Archive for July, 2008

Quinolone Film

Monday, July 28th, 2008

I am back from my trip to Baltimore. The movie about quinolone toxicity is going to be very good. The director, producer, camera man, sound technician and everybody else were simply great. They were all extremely supportive and caring people. They have interviewed doctors, pharmacists, pharma reps, lawyers, and many floxed individuals. Tomorrow they are going to interview an airline pilot that has been severely neurologically impaired. 

 

They are trying to eventually get a premier done in Philadelphia, Wash D.C and New York City. This was not any type of low budget production. There were so many individuals on the set that it seemed almost like some sort of Hollywood movie production. I am really glad that something like this is finally going to be done that has a fairly large financial backing. I spoke to the airline pilot that is going to be filmed. I know he lost his job for a while. I am not sure if he has made it back to work. He has severe light sensitivity and confusion among other side effects. He will certainly be a good case study for the film. 

Advocacy

Wednesday, July 23rd, 2008

My parents are driving me down to Baltimore this Sunday to be in a film about the terrible damage that Levaquin and other quinolones cause. The movie director is from Hollywood California and she got slammed by Levaquin. She has had a very difficult time walking like so many of us. Apparently, some individuals that have already been filmed have said it is going to be a very well done and professional looking documentary.

Another individual who has been disabled for many years is meeting with a state senator and attorney general about the the potential irreversible neurological and physical side effects of these antibiotics. A Black Box warning isn’t enough. Much more needs to be done to make this toxicity known to the public and hopefully one day gets these antibiotics removed from the market. 

Finally a Black Box warning on Levaquin and other quinolones

Tuesday, July 8th, 2008

It took decades for this warning to finally appear on the quinolones. The warning label is a Black Box warning on Quinolones for tendon pain and tendon rupture. I wish they would have added one for all of the neurological adverse effects. I think these side effects outnumber all of the tendon disorders. Hopefully future warnings will appear about the devastating central nervous system effects.

Levaquin induced madness

Monday, July 7th, 2008

A former police officer claims in a new lawsuit that medicine prescribed to him at Newton Memorial hospital drove him to madness, causing him to charge into his neighbors house and hold them at gunpoint, convinced they were gang membors.

William Koehler, 41, of Andover Township, is suing the hospital, the doctor who treated him there and the maker of the drug he was prescribed for bronchitis in February of 2003. He claims the drug, Levaquin, reacted with the ibuprofen he was already taking for a cold and caused acute psychosis. The lawsuit states that Koehler began feeling restless, anxious, confused, and paranoid by Feb 14th after two days on Levaquin.

Koehler began compulsive cleaning of his house and prepared his home for a possible terrorist attack. He placed all his clothes, tools, paperwork and food into a plastic baggies. The next day he began walking around his house with a gun looking for intruders. Koehler continued this behavior the next day pacing in his house with a gun, emptying cabinets and pulling appliances out of the walls. Then on Feb 17th he bagan hallucinating. At approximately 5 p.m. believing his neighbors were involved in a major drug/gang criminal activity, Koehler barged into his neighbor’s house and held three people at gunpoint. 

In an interview with the New Jersey Herald the day after the incident, Chris Carman, one of the three people in the house, said Koeher, after forcing them to lie on the floor, tossed a cell phone to a person on the sidewalk outside and ordered him to call the police. He was pointing the gun at us and saying, get the ( expletive ) on the ground, Carman said. Our dog, a yellow lab, came out and he was pointing the gun at the dog and saying, if that dog comes near me I am going to shoot it. The guy was just crazy. When Newton police arrived, according to the lawsuit,  Koehler told them: I think one of them got away. I don’t know where the other one went. I’m on the job. Authorities at the time said Koehler briefly waved his gun in the air before complying with officers instructions to toss the weapon and get face down on the porch.

Koehler was charged with burglary, aggravated assalt with a weapon, making terroristic threats and possesion of a weapon for an unlawful purpose. He was placed on paid leave by the West Orange police department.

According to the lawsuit, he was later fired and he spent three months in jail. Koehler is seeking unspecified damages for medical malpractice against Newton Memorial Hospital and Revoredo, claiming they should have informed him that Levaquin has been known to cause severe physical and psychological impairments. He also seeks damages against drug-maker Ortho-McNeil, and it’s parent company, Johnson and Johnson for selling a defective drug with inadequate warnings. According to its web site, Levaquin’s warning label lists among its possible effects tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely suicidal thoughts or acts. Doug Arbesfeld, an Ortho-McNeil spokesman, said nothing in the label mentions Ibuprofen or its possible effects on someone taking Levaquin.

What a terrible story! Just another terrible tragedy from taking Levaquin. Please educate others on the crippling side effects of Levaquin and other quinolone antibiotics. Thousands of healthy people are crippled physically and neurologically from these antibiotics.  JFratti@comcast.net 

Quinolone adverse reaction percentages from Dr. Jay Cohen

Wednesday, July 2nd, 2008

Dr. Jay Cohen writes that severe reactions to quinolones are occurring in patients who are usually healthy, active, and young. That was me for sure!

Dr. Cohen writes that reactions are acute, severe, frightening, and often disabling. In most cases, side effects are multiple, involving many systems of the body. In Dr. Cohens study, nervous system symptoms occured in 91% of patients, musculoskeletal 73%, sensory system 42%, cardiovascular 36%, skin 29%, gastrointestinal 18%.

With millions of prescriptions written for quinolones millions of people are crippled every year.

An Open Letter To Congressman Holt on Severe, Disabling Reactions Linked to Cipro, Levaquin, and Other Fluoroquinolone Antibiotics

 

Dear Congressman Holt,

Thank you for taking the time to speak with people concerned about, or injured from, reactions associated with fluoroquinolone antibiotics (e.g. Levaquin, Cipro, Floxin, Tequin). I am the author of a study about severe, long-term fluoroquinolone reactions published in the December 2001 issue of the Annals of Pharmacotherapy.1 Actually, the publisher and I pre-released this article in October 2001, during the anthrax scare when Cipro was being prescribed indiscriminately and without warnings to patients. Within days of publication of my paper, the U.S. Centers for Disease Control changed their guidelines, placing the antibiotics doxycycline and penicillin above Cipro as the preferred treatments for anthrax exposure. Doxycycline and penicillin are associated with fewer severe side effects than fluoroquinolones, and they are not linked with the devastating, disabling, long-term reactions that my study identified.

These severe reactions are occurring in patients who are usually healthy, active, and young. Most often, the antibiotics are prescribed for mild infections such as sinusitis, urinary or prostate infections. Most reactions occur very quickly, sometimes with just a few doses of the fluoroquinolone antibiotic. Reactions are acute, severe, frightening, and often disabling. In most cases, side effects are multiple, involving many systems of the body. In my study, nervous system symptoms occurred in 91% of patients, musculoskeletal 73%, sensory system 42%, cardiovascular 36%, skin 29%, gastrointestinal 18%.

These numbers do not adequately capture the severity and permanence of these reactions. Here are some examples:


Male, age 36, previously in good health, received Cipro for possible urinary infection: Chronic, debilitating multi-focal neuropathy, fibromyalgia, chronic fatigue, gastrointestinal problems, heart arrhythmia requiring pacemaker, carpal tunnel syndrome, chronic multiple joint pains, chronic pain. Functional ability: disabled. Duration: 5 years (patient now age 41).

Female, age 32, previously in good health, received Cipro for urinary infection: After 5 days, developed pain in wrists, neck, back, knees, hips, elbows, shoulders, and Achilles tendons. Having difficulty writing. Medical workup normal. Functional ability: greatly limited.

Female: age 47, previously in good health, received Levaquin for sinusitis: Within 2 days developed joint pain (severe in hands), insomnia, severe agitation, weakness, dizziness, severe fatigue, mental infusion, abnormal dreams, gastrointestinal symptoms. Duration: Still severe after 7 months.

Female, age 49, previously in good health, received Floxin for a pelvic infection: Burning pain, memory loss, joint pains, palpitations, nerve pain, insomnia, abnormal sense of smell, tinnitis, panic attacks. Duration: more than 3 years.

Male, age 34, previously in good health, received Levaquin for prostate infection: Muscle spasms and twitching, numbness, impaired coordination, weakness, increased sensitivity to temperatures, fatigue, multiple joint, muscle pain, palpitations, blurred vision. Duration: more than 1 year.

Male, age 35, in good health, received Levaquin for prostate infection: 1 dose was followed by ringing in the ears and peripheral nerve symptoms lasting 2 weeks. Then tendonitis began in shoulders, elbows, wrists, hands, and Achilles tendons, with burning pain and tightness in calves. After 2 months, still unable to walk more than a short distance. This man told me, “Prior to taking the medication I asked about side effects and was told there were none for adults except an upset stomach. Afterwards I was told that what I was experiencing could not be related to the drug. Obviously the doctor had never read the documentation that states otherwise.”


These are not isolated cases. Since the publication of my article with its 45 cases two and a half years ago, I have received e-mails from more than 100 people seeking help for their reactions. In most cases, their doctors have dismissed their complaints or outright deny that the reactions could occur with fluoroquinolones. Yet extensive medical workups do not find any other cause. Worse, there are no known effective treatments. Thus, these people suffer pain and disability for weeks, months, years.

Overall, my sense is that these reactions are not rare. I have spoken to the U.S. Food and Drug Administration about this. I am shocked that the agency still hasn’t acted. Other major reactions such as Stevens-Johnson syndrome or Churg Strauss syndrome from medications are posted prominently on drug labels. These reactions are much rarer than the ones occurring with fluoroquinolone antibiotics. At the very least, black boxes should be placed in fluoroquinolone package inserts about severe, multi- system reactions.

I readily agree that fluoroquinolone antibiotics play an important role in treating infections diseases, but we must alert doctors and patients about the potential devastating effects linked to these drugs. We must educate them that if any signs of reactions occur, such signs should be reported immediately and the drugs should be discontinued. Patients have a right of informed consent, and this includes warnings of potential serious, disabling reactions. Most of all, we must educate doctors to avoid prescribing fluoroquinolones for minor infections, instead saving them for serious infections, just as we do with other groups of antibiotics with serious toxicities.

I hope you will look seriously at this problem and respond accordingly. These people need your help. This is a largely preventable problem. Thank you.

Jay S. Cohen, M.D.
Associate Professor (voluntary)
Departments of Family and Preventive Medicine and of Psychiatry
University of California, San Diego

President and Executive Director
The Center for the Prevention of Medication Side Effects
A Nonprofit, Tax-Exempt [501(C)(3)] Corporation