Hydroquinone, a product used in some skin bleaching agents, could have dangerous health consequences.  The toxic substance is banned in the UK, but in the US the use of hydroquinone in over-the-counter cosmetics is restricted, but allowed.  Despite its legality, the United States Food and Drug Administration (FDA) says that testing cannot rule out hydroquinone’s potential cancer risk in humans.

Skin bleaching—using chemical or natural products to lighten skin color—is common in the US and other countries and psychologists say consumer demand can be traced to the belief that lighter-skinned or white people are more successful, intelligent, and sexually desirable.  Cosmetics industry experts feel that as Asian, African, and African-Caribbean communities grow, so too will ethnic spending power for products marketed to lighten skin tone, some containing hydroquinone.  Cosmetics industry analysts say cosmetics companies realize there’s money to be made here and claim minority communities are an underserved market with a long tradition of buying bleaching products, legal or otherwise.

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Secondhand smoke can cause lung damage and emphysema is an oft repeated refrain.  But doctors lacked a way to prove this as previous detection methods simply weren’t sufficiently sensitive.  Now, for the first time, researchers say they have discovered a way to prove that long-term exposure to secondhand smoke can cause structural damage in the lungs, indicative of emphysema.  Research also suggests that modified magnetic resonance imaging (MRI) technique used to detect the lung damage may be able to spot emphysema long before symptoms occur.  The results of the study—conducted by researchers at the University of Virginia School of Medicine in Charlottesville and The Children’s Hospital of Philadelphia in Pennsylvania—were presented at the annual meeting of the Radiological Society of North America (RSNA).

In recent years, secondhand smoke has emerged as a public health threat,  and the toxic substance has been classified as a carcinogen by the Environmental Protection Agency and linked to heart disease, lung cancer, and a number of respiratory ailments, including asthma and chronic bronchitis.  Children are particularly susceptible to the harmful effects of secondhand smoke.  According to the American Lung Association, 35 percent of American children live in homes where regular smoking occurs.

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Toy Recalls and dangerous toys are of particular concern to parents.  Yet, the American Academy of Pediatrics (AAP) agrees that parents—a group who should be among the first to know about dangers to their children—are the last made aware about dangerous toys.  The AAP urges parents to be informed.  Challenging given that this year, the U.S. Consumer Product Safety Commission (CPSC) recalled 61 dangerous toys involving more than 25 million products.  Toys are undergoing increased reviews which may lead to additional recalls before year-end.

Firms take steps to remove recalled products from market, but it is impossible to police toys sold at thrift stores, garage sales, and Internet auction sites.  Recalls extend to nontoy products and, sometimes, action is not swift.  The death of an 8-month old a year ago prompted the recall of 36,000 racks sold by Jetmax only this month. It took three weeks for the CPSC to pick up a faulty Bassettbaby’s crib for review—nearly 9000 were recalled due to construction flaws posing entrapment and strangulation hazards.  Nearly one million Graco and Simplicity cribs were recalled due to a design flaw resulting in three children’s deaths.  The CPSC was criticized for its handling of the Graco and Simplicity Crib investigation and the Chicago Tribune claims the recall was only issued after the agency learned the paper was going to press about their neglect.  The CPSC has also been harshly criticized for being influenced by the companies it regulates.  Incomprehensively, high-level officials accepted free trips paid for by the industries they were charged to oversee.

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Tamiflu and Relenza, drugs used to treat the flu, should bear warnings about possible psychiatric side effects, a Food & Drug Association (FDA) panel said yesterday.  The recommendation came in the wake of a number of reports that both Tamiflu and Relenza had been linked to episodes of abnormal behavior that included delirium and hallucinations.  Many of the reports involved children treated with Tamiflu or Relenza, and some where fatal.

The FDA advisory panel recommendations where based on a review of nearly 600 psychiatric adverse event reports in Tamiflu patients, and another 115 reports among people taking Relenza.  Documents posted online by FDA staffers last week said that there have been reports of 596 neuropsychiatric events, including 16 neuropsychiatric-related deaths, among children and adults taking Tamiflu. Among those reports, 75% came from Japan. In total, the FDA said, there were 25 deaths from all causes reported among Tamiflu users on a world-wide basis in patients younger than 21.  Japan was also the origin of 81 of the Relenza reports, but no deaths where associated with that drug. Of the 48 million people treated with Tamiflu since its approval in 1999, the majority of users – 35 million – have been in Japan.

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The ConAgra executive who was involved in this year’s Banquet Pot Pie and Peter Pan Peanut Butter recalls will be leaving the company next July. Even though the two separate Salmonella outbreaks linked to the recalled Banquet Pot Pies and Peter Pan Peanut Butter have tarnished ConAgra’s image, the company is insisting that those events had nothing to do with Dean Hollis’ decision to leave.

