For years, American lawmakers and the Food and Drug Administration (FDA) ignored the cries for help from those taking the antidepressant medication, Serzone, of Nefazodone.  Serzone was prescribed for those patients needing an affective antidepressant.  Doctors and scientists claimed that one of the major advantages of Serzone over other antidepressant was that it was not as likely to cause sexual dysfunction, or insomnia.  In fact, it was Serzone that was often given as an alternative to other antidepressants, because more people seemed to respond positively to its effects. At its height in 2002, Americans had almost 3 million prescriptions that pharmacies were filling.

However, as more testing was conducted, it was found that Serzone was the cause of a large amount of liver failures on patients.  Given to younger people, the risk of suicide increased, as well.  This drug was known to be dangerous, and yet the FDA did nothing. Patients were forced to have liver transplants (if they were lucky enough to get one), children died, and still the US did not ban the drug.  It wasn’t until Canada and many European countries started banning this drug that America started to question its use.

The FDA needs to take more responsibility when hearing out the concerns of patients in the public. It is their job to protect us and the products that come to us. In the case of Serzone, they failed.

US Food and Drug Administration (FDA) officials announced today that it would require manufacturers of certain antibiotics to put a prominent "black box" warning on their products detailing a link between the medication and an increased risk of tendon ruptures.

Flouroquinolone antibiotics, a potent class of antibiotics which includes Cipro (manufactured by Bayer) and Levaquin (manufactured by Ortho-McNeil), though valued for their effectiveness against deadly bacteria such as anthrax, have been the subject of intense criticism after it was revealed that patients taking the drugs were prone to tendon ruptures and tendonitis. According to consumer advocacy group Public Citizen, over 400 reports of tendon rupture and nearly 350 reports of tendonitis had surfaced by the end of 2007.

Tendons are rope-like tissues which bind muscles to bones and enable body movement. Serious tendon injuries may require surgery to repair, and may cause permanent disability.

Public Citizen filed a petition nearly two years ago complaining that the FDA needed to do more to warn people of the potential risk associated with taking these antibiotics, a call which was answered only today. 

FDA officials said that warnings about possible drug side effects have been provided since the drugs went on the market, and that today's announcement was made to increase public awareness of the situation. They emphasized that tendon damage appeared to be preventable if patients stopped taking the drugs at the first sign of pain or swelling.

US Food and Drug Administration (FDA) officials announced today that it would require manufacturers of certain antibiotics to put a prominent "black box" warning on their products detailing a link between the medication and an increased risk of tendon ruptures.

Flouroquinolone antibiotics, a potent class of antibiotics which includes Cipro (manufactured by Bayer) and Levaquin (manufactured by Ortho-McNeil), though valued for their effectiveness against deadly bacteria such as anthrax, have been the subject of intense criticism after it was revealed that patients taking the drugs were prone to tendon ruptures and tendonitis. According to consumer advocacy group Public Citizen, over 400 reports of tendon rupture and nearly 350 reports of tendonitis had surfaced by the end of 2007.

Tendons are rope-like tissues which bind muscles to bones and enable body movement. Serious tendon injuries may require surgery to repair, and may cause permanent disability.

Public Citizen filed a petition nearly two years ago complaining that the FDA needed to do more to warn people of the potential risk associated with taking these antibiotics, a call which was answered only today. 

FDA officials said that warnings about possible drug side effects have been provided since the drugs went on the market, and that today's announcement was made to increase public awareness of the situation. They emphasized that tendon damage appeared to be preventable if patients stopped taking the drugs at the first sign of pain or swelling.

According to a report issued by the Food and Drug Administration (FDA) last week, a recent study of 11 drugs concluded that the class of medications known as "antiepileptics" carries an increased risk of suicidal thoughts and behaviors. Antiepileptics are used to treat epilepsy, bipolar disorder, migraine headaches, among other conditions. The study concluded that patients taking antiepileptics had roughly double the risk of suicidal thoughts and behaviors compared to those who were given placebos.

Although only 11 drugs were used in the study, the FDA expects that all medicines classified as antiepileptics share the increased risk of "suicidality." Patients currently taking antiepileptics are advised to speak with their health care provider before making any changes. The FDA also encouraged the family and friends of those on antiepileptics to remain alert to any signs of suicidal behavior.

Perhaps prompted by recent attention on the connection between the drug Chantix and suicidal thoughts, the US Food and Drug Administration (FDA) announced a new policy requiring drug makers to study the effect of their products on suicidal tendencies.

According to a report published by the New York Times, warnings about a possible link between antidepressant drugs and suicide in children and teens were discounted by top FDA officials as little as four years ago. However, a team of researchers from Columbia University were authorized to reassess records from clinical trials and concluded that such concerns were genuine. That result, coupled with findings that most negative data from clinical drug trials are never published, may have been the catalyst behind the new FDA regulations. Reports indicate that Eli Lilly, Merck, and Sanofi-Aventis are already using suicide assessment as part of their clinical tests, and that the FDA has been contacting a host of other drug manufacturers about the new policy over the last few months.