Category: Dangerous Drugs

Dangerous Drugs: Fluoroquinolone Side Effects

Used to treat mild to moderate bacterial infections, fluoroquinolones
are among the most highly prescribed medications in the United States.

When 33 year old Manhattan resident and Website Manager for the City College of New York Lloyd Balch sought medical attention for a fever and cough in April 2013, his doctor deduced from a chest x-ray that he had a mild case of pneumonia. Bach was given a popular antibiotic, Levaquin and shortly thereafter developed severe pain in his joints and vision problems. Balch continued taking the medication and soon became unable to walk uphill and see clearly. He experienced ringing in his ears, tingling in his hands and feet, uncontrollable shaking and muscle spasms. Doctors who have studied the risks of Levaquin say reactions like Balch’s are not unusual for users of fluoroquinolone antibiotics.

Used to treat mild to moderate bacterial infections, fluoroquinolones are among the most highly prescribed medications in the United States. In 2011, the US Food and Drug Administration (FDA) reported approximately 23.1 million prescriptions, with an additional 3.8 million hospital patients treated with them via injection. Fluoroquinolones include Cipro, Avelox, Noroxin and Levaquin – the latter being the bestselling antibiotic in 2010. By 2012, however, Levaquin was also the subject of more than 2,000 lawsuits by patients who had experienced severe side effects.

Peripheral neuropathy is a condition that causes damage to the nerves that send information from the brain to the spinal cord and throughout the rest of the body.

In August 2013, the FDA issued a notice requiring drug labels and medication instructions for all fluoroquinolone antibacterial drugs to more accurately describe the serious side effect of peripheral neuropathy (PN) experienced by many users. According to the Mayo Clinic, Peripheral neuropathy is a condition that causes damage to the nerves that send information from the brain to the spinal cord and throughout the rest of the body. Usually occurring in the arms or legs, symptoms include pain, tingling, numbness or changes in sensation of pain, temperature or body position.

Development of PN is only a risk when fluoroquinolones are taken orally or by injection; topical formulations applied to the eyes or ears are not known to cause nerve damage. Symptoms of PN may occur soon after the drug is taken and can last for months or years after use is suspended or may even be permanent.Fluoride, a known neurotoxin, is a central component of fluoroquinolones and can penetrate into very sensitive tissues, entering the brain and damaging the central nervous system. Doctors at the Center for Disease Control and Prevention have expressed concern that fluoroquinolones are often prescribed unnecessarily to patients without considering less risky alternatives. Meant for serious, life-threatening bacterial infections, they are frequently prescribed for earaches, bronchitis, urinary infections and other ailments that may go away without treatment or with less potent drugs.

…patients taking fluoroquinolone antibiotics were five times more likely to suffer potentially blinding retinal detachment, kidney failure and tendonitis.

The risks don’t end with nerve damage: In an April 2013 study at the University of British Columbia, Pharmacological Epidemiologist Mahyar Etminian found that patients taking fluoroquinolone antibiotics were five times more likely to suffer potentially blinding retinal detachment, kidney failure and tendonitis. Dr. Etminian expressed concern as well, asserting that the drugs are overused by “lazy doctors who are trying to kill a fly with an automatic weapon.” The American Thoracic Society has issued drug use guidelines that specify fluoroquinolones should not be prescribed as a go-to treatment for non-life threatening conditions, including community-acquired pneumonia. Had Lloyd Balch and other patients harmed by fluoroquinolones known about the risk factors and alternatives, they may have requested a different treatment.

When fluoroquinolone antibiotics are offered for mild conditions
like sinus, urinary tract or ear infections
without any proposed alternatives,
physicians may be negligent in prescribing them
and may be found responsible for resulting pain and suffering.

…it is also a health care professional’s responsibility to provide this information.

Many patients don’t see the mandated FDA warnings on packaging and are not notified by doctors of the potential side effects. While it is always wise to ask about associated risks and possible alternatives when starting drug treatment, it is also a health care professional’s responsibility to provide this information. To avoid further injuries and additional lawsuits, drug manufacturers are now warning patients about fluoroquinolones but, given their potential to harm, it is important that physicians also take the time to discuss their use with patients.When fluoroquinolone antibiotics are offered for mild conditions like sinus, urinary tract or ear infections without any proposed alternatives, physicians may be negligent in prescribing them and may be found responsible for resulting pain and suffering.

Okun Oddo & Babat specializes in Medical Malpractice and Medical Negligence claims. Contact us today or call or call us at 212.642.0950 to arrange an appointment with one of our experienced New York attorneys.

Article by Shea Bergesen for Lavery Design Associates, Ltd. copyright 2013. This article may not be reproduced without permission from the author.

