Most drugs for Parkinson's psychosis unproven (Reuters)

NEW YORK (Reuters Health) – Nearly every prescription written to treat Parkinson's psychosis -- a common psychiatric side effect of Parkinson's disease -- is for medications that have not been shown to improve the condition, a new study finds.

The study also found that about three of every 10 prescriptions are for drugs that can actually harm patients.

"For ninety-eight percent of prescriptions there is no clear proof that they improve psychosis symptoms in Parkinson patients, other than clinician experience," said Dr. Daniel Weintraub, the lead author of the study and an associate professor of psychiatry at the Hospital of the University of Pennsylvania and a physician at the Philadelphia Veterans Affairs Medical Center.

Just one drug, clozapine, is known to improve psychotic symptoms in Parkinson's patients, but only two percent of prescriptions are for clozapine, Weintraub and his colleagues report in the Archives of Neurology.

Parkinson's disease affects nerve cells in the brain that help control muscle movement. As many as six of every 10 people with the condition develop Parkinson's psychosis at some point in their lives. It includes hallucinations and sometimes delusional thinking. One of the major contributors is thought to be the drugs used to treat the physical symptoms of Parkinson's disease.

The researchers tallied up the prescriptions for about 2,500 patients who were treated for Parkinson's psychosis at Veterans Affairs facilities in 2008.

About half of the patients received medication for their psychosis. Two thirds of prescriptions were for quetiapine, which goes by the brand name Seroquel. It's approved by the Food and Drug Administration to treat schizophrenia, which is another type of psychosis.

"Quetiapine became such a dominant medication," Weintraub said, yet "none of the efficacy studies show that it's beneficial" for Parkinson's psychosis.

In four studies, quetiapine didn't worsen patients' muscle problems but it also didn't help their psychosis, said Dr. Joseph Friedman, the director of the Parkinson's Disease and Movement Disorders Center at NeuroHealth, a medical center in Rhode Island.

Still, Friedman and Weintraub support the use quetiapine, and prescribe it to their own patients.

"It's a peculiar sort of thing, because we pride ourselves on using evidenced-based medicine," Friedman, who was not involved in this study, told Reuters Health. But doctors have found, in their own personal -- and unscientific -- experience, that quetiapine appears safe and useful in patients with Parkinson's psychosis, he added.

Doctors often order medications that are tested and approved for a condition other than the one they are treating, a practice called "off-label prescribing." It lets physicians treat diseases for which there might not be a formally approved drug.

Of concern to Friedman was the finding that the second most popularly prescribed drug was risperidone, another schizophrenia medication that is marketed as Risperdal.

About 17 of every 100 patients treated with a drug for Parkinson's psychosis received risperidone.

Risperidone and another drug, olanzipine, are thought to worsen the symptoms of Parkinson's disease.

Olanzipine, whose brand name is Zyprexa, was prescribed 11 out of every 100 times.

Use of these two drugs shows "ignorance" on the part of physicians who prescribe them without keeping up to date on new studies about their safety, Friedman said of the results.

He encouraged doctors to learn more about the drugs. "The patients shouldn't be asked to read the literature."

Clozapine, the one drug with good results in clinical studies, was "grossly underutilized," Friedman said. It was used for just two of every 100 prescriptions.

The reason clozapine is rarely used, explained Weintraub, is that it requires regular blood testing to monitor for a serious but rare side effect. "It makes it somewhat impractical and a burden to the patients," Weintraub said.

He said the best approach to treating psychosis is to first try and limit, if possible, the Parkinson's medications that might be contributing to the hallucinations or delusions. If that fails, Weintraub then turns to quetiapine or clozapine for treatment.

He said medications should be used very cautiously for patients who also have dementia, because there is an association between anti-psychotic drugs and an increased risk of early death among people who have Parkinson's and dementia.

His study, which was funded by the National Institute of Mental Health, found that of the Parkinson's patients who were treated for psychosis, nearly a third had dementia and more than half of those patients were prescribed an anti-psychotic drug.

Physicians should keep in mind the potential complications of the drugs among Parkinson's patients with dementia, Weintraub said. "Medications should be used only when necessary and not indefinitely."

SOURCE: http://bit.ly/mR5cA4 Archives of Neurology, July, 2011.

Generic, Brand-Name Heart Drugs Seem to Have Same Effect on Thyroid (HealthDay)

WEDNESDAY, July 13 (HealthDay News) -- For patients taking the heart rhythm drug amiodarone (Cordarone), generic versions of the drug do not cause more incidents of thyroid dysfunction than the brand-name medication, researchers report.

