FDA: Sudden Hearing Loss Linked To Erectile Dysfunction Drugs

money.cnn.com

The U.S. Food and Drug Administration said Thursday it's approved new erectile dysfunction drug labels to more prominently display the potential risk of sudden hearing loss.

The labeling change - first reported by CNBC - applies to Pfizer Inc.'s (PFE) Viagra, Eli Lilly & Co.'s (LLY) Cialis, Levitra marketed by GlaxoSmithKline PLC (GSK), Schering-Plough Corp. (SGP) and Bayer AG (BAY). The agency said the change will also apply to Pfizer's Revatio, a drug with the same active ingredient as Viagra that's used to treat pulmonary arterial hypertension.

The FDA said it found a total of 29 reports of sudden hearing loss among patients taking the erectile dysfunction drugs. The agency said the search of its adverse-events database was prompted by a case report in medical literature of a patient with sudden hearing loss who was taking Viagra. Such adverse-event reports, which are filed to the FDA by drug companies, doctors and patients, does not mean a particular drug has caused a problem.

The FDA said hearing loss was also reported in a few patients in clinical trials of these drugs. The FDA said in most cases the sudden hearing loss occurred in one ear.

All of the drugs fall into a category of drugs known as PDE5 inhibitors.

"Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class," the FDA said in a statement posted on its Web site.

The agency noted that hearing loss is commonly reported in an aging population, especially in patients with risk factors for erectile dysfunction. "However, sudden hearing loss is an uncommon event at any age," the agency said.

Bicycle-Related Injuries a Big Concern for Kids

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New research reveals bicycle injuries are more common in children and adolescents than previously believed.

Researchers from Columbus Children’s Hospital in Ohio analyzed data from the 2003 Healthcare Cost and Utilization Project’s Kids’ Inpatient Database. They looked at hospitalization for bicycle-related injuries according to patient demographics, type of injury, total hospital charges, and length of hospital stay.

Results show bicycle-related injuries lead to nearly $200 million a year in hospital inpatient costs. Gray Smith, M.D., Dr.PH., from The Ohio State University College of Medicine, was quoted as saying, “Bicycles are associated with more childhood injuries than any other consumer product except the automobile. The high rate of hospitalization and use of healthcare resources identified in our study supports the need for increased attention to bicycle-related injuries.”

Researchers report motor vehicles were involved in about 30 percent of bike-related hospitalizations, and the link with motor vehicles increased among older children. Researchers also found one-third of kids who landed in the hospital for a bicycle-related injury had a traumatic brain injury - a statistic that could be lowered by consistent use of bike helmets. Dr. Smith reports, “The findings from our study can be used to promote targeted prevention strategies to lessen the severity of injury and the number of deaths resulting from pediatric bicycle-related injuries. We know that bicycle helmets can reduce the risk of brain injury by up to 85 percent. We need to increase efforts to promote helmet use by children riding bicycles.”

The current study reveals about 10,700 children are hospitalized for a bicycle-related injury each year. Statistics show children and adolescents age 20 and younger make up more than 50 percent of approximately 85 million bicycle riders in the United States.

Amoeba Warning Signs To Be Posted

www.azcentral.com

Signs warning of the dangers of a rare amoeba will be posted at Lake Havasu, suggesting swimmers take precautions such as plugging their noses when they dive.

The City Council decided to take the action after last month's death of Aaron Evans, 14, who doctors believe was infected with the microscopic amoeba, Naegleria fowleri (nuh-GLEER-ee-uh FOWL'-erh-eye), while swimming at the lake.

"I'm happy with it," said Keith Evans, Aaron's grandfather. "It shows they're stepping up."

The city will post the signs 1 mile from the lakefront. Arizona and California share jurisdiction on the remaining lake frontage, along with county and state agencies and Indian tribes.

Mohave County also is considering posting signs and the Board of Health will take up the matter next month.

The signs the city plans to post will warn against dangers including "drowning, physical injuries and illnesses caused by amoebas and bacteria, which exist naturally," according to city staff.

The signs direct bathers not to inhale water through their mouth and nose, and to avoid diving into murky or shallow water.

Human infection by the amoeba is extremely rare but almost always fatal, with six deaths, including Evans, reported this year in the U.S. When inhaled, the single-cell creature at attaches itself to the olfactory nerve, then makes its way to the brain.

City Manager Richard Kaffenberger said Tuesday that he believes the city should take the lead role in encouraging a multistate educational campaign about the amoeba.

Besides posting signs, the city may also run public service announcements during periods when the amoeba becomes active, city spokesman Charlie Cassens said.

Parental Heart History Critical For Both Genders

www.chicagotribune.com

By Melissa Healy

When a man suffers a heart attack at a young age, klaxons sound and red flags flutter for his son. Pointing to a son's inherited risk of going down the same road, physicians probably will urge him to stay away from cigarettes, watch his weight and exercise regularly. And there's growing evidence that that advice prompts many men to take heed - especially the recommendation to exercise.

But do alarm bells sound for the female child of a premature heart attack victim - and does she hear them? A study in the September issue of the American Heart Journal suggests the answers are no and no. The study establishes that although the daughters of families with premature heart disease are at higher risk of developing heart disease themselves, they either are failing to get that message or not bothering to heed it.

Between ages 30 and 50, these women are more likely to be overweight and to smoke than are their female peers without a family history of heart disease. Further, they are only slightly more likely to exercise and, overall, appear less inclined than men are to shape up when an immediate blood relative is stricken with heart problems.

"Women seem to feel they have a get-out-of-jail-free card when it comes to heart disease," says Dr. Alexis Anvekar, a Pasadena, Calif.-based internist and American Heart Association spokeswoman. "They seem to feel that it's a man's disease."

The American Heart Journal study looked at data collected on 2,400 people as part of the Dallas Heart Study, which surveyed and examined about 6,000 Texas residents to track the incidence and development of heart disease. University of Texas Southwestern Medical Center internal medicine specialist Dr. Amit Khera and colleagues looked at how men and women, with and without histories of heart disease, compared on measures of cardiovascular risk factors, arterial blockage as detected on scans, and their reports of exercise activity and tobacco use.

The data supported the long-held belief that women generally have lower levels of plaque and fatty buildup in their arteries. But closer inspection showed that among those women with a family history of premature heart disease, the concentration of arterial plaque and fatty deposits was twice that of women with no such family history. And these women's atherosclerosis was on par with that of men with no family history of heart disease. A family history of heart disease, in effect, wiped out the biological protection against heart disease most females enjoy.

"Having a family history kind of turned a woman into a man biologically," said Khera, the study's senior author.

Along with vulnerable genes, parents with heart disease tend to pass down to their children unhealthful habits. As a result, both men and women with a family history of heart disease were more likely than their same-sex peers without such a history to smoke, weigh too much and (for women but not men) to be sedentary.

But for men, the differences were typically narrow, suggesting that many men with family histories of heart disease had rejected unhealthful habits in an effort to reduce their risk.

There was little evidence that women in the same situation had made such changes.

Khera suggests that, with major public campaigns to educate women to heart disease risks, things might be a little different now than three to five years ago, when the Dallas snapshot was taken. But he said women with family heart disease history - as well as their doctors - still have far to go.

"People are finally getting the message, and women are often more compliant, " when told they must change their ways, Khera says. But if a woman is to be saved from her father's disease, he adds, she needs to get the message, get the treatment and make the changes that could make the difference.