Posts for the 'Antibiotics' Category
How Long Will it Take FDA to Act on Public Citizen Avandia Recall Petition?
Last week a petition was filed by Public Citizen calling on the FDA to issue an Avandia recall as a result of serious and life threatening side effects associated with GlaxoSmithKline’s diabetes drug. No official response has been released by the FDA and it is unclear how long it will take the regulatory agency to respond to the petition.
Levaquin Achilles Tendon Rupture Side Effects Still Not Sufficiently Disclosed
Since Levaquin was introduced in 1997, Johnson & Johnson has failed to adequately warn about the risk of tendon ruptures side effects associated with the antibiotic, particularly involving the Achilles tendon. Although a “black box” warning was announced in July 2008 for all antibiotics in the same class, Johnson & Johnson still does not indicate that Levaquin is more tendon toxic than the other drugs in the class.
Stevens Johnson Syndrome Lawsuit Results in Defense Verdict
Last week, a California jury ruled in favor of Johnson & Johnson in a Stevens Johnson Syndrome lawsuit which alleged that the ibuprofen in Children’s Motrin caused an 11-year-old girl to develop a severe skin reaction, which blinded her.
>>INFORMATION: Stevens Johnson Syndrome (SJS) Lawsuits
Avoid the risk of a Levaquin tendon rupture
Following several years of concern about the increased risk of tendon ruptures associated with Levaquin, the FDA announced last week that a black box warning would be added to the antibiotic and other fluoroquinolone antimicrobial drugs, such as Cipro and Floxin. Users will also now receive a Medication Guide which will provide additional information about the side effects and recommendations which may reduce the risk of a tendon rupture.
>>INFORMATION: Cipro and Levaquin Tendon Rupture Risk
Cipro and Levaquin Black Box Warning added by FDA
On Tuesday, the FDA announced that they are requiring the makers of fluoroquinolone antibiotics, such as Cipro and Levaquin, to add a black box warning about an increased risk of tendinitis and tendon ruptures. They are also requiring that patients receive a Medication Guide highlighting the possible tendon side effects. The lawyers at Saiontz & Kirk, P.A. have been investigating potential Cipro and Levaquin lawsuits against the manufacturers as a result of their failure to warn about the risk of the debilitating tendon ruptures. The failure to provide this detailed warning sooner has likely resulted in thousands of preventable and unnecessary injuries.
>>FDA LINK: Cipro and Levaquin Black Box Warning
Cipro and Levaquin Achilles Tendon Rupture Lawsuits
The antibiotics Cipro and Levaquin have been associated with an increased risk of tendon ruptures, particularly involving the Achilles tendon. Despite a disturbing number of reports of problems, the manufacturers have failed to adequately warn about the risk of tendon damage and many users have not been made aware that they should immediately report any early signals of tendon pain.
>>INFORMATION: Levaquin Achilles Tendon Rupture Lawsuits
Cipro and Levaquin tendon ruptures continue to cause problems
Popular antibiotics known as fluoroquinolones, which include Cipro and Levaquin, have been associated with a potential increased risk of ruptured tendons. Although this risk has been known for some time, manufacturers of these antibiotics provide inadequate warnings to doctors and consumers. As a result, users continue to experience Cipro and Levaquin tendon ruptures because they are not aware that they should be concerned about development of tendon pain or inflammation.
>>PRIOR POST (1/7/08): Cipro and Levaquin lawsuit filed by consumer group
regarding risk of tendon ruptures
Cipro and Levaquin lawsuit filed by consumer group due to poor warnings about risk of tendon injury
The consumer protection group Public Citizen has filed a federal lawsuit against the FDA regarding tendon problems associated with fluoroquinolone antibiotics. They are asking the court to require the federal drug regulators to act on a petition filed 16 months ago requesting that new warnings be added about side effects of antibiotics, such as Cipro and Levaquin, which could increase the risk of tendonitis and tendon ruptures.
FDA evaluating risk of death associated with Maxipime antibiotic injection
The FDA issued an early communication yesterday regarding a possible increased risk of death associated with Maxipime, an antibiotic injection used for pneumonia and other serious infections. The federal drug regulators are reviewing safety data and have requested additional information from the manufacturer to complete a review of the rate of death among patients treated with the antibiotic.
>>FDA LINK: Maxipime Risk of Death
Antibiotic injection Rocephin linked to newborn deaths
The FDA reported today that a new warning will be added to Rocephin for Injection, an antibiotic manufactured by Roche Holding AG. When combined with calcium or calcium-containing products, the antibiotic could cause a fatal reaction in the lungs and kidneys of newborn babies, especially those born premature. Read the rest of this entry »
