Tagged Articles

OxyContin 38 articles

Five new black box warnings added to long-acting, extended-release opioid painkillers

Five new black box warnings are being added to the safety labels of extended-release and long-acting opioid painkillers, warning that the drugs are addictive, can cause life-threatening problems, and are easily abused and misused, the Food and Drug Administration (FDA) announced. Opioids are a potent class of painkillers that also give patients a feeling of euphoria, making them choice recreational drugs. The following brand-name drugs and their generic counterparts have updated labels reflecting the new warnings: Avinza (morphine sulfate) Extended-Release Capsules,
 Butrans (buprenorphine) Transdermal System, 
Dolophine (methadone hydrochloride) Tablets,
 Duragesic (fentanyl transdermal system), 
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release ... 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

Legislation aims to revoke FDA’s approval of new opioid Zohydro

A group of lawmakers concerned about health risks and a growing epidemic of prescription drug abuse has introduced legislation to revoke the Food and Drug Administration’s approval of the new, highly potent opioid painkiller Zohydro ER. “I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation,” Sen. Joe Manchin, D-W.Va., said in a statement. He teamed up with Rep. Stephen Lynch D-Mass, and Rep. Hal Rogers, R-Ky., on the bill. Zohydro ER is the first pure hydrocodone drug to be approved ... Read More

Potent Zohydro painkiller faces more hurdles as it enters market

The fate of the newly approved, potent opioid painkiller Zohydro continues to hang in the balance. The drug is expected to hit the market later this month despite petitions from physician groups, consumer watchdog groups, addiction counseling groups, and even a team of attorneys general urging the Food and Drug Administration (FDA) to rethink its recent approval of the drug. Two senators have also requested an investigation into whether pay-for-play practices played a role in the approval of Zohydro. Now, the painkiller faces another challenge: the makers of OxyContin say they have completed testing of an abuse-resistant version of the ... Read More

FDA approves pure form of painkiller hydrocodone, deemed stronger than Vicodin

Just days after the Food and Drug Administration (FDA) proposed stricter rules for drugs containing hydrocodone – such as Lortab and Vicodin – to help curb the growing epidemic of prescription drug abuse, the agency announced that it has approved a purer form of hydrocodone that is even stronger than other drugs in its class. The FDA approved Zohydro ER to treat pain severe enough to require around-the-clock, long-term treatment. The drug is approved for patients for whom alternative treatment has proved inadequate or ineffective. The FDA did require the drug’s maker, Zogenix, to conduct post marketing studies for Zohydro ER ... Read More

FDA proposes stricter guidelines for widely prescribed painkiller hydrocodone

Proposed new guidelines for painkillers aims to put drugs containing hydrocodone, such as Lortab and Vicodin, in the same category as potent opioids like Oxycontin and morphine. The Food and Drug Administration’s (FDA) recommendation for the highly addictive class of painkillers must first be approved by other Health and Human Service Department officials before it can go into effect. The major policy change comes more than a decade after the Drug Enforcement Administration (DEA) first asked that hydrocodone-containing drugs be more restricted. Hydrocodone drugs are the most widely prescribed medications in the country, with more than 131 million prescriptions written ... Read More

Deadly flesh-eating street drug turns up in Arizona

A disfiguring, flesh-eating home-manufactured drug that maims and kills users has made its way into the United States. Krokodil, a lethal injectable combination of codeine and hydrocarbons like oil, paint thinner, gasoline or alcohol, offers a high similar to heroin but is far less expensive. Once injected, the drug damages blood vessels and tissue that causes the flesh to rot from the inside out. Flesh can turn green and scaly, resembling a crocodile, giving the drug it’s namesake. As the flesh rots away, sores burrow deep into the flesh and in some cases bone can be exposed. Gangrene and amputations are a ... Read More

FDA rejects drug maker’s request to block generic versions of opioid painkiller

The Food and Drug Administration (FDA) has vowed to crack down on powerful opioid painkillers that are easily abused and misused; however, the agency this week voted to deny a request by drug maker Endo Health Solutions to block generic competition of its painkiller Opana ER from being approved. Endo says the generic versions are easier to abuse than its brand-name drug. Opana ER is an extended-release drug approved for the treatment of moderate to severe pain. It is similar to morphine. Opana is in the opioid class of drugs, which are often crushed and injected or snorted by drug ... Read More

FDA slows generic competition of OxyContin by requiring tamper-resistant formulations

Just days before the patent of the best-selling narcotic OxyContin expires, opening the door for generic competitors to apply for marketing rights, the Food and Drug Administration (FDA) announces it will not approve generic versions of the drug unless they are manufactured in a way that makes them harder to abuse. The agency said the original formula of the drug “poses an increased potential for certain types of abuse.” OxyContin, which is made by Purdue Pharma, is a blockbuster opioid, generating nearly $3 billion in sales last year alone. When it was approved in 2005, OxyContin was considered as a breakthrough ... Read More

FDA stops pediatric testing of calcium-sensing receptor Sensipar

Pediatric clinical trials of the drug Sensipar (cinacalcet hydrochloride) have been halted by the Food and Drug Administration (FDA) after a 14-year-old patient died. The FDA says it has not yet confirmed whether the drug played a role in the teenager’s death, but has stopped the pediatric trials while it evaluates information. Sensipar is a calcium-sensing receptor agonist indicated for adults for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid cancer, and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. The drug is FDA-approved to treat adults with ... Read More