New warning for Cipro and other "quinolone" antibiotics

The U.S. Food and Drug Administration (FDA) notified manufacturers of so-called "quinolone" or "fluoroquinolone" antibiotics that a new warning is necessary. The FDA would like a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture.

Information about these risks is already contained in the product labelling for these medications, but the "Boxed Warning" strengthens the warning and makes the information more prominent.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. "Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms that use of fluoroquinolones is associated with an increased risk of tendon rupture. It also demonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in people older than 60 years of age, in those who take corticosteroid drugs, and in kidney, heart, and lung transplant recipients.

Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

The medications involved in this action are:
Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Gels and creams better than pills for knee pain

New research now suggests that appling gels or creams containing pain releivers to the skin work just as well as taking pills for chronic knee pain, but the gels and creams cause fewer side effects.



A study in the UK enrolled almost 600 patients over the age of 50 years. Each patient had pain in the knee from osteoarthritis, which is a condition caused by breakdown of cartilage in the joint.



The study compared non-steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen taken by mouth in pill form or applied on the skin over the affected knee joint.



Both treatments reduced pain, but the pill form caused more side effects such as stomach upset, indigestion, increased blood pressure and worsening asthma. These are side effects commonly associated with NSAIDs.



Gels and creams tend to cost most than pills used for joint pain, but the benefit is increased safety and fewer side effects.

New warning for medications used for dementia

The Food and Drug Administration (FDA) will require manufacturers of so-called "antipsychotic" drugs to provide a new warning about an increased risk of death when these medications are used to treat behavioral problems in older people with dementia.


In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. The warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of medications will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.


"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."


Antipsychotic drugs commonly are categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."


Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.


Recently, two studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The researchers compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.


People taking these medications should not abruptly stop taking them. Caregivers and patients should talk to their personal health care prvodiers about any concerns.


The medications involved in this action are:


Compazine (prochlorperazine)
Abilify (aripiprazole)
Haldol (haloperidol)
Clozaril (clozapine)
Loxitane (loxapine)
FazaClo (clozapine)
Mellaril (thioridazine)
Geodon (ziprasidone)
Moban (molindrone)
Invega (paliperidone)
Navane (thithixene)
Risperdal (risperidone)
Orap (pimozide)
Seroquel (quetiapine)
Prolixin (fluphenazine)
Zyprexa (olanzapine)
Stelazine (trifluoperazine)
Symbyax (olanzapine and fluoxetine)
Thorazine (chlorpromazine)
Trilafon (perphenazine)

Singulair possibly linked to suicidal thinking

The FDA announced on March 27, 2008 that is is investigating a possible association between the use of Singulair (montelukast) and behavior/mood changes, including suicidal thinking and behavior and suicide. Singulair is is classified as a leukotriene receptor antagonists. It is used to treat asthma and the symptoms of seasonal allergies such as sneezing, stuffy nose, runny nose, itching of the nose and to prevent exercise-induced asthma.

FDA is working with Merck, the manufacturer of Singulair, to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their personal physician if they have questions about this new information. Until further information is available, caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

Early diabetes benefits from insulin

A new study published in The Lancet shows that newly diagnosed type 2 diabetes patients do better if they receive a short course of treatment with insulin compared to oral diabetes medications.

This is suprising because most newly diagnosed diabetes patients get oral medication first. Insulin is typically reserved for those who don't respond adequately to oral medications.

Patients in the trial were given an insulin infusion, daily insulin injections or oral diabetes medications for a period of 2 weeks after blood sugar levels were controlled.

A year later, about 50% of patients who received an insulin infusion and 45% who received insulin injections had maintained their appropriate blood sugar levels with diet and exercise alone. Only 27% of those who received oral drugs maintained good blood sugar levels with diet and exercise.

Researchers theorize that this early insulin treatment might have restored the function of insulin-producing cells in the body.

This development has the potential to completely change our approach to how type 2 diabetes is treated, but more research is needed before this approach will be widely implemented.