A Little Known Disease Cause Venus Williams to Withdraw From U.S. Open

THURSDAY, Sept. 1 -- Venus Williams' surprising withdrawal from the U.S. Open on Wednesday has shifted the spotlight from the tennis star's daunting serve to her diagnosis with a little-known disease known asSjogren's syndrome.

Williams, 31, said the disease has diminished her energy level and caused joint pain, curtailing her ability to continue in the tournament.

More than 4 million Americans have the chronic autoimmune disease, which also causes dry mouth and dry eyes. Ninety percent of those with the disease are women.

Sjogren's syndrome "targets and destroys over time the exocrine glands responsible for tear production and saliva -- and is characterized by dryness of the mouth and eyes," said Dr. Michael Belmont, an associate professor of medicine in the division of rheumatology at NYU Langone Medical Center and medical director for Hospital for Joint Diseases. Less commonly, it can cause severe arthritis involving joint deformity and impaired function, he noted.

The publicity surrounding Williams' announcement is expected to increase awareness of the systemic disease, potentially leading to better diagnostic and treatment options.

"Sjogren's syndrome can occur as a primary disorder or secondary to other autoimmune diseases, principally rheumatoid arthritis or systemic lupus erythematosus [lupus]," Belmont said. Multiple organs, including the kidneys, lungs, gastrointestinal system, blood vessels and the central nervous system, can also be involved.

When Sjogren's progresses to a multi-organ disease, treatment becomes complex, said Dr. Victoria Shanmugam, a rheumatologist at Georgetown University Medical Center.

"Treatment for Sjogren's ranges from therapies to alleviate symptoms, such as topical therapies for dry eyes and dry mouth, to drugs that suppress the immune system, including hydroxychloroquine, methotrexate and steroids," said Shanmugam, who is not involved in Williams' care. "We also use medications that help fight fatigue and fibromyalgia symptoms."

Fibromyalgia is another chronic autoimmune disease.

Sjogren's, first identified in 1933, affects virtually every racial and ethnic group, according to the Sjogren's Syndrome Foundation. It is difficult to diagnose because symptoms mimic other diseases. It takes nearly seven years, on average, for a diagnosis.

How the disease will play out for Williams is unclear. Symptoms can remain mild, worsen or, occasionally, go into remission, Belmont said.

While the exact cause of Sjogren's syndrome is not known, Belmont said genetic factors appear to be involved. "An as-yet unidentified environmental factor likely plays a role, as observation finds that identical twins with the same DNA do not always share the illness," he said.

However, it is found more commonly in families that have members with other autoimmune illnesses, he said, noting this supports the genetic theory.

"Early diagnosis and proper treatment are important -- they may prevent serious complications and greatly improve a patient's quality of life," he said.

More information

To learn more about the disorder, visit the Sjogren's Syndrome Foundation.

Posted: September 2011

Research Reveals Why Blacks More Prone to Kidney Failure

THURSDAY, Sept. 1 -- Black Americans are more likely than whites to have a condition in which the kidneys spill protein into the urine, which may help explain why blacks are four times more likely than whites to develop kidney failure, a new study suggests.

Emory University researchers analyzed data from about 28,00 people (40.5 percent blacks, 59.5 percent whites) in the United States and found that 133 of them developed kidney failure after an average follow-up of 3.6 years.

There were 96 cases of kidney failure among blacks and 37 cases among whites.

Kidney failure was more common among people who excreted large amounts of protein in their urine, and blacks were more likely than whites to have this problem.

The researchers suggested a number of reasons why blacks are more likely to excrete more protein in their urine, including: blood pressure and other heart-related issues; smoking, vitamin D levels, obesity, income, genetic differences and birth weight.

All these factors can impact kidney health.

Treating urinary protein excretion could reduce racial disparities in kidney failure rates and also slow the rate of progression to kidney failure among patients of all races, the researchers said.

The study appears in an upcoming issue of the Journal of the American Society of Nephrology.