Dean Hollis was named president and chief operating officer of Consumer Foods in 2005, the ConAgra division responsible for producing Banquet and store brand pot pies and Peter Pan and Great Value Peanut Butter. ConAgra’s Banquet and store brand pot pies were first linked to dozens of cases of Salmonella poisoning throughout the country on October 9. That day, ConAgra issued a health alert about the Salmonella pot pie outbreak, warning consumers not to eat any of its 7-ounce store brand or Banquet Pot Pies with the codes “P-9” or “Est 1059” on the package. Despite the health alert, ConAgra did not recall the tainted Banquet pot pies. Instead, ConAgra tried to deflect blame for the Salmonella pot pies by claiming that consumers caused the outbreak by failing to cook the pies properly. On October 11, ConAgra finally did issue a pot pie recall.

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Myfortic, a drug used to prevent organ rejection in transplant patients, has been linked to drug side effects that include an increased risk of birth defects and miscarriage. Because of this, the Food & Drug Administration (FDA) has added a new boxed warning to the Myfortic label, and Novartis Pharmaceuticals, the drug’s maker, has sent a letter to physicians informing them of the Myfortic birth defect and miscarriage risk and labeling changes.

Myfortic is used in preventing organ rejection following kidney, liver, or heart transplants, and is generally used in combination with cyclosporine and corticosteroids. According to the FDA, postmarketing data collected by the US National Transplantation Pregnancy Registry, as well as other postmarketing data, indicated that Myfortic puts pregnant women at a high risk of miscarriage, and that it is more likely that babies born to women taking Myfortic will suffer from birth defects.

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The Avandia debacle has prompted a safety official from the Food & Drug Administration (FDA) to call for changes in the way diabetes medications are approved for use in the United States.  The FDA official, who reviewed the original approval application for Avandia, told the Journal of Diabetes Care that the safety and effectiveness of experimental diabetes medications should be tested against existing drugs before they are approved.  If such a testing protocol were to be adopted by the FDA, it would mark a significant departure from the way most medications are granted approval in the United States.

Avandia has been a subject of debate since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Since the Cleveland Clinic study was published, a great deal of controversy has swirled around Avandia. In June, Congress held hearings to discuss Avandia and the FDA’s handling of its safety issues. At those hearings, it was revealed that GlaxoSmithKline, Avandia’s manufacturer, had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. Since those revelations were made public, the FDA has been under a great deal of pressure to take action on Avandia. 

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Risks associated with Avandia have led the American Diabetes Association to call on doctors to use more caution when prescribing oral medications to treat people with type two diabetes.  The Association announced on Tuesday that it was updating its “consensus statement” on the use of oral diabetes medications in light of the increased heart attack risks linked to some diabetes medicines, such as Avandia.

Avandia’s heart attack link came to light in May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43% higher risk of having a heart attack.  Earlier this month, the Food & Drug Administration (FDA) announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks.  However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on both GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.

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World Trade Center first responders are not the only people suffering physical and mental health problems as a result of their work at Ground Zero following the 9/11 terrorist attacks. Thousands of World Trade Center Emergency Workers who helped with recovery efforts in the days, weeks and months after the Twin Towers fell might also be coping with a wide variety of physical and emotional problems, says a study published in the November issue of the Journal of Occupational and Environmental Medicine.

In the days after 9/11, thousands of rescue workers descended on Ground Zero to help with recovery efforts. Sifting through dust and rubble, sometimes with their bare hands, many lacked the clothing and equipment that could have kept them safe from harm. Several studies earlier this year confirmed that Ground Zero first responders were suffering from ill health as a result of their exposure to toxic dust at the site. Released in May, the initial findings of a three-year study conducted by the Mt. Sinai Medical Center found that of the 9,000 WTC first responders examined, 70-percent had suffered some type of lung ailment after the attacks, and that 60-percent still faced respiratory problems. Another report released by the FDNY in early May reported that cases of the rare lung disease sarcoidosis had risen dramatically among firefighters and EMS workers who were first responders at Ground Zero. And the New York City Department of Health also found that one in eight first responders still suffer from Post Traumatic Stress Disorder.

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Medtronic Sprint Fidelis Defibrillator Lead wires could have even more problems than once thought.  While the Sprint Fidelis Leads where recalled by Medtronic in October because of a higher-than-normal fracture rate, there is now concern that the leads could also have poor sensing capabilities.  This defect could cause a Medtronic defibrillator to deliver inappropriate shocks to the heart.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync.  When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

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