This past week new data suggested that some people taking the anti-obesity drug Meridia (sibutramine) are at greater risk of heart attacks and strokes than people taking a placebo. It also raised blood pressure and heart rate among users. What is interesting is how two large regulatory agencies responded to this data. The European Medicines Agency (EMEA) has already advised physicians and pharmacists to stop prescribing and dispensing the medication, while the U.S. FDA has urged pharmaceutical company Abbott Laboratories, the maker of Meridia, to place a stronger warning on the drug. The warning is to caution against the use of the drug by people who are already at increased risk of cardiovascular disease. Was the EMEA too hasty in its decision or is the FDA not forceful enough? Proponents of the drug agree that it shouldn’t be given to those with cardiovascular disease or diabetes, while critics are in favor of an overall ban. In the drug’s twelve years on the market it has been linked to more than 80 deaths, including 30 people under age 50. [via New York Times]
Researchers from Tufts University are concerned that some nutritional labels may be underestimating the caloric content of their respective products. After evaluating 29 commercially-prepared restaurant foods and 10 frozen meals which are found throughout US, researchers discovered that the sit-down restaurant foods averaged 18% more calories than stated and the frozen meals averaged 8% more calories than advertised. The authors note that the US Food and Drug Administration allows up to 20% excess energy content but weight must be no less than 99% of the stated value. This might lead manufacturers to add more food to insure compliance with the weight standards and thereby exceed the stated energy content. However, it’s the allowable 20% caloric excess that is appalling. As the researchers note – a positive energy balance of just 5% per day for an individual requiring 2,000 kcal/day could lead to a 10-lb weight gain in a single year. [via Science Daily]
Here’s some good news for patients with chronic obstructive pulmonary disease (COPD) and other conditions with chronic mucus production. A new device called the Lung Flute, which has just been approved by the FDA, can vibrate away mucus by simply blowing into it. Blowing into the instrument sends a steady 16-hertz vibration into the user’s chest which breaks up mucus and allows the body to better expel the sticky substance. Although there are other devices that also use vibration to loosen mucus, the Lung Flute costs a great deal less at $40 a piece, making it much more accessible. See a video of the device in action here. [via PopSci.com]
On November 13, 2009 the FDA issued notification to 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products. “The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs. The problem is that caffeine has not been approved by the FDA to be added to alcoholic beverages. However, some substances which are Generally Recognized As Safe (GRAS), or have been subject to prior sanction, are legality able to be used as food additives. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts. Thus, the FDA is giving these companies 30 days to produce data to support that the use of caffeine in their products is GRAS or have been previously sanctioned. Click here for a full list of companies and products affected. [via FDA]
The FDA is working with pharmaceutical company Eli Lily to update label information on a common drug used to treat type 2 diabetes. The drug, called Byetta, is an injectable medicine that helps to control blood sugar levels. However, over a three-year period, the FDA received 78 reports of kidney problems, including kidney failure, among patients taking Byetta. Thus, new Byetta drug information will carry the warning that the medication may contribute to kidney malfunction. Signs of kidney problems can include change in the frequency of urination, urine color and amount of urine produced. Also, hand and feet swelling, low back aches, fatigue and changes in appetite can also be signs of kidney damage. Patients taking Byetta should notify their physicians if they experience any of these symptoms because kidney failure can cause serious problems due to the build up of metabolic waste products in the body. [HealthDay via Businessweek]
The FDA recently announced the approval of a second HPV vaccine for the U.S. market. Cervarix, manufactured by GlaxoSmithKline, is the sole competitor to rival vaccine Gardasil, produced by Merck & Co. The vaccines differ in the strains of HPV they guard against, but both will fight the two most common strains that cause 70% of cervical cancers. At the same time, however, the FDA also granted approval for Merck’s Gardasil to be used in preventing genital warts (not genital cancer) in boys and men ages 9 through 26. But, do our children need yet another vaccine? You be the judge. Both vaccines are expected to net their respective companies over $1 billion per year in the coming years. [via ABC News]