More information

The American Urological Association has more about kidney failure.

Posted: September 2011

Half of Americans Will Suffer Mental Health Woes, CDC Says

THURSDAY, Sept. 1 -- About half of Americans will experience some form of mental health problem at some point in their life, a new government report warns, and more must be done to help them.

Mental health issues run the gamut from depression to post-traumatic stress disorder to suicide, and many of those suffering presently do not get help, experts say.

The new report, from the U.S. Centers for Disease Control and Prevention, tallied the national burden of mental illness based on country-wide surveys.

There are "unacceptably high levels of mental illness in the United States," said Ileana Arias, principal deputy director of the CDC. "Essentially, about 25 percent of adult Americans reported having a mental illness in the previous year. In addition to the high level, we were surprised by the cost associated with that -- we estimated about $300 billion in 2002."

The high cost includes care for the illness and lost productivity, Arias said.

It isn't clear why so many Americans suffer from mental illness, Arias added. "This is an issue that needs to be addressed," she said, not only because of the illness itself, but because mental disorders are associated with other chronic illnesses such as heart disease and cancer.

And while having a psychiatric illness is tough enough, the stigma surrounding these diagnoses adds to the burden, experts said.

"Mental illness is frequently seen as a moral issue or an issue of weakness," Arias explained. "It is a condition no different from cancer or other chronic diseases. People need to accept the difficulties they are having and avail themselves of the resources that are available."

The report was published Sept. 2 as a supplement to the CDC's Morbidity and Mortality Weekly Report.

One survey done in 2009 by the Substance Abuse and Mental Health Services Administration found that 11 million people -- nearly five percent of the population -- experienced serious mental illness during the past year, defined as conditions that affected the ability to function.

In addition, some 8.4 million Americans had suicidal thoughts in the past year and 2.2 million made plans to kill themselves. One million attempted suicide, the report found.

Information from other sources confirmed these numbers, with slight variations, the report said.

Dr. John Newcomer, professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, believes the problem may be even bigger than the CDC report indicates.

For example, state Medicaid programs spend a great deal on drugs to treat mental illness, which the CDC didn't take into account, Newcomer said. "For several years the top three drugs were antipsychotic drugs," he noted.

Also, many people with mental illness hide the problem from others, Newcomer said. The CDC report looked at people already in the health-care system, "but there is a big problem with underdiagnosis and undertreatment," he said.

Dr. Alan Manevitz, a clinical psychiatrist at Lenox Hill Hospital in New York City, said healthy living -- getting enough sleep, eating right, exercising -- can help people avoid some mental illness.

"Understanding how to deal with psychological stresses is also important," he said. "How to deal with emotional reactivity and stress tolerances are also important skills to develop early in life."

Manevitz said people should always seek help for mental health troubles whenever "you are not functioning well in your life and isolating yourself."

More information

The U.S. National Institute of Mental Health has more about mental health.

Posted: September 2011

Excessive Heat Can Harm Medications

SATURDAY, Aug. 20 -- Medications can be harmed by high temperatures, say pharmacists.

Although just a handful of drugs have been tested at temperatures above 86F, all medications could be altered by extreme heat, they warn.

According to Dr. Amy Peak, clinical pharmacist and director of Drug Information Services at Butler University, several medications have been tested at high temperatures. She outlined some of the changes the researchers found:

• Albuterol inhalers: The container could burst at temperatures above 120F. Moreover, when stored at high temperatures, there may be a decrease in the amount of medication inhaled.
• Concentrated epinephrine: Cyclical heating could reduce 64 percent of the medication's potency.
• Diazepam: Concentration of this drug dropped 25 percent when stored at 98.6F.
• Formoterol (capsules that are placed in inhalers): Following four hours of exposure to 158F heat, the amount released from the capsules was less than half the normal amount.
• Lorazepam: When stored at 98F, concentration decreased 75 percent.
• Mometasone (formoterol inhalers): Temperatures above 120F may cause the container to burst.

