Edmund's Newsletter January 20, 2009 Issue: #3 Volume 9 Check Out My Book Check Out My Book Join Our List In This Issue FDA Public Health Advisory -- Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions New Drug Holds Out Promise Of Normal Diet For Sufferers Of Devastating PKU Genetic Disease UNC Study Supports Role Of Circadian Clock In Response To Chemotherapy Free Antibiotics: Wrong Prescription For Cold And Flu Season Update of Safety Review -- Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor) Popular Cold And Cough Treatment May Create Respiratory Distress In Young Children FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days Drug Shortages Quick Links Edmund's Blog Edmund's Newsletter Edmund's Web Page Past Issues SPECIAL THANKS TO Michael R. 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PRAY FOR PEACE © 2001,2002, 2003, 2004, 2005, 2006, 2007 Join Our List FDA Public Health Advisory -- Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions FDA is issuing this advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from medical tests and conditions.  In February 2007, FDA issued a Public Health Advisory- Life-Threatening Side Effects with the use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures -that described the deaths of two young women who used topical anesthetics prior to laser hair removal [http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm].  Now, FDA is aware that lidocaine, a type of topical anesthetic, was studied to see if it may reduce discomfort during breast mammography1. During the study, the topical product was spread over a wide area and covered with plastic wrap. Although no serious side-effects were reported in this study, it was not large enough to evaluate whether uncommon but serious reactions could occur with this use. FDA remains concerned about the potential for topical anesthetics to cause serious and life-threatening adverse effects when applied to a large area of skin or when the area of application is covered.   Topical anesthetics work by blocking pain sensation in the skin.  Some of the medication in a topical anesthetic can pass through the skin into the blood stream.  More of the medication will pass into the blood stream if the topical anesthetic is applied over a large area of the skin, if a large amount is applied, if it is applied to irritated or broken skin, or if the skin temperature increases.  Skin temperature can increase during exercise, by covering the skin with a wrap, or with use of a heating pad.  Under these circumstances, the amount of anesthetic medication that reaches the blood stream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death. Read more..... New Drug Holds Out Promise Of Normal Diet For Sufferers Of Devastating PKU Genetic Diseasee Severe protein restrictions normally the only way to avoid brain damage and retardation Imagine being forced to say no to a child crying for more food at supper. Sadly, Margie Fischer doesn't have to imagine it; that was normal life at her family's dinner table for years. Her daughter Maggie, now 20, suffers from phenylketonuria (PKU), a genetic disease that means her body can't tolerate anything more than a low-protein diet. PKU is described by scientists as an autosomal recessive genetic disease that is characterized by a deficiency in an enzyme called phenylalanine hydroxylase (PAH). Without PAH, the body cannot metabolize the amino acid phenylalanine. It then builds up in the blood, crosses the blood-brain barrier and causes severe brain damage. Fortunately, PKU can be detected at birth in blood tests, and was one of the first treatable genetic diseases. From infancy, PKU sufferers are restricted to a low-protein diet to avoid the worst complications of the condition. This diet is essential during childhood to prevent damage to the brain while it is still growing; however, it is now also recommended for life to optimize school performance, concentration and the ability to think clearly. Read more..... UNC Study Supports Role Of Circadian Clock In Response To Chemotherapy For years, research has hinted that the time of day that cancer patients receive chemotherapy can impact their chances of survival. But the lack of a clear scientific explanation for this finding has kept clinicians from considering timing as a factor in treatment. Now, a new study from the University of North Carolina at Chapel Hill has suggested that treatment is most effective at certain times of day because that is when a particular enzyme system - one that can reverse the actions of chemotherapeutic drugs - is at its lowest levels in the body. The study, performed in mice, could also have implications for the prevention of new cancers. The enzyme system implicated - called nucleotide excision repair- repairs many types of DNA damage that come not just from chemotherapy but also from the ultraviolet rays of the sun. Thus, by understanding the cyclical nature of this system, physicians may be able to pinpoint when it is most crucial for people to protect themselves from sun exposure to minimize their risk of skin cancer. "Timing is everything, and here we have molecular data showing why this is especially true with regard to cancer," said senior study author Aziz Sancar, M.D., Ph.D., a member of the UNC Lineberger Comprehensive Cancer Center and Sarah Graham Kenan professor of biochemistry and biophysics in the UNC School of Medicine. Sancar is also a member of the National Academy of Sciences and the Turkish Academy of Sciences. "By hitting cancer cells with chemo at a time when their ability to repair themselves is minimal, you should be able to maximize effectiveness and minimize side effects of treatment." Read more..... Free Antibiotics: Wrong Prescription For Cold And Flu Season With an epidemic of antibiotic-resistant infections growing, experts are warning grocery-store pharmacies that antibiotics giveaways are an unhealthy promotional gimmick. If grocery stores want to help customers and save them money during cold and flu season, the Infectious Diseases Society of America (IDSA) says, they should offer free influenza vaccinations instead. Giant, Stop & Shop, and other grocery stores have recently begun offering free antibiotics at their pharmacies. Most concerning are promotions such as Wegmans' that link antibiotics to the winter cold-and-flu season-despite the fact that antibiotics will have no effect on these viral illnesses and carry risks of serious side effects. "While it may make good marketing sense, promoting antibiotics at a time when we are facing a crisis of antibiotic resistance does not make good public health sense," said IDSA President Anne Gershon, MD. "On the other hand, grocery stores would be doing a tremendous service if they help more people get their flu shots." A new study in the February 1 issue of Clinical Infectious Diseases shows that workers age 50-64 who received influenza vaccine lost substantially fewer days of work and worked fewer days while ill. But influenza vaccine is underutilized. Millions of doses were thrown away at the end of the last two flu seasons. Read more..... Update of Safety Review --  Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor) On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia).  (http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm). Preliminary results from this trial had indicated that there was no significant difference between Vytorin and simvastatin-treated patients in the thickness of the carotid (neck) arteries despite greater lowering of LDL (bad) cholesterol with Vytorin compared to simvastatin. The thickness of the carotid arteries, also known as carotid intima-media thickness or cIMT, is a marker of risk for cardiovascular disease. The preliminary results from the ENHANCE trial raised several questions, some of which involve the relationship of cIMT to LDL cholesterol levels and the role of cIMT in drug development. The FDA has completed its review of the final clinical study report of ENHANCE.  Following two years of treatment, carotid artery thickness increased by 0.011 mm in the Vytorin group and by 0.006 mm in the simvastatin group. The difference in the changes in carotid artery thickness between the two groups was not statistically significant.  However, the levels of LDL cholesterol decreased by 56% in the Vytorin group and decreased by 39% in the simvastatin group. The difference in the reductions in LDL cholesterol between the two groups was statistically significant. The results from ENHANCE do not change FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease. Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the ENHANCE trial. Read more..... Popular Cold And Cough Treatment May Create Respiratory Distress In Young Children New research out of Wake Forest University Baptist Medical Center suggests that Vicks® VapoRub®, the popular menthol compound used to relieve symptoms of cough and congestion, may instead create respiratory distress in infants and small children. Vicks VapoRub may stimulate mucus production and airway inflammation, which can have severe effects on breathing in an infant or toddler. The study appears in this month's issue of Chest, the peer-reviewed journal of the American College of Chest Physicians, and reports that the product may stimulate mucus production and airway inflammation, which can have severe effects on breathing infants or young children because of the small size of their airways. "The ingredients in Vicks can be irritants, causing the body to produce more mucus to protect the airway," said Bruce K. Rubin, M.D., lead author of the study and a professor in the department of pediatrics at Brenner Children's Hospital, part of Wake Forest Baptist. "Infants and young children have airways that are much narrower than those of adults, so any increase in mucus or inflammation can narrow them more severely." Read more..... FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today. Read more..... Believe it or not NY man demands estranged wife pay him for kidney Doctor wants kidney back as part of divorce GARDEN CITY, N.Y. - A Long Island surgeon embroiled in a nearly four-year divorce proceeding wants his estranged wife to return the kidney he donated to her, although he says he'll settle for $1.5 million in compensation. Dr. Richard Batista, a surgeon at Nassau University Medical Center, told reporters at his lawyer's Long Island office Wednesday that he decided to go public with his demand for kidney compensation because he has grown frustrated with the negotiations with his estranged wife. He claimed he has been prevented from seeing their children, ages, 8, 11 and 14, for months at a time. "This is my last resort; I did not want to do this publicly," Batista said. He said he gave his kidney to Dawnell Batista, now 44, in June 2001. She filed for divorce in July 2005, although he claims she began having an extramarital affair 18 months to two years after receiving the kidney transplant, his attorney, Dominick Barbara said. Douglas Rothkopf, the attorney representing Dawnell Batista, did not return telephone calls seeking comment. Matrimonial attorneys were quick to shoot down any possibility Batista would succeed. "I've been in this business over 40 years and I've never heard of that," said Seymour J. Reisman, a Long Island divorce lawyer. "It's not marital property, not a marital asset you can put a price tag on." Manhattan attorney Susan Moss said, "The good doctor is out of luck and out a kidney. This is similar to cases where a husband wants to be repaid for the cost of breast implants and the such. Our judges are not willing to value such assets, so to speak." Batista, 49, said he has no regrets about donating the kidney, only about the failed marriage. The couple was married in 1990 and lived in a million-dollar home in Massapequa. They met while he was working at a hospital and she was training to be a nurse. He still recalls the day after the surgery took place. "There is no greater feeling on this planet. As God is my witness, I felt as if I could put my arm around Jesus Christ. It was an unbelievable; I was walking on a cloud. To this day I would still do it again." News From MedWatch Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE   Recently Approved Drugs/Indications Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE   FDA Recalls and Safety Alerts in the Past 60 Days: To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE   Drug Shortages: As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE   Recommend Edmund's Newsletter Edmund's Newsletter is published for only one reason and that is expand our knowledge base, join people together with like minds and to disseminate valuable information. If you feel this newsletter is of worth, please pass it along to your friends and colleagues. 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