Antipsychotics Prescribed For Elderly Patients

The world’s eighth largest drug manufacturer, Johnson & Johnson, agreed to pay as much as $2.2 billion earlier this month to settle US probes into the marketing of antipsychotic drugs – including Risperdal – to older adults, children and the disabled. According to a New York Times article The Justice Department has determined that the company promoted psychiatric medications for uses not approved by the Food and Drug Administration and may have even offered incentives for physicians to frequently prescribe them.

This latest lawsuit kindles concerns
that antipsychotics are being widely and
improperly prescribed to millions of Americans each year.

The American Chemical Society, based in Washington DC published that Antipsychotic drugs like Risperdal work by blocking dopamine, the chemical in the brain that contributes to high risk behaviors. Use of antipsychotics nearly tripled in the past two decades in the United States, with more than 16 million annual prescriptions for drugs such as Abilify, Clozaril and Seroquel. According to a study by Stanford University in 2008, more than half of prescriptions were for “off-label” use not approved safe and effective by the FDA. This latest lawsuit kindles concerns that antipsychotics are being widely and improperly prescribed to millions of Americans each year.

Particularly worrisome is the use of antipsychotics to treat vulnerable patients, including elderly nursing home residents. The federal government alleges that Johnson & Johnson and its subsidiaries promoted the use of the Risperdal for elderly patients with dementia, despite evidence that this would increase their risk of stroke, weight gain and diabetes. According to an audit by the US Department of Health and Human Services, Medicare claims were filed for antipsychotic drugs for 1 in 7 nursing home residents over the age of 65, with 83% attributed to off-label use.  Antipsychotic drugs are increasingly used to treat problems related to dementia in older adults, though the medication has proven more effective for sufferers of schizophrenia and can cause serious side effects.

Antipsychotics are not the only drugs that are commonly misprescribed among the elderly. In 2011, a study published by the British Medical Journal suggested that the prescription of antidepressants may need to be reevaluated as well. The study showed that adults over 65 who took newer generation antidepressants – known as serotonin reuptake inhibitors (SSRIs) including Prozac and Zoloft –  had a greater risk of having a stroke, seizures and higher salt levels in the blood than those who took older medications, known as tricyclic antidepressants (TCAs). These findings are contrary to the prevailing view that SSRIs are safer than TCAs.

In 2012, antidepressants were tied to a higher risk of falls
for nursing home residents, especially those with dementia. 

While antipsychotics are used to manage psychosis symptoms related to schizophrenia and bipolar disorder, antidepressants are used to treat disorders like depression or anxiety and are intended to alter mood. As with antipsychotics, the use of antidepressants has increased since 1990 and has been a subject of much debate. Medical News Today reported that in 2012, antidepressants were tied to a higher risk of falls for nursing home residents, especially those with dementia.

Although all prescription medications can have adverse side effects, physicians and drug manufacturers have an ethical obligation to disclose the associated risks and potential
alternatives to patients or family members.

The American Journal of Geriatric Pharmacotherapy reported in 2011 that nearly 50% of nursing home residents are given antidepressants, though there is little knowledge available regarding how antidepressants are prescribed. Many may be dispensed solely on the basis of nurses’ observations or patient’s behavior rather than a proper diagnosis by a doctor.
Although all prescription medications can have adverse side effects, physicians and drug manufacturers have an ethical obligation to disclose the associated risks and potential alternatives to patients or family members.

The prevalence of lawsuits associated with antipsychotic and antidepressant drugs sends a strong message to drug manufacturers that they must practice full disclosure regarding the possible side effects, uses and abuses of psychiatric medications – and practitioners should exercise much greater caution in prescribing them.

Okun Oddo & Babat specializes in Medical Malpractice and Medical Negligenceclaims. Contact us today or call or call us at 212.642.0950 to arrange an appointment with one of our experienced New York attorneys.

Article by Shea Bergesen for Lavery Design Associates, Ltd. copyright 2013. This article may not be reproduced without permission from the author.

Type 2 Diabetes Risk: Antipsychotic Drugs and Children

The use of second generation antipsychotic drugs (SGAs) appears to increase the risk of Type 2 diabetes in children, according to a 2001-2008 study by the Agency for Healthcare Research and Quality. While it was previously known that SGAs could double adult users’ chances of developing diabetes, the study suggests that children who are prescribed them are three times as likely to be diagnosed with the condition.

