 7,000 people die from medication problems including misprescribed pills and dosage errors.

-83,000 people die in hospitals every year of causes that have been labeled "potentially preventable".

-Some people are not getting enough care while others may actually be getting too much. Overall, Americans are receiving about half the recommended care annually, which includes basic checkups and preventive medicine. At the same time, 30% of people may be receiving care they don't need or is unnecessary.

That last statistic is especially troublesome. The groups of people that are not getting the recommended care are likely less healthy, and the people receiving extra care are driving prices up. Additionally, excessive healthcare is not necessarily "better" as certain treatments have significant negative side effects.

It would appear that if you want to lower costs, rather than limit the civil courts system, it should be allowed to hold negligent doctors and hospitals accountable for errors that drive up prices as well as take a terrible human toll. If you or someone you love has been injured by a medical error and you would like to receive legal counsel, contact a St. Louis medical malpractice attorney as soon as possible.

The U.S. Food and Drug Administration released a statement expressing concern over the risks associated with certain imaging agents used during MRI procedures. The agency warned against dangerous side effects of the drugs, especially for people who have existing kidney problems.

The specific substances in question are gadolinium-based contrasting agents which are injected into patients prior to a MRI scan. These agents help produce clearer MRI images for doctors.

Some patients who receive the injections develop a disorder called nephrogenic systemic fibrosis, a condition where the skin and other tissues thicken causing problems with movement and other bodily functions. The risks for this condition, which can prove to be fatal, are drastically higher for patients with kidney disorders, according to the FDA.

FDA officials have been aware of the risks of these potentially dangerous products for a few years, but the warnings have always been a general caution regarding all gadolinium-based agents. Now the agency is saying that specific products may be more dangerous than others and rates for developing the condition may be higher for contrast agents developed by some companies than others.

Specifically, the agents mentioned by the FDA as possibly being more likely to result in the skin condition are GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark. Some of the companies have already issued statements saying they recognize the risks associated with their agents, especially for patients with kidney disorders, but feel there is no conclusive evidence to say that one product is more dangerous than another.

The Food and Drug Administration has announced the drug Meridia (also known as sibutramine) is being taken off the market by its distributor after clinical trials demonstrated there was an increased risk for strokes and heart attacks among people who used it.

Meridia is developed by Abbott Laboratories, who voluntarily withdrew the drug, and is used to treat obesity. 8 million people around the world use it.

Clinical trials showed the potential dangers of taking the drug were a 16 percent increase in non-fatal heart attacks and strokes. Representatives from the study said the drug has only a small effect on a patient's weight and the risks far outweigh the benefits of the drug.

The FDA recently changed regulations regarding clinical trials aimed at finding health risks of defective drugs. No indication was given as to whether the new regulations contributed to the withdrawal of Meridia.

The Food and Drug Administration is laying down new rules for clinical trials and how they report potentially dangerous defects in drugs they are evaluating.

The new regulations handed down by the FDA will make the reports required of clinical trials more comprehensive in how they document risks and speed up the timeline in which these reports must be filed.

Pharmaceutical companies must now report to the FDA within 15 days of becoming aware of certain risk factors.

Companies must report any results from a epidemiological or clinical study that indicate risk for study participants. Companies must also report if certain side effects, which may have been expected, are occurring at a higher rate than expected. The changes to the U.S. regulations will also affect how drug absorption rates are reported and document any differences between generic and name brand drugs.

Many of these changes will make U.S. regulations more consistent with international regulations developed by the World Health Organization.

In recent years, there have been several high profile studies done demonstrating dangerous side effects of popular drugs. Prempro, a hormone replacement for women; Trasylol, a blood clotting agent; and Avandia, a diabetes treatment, have all recently come under scrutiny after the potential for dangerous side effects were reported for each drug.