FDA Backpedaling on Plan to Withdraw Drug for Low Blood Pressure?

Fifteen years after granting provisional approval for midodrine hydrochloride, a drug prescribed for orthostatic hypotension, the US Food and Drug Administration’s efforts to obtain evidence to confirm the drug’s clinical effectiveness remain mired. (Image: JAMA, ©AMA)

Efforts by the US Food and Drug Administration (FDA) to withdraw from the market a drug to treat low blood pressure that received approval 15 years ago through the agency’s accelerated-approval process appear stalled. The drug, midodrine hydrochloride, was approved with the understanding that its manufacturer would provide solid evidence of its benefit to patients, but such evidence has not been forthcoming.

The FDA’s accelerated-approval process allows market access to a drug for a serious or life-threatening illness based on surrogate end points (indirect markers or measurements) rather than more definitive evidence that the drug will actually provide clinically meaningful benefit to the patient. Companies receiving accelerated approval of a drug are then expected to conduct more rigorous clinical trials to provide evidence the drug is effective—and if the company fails to meet this requirement, the FDA has the power to withdraw the drug. Continue reading

More Cases Expected In Listeria Outbreak

Federal health officials expect more cases in the widespread listeria outbreak traced to contaminated cantaloupe. (Image: Jakub Wójtowicz/iStockphoto.com)

Two weeks after cantaloupes contaminated with Listeria monocytogenes were recalled, federal health officials say they expect to see more listeriosis cases reported because it can take 2 months or longer for symptoms to appear once the tainted fruit has been eaten.

“Listeria is an unusual bacteria in a couple of ways,” said Thomas Frieden, MD, MPH, director of the US Centers for Disease Control and Prevention (CDC), during a media briefing yesterday. He explained that it can take anywhere from 1 to 3 weeks to 2 months or more for listeriosis symptoms—fever, muscles aches, diarrhea, and in some cases headache, stiff neck, confusion, and convulsions—to develop. Continue reading

Use of ADHD Medication Continues to Increase and Vary Across Groups

Use of stimulant drugs such as methylphenidate to treat attention-deficit/hyperactivity disorder continues to increase in the United States, though more slowly than in the past. (Image: Martin McCarthy/iStockphoto.com)

Although diagnoses of attention-deficit/hyperactivity disorder (ADHD) and use of stimulant medications to treat the condition continue to rise, treatment with these agents has shifted toward older age groups, according to study findings published online today in the American Journal of Psychiatry.

A sharp increase during the 1990s in the use of stimulant medications such as methylphenidate or amphetamines to treat children with ADHD stirred considerable debate. Critics questioned whether these drugs were being overprescribed and, particularly, whether they should be used in very young children. Since that period, ADHD diagnoses have continued to rise, with data from the National Survey of Children’s Health indicating an increase in such diagnoses from 7.8% to 9.5% between 2003 and 2007. Continue reading

Author Insights: Off-Label Use of Antipsychotics Helpful for Only a Few Conditions

Alicia Ruelaz Maher, MD, a researcher at RAND Health in Santa Monica, Calif, and her colleagues found that patients with eating disorders and substance abuse problems don’t benefit from treatment with atypical antipsychotic medications. (Image: Caara Shayne)

While off-label use of atypical antipsychotics has skyrocketed in recent years, such treatment is beneficial for only a handful of conditions, an analysis published today in JAMA found.

The US Food and Drug Administration has approved the use of atypical antipsychotic medications to treat adult patients with schizophrenia and bipolar disorder. Certain antipsychotics have also been approved for treating a subset of patients with depression. However, US physicians are also allowed to use drugs “off label” to treat other conditions. A doubling of such off-label use of atypical antipsychotics is a driving force behind an increase in medication visits related to these drugs, from 6.2 million visits in 1995 to 14.3 million in 2008.

These trends have raised concerns among some clinicians because this class of drugs is associated with serious adverse events that include substantial weight gain, movement disorders, and even death. Continue reading

Experts Advise Broader Vaccination for Whooping Cough

Updated recommendations expand the populations eligible to receive immunization against pertussis. (Image: Cheryl Casey/iStockphoto.com)

In the wake of last year’s outbreak of pertussis (whooping cough) in California, the American Academy of Pediatrics and the US Centers for Disease Control and Prevention have amended previous recommendations and are expanding the populations of children and adults eligible for vaccination against the highly contagious disease. The amended recommendations appear online today in Pediatrics.

Pertussis primarily affects adolescents and adults, but it can cause severe illness and death to infants who are too young (younger than 2 months of age) to be immunized. Guidelines advise starting immunizing for pertussis (as well as tetanus and diphtheria) with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine at ages 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. And to maintain this immunity, a similar vaccine—called the tetanus toxoid, reduced-content diphtheria toxoid, and acellular pertussis (Tdap) vaccine—was approved in 2005 and licensed for use in children beginning at the age of 11 years through age 18 years. Continue reading

Insecticides Used to Fight Bed Bugs Can Cause Illness

Improper use of insecticides to rid a residence of bed bugs can make occupants sick. (Image: Janice Haney Carr/CDC)

Bloodsucking bed bugs lurking in infested mattresses, bedding, and furniture can make life miserable. But experts warn that the insecticides used to get rid of them can be toxic.

In an article appearing today in the US Centers for Disease Control and Prevention’s (CDC’s) Morbidity and Mortality Weekly Report, federal and state public health experts report that improper use of insecticides to eradicate bed bugs resulted in 111 people becoming sick, including 1 woman who died. The findings, for 2003 through 2010, come from a database of 12 states that conduct surveillance of pesticide-related illness. Seven of those states—California, Florida, Michigan, North Carolina, New York, Texas, and Washington—reported such illness. Continue reading

New Data Say Blood Tests Linking Retrovirus With Chronic Fatigue Are Unreliable

New data cast more doubt on the link between chronic fatigue syndrome and a retrovirus known as XMRV. (Image: Hiob/iStockphoto.com)

The 2-year roller coaster ride that raised hope but then cast doubt that a mouse retrovirus known as XMRV is linked with chronic fatigue syndrome may be coming to an end.

New data published online today in Science report that in independent tests, 9 laboratories couldn’t confirm previous study results showing that 67% of 101 patients with chronic fatigue had XMRV genetic material in their blood compared with only about 4% of healthy controls.

The laboratories carried out blinded tests of blood samples from 15 healthy people and 15 patients, most with chronic fatigue, who tested positive for XMRV in previous studies. Only 2 of the laboratories could detect the retrovirus or antibodies to it in any of the blood samples. But some of the positive results came from people who the laboratories had said didn’t have the retrovirus. In follow-up tests, healthy people were just as likely as those with chronic fatigue to test positive for the virus. Continue reading