When it comes to thyroid disease, there is no difference between the two drugs, according to the report released online July 11 in CMAJ (Canadian Medical Association Journal).

Amiodarone, a drug used to control arrhythmia -- a type of irregular heartbeat -- is known to cause hypothroidism and hyperthyroidism. These conditions affect the body's metabolism by altering the amount of hormone produced by the thyroid gland. Not enough thyroid hormone causes the body to slow down, resulting in weight gain, thinning hair and muscle pain. On the flip side, too much thyroid hormone results in nervousness, weight loss, rapid heart rate and diarrhea.

In conducting the study, researchers compared 2,804 atrial fibrillation patients aged 66 or older taking brand-name amiodarone (Cordarone) with 6,278 patients taking the generic form of the drug. The study revealed the two groups were equally affected by thyroid dysfunction.

"The incidence rate for thyroid dysfunction was estimated at 14.1 per 100 person-years, similar for both formulations," study author Dr. Louise Pilote, of the McGill University Health Center, and colleagues said in a journal news release. "The incidence rates for hypothyroidism and hyperthyroidism per 100 person-years were comparable between brand-name and generic formulations, with hypothyroidism occurring more commonly than hyperthyroidism."

The study authors pointed out that the findings should provide doctors and policy makers with critical information regarding the use of brand-name vs. generic drugs.

The researchers also noted that patients taking amidarone should be aware of the drug's possible side effects so they can recognize and report any symptoms.

More information

The U.S. National Library of Medicine provides more information on thyroid diseases.

Millions will die if India stops AIDS drugs: U.N. (Reuters)

NEW DELHI (Reuters) – Millions of people dependent on life-saving generic drugs to treat HIV/AIDS will die if India stops producing cheap drugs for the disease due to its trade deal with the European Union, the head of UNAIDS warned on Tuesday.

The EU and India are currently negotiating a free-trade agreement, which campaigners say will restrict India's ability to produce anti-retroviral (ARV) drugs, preventing the world's poor from accessing cheap drugs for their treatment.

"India should resist removing any flexibility because any trade agreement which could lead to India not being able to produce will be terrible for the rest of the world," said Michel Sidibe, executive director for the Joint United Nations Program on HIV/AIDS (UNAIDS).

"Millions of people will die if India cannot produce and Africa will be the most affected. For me, it is an issue of life or death," he told Reuters in an interview, adding that about 86 percent of people on treatment were taking drugs made in India.

The EU-India trade deal includes measures that could delay or restrict competition from generic medicines by extending patent terms, requiring data exclusivity and tightening border enforcement rules.

Such moves could drive up prices for India's anti-retroviral treatments, limit dosage options and delay access to newer and better drugs, said a U.N. report in September last year.

REVERSING GAINS MADE

Thirty years after the HIV/AIDS virus was first discovered, experts say that while substantial progress has been made by the global community in stemming it, only a fraction of those living with the illness are on medication.

At a high level U.N. meeting last month, nations agreed on a set of ambitious targets to rid the world of disease, including scaling up the provision of generics to reach 15 million patients from six million by 2015.

The trade deal, Sidibe said, would reverse many of the gains made in improving the lives of the world's poor.

"We have been fighting for so long to make sure that poor people could have access to treatment," he said. "For me, it will be the beginning of reversing all the gains we made on social justice and redistribution of opportunity."

Sidibe, a Mali national, said African leaders were asking India to really pay serious attention to any trade agreement which would block them from producing quality generic drugs for very poor people.

"It is not a rich pocket of people in the developed world who will be deprived of drugs, it will be the most needy, the most poor."

Some Drugs for Rheumatoid Arthritis, Psoriasis May Cut Diabetes Risk (HealthDay)

TUESDAY, June 21 (HealthDay News) -- Some medications commonly used to treat rheumatoid arthritis and psoriasis may help patients with these autoimmune disorders lower their risk of developing diabetes, researchers say.

New research found that a particular class of disease-modifying antirheumatic drugs (DMARDs) known as tumor necrosis factor (TNF) inhibitors and the antimalarial drug hydroxychloroquine can reduce diabetes risk by 38 percent and 46 percent, respectively, in people with rheumatoid arthritis or psoriasis.

"If you have rheumatoid arthritis or psoriasis, you may be at an increased risk of diabetes, and a number of different antirheumatic drugs may reduce your future risk of diabetes," said study author Dr. Daniel Solomon, chief of clinical science in rheumatology at Brigham and Women's Hospital in Boston.

