FDA

The Food and Drug Administration has stepped up warnings about the dangers of combining opioid painkillers with benzodiazepine sedatives. The agency is requiring new warnings on labels for opioids such as oxycodone, hydrocodone and morphine, as well as for benzodiazepines such as alprazolam and diazepam.

If a tobacco company changes a label for a product, the Food and Drug Administration cannot consider it a new product for regulatory purposes, a federal judge ruled this week.

Many e-cigarette products were rushed to market ahead of new Food and Drug Administration regulations on tobacco products, which took effect Monday. The new rules require companies to submit e-cigarettes for government approval, Reuters reports.

An advisory panel to the Food and Drug Administration has recommended approving a long-acting opioid painkiller that the manufacturer says could deter abuse. The company that makes the new drug, Arymo ER, says it comes in a tablet that is extremely hard, making it more difficult to break down.

The Food and Drug Administration’s new rules on tobacco products, including e-cigarettes, went into effect Monday, HealthDay reports. Under the rules, announced in May, the agency is banning sales of e-cigarettes, cigars, pipe tobacco and hookah tobacco to people under age 18.

The Food and Drug Administration’s new regulations on tobacco originally included language that would have removed flavored e-cigarettes from the market until the agency authorized them, according to Reuters. The final rule deleted that wording.

The Food and Drug Administration on Thursday announced it is extending its oversight to all tobacco products, including e-cigarettes, Reuters reports. The agency will ban sales of e-cigarettes, cigars, pipe tobacco and hookah tobacco to people under age 18.

A Food and Drug Administration advisory panel on Wednesday voted to recommend requiring doctors who prescribe opioids to receive training. Doctors’ groups have resisted mandatory training.

A panel of experts convened by the Food and Drug Administration is meeting this week to consider whether to require doctors to undergo training to prescribe opioid painkillers. Doctors’ groups have resisted mandatory training, The New York Times reports.

Thirty health groups are urging President Obama to issue a final rule that would let the Food and Drug Administration regulate all tobacco products, including e-cigarettes, The Hill reports.

An analysis of sports supplements that claim to burn fat or improve your workout may contain a stimulant drug banned by the World Anti-Doping Agency. Researchers from Harvard Medical School say the stimulant may pose health risks.

The Food and Drug Administration is urging makers of generic drugs to redesign opioid painkillers to make them abuse-deterrent, according to HealthDay.

The Food and Drug Administration announced Tuesday it will require immediate-release opioid painkillers to carry a “black box” warning about the risk of misuse, abuse, addiction, overdose and death, CNN reports.

The new head of the Food and Drug Administration, Dr. Robert Califf, told a panel of advisers this week that the agency will support the development of abuse-deterrent opioids, the Associated Press reports.

Officials from state and local health departments around the country are urging the Food and Drug Administration to add “black box” warnings to opioid painkillers and sedatives known as benzodiazepines, to alert people that taking them together increases the risk of fatal overdoses.

The U.S. Food and Drug Administration has announced it will reassess its approach to opioid medications, in an effort to reverse the epidemic of abuse. The plan comes in response to pressure from Congress, The New York Times reports.

The Obama Administration has been too slow in granting the Food and Drug Administration regulatory authority over e-cigarettes, according to the American Lung Association.

An advisory panel to the Food and Drug Administration recommended Tuesday that the agency approve the buprenorphine implant Probuphine as a treatment for opioid addiction.

The U.S. Food and Drug Administration (FDA) declined to approve a new drug application for a second nasal spray version of the opioid overdose antidote naloxone, Medscape reports. The FDA approved a nasal spray version of naloxone last month.

Critics of the Food and Drug Administration’s decision to approve use of OxyContin in certain children as young as 11 say the move could increase painkiller abuse, The Wall Street Journal reports.

Attorneys general from 33 states are calling on the Food and Drug Administration to require health warning labels on liquid nicotine, Reuters reports.

The Food and Drug Administration on Tuesday ordered tobacco company R.J. Reynolds to stop selling four cigarette products. It is the first time the agency has ordered a major tobacco company to stop selling products, according to NPR.

The Food and Drug Administration issued a rule this week that allows the agency to destroy poor-quality or fake drugs valued at $2,500 or less that are refused admission into the United States. Until now, only counterfeit or poor quality food or medical devices could be destroyed.

An advisory panel to the Food and Drug Administration (FDA) has voted in favor of approving a new opioid painkiller made by Collegium Pharmaceuticals. The panel’s unanimous vote was contrary to a recommendation by FDA staff, according to Reuters.

The Food and Drug Administration’s decision last month to approve the opioid painkiller OxyContin for children as young as 11 has been welcomed by some pediatricians and pain specialists, The Washington Post reports. Some critics, however, say the decision could lead to increased abuse of the drug.