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prescription drug abuse 25 articles

FDA ramps up warnings on opioid painkillers

The Food and Drug Administration (FDA) is ramping up its fight against prescription drug abuse this week by adding stronger warnings to opioids and issuing a plea to prescribers to help “prevent abuse, save lives and treat (opioid) dependence while still providing patients in pain access to effective relief,” the agency said in a safety announcement. The FDA announced that it is requiring immediate-release versions of opioid pain killers – which make up about 90 percent of the class – to add a new black box warning about the risks for misuse, abuse, addiction, overdose and death. Opioids include the ... Read More

Anti-addiction groups call for FDA chief’s resignation amid prescription drug abuse epidemic

Frustrated by the Food and Drug Administration’s approval of potent opioid medications during a nationwide epidemic of prescription drug abuse, anti-addiction activists are calling for the resignation of the agency’s top official. More than a dozen groups have banded together and are appealing to the Obama administration to replace FDA Commissioner Dr. Margaret Hamburg, who has headed up the agency since 2009. Activists have been vocal about their disappointment with the agency for its approval of Zohydro, the only single-ingredient hydrocodone on the market. Hydrocodone is in a class of narcotics known as opioids, which are known for their euphoric effects. ... Read More

FDA approves oxycodone combination drug that resists abuse

A powerful combination opioid painkiller whose euphoric effects can be rendered inactive if the drug is tampered with has been approved by the Food and Drug Administration (FDA). The drug’s formulation aligns with the agency’s commitment to combat the misuse and abuse of opioids. “The development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Dr. Sharon Hertz, deputy director of the division of anesthesia, analgesia, and addiction products in the FDA’s Center for Drug Evaluation and Research, said in an news release. Targiniq ... Read More

Abuse-resistant version of opioid Zohydro could hit the market soon

Pharmaceutical company Zogenix is hoping to get a tamper-resistant formulation of its powerful opioid Zohydro reviewed by drug regulators this fall and, if approved, begin marketing it by early next year. Zohydro is a pure hydrocodone painkiller which was approved by the Food and Drug Administration (FDA) last fall and hit the market earlier this year amid much controversy. Medical groups and anti-abuse organizations teamed up to petition the FDA to reconsider its approval of Zohydro, and several attorneys general joined the fight arguing that allowing another powerful painkiller on the market would only exacerbate the prescription drug abuse epidemic ... Read More

City of Chicago files lawsuit accusing drug companies of deceptively marketing addictive painkillers

In the latest battle against prescription drug abuse, the City of Chicago has filed a lawsuit against five drug companies alleging they engaged in deceptive marketing practices for their highly addictive painkillers to reel in extra profit. The lawsuit, filed this week in Cook County Circuit Court, claims the pharmaceutical companies pushed long-term use of their powerful opioids to treat non-cancer pain, which was false, misleading and “unsupported by science.” The lawsuit comes just one month after two California counties filed a similar lawsuit against the same five drug companies – Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, Actavis, Endo ... Read More

FDA panel slated to review powerful new opioid painkiller

Just weeks after the Food and Drug Administration (FDA) refused to take the advice of medical doctors, anti-drug abuse groups, and several attorneys general to reconsider its approval of the powerful new opioid Zohydro, another drug company announced that the agency has agreed to review its investigational extended-release oral formulation of the same narcotic plus acetaminophen. Critics warned the FDA that approving another powerful opioid would only fuel an already growing epidemic of prescription drug abuse. Opioids, which include the medications morphine and oxycodone, are the most abused prescription drug in the United States. Drug company Mallinckrodt is seeking approval ... Read More

Federal judge blocks Massachusetts ban of new painkiller Zohydro

Drug maker Zogenix Inc., won another battle in its war to get its controversial painkiller Zohydro on the market. This week, a Massachusetts federal judge blocked plans by Massachusetts Gov. Deval Patrick to ban prescriptions and sales of the newly approved narcotic in the state in an attempt to curb a growing trend of prescription drug abuse. Zogenix filed a lawsuit alleging the move was unconstitutional. U.S. District Judge Rya Zobel ruled that the ban conflicted with federal laws, which take precedence against state laws when the two are in conflict. The U.S. Food and Drug Administration (FDA) approved Zohydro ... Read More

Massachusetts governor’s ban of Zohydro may be unconstitutional

Massachusetts governor Deval Patrick’s banning of the controversial new painkiller Zohydro may be the first time a state has tried to block distribution of an FDA-approved drug and sets the stage for a heated constitutional debate. Last week, Gov. Patrick restricted doctors in Massachusetts from prescribing or dispensing Zohydro, the only pure hydrocodone on the market. The medication was approved by the FDA last fall and was distributed nationwide last month. Gov. Patrick banned the drug in an effort to curb a growing prescription drug abuse epidemic. In response, Zohydro’s maker, Zogenix, filed a lawsuit this week in an attempt ... Read More

Was the FDA’s approval of the controversial painkiller Zohydro influenced by drug companies?

Two senators are pushing for an investigation into reports that pharmaceutical companies paid to attend private meetings between Food and Drug Administration (FDA) officials and medical professionals in an effort to influence the approval of the controversial new opioid painkiller Zohydro ER. These so-called “pay-to-play” meetings, during which drug companies allegedly paid between $25,000 and $35,000 to the University of Rochester Medical Center to participate, demonstrate a clear, illegal conflict of interest that put consumer safety at risk, Sen. David Vitter said in a statement issued earlier this week. Vitter and Sen. Mike Lee are urging the U.S. Department of ... Read More

Attorneys general ask FDA to rethink its approval of first single-ingredient hydrocodone painkiller

Twenty-eight attorneys general are calling for the removal of powerful new painkiller Zohydro, arguing that the narcotic would only add to the national epidemic of prescription drug abuse. Zohydro, the first and only single-ingredient hydrocodone painkiller approved by the Food and Drug Administration (FDA), was granted clearance by the agency in October. It is an extended release formulation that is considered five to 10 times more potent than hydrocodone combination pill such as Vicodin. The state prosecutors are asking the FDA to either revoke the drug’s approval or require the drug maker Zogenix to change the formulation so that it ... Read More