November 24, 2012
The news about children and asthma is both good and bad. Better treatments have banished the stereotype of the asthmatic child as frail and inactive, heavily relying on an inhaler to breathe. Children with asthma are now living active, independent lives.
The Food and Drug Administration (FDA) is working to make sure that the drugs and devices used to treat asthma—a chronic lung disease that inflames and narrows the airways—are safe and effective.
The bad news is that the number of reported cases of asthma in children has been rising. In 2010, there were 7 million children with asthma, 9.4% of Americans under 18, according to the Centers for Disease Control and Prevention, up from 6.5 million, or 8.9%, in 2005.
One reason may be that doctors are diagnosing more kids; illnesses once known as bronchitis or a croupy cough are now being recognized as asthma. Its symptoms may include coughing, wheezing (a whistling sound when you breathe), chest tightness and shortness of breath, according to the National Heart, Lung and Blood Institute (NHLBI).
Uncontrolled asthma can lead to chronic lung disease and a poor quality of life, and may slow growth. Benjamin Ortiz, M.D., a medical officer in FDA’s Office of Pediatric Therapeutics, recommends that parents work with a pediatrician, and an allergist or pulmonologist (lung specialist) if needed, to develop and follow an asthma action plan that details the treatment options when certain symptoms occur.
“We know what makes asthma worse or better, but don’t know the primary cause,” Ortiz says. The things that make asthma worse are known as “triggers.” They include:
- Season and climate changes
- High levels of air pollutants
- Tobacco smoke
- Mites, roaches
- Plant pollen
- Pet dander
- Strong scents, like perfumes
In addition, certain factors may increase a child’s risk of developing asthma:
- Family history of asthma
- Multiple episodes of wheezing before age 2
- Living in crowded housing
- A family member who smokes
- Early development of allergies or eczema
November 17, 2012
If you’re one of the 44 million Americans at risk for osteoporosis—a disease in which bones become weak and are more likely to break—you may be taking bisphosphonates. This class of drugs has been successfully used since 1995 to slow or inhibit the loss of bone mass. Doctors commonly prescribe such brand-name drugs as Actonel, Atelvia, Boniva, and Fosamax (as well as a number of generic products) for osteoporosis. In fact, more than 150 million prescriptions were dispensed to patients between 2005 and 2009.
Bones go through a continual process of remodeling, in the form of bone resorption (disintegration) and bone formation. Bone loss related to osteoporosis occurs when resorption is greater than formation. Bisphosphonates decrease bone resorption, thereby slowing bone loss.
During treatment, bisphosphonates become part of the newly formed bone and can stay there for years, through many cycles of resorption and formation. Patients continue to be exposed to the effects of the drug even long after they’ve stopped taking it.
According to Whitaker, the studies that FDA considered focused on patients who had been using bisphosphonates for at least three years and as many as 10. They looked at outcomes related both to bone mineral density and bone fractures.
“Bisphosphonates have been proven very effective in protecting against bone fractures in clinical trials lasting three to four years,” says Whitaker. But it’s still unknown whether the benefit lasts longer than that in decreasing the risk of fractures.
Bisphosphonate labels have carried a safety warning about severe jaw bone decay (osteonecrosis of the jaw) since 2002. In October 2010, FDA warned patients and health care professionals about the increased risk of unusual thigh bone fractures and directed manufacturers to include the warning in the safety labels and medication guides that come with prescription medications. FDA continues to evaluate the possible association of bisphosphonates with esophageal cancer. These associations would suggest that health care professionals may want to reconsider how long patients should continue taking the drugs.
November 5, 2012
People who suffer chronic pain face a good news/bad news situation in choosing a treatment. There are powerful medicines called opioids that can help manage pain when prescribed for the right condition and when used properly. But when prescribed by physicians to patients who should not receive them, or when used improperly or for recreational purposes, they can cause serious harm, including overdose and death.
To reduce these risks as much as possible, the Food and Drug Administration (FDA) has approved a risk management plan for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics, used to treat moderate to severe chronic pain. This plan is designed to ensure that health care professionals are trained on how to properly prescribe these medicines and how to instruct their patients about using them safely.
“There are a limited number of options available for the treatment of pain. Opioids are one option, but they carry a significant risk of misuse, abuse, overdose and death,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products. “We’re trying to help physicians manage the risks and improve the safety of using these medicines.”
Opioids—so named because they are synthetic versions of opium—are narcotics that work by changing the way the brain perceives pain. They are available— in forms that include pills, liquids and skin patches—to treat moderate to severe chronic pain. Hertz explains that the ER/LA opioids are more of a safety concern than immediate-release formulas because they are stronger and either stay in the body longer or are released into the body over longer periods of time. The drugs that will be required to have a REMS include:
- Butrans (transdermal buprenorphine)
- Dolophine (methadone)
- Duragesic (transdermal fentanyl)
- Exalgo (hydromorphone)
- MS Contin
- Opana ER (oxymorphone).
- Oramorph (all morphines)
- OxyContin (oxycodone)
“When too much is taken, the risk of overdose is serious and it can cause death,” says Hertz. “We’ve seen that happen to people who overdose accidentally when they are taking an opioid for pain and to others who are taking it to get high.”
Hertz says that’s why it’s important that patients securely store their medications, both to prevent the accidental exposure of family members and to keep them away from others looking to get high.
And patients should not be sharing their pain relievers, Hertz says. “Just because it’s safe for the patient, doesn’t mean it’s safe for someone else,” she says, noting that there have been cases of people overdosing and dying after taking an opioid medication prescribed for a friend or family member.