September 22nd, 2015|
As men age, their testosterone levels decrease, which can lead to reduction in muscle mass, energy, and sex drive.
Many men use certain medications to help increase testosterone levels, but the safety of these drugs is now under scrutiny.
Many patients claim testosterone replacement medications led to adverse cardiac events, such as heart attacks and strokes, and point to scientific research to support those claims. Some victims have filed “Low T” heart risk lawsuits for damages as a result.
In response to these allegations, federal regulators are calling for more research on the safety of testosterone replacement drugs and therapies that utilize these medications. According to Medscape, the U.S. Food and Drug Administration (FDA) is asking companies that manufacture testosterone replacement drugs to work together to get research done as fast as possible.
The request comes on the heels of an FDA request for testosterone replacement drug warning labels to be updated to inform patients about the risks of stroke.
At Norris Injury Lawyers, we know the risks that can come with using testosterone replacement medications, and our Birmingham drug injury lawyers are hopeful the actions being taken to address these risks help prevent future injuries.
January 13th, 2015|
Laws regulate the testing procedures medications bound for the U.S. marketplace must undergo to ensure safety. However, overseeing these regulations with a limited staff has proven daunting for the U.S. Food and Drug Administration (FDA) in recent years. That’s why the agency launched the Office of Pharmaceutical Quality to help reduce drug injury numbers.
The Regulatory Affairs Professionals Society reports that the FDA announced the creation of the office in 2012, but it took several years for the organization to come to fruition. Two of the main tasks the office has clearly stated it plans to address are shortages in drug manufacturing and a lack of modernization in manufacturing techniques, the latter of which could significantly improve drug safety in the United States.
The new branch is now responsible for approving or denying more than 10,000 drug applications each year and could bring predictability in the approval process to drug manufacturers.
At Norris Injury Lawyers, we recognize the dangers taking certain medications can pose. That’s why our Birmingham personal injury attorneys are hopeful the new system is a success.
April 23rd, 2013|
April 23, 2013
A discussion has been scheduled by U.S Food and Drug Administration (FDA) officials to discuss findings of a study on the safety of the GlaxoSmithKline drug Avandia®.
The drug is used in the treatment of Type II Diabetes to help the body better control glucose levels. In September 2010, the medication was pulled from the European market because of serious Drug Injury dangers to patients, including cardiovascular risks.
The FDA acknowledged the drug’s risks by limiting its use to certain patients and calling for a new study to reevaluate the effects of the medication. The study was performed at Duke University and conclusive results were recently reached.
According to an article released by Medscape Today, the FDA has scheduled its Endocrinologic and Metabolic Drugs Advisory and Drug Safety and Risk Management Advisory Committees to convene this June to discuss the results. Some experts believe the findings could lead to the drug being completely pulled from the market. Many feel this is the best solution because safer, more effective drugs are currently on the market.
The Birmingham Personal Injury Attorneys with Norris Injury Lawyers applaud the efforts made to ensure that medications available to patients in the United States are safe. The firm is hopeful the upcoming panel meeting will be successful in determining the safety of Avandia® and the best course of action to take in distributing the drug.