Published in JAMA Psychiatry earlier this year, the study examined the state-provided, anonymous medical records of approximately 43,000 youth under 24 years of age in Tennessee. About 29,000 were recent initiators of SGAs while 14,000 matched controls were receiving other treatments. Researchers found an estimated 16 additional cases of Type 2 diabetes per 10,000 children taking antipsychotic drugs for one year, with increased risk from cumulative dose.
SGAs, also referred to as atypical antipsychotics, are used in the treatment of severe mental health conditions including schizophrenia, schizoaffective disorder and mania. By altering the effects of natural chemicals in the brain including serotonin and dopamine, they regulate mood, emotions, sleep, appetite and other aspects of behavior. While side effects vary by individual drug, SGAs generally cause weight gain, changes in blood sugar level and increase in insulin resistance which all heighten the risk of diabetes.

The use of antipsychotic drugs in children is becoming more and more common. Since 2002, prescriptions for patients under 17 years of age have increased 65% — from 2.9 million to 4.8 million—according to the US Food & Drug Administration. While the FDA has approved SGAs such as Abilify and Seroquel for treatment of schizophrenia, many young people are now prescribed them for bipolar disorder, ADHD, depression and other mood disorders when other psychiatric medications including antidepressants, lithium and psychostimulants are available.

The researchers in the AHRQ study excluded any children who suffered from conditions that could only be treated by SGAs, noting that all those involved were taking antipsychotics for non-psychosis related mood, attention or behavioral disorders. Dr. Wayne Ray, professor of Preventive Medicine and a senior author of the study, said the findings should make doctors more cautious about prescribing antipsychotics to children. “If it turns out that the child does ultimately need an antipsychotic, they should be carefully monitored for metabolic effects and the dose should be as low as possible for the shortest amount of time,” he said. Given the additional risk, why would a doctor choose to prescribe SGAs when alternative treatments are available? One Rutgers University study in 2010 found that children from low income families receiving Medicaid are four times as likely as the privately insured to be prescribed anti-psychotic medication because they do not have access to the best known alternatives: cognitive-behavioral therapy and counseling.

In July,16 State Medicaid directors released a study recommending states require second opinions, outside consultations and other methods to ensure SGAs are not improperly prescribed. Some states including Florida and California have already put laws in place restricting doctors from dispensing SGAs to children. Without authorization from the state, children younger than 3 in Texas cannot receive antipsychotics and Arkansas now requires parents to give informed consent before a child is prescribed an anti-psychotic drug.

Additional Sources:
www.ahrq.gov
www.fda.gov

Article by Shea Bergesen for Lavery Design Associates, Ltd. copyright 2013. This article may not be reproduced without permission from the author.

Effectiveness and Reliability of the Drugs Presently Prescribed to Treat Hypothyroidism

According to a recent publication in the Wall Street Journal, some sufferers of hypothyroidism and several associated activist organizations are calling for more thorough screening tests and more effective treatment of the condition.
Though studies regarding alternative therapies and medications show conflicting results, Michelle Bickford, the 36 year old founder of the advocacy group, ThyroidChange, insists she experienced higher energy and less anxiety, depression and fatigue when she was prescribed a less commonly distributed, animal-derived medication. Bickford had been taking the popular levothyroxine prescription for hypothyroidism since the age of 11 but reports minimal alleviation of her symptoms until the switch.
Associate Professor of Medicine at Harvard Medical Center Jeffrey Garber, on the other hand, believes, “The vast majority of people are fine on the standard therapy.”

While thyroid patients and medical professionals may be at odds over what, if any, further research is needed, the complaints have called into question the effectiveness and reliability of the drugs presently prescribed to treat hypothyroidism.

Earlier this year, the brand Levoxyl recalled 52,000 bottles of levothyroxine due to a bad odor.
Uncertainty about stability and potency in a second batch of the drug led to another recall, potentially causing a shortage of the drug for the remainder of 2013.

Another levothyroxine brand, Synthroid has a long history of problems, including a class action lawsuit in the 1990s claiming millions of patients were overcharged for the drug, as well as more recent concerns over batch potency and stability.

Low potency of hypothyroid medication can cause serious harm to patients who depend on them, including little to no relief of symptoms and exacerbation of the condition. In such cases, patients may opt to take more than the recommended amount of the drug and an overdose is possible.

Thyroid disease affects 15 million people in the United States. The American Thyroid Association reports that approximately 50% of sufferers are not even aware that they have it, attributing it to other issues they are experiencing like aging, menopause or depression. The thyroid, a small, butterfly-shaped gland at the back of the neck, controls the body’s metabolism. It affects the functioning rate of cells, tissues and organs and controls heart rate, weight, temperature, energy level and muscle strength.
Thyroid malfunctions can happen in one of two ways.