However, Solomon was quick to point out that this was an observational study, and does not prove a cause-and-effect relationship between taking these medications and a reduced risk of diabetes. He said that for people who already have to take these drugs for other conditions, this research shows that there may be an added benefit with taking some of them.

The findings are published in the June 22/29 issue of the Journal of the American Medical Association.

Using statistics from two large health insurance company databases -- one in Canada and one in the United States -- the researchers reviewed data on people who had either rheumatoid arthritis or psoriasis. From a group of 121,280, the researchers immediately excluded the 12,996 who already had a diabetes diagnosis.

"These patients are at high risk of type 2 diabetes. This study found that about 10 percent already have it, which is higher than would be expected in the general population," said Dr. Joel Zonszein, director of the clinical diabetes program at Montefiore Medical Center in New York City.

The investigators then looked for those who had a prescription for at least one of the medications used for these conditions, and found that 13,905 were taking at least one of these drugs. The researchers further divided the group into four subgroups: those taking TNF inhibitors with or without other DMARDs; people taking methotrexate without a TNF inhibitor or hydroxychloroquine; hydroxychloroquine without TNF inhibitors or methotrexate; or other DMARDs without TNF inhibitors, methotrexate or hydroxychloroquine.

The study found that the rate of diabetes diagnoses over 12 years was 19.7 per 1,000 person-years for TNF inhibitors, 22.2 for hydroxychloroquine, 23.8 for methotrexate and 50.2 for other DMARDs. Compared to the other DMARDs, this translates to a reduced risk of 38 percent for TNF inhibitors, 23 percent for methotrexate and 46 percent for hydroxychloroquine.

Solomon said in an adjusted analysis, hydroxychloroquine and TNF inhibitors were the two types of drugs that appeared to make a significant difference in diabetes risk. These drugs are sold under brand names such as Plaquenil (hydroxychloroquine) and Enbrel, Humira and Remicade (TNF inhibitors).

Solomon said the reason these drugs might be protective isn't known, but the researchers suspect they reduce inflammation, which reduces insulin resistance and diabetes.

"Careful treatment of inflammatory conditions may reduce your future risk of diabetes," Solomon added.

"In a population with a very high incidence of diabetes, some medications may prevent or slow down the process of type 2 diabetes," said Zonszein.

Both experts added that these medications may have significant side effects. In addition, they can be expensive.

"The question is always, 'Is it worth giving these drugs?' You may prevent diabetes, but in doing so, will you create other problems?" said Solomon, who added that the information from this study might be helpful in selecting one treatment regimen over another for people with rheumatic diseases.

More information

Learn more about rheumatoid arthritis and disease-modifying antirheumatic drugs (DMARDs) from the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases. They also have more information on psoriasis.

No state lawsuits on generic drugs: US Supreme Court (AFP)

WASHINGTON (AFP) – The US Supreme Court narrowly ruled on Thursday that people may not sue generic drug makers under state laws if they believe a generic drug label failed to adequately warn of side effects.

The 5-4 ruling handed a victory to drug makers Teva Pharmaceutical Industries Ltd of Israel, the US company Mylan Inc and Actavis Inc of Iceland by blocking three consolidated lawsuits against them.

Plaintiffs had argued that they suffered a neurological disorder called tardive dyskinesia after taking the generic anti-heartburn drug metoclopramide (Reglan, Metozolv), which they said did not contain adequate warning labels.

The plaintiffs were prescribed the generic drug for Reglan in 2001 and 2002.

As early as 1985, evidence began to surface that long-term use of the drug could have serious side effects, but strong warnings were not added to the brand name drug labels by federal regulators until 2004 and 2009.

In 2009, the Food and Drug Administration ordered its strongest black box label warning that "metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible... treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases."

Even though the plaintiffs were prescribed the generic drugs before the stronger labels were federally ordered, they argued that the state should have done more to protect them by changing the generic drug labels because there was evidence to suggest long-term use could be harmful.

They sued the generic manufacturers under state tort laws that said the companies should have taken steps to protect consumers.

However the US high court said that federal laws require generic drugs to have the same labels as the brand names they copy, so courts could not demand they meet a different state standard at the same time.

"State tort law places a duty directly on all drug manufacturers to adequately and safely label their products," said the decision read by Justice Clarence Thomas.

"If the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.

"Thus, it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same."

The four liberal justices -- Sonia Sotomayor, Ruth Bader Ginsburg, Elena Kagan and Stephen Breyer -- dissented.

"As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug," said Sotomayor.

The decision affects 75 percent of all prescription drugs dispensed in the United States, the court said. When a generic is available to substitute for a brand name drug, the generic version is given out 90 percent of the time.