Saturday, July 16, 2011

CPSC Announces New, Lower Limit for Lead Content in Children's Products

The U.S. Consumer Product Safety Commission (CPSC) voted (3-2) that there was insufficient evidence to make a determination that manufacturers of children's products sold in the United States could not meet a total lead content limit of 100 parts per million (ppm) for a product or product category. The new total lead content limit, which is called for in the Consumer Product Safety Improvement Act (CPSIA), goes into effect on August 14, 2011 for manufacturers, importers, retailers and distributors of children's products.

Through the CPSIA, Congress set tough new levels for lead content in products designed or primarily intended for children 12 and younger. Lead is a heavy metal that is toxic for children, and associated with lowered levels of learning, impaired hearing, brain damage and, at high levels, can be fatal.

Congress directed CPSC to phase in the reduced levels for lead content over a three year period, starting with 600 ppm on February 10, 2009. The level dropped to 300 ppm on August 14, 2009. Finally, Congress directed the total lead content limit be set at 100 ppm, unless the Commission determined it was not technologically feasible for a product or product category.

The Commission was not able to determine that 100 ppm total lead content is not technologically feasible, as staff found that materials containing less than 100 ppm total lead content are commercially available in the marketplace for manufacturers. CPSC staff also found many products currently on the market, that have been tested by CPSC or other organizations, that are already in compliance with the new 100 ppm total lead content limit.

Starting on August 14, 2011, manufacturers, importers, retailers and distributors of children's products must comply with the new 100 ppm federal limit for total lead content. CPSC will not enforce the CPSIA's independent third party testing requirement for total lead content until December 31, 2011, due to a stay of enforcement that is already in place.

The stay of enforcement does not apply to children's metal jewelry, which currently must undergo independent third party testing.

The new 100 ppm lead content limit does not apply to inaccessible (internal) parts of children's products and certain component parts of children's electronic devices, like electronic connectors and plugs, including headphone plugs.

Lead content levels for children's products are different from the levels Congress set for lead in paint or surface coatings. The limit for lead in paint or surface coatings is .009 percent. The .009 percent level has been in place since August 14, 2009 and independent third party testing is required for all paints or surfaces coatings used on children's products.

Saturday, March 19, 2011

CPSC and HUD Issue Updated Remediation Protocol for Homes with Problem Drywall

The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Department of Housing and Urban Development (HUD) are issuing an updated remediation protocol for homes with problem drywall. A study conducted on behalf of CPSC by Sandia National Laboratories in New Mexico, finds no evidence of a safety hazard to home electrical systems. Sandia simulated long-term exposure of wiring and other electrical components to hydrogen sulfide gas, which is associated with problem drywall.

Based on this study, CPSC and HUD staff, representing the Interagency Task Force on Problem Drywall, are no longer recommending the removal of all electrical wiring in homes with problem drywall. This change in the government's protocol may reduce the cost of remediation for many homes.

After simulating more than 40 years of corrosive conditions that could exist in problem drywall homes, Sandia staff did not observe any acute or long-term electrical safety events, such as smoking or fire. Corrosion and blackening of the exposed electrical components did occur and was observed to be consistent with the characteristic corrosion reported to CPSC by thousands of consumers. Based on this study, it is the belief of the staffs of CPSC, HUD and Sandia that long-term exposure of wiring and other electrical components to hydrogen sulfide gases does not indicate a safety hazard to a home's electrical systems.

With these changes, the remediation guidance for homes with problem drywall calls for the replacement of all:
* problem drywall;
* fire safety alarm devices, including smoke and carbon monoxide alarms;
* electrical distribution components, including receptacles, switches and circuit breakers; and
* gas service piping and fire suppression sprinkler systems.

CPSC and HUD staffs are also issuing an updated identification guidance, which broadens the range of installation years of affected homes to include homes where drywall was installed as late as 2009. Importantly, the drywall installed in 2009 had been previously imported during the years 2006-2007 and does not represent any new importation of problem drywall.

The staffs of CPSC and HUD believe that following the updated identification and remediation protocols will enable homeowners to correctly identify homes containing problem drywall and comprehensively remediate those homes to address any potential health and safety issues associated with the problem drywall.

CPSC is in the final stages of completing its scientific investigation into problem drywall. For additional findings from the Interagency Drywall Task Force's investigation, visit www.DrywallResponse.gov

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Friday, March 04, 2011

FDA: Risk of oral birth defects in children born to mothers taking topiramate

New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.

Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry2, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

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Monday, February 28, 2011

Smoking Early in Pregnancy Raises Risk of Heart Defects in Infants

Maternal cigarette smoking in the first trimester was associated with a 20 to 70 percent greater likelihood that a baby would be born with certain types of congenital heart defects, according to a study by the Centers for Disease Control and Prevention. Congenital heart defects are the most common type of birth defects, contributing to approximately 30 percent of infant deaths from birth defects annually.

The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.

"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."

Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.

"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.

The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.

Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.

It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.

Source:  PRNewswire

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Wednesday, February 23, 2011

FDA warns against certain uses of asthma drug terbutaline for preterm labor

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch1.

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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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