The first, hypothyroidism, involves too little production of the thyroid hormone, causing the body to function at a lower rate.
Hypothyroidism is the most common type of thyroid disease, affecting 11 million Americans in 2012 according to the Center for Disease Control. Symptoms include:
• Fatigue
• Memory loss
• Depression
• Difficulty concentrating
• Coarse, dry skin and hair
• Intolerance to cold
• Constipation

Too much of the thyroid hormone (hyperthyroidism) causes the metabolism to function at a higher rate. Symptoms include:
• Nervousness
• Irregular menstrual cycles
• Weight loss
• Irregular heartbeat
• Increased metabolism
• Nervousness
• Perspiration

After the age of 35, The American Thyroid Association recommends anyone with a family history of testing positive for thyroid disease be evaluated every five years. Doctors can provide a definitive diagnosis with a simple blood test to measure the levels of thyroid hormones TSH, T-4 and T3. If a doctor fails to diagnose or improperly treats thyroid disease, the patient can experience severe consequences including heightened lethargy, depression, anxiety, weight gain, hair loss, bulging of the eyes, and hypoglecemia.

Sources:

http://online.wsj.com/article/SB10001424127887324635904578644532652110970.html

http://online.wsj.com/article/BT-CO-20130510-713949.html

http://nahypothyroidism.org/

Article by Shea Bergesen for Lavery Design Associates, Ltd. copyright 2013.
This article may not be reproduced without permission from the author.

U.S. Department of Justice Releases Details of Rapamune Kidney Transplant Drug Settlement Case against Wyeth Pharmaceuticals

The marketing and sales practices of major pharmaceutical companies has been under scrutiny in the last few years. This week, the U.S. Justice Department announced that drug maker Wyeth Pharmaceuticals has agreed to a $490.9 million settlement for criminal and civil liability charges in connection with improperly marketing Rapamune, the kidney transplant drug. Wyeth Pharmaceuticals was acquired by Pfizer in 2009. According to the Press Release issued by the Justice Department on Tuesday, July 30 the drug was not approved as safe and effective by the U.S. Food and Drug Administration (FDA). Continue reading “U.S. Department of Justice Releases Details of Rapamune Kidney Transplant Drug Settlement Case against Wyeth Pharmaceuticals”

Glass Particles May Be Found in Generic Lipitor

According to a November 29 article by Katie Thomas in The New York Times, Ranbaxy Pharmaceuticals has stopped producing its generic version of Lipitor, pending investigation into the possibility of small glass particles being found in pills. The Food and Drug Administration announced the halt earlier that day. The FDA claims they have not received any reports of consumers being harmed. Thomas’ article sites a recall by the drug manufacturer earlier this month and extensive details on Ranbaxy manufacturing problems at its plants in the US and in India.

How Much Legal Authority Does the FDA Have, and Use in Regulating Drug Compounding?

Legal experts are engaged in a new debate over the Food and Drug Administration’s authority of the drug compounding industry and perhaps their failure to use it. The recent outbreak of meningitis and the shutdown of Massachussets-based New England Compunding Center have again surfaced this issue with law makers and it is raising the question on the need for criminal investigation. Laws and regulations surrounding the compounding industry and the pharmaceutical industry and role that pharmacies play in mixing medicine for individual patients – which is related from state-to-state – are sketchy. It is unclear how many people may be at risk from the use of potentially contaminated drugs and could be at risk for severe infection and perhaps wrongful death. Several drugs produced by New England Compounding Center are used during surgical procedures. The October 15 New York Times article “F.D.A. Warns of Further Risk From Tainted Drugs” explains in more detail.

FDA May Take Action Against Johnson & Johnson

The New York Times (5/28, B1, Singer) reports that McNeil Consumer Healthcare, the division of Johnson & Johnson that recalled millions of bottles of liquid children’s Tylenol, “may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday.” At a Congressional hearing yesterday, the principal deputy commissioner at the FDA, Joshua Sharfstein, said that the agency found “a pattern of violations in manufacturing and quality control practices” that “led to a number of recent recalls.”

Following revelations at the hearing that McNeil hired contractors to buy the products under orders not to mention the word ‘recall,’ the chairwomen of Johnson & Johnson’s consumer division, Colleen Goggins, apologized “to the mothers and fathers and caregivers for the concern and inconvenience” caused by the recall. Los Angeles Times (5/28, Zajac)

Senate Committee Links Diabetes Drug Avandia to Heart Attacks, Death

On February 20, 2010 the New York Times carried a front-page story reporting that hundreds of patients taking the controversial diabetes medicine, Avandia (rosiglitazone), needlessly suffered heart attacks and heart failure each month, according to confidential governmental reports.  The Wall Street Journal (Monday, 2/22), reported that a Senate Finance Committee concluded that Glaxo was aware of the risks, but minimized the issue and tried to suppress concerned physicians.  FDA documents indicate that in 2008, agency scientists recommended that the drug be pulled from the market, but FDA chiefs rejected the recommendation.  It is estimated that the drug caused 83,000.00 heart attacks between 1999 and 2007.