Some researchers believe the popularity of indoor tanning among adolescent girls in recent years may be behind a recent increase in melanoma rates among U.S. women aged 15-39. Melanoma is a dangerous type of skin cancer. This has prompted the FDA to recommend to indoor tanning operators that teenagers be limited to three or fewer sessions in the first week of tanning. However, a new study published in the Archives of Dermatology shows that only about 11% of operators followed these guidelines, and 71% of tanning bed operators said they would allow a teen to tan seven days a week. “Exposure to UV radiation from indoor tanning lamps has been linked with both melanoma and squamous cell cancer, and first exposure before age 35 years may increase melanoma risk by as much as 75 percent,” said the study authors. [CBS News]
Simone Davis, a 17 year-old British girl has been denied US permanent residency because she refused to take the Gardasil vaccine, which protects against a few strains of HPV and reduces the risk of cervical cancer. Since 2008, the US government has required that female immigrants between the ages of 11 to 26 applying for permanent residency or refugee status receive Gardasil, which was approved by the FDA in 2006. According to the 1996 Immigration and Naturalization Act girls and women within a specified age group must receive vaccinations against certain specified diseases “and any other vaccinations recommended by the CDC’s Advisory Committee for Immunization Practices. Said Davis, “I am only 17 years old and planning to go to college and not have sex anytime soon. There is no chance of getting cervical cancer, so there’s no point in getting the shot.” A devout Christian, Simone has taken a virginity pledge and plans to attend Pensacola Christian College, where she was conditionally accepted, pending her legal status. The vaccine is not mandated for girls or women who are already legal US residents. [via ABC News]
Since the introduction of their Gardasil vaccine (marketed for the prevention of cervical cancer in women), pharmaceutical giant Merck has been wanting to expand the vaccine’s use to include males. Currently, the vaccine is approved for use in girls and women between the ages of 9 and 26. If Merck has its way Gardasil will be used in boys and men ages 9 to 26 as well. In documents posted online, the FDA said the vaccine prevented genital warts in males 90 percent of the time. Based on this the FDA’s Vaccines and Related Biological Products Advisory Committee is supporting the use of Gardasil in males. However, it is unlikely that the use of the vaccine will prevent a significant amount of penile and anal cancers, compared with cervical cancer. Cancer of the penis and anus are extremely rare, with less than 2,000 cases reported annually. Gardasil was approved for women in 2006 and had sales over $1 billion last year. [via CBS News]
In a warning letter to General Mills, makers of the popular Cheerios Toasted Whole Grain Oat Cereal, the FDA is claiming that the marketing of Cheerios qualifies it as a drug because of its claims in reducing cholesterol. The phrases in question include “you can Lower Your Cholesterol 4% in 6 weeks” and “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent?” According to the FDA these statements violate the Federal Food, Drug, and Cosmetic Act, which defines what a drug is. General Mills has 15 days to address the violation in question. Read the FDA letter.
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About Dr. Steven Chang
Dr. Steven Chang, the author of DailyDose, is a staff physician with Kosmix RightHealth. Dr. Chang practices Family Medicine at the University of California Davis Medical Center, where his medical interests include both pediatric and geriatric care, public health, gay and lesbian health, and sleep medicine. Dr. Chang trained at the Stanford University affiliated O'Connor Hospital, and was a research fellow at the National Institute of Health. He holds an M.D. from McGill University and a BA in Public Health from Johns Hopkins University.
Dr. Steven Chang, the author of DailyDose, is a staff physician with Kosmix RightHealth. Dr. Chang practices Family Medicine at the University of California Davis Medical Center, where his medical interests include both pediatric and geriatric care, public health, gay and lesbian health, and sleep medicine. Dr. Chang trained at the Stanford University affiliated O'Connor Hospital, and was a research fellow at the National Institute of Health. He holds an M.D. from McGill University and a BA in Public Health from Johns Hopkins University.