Wednesday, January 26, 2011

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

* Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
* Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
* There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
* Women should monitor their breast implants and contact their doctor if they notice any changes.
* Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.


The FDA published its literature review in a document posted on FDA's website site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses."

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

For more information:

ALCL and Breast Implants

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Breast Implant Consumer Information

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063717.htm

ALCL and Breast Implants Consumer Article

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm

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Tuesday, January 18, 2011

Bath Salts: For Bathing or the Latest High?

/PRNewswire/ -- Some bath salts – with names like Ocean Burst and Ivory Wave – aren't really for bathing. Rather, they are the latest high for naive teens and young adults as well as established drug abusers.

"Fake cocaine and fake meth are laced in bath salts and sold legally on the Internet and in convenience stores, gas stations, truck stops and head shops in most states. This newest boutique chemical substance is being used for a narcotic effect and often sends users to emergency rooms," warns Greg L. Jones, M.D., addiction medicine physician at Willingway Hospital, an alcohol and drug abuse treatment center in Statesboro, Ga.

According to Dr. Jones, manufacturers are using engineered molecules similar to controlled substances in the fake bath salts, which are labeled 'not for consumption,' to skirt the law. The molecules are derivatives of two controlled substances –MDPV (methylenedioxypyrovalerone, which is similar to Ritalin, but more potent) and mephedrone (an amphetamine-like drug). Also known as party salts and party powders, fake bath salts are snorted or ingested to create a stimulant, narcotic effect like that of cocaine.

"Users are snorting and ingesting the fake bath salts as a stimulant, to create a sense of euphoria and to stay up and party longer," Dr. Jones explains. "However, it can increase pulse and blood pressure to dangerous levels and cause delirium and confusion."

People using the bath salts as a narcotic have been treated for paranoia, hallucinations, agitation, hypertension, chest pain and headaches.

"Drug-naive teens and college students are showing up in ERs across the country because they purchased and used these products. They probably think that since they didn't buy them from a drug-dealer that they aren't as dangerous as the real thing, so they load up on them and reach a toxic state," Dr. Jones said.

As attention is being drawn to this latest drug abuse fad, Dr. Jones predicts that, as Willingway Hospital is now doing, facilities will be adding questions about use of party powders and fake bath salts to their drug and alcohol history questionnaires. And, more prevalent use is leading to a ban of these products, such as in Louisiana where two weeks ago, Governor Bobby Jindal announced that the so-called bath salts are now defined as illegal narcotics under State of Louisiana law.

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Wednesday, January 12, 2011

Survey: Exposure to Anti-Drug Messages Among Teens Drops Dramatically by Two-Thirds as Drug Use Goes Up

/PRNewswire/ -- The University of Michigan's Monitoring the Future study (MTF) – the largest survey on teen drug abuse tracking over 46,000 8th, 10th and 12th graders – found a huge falloff in teens' recalled exposure to drug abuse prevention messages over the past seven years. The new data from the MTF study have been released at a time when teens themselves report finding the drug-prevention messages to be effective.

Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed. Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago.

"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means – through prevention ads, in schools and through their families," said Johnston. "If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."

Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities – programs in sports, civics and the arts – that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.

"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."

Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective

While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, and 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.

Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.

"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. "The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."

Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages

The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.

"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."

The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.

To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org

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