14 Jan
On Wednesday, drugmaker Wockhardt said it has received tentative approval from the US Food & Drug Administration to marketing various doses of anti-bacterial Levofloxacin.
Levofloxacin is the generic name for the brand Levaquin, marketed in the US by Ortho Mcneil, a subsidiary of Johnson & Johnson.
Wockhardt plans to launch the product immediately upon expiration of the patent on June 20, 2011.
So, what do you think? Will cheaper Lev be good for America?
19 Nov
Johnson & Johnson (the manufacturer of Levaquin) is trying to prevent the first Levaquin lawsuits from being consolidated into a single trial. Plaintiffs’ attorneys want to have the first three “Bellweather” cases tried together. They claim that these cases are very similar; since the plaintiffs have similar injuries, claims, and situations, it is more efficient for the court to handle them as a single trial.
Attorneys for J&J disagree, arguing that the potential differences in the plaintiffs’ medical histories and their unique injuries suffered may confuse the jury.
There are now hundreds of cases pending against Levaquin in state and federal courts. The first cases to go to trial in products liability cases such as this are often the most important ones for both plaintiffs and defendants – if plaintiffs lose, future plaintiffs will find an emboldened defendent and face an uphill battle. However, if the first plaintiffs prevail, oftentimes the defendants may rethink their strategy and might find settlement to be a viable option. (Thus these first cases are referred to as Bellwether cases.)
The majority of the lawsuits allege that the antibiotic medication caused the plaintiffs tendon ruptures, tendonitis, and other tendon injuries.
In July of 2008, the U.S. Food and Drug Administration mandated the manufacturers of the fluoroquinolone class of antibiotics (including Levaquin, Cipro, Avelox & others) to include a “black box” warning label, which states clearly that there is significant risk of tendon injuries for users of these drugs. Prior to that date, any warnings of such injuries were not clearly displayed (allegedly buried in a long list of potential side effects. Currently, the language is clear:
WARNING
Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See WARNINGS AND PRECAUTIONS].
Source: http://www.injuryboard.com/printfriendly.aspx?id=274696 (Author: Scott Kappes)
4 Nov
Here’s a post from Ivanhoe Broadcast News. Some scary statistics: Americans are 10x more likely to be hospitalized from an adverse drug reaction than a car crash. These reactions are the 4th leading cause of death in the US. Doctors and patients need to read and understand the potential risks with these drugs, but the information given them needs to be accurate and fair. When the drug companies themselves are “paying for more than 1/2 of all reviews” (more than $600 million of the FDA’s budget, which the FDA needs to survive), can this information truly be impartial? Especially when the drug companies’ main incentive is to get it to market as soon as possible? You tell me – is “trust us” a good method of review for the FDA to base its reviews on?
23 Oct
Here is a thoughtful piece from John Fratti of Levaquin Adverse Effects Blog. If you have any questions for John, his email address appears below.
Quinolones are currently one of the most commonly prescribed classes of antiobiotics. They are very powerful medications used to treat many types of infections such as respiratory infections, urinary tract infections, and sinus infections. The two most commonly prescribed quinolones are Levaquin and Cipro. Like all medications this class of antibiotics has side effects. However, what differentiates this class of antibiotics from others is that quinolones have the ability to cause severe and permanent disability. Many of these side effects can even occur weeks to months after taking the antibiotic. Approximately half of the quinolones that were once on the market have now been removed from clinical practice due to their severe toxicities. Examples include Tequin, Omniflox, Trovan, and Zagam. The package insert for all quinolone antibiotics lists irreversible pain and irreversible neurological damage as possible side effects.
There is no question that quinolone antibiotics have their usefulness. They are extremely powerful medications that work very well to kill difficult to treat infections. They have proved to be life saving in certain situations. However, they were never meant to be used as a first line of defense against mild infections which is how they are often prescribed today.
In July of 2008, the FDA mandated that all quinolone antibiotics carry a “Black Box “ warning for tendon rupture and tendonitis. This is the strongest warning label a drug can have before it is removed from the market. Public Citizen, a consumer advocacy group, sued the FDA demanding quinolones carry a Black Box warning. If Public Citizen had not taken this action there may not be any “Black Box” warning for this class of antibiotics. The FDA gets approximately 50% of their funding directly from the pharmaceutical companies in what is called prescription drug user fees. This is an absurd conflict of interest that has made the FDA very slow and often reluctant to react to drug toxicities of all kinds. What the FDA is doing and what the public thinks the FDA is doing is as different as night and day- A quote from Dr. Herbert Ley, former commissioner of the FDA. If you look closely at the track record of the FDA it would indicate that they are serving interests other than yours and mine. In 2007, China executed Zheng Xiaoyu, who was the head of the food and drug administration in that country for taking $800,000 of money from the drug companies. In America, this behavior seems to be simply business as usual.
Dr. David Graham, from the FDA, says that the Vioxx debacle alone caused more than 60,000 deaths. To put that in perspective, that is more deaths than the number of American troops that died in the Vietnam war. Since the major media outlets obtain considerable advertising revenue from the drug industry they are often reluctant to do a story on the damaging side effects of medications. They don’t like to bite the hand that feeds them.
Unfortunately, the Black Box warning is far too late for the thousands of people that are now living with devastating disabilities. Lariam, a quinolone derivative, that is used strictly for malaria prevention has been widely prescribed to US troops since the 1990’s. An award winning documentary titled “Taken as Directed“ details the extensive physical and neurological damage caused by Lariam. 60 Minutes and Consumer Reports magazine also did a story on Lariam toxicity. Some of the many websites that describe the severe adverse reactions to quinolones include: Antibiotics.org, Favc.info, Fqvictims.org, Fqresearch.org, and Lariaminfo.org
Dr. Jay Cohen, a medical researcher and associate professor at the University of California, San Diego published a paper on severe peripheral neuropathy caused by quinolones. Dr. Cohen mentions that these debilitating reactions are not rare. He mentions that most doctors have dismissed patient complaints or outright deny that quinolones can cause this type of long term damage even though it is mentioned in the package insert. Even if one person in 100 suffers a grave side effect that can still mean millions of people affected. Even the FDA admits that less than 5 % of all adverse drug reactions ever get reported to their agency.
David Flockhart, professor of medicine and chief of clinical pharmacology at Indiana University School of Medicine, says as many as a third of patients taking a quinolone will experience some sort of psychiatric side effect, such as anxiety, personality change, or confusion. “ The psychiatric effects of the quinolones are underappreciated by the medical profession as well as by the public,” says Dr. Flockhart, who has treated more than one hundred patients with severe psychiatric side effects.
Before anyone takes this class of antibiotics they should have the right to know that it can cause irreversible damage. People need to be afforded the right of informed consent. The prescribing literature patients receive at the pharmacy is far different than what is in the tiny print in the package insert. Why am I writing an article on quinolone antibiotics? I feel that I have a moral obligation to warn as many people as possible. I was a pharmaceutical sales representative who was in great health and led a very clean life. I worked hard to obtain a master’s degree and I loved my job. Over three and a half years ago I was prescribed a handful of Levaquin pills for a possible infection and like tens of thousands of others my life has been turned into a living hell. I write this article in the hopes of preventing others from suffering a similar fate.
Jfratti@comcast.net
www.Levaquinadversesideeffect.com
30 Sep
This is one of the early news reports from when the Black Box warning was first announced. As always, if you notice tendon pains and you are taking fluoroquinolones, please contact your doctor immediately.
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