Peak says several more medications may be susceptible to excessive heat, including:

• Insulin: Excessive heat could make the insulinless effective. It could also cause the insulin vials to explode.
• Thyroid hormones: Thyroid hormones could be altered by excessively high temperatures, resulting in inconsistent doses.
• Any medications in aerosolized canisters could burst when exposed to temperatures above 120F.

Although the United States Pharmacopeia Convention Inc. recommends that medications be protected from excessive heat, only a few drugs are actually tested at temperatures above 86F, Peak pointed out.

Nevertheless, she noted there are a number of steps people can take to ensure the quality of their medications during heat waves, including:

• Be aware that temperatures inside cars can top 160 F. When driving, be sure to keep medications out of the trunk and in the climate-controlled passenger compartment.
• Never leave medications in a parked car.
• During heat waves, have medications shipped overnight in special cooled containers.
• Request a one-time replacement from your insurance company or drug manufacturer for any medication that may have been affected by excessive heat.

More information

The National Institutes of Health provides more information on storing medicine safely.

Posted: August 2011

Safe Use Initiative: Preventing Harm from Medicines

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, or when prescribed inappropriately.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

• identify specific, preventable harm related to medication use
• develop methods (interventions or strategies) to reduce harm
• identify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

Working Together

In its regulatory role, FDA has always tried to prevent medication errors, says Weiss. “A lot of what we do at FDA to reduce medication errors is because we have the authority from Congress to regulate drugs, drug labeling, and drug manufacturing standards.”

But the Safe Use Initiative is different, says Weiss, because it involves collaborations with other parts of the health care industry and professions—besides drug manufacturers and distributors—to reduce harm in ways that do not require regulation. Potential collaborators include

• physicians, nurses, and other health care professionals and their professional societies
• state and federal agencies
• pharmacies, hospitals, and other health care facilities
• health insurers
• patients, caregivers, consumers, and groups representing their interests

Opportunities

FDA continues to add opportunities for collaboration to its growing list of projects that could reduce preventable harm from medicines. Two such opportunities are

• to support and assist in the removal of abbreviations on prescription container labels
• to support efforts to educate patients about the misuse and abuse of prescription drugs

Although FDA regulates prescription drug labeling—the printed material that accompanies such drugs—individual states regulate the label that the pharmacist attaches to the pill bottle. FDA is working with pharmacies, medical standards organizations, and others to set standards for this bottle label, such as spelling out the full name of a prescription drug instead of using an abbreviation that consumers may not understand.

For example, the prescription form of acetaminophen is often abbreviated “APAP” on the label of the bottle the consumer is given at the pharmacy. If consumers don’t know that “APAP” and “acetaminophen” are the same and are already taking an over-the-counter acetaminophen product (such as Tylenol or another brand), they could be taking too much acetaminophen and accidentally overdose. Too much acetaminophen can cause liver damage.

The Safe Use Initiative team is also working to make consumers aware of the importance of checking drug labels in general because many have the same ingredient—like acetaminophen, which can be found in more than 600 medications.

Another Safe Use Initiative project addresses the taking of prescription drugs when not needed. “About 55 percent of people who misuse or abuse prescription drugs get them from friends and family,” says Dale Slavin, Ph.D., associate director of the Safe Use Initiative.

“We need to create opportunities for discussion between the patient and the doctor,” Slavin says. “We, through collaborative efforts, want to provide tools that the doctor can use to have frank conversations with patients, and tools that the patient can use to understand the benefits, risks, and limitations of their treatment.”

This is especially important for opioid drugs, says Slavin, “where the abuse potential is there, the dependence potential is there, and the potential for others to steal or misuse their drugs is there.”

FDA invites comments and suggestions on drug safety issues and how to prevent harm atcdersafeuseinitia@fda.hhs.gov.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted June 29, 2011

For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.