This year an important Supreme Court case was decided, the verdict letting off the manufacturing companies and forbidding citizen from bring cases to a court that involve faulty medical instruments (which were approved by the FDA). If the FDA approved the instrument, then the court says they cannot bring a case against the FDA.

The explains that the court gave were artificial hearts, breast implants, or defibrillator—if any of these devices malfunction and lead to injury, the company who made the device is no longer liable for damages.  This puts a higher burden on the patients, who now have very little chance of gaining rightful damages from the company, but also on the doctor who will now be sued for malpractice, and the FDA which will be forced to step up testing and take on the defect cases.

This is a great oversight by the court to punish the patients and to let off the manufacturing companies.

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.

The Food and Drug Administration has announced that they are going to look into a possible link between Merck's best-selling Singulair and suicide. The agency is reviewing a handful of reports of mood changes, behavioral changes, suicidal behavior, and suicide in people who had taken Singulair.

Singulair is an asthma and allergy medication. Merck has revisted the drug's label four times in the past year. They have added information each time concerning reported side effects. The new side effects on the label include tremors, anxiousness, depression, and suicidal behavior.

 The FDA has currently asked Merck to look into its data concerning Singulair for evidence of possible links to suicide. The FDA says it has not established a causal relatonship between suicide and Singulair. The reivew of the drug was prompted by a few suicide reports that have been received since last October. The investigation could take up to 9 months to complete. Merck is currently emphasizing that the suicide reports were based on use, not statistical evidence.

 Singulair was first approved in 1998 and had sales of $4.3 billion in 2007.