Health Highlights: March 10, 2015
Maker of Children's Tylenol, Motrin to Plead Guilty to Selling Contaminated Medications Soft Drinks Dropped From Burger King's Kid's Menu/Meals New Treatment for Double Chin Should be Approved: FDA Advisory Panel New Drug OK'd for a Deadly Pediatric Cancer Boxed Warning to Remain on Chantix: FDA Teen Forced Into Chemotherapy in Remission Affordable Care Act Will Cost Less Than Projected: CBO Specialty Drugs Push Prescription Spending Increase
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Maker of Children's Tylenol, Motrin to Plead Guilty to Selling Contaminated Medications
The maker of liquid Tylenol and Motrin for children and infants has agreed to plead guilty Tuesday to selling the over-the-counter medications even though the bottles were contaminated with metal particles.
McNeil Consumer Healthcare will pay $25 million as part of its plea agreement, the Associated Press reported. The Fort Washington, Pa.-based company, a unit of Johnson & Johnson, was facing a federal criminal charge for knowing for nearly a year that metal particles, including nickel, iron and chromium, were getting inside the bottles of medicine during the manufacturing process.
Although no immediate steps were taken to fix the problem, the Fort Washington plant where the contaminations occurred was shut down in 2010 and a new, yet-to-open plant has been built in its stead, the AP reported.
McNeil was first alerted to the problem in 2009 following a customer complaint, but the company kept selling the medications for several months before issuing a recall, according to the AP. At the time, the U.S. Food and Drug Administration said the chances for serious medical problems were unlikely, but it advised consumers to stop taking the medications, the wire service reported.
The health care company is currently in an agreement with the FDA that includes increased inspections and oversights at it manufacturing plants, according to the AP.
Soft Drinks Dropped From Burger King's Kid's Menu/Meals
Soft drinks have been dropped from Burger King's children's menu and are no longer included in the fast food chain's kids' meals.
The unannounced move was made late last month and followed similar changes by McDonald's and Wendy's, USA Today reported.
Instead of soft drinks, Burger King's menu for children will offer fat-free milk, 100 percent apple juice and low-fat chocolate milk.
The change is "part of our ongoing effort to offer our guests options that match lifestyle needs," Alex Macedo, president of Burger King North America, said in an e-mailed statement to USA Today.
Growing pressure from consumers and activists has prompted a number of menu changes at large fast-food chains.
New Treatment for Double Chin Should be Approved: FDA Advisory Panel
An injectable drug to treat double chin in adults should be approved for sale in the United States, a Food and Drug Administration advisory panel says.
Kythera Biopharmaceuticals' treatment, called ATX-101, would offer a nonsurgical option for double chin, the Wall Street Journal reported.
The injectable drug -- which was tested in 19 clinical trials involving about 2,600 people -- is a formulation of a pure, non-animal derived deoxycholic acid that helps break down fat, according to the California-based company.
The FDA typically follows the recommendations of its advisory panels. If approval is granted, Kythera said sales of ATX-101 could begin in the second half of the year, WSJ reported.
New Drug OK'd for a Deadly Pediatric Cancer
A new drug to treat high-risk neuroblastoma has been approved by the U.S. Food and Drug Administration.
Neuroblastoma is a type of cancer that most often occurs in children under age 5. Patients with high-risk neuroblastoma have only a 40 to 50 percent chance of long-term survival despite aggressive treatment.
The FDA approved the drug Unituxin (dinutuximab) as part of a combined treatment regimen -- including surgery, chemotherapy and radiation therapy -- for patients who had at least a partial response to a previous combined treatment program.
"Unituxin marks the first approval for a therapy aimed specifically for the treatment of patients with high-risk neuroblastoma," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"Unituxin fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma," he added.
Boxed Warning to Remain on Chantix: FDA
A boxed warning about suicidal behavior and other psychiatric side effects will remain on the packaging of Pfizer's anti-smoking drug Chantix, the U.S. Food and Drug Administration said Monday.
The decision came after the agency reviewed the drug maker's findings suggesting the twice-a-day tablet does not increase the risk of such problems, the Associated Press reported.
Chantix has carried a black box warning -- the strongest type -- since 2009 after the FDA received reports of suicidal and violent or bizarre behavior among some people taking the drug.
On Monday, the FDA also announced a number of updates to the drug's labeling, including a new warning about its potential interaction with alcohol. The agency has heard about unusual or aggressive behavior among some people who drink while on Chantix, the AP reported.
Last year, Pfizer asked the FDA to remove the black box warning on Chantix, claiming that its own studies showed that people taking the drug were not more likely to have psychiatric problems than people using other stop-smoking treatments.
But the FDA said the drug maker's studies did not look at all types of psychiatric problems and had limitations that prevented the agency "from drawing reliable conclusions," the AP reported.
A larger Pfizer study of Chantix's psychiatric side effects is expected to be completed late this year.
Currently, the labeling on Chantix tells patients to stop taking the drug immediately if they develop agitation, depressed mood, suicidal thoughts and other mental health changes, the AP reported.
Teen Forced Into Chemotherapy in Remission
A Connecticut teen with Hodgkin's lymphoma who was forced into chemotherapy by state officials is in remission.
The 17-year-old girl is known as Cassandra C. in court papers. On Jan. 8, the state Supreme Court upheld a Superior Court order that give the Department of Children and Families temporary custody of Cassandra, who ran away after receiving two chemotherapy treatments, the Hartford Courant reported.
Court-ordered chemotherapy began in late November and was scheduled to continue for six months. Doctors said Cassandra would die without chemotherapy, but would have an 80 to 85 percent chance of survival and full recovery if she received the treatment.
"We are very pleased with Cassandra's progress toward a complete recovery. We understand how difficult this has been for Cassandra and her family, but we have had full confidence throughout that the medical professionals involved in her treatment would be successful in saving her life," Department of Children and Families Commissioner Joette Katz said in a statement released Sunday, the Courant reported.
Affordable Care Act Will Cost Less Than Projected: CBO
The cost of the Affordable Care Act is falling along with slower increases in health care costs, according to the nonpartisan Congressional Budget Office.
On Monday, the CBO said the health care overhaul is expected to cost taxpayers $142 billion over the next decade, which is 11 percent lower than previous estimates, the Associated Press reported.
There are two reasons for the lower estimate, according to the CBO. Health insurance premiums are increasing slower than expected, and new data shows there were fewer Americans without insurance before the law, which means less people will need to make use of the law to get coverage.
Even so, the CBO said 24 million to 25 million people a year will get health coverage over the next decade due to the law, the AP reported.
Specialty Drugs Push Prescription Spending Increase
Expensive specialty drugs were a major cause of the 13 percent rise in prescription spending in the United States last year, according to Express Scripts.
The nation's largest pharmacy benefits manager said specialty drugs represented only 1 percent of all prescriptions filled, but accounted for about 31 cents of every dollar spent on prescriptions, the Associated Press reported.
A number of insurers have warned for more than a year about the growing costs of specialty drugs used to treat complex or chronic conditions such as multiple sclerosis and hepatitis C.
However, Express Scripts also said that specialty drug spending will slow to more sustainable levels over the next three years, the AP reported.