Concerns Arise After FDA Approves Frighteningly Potent Pain Pill

Posted by azdrugrehabctr on March 4, 2014 under AZ Drug Rehab News, Prescription Drugs | Comments are off for this article

The Food and Drug Administration has recently approved a potent new painkiller scheduled to become available to patients this month. As part of the hydrocodone-based family of opioid analgesics, Zohydro, a high-dose pain pill is expected to be a dangerous new factor in the growing prescription abuse epidemic in the U.S.

A league of more than 40 health care, consumer and addiction treatment groups is urging the FDA to revoke its approval of the prescription. In a letter to FDA Commissioner Dr. Margaret Hamburg, addiction experts echoed concerns surrounding the risks tied to the drug.

Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing has a strong opinion on this subject. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said the doctor. “It will kill people as soon as it’s released.”

That is not the only letter of concern in the FDA’s mailbox. Other groups petitioning the FDA to revoke their approval include members of the congress and 29 state attorneys general, among others. The common fear among these groups is the high-dose and its potential to amplify already-rising overdose numbers.

Prescription opioid deaths more than quadrupled since 1999, according to the Centers for Disease Control. There were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.

Zohydro is reported to be approximately five times more potent than what is available now. Both the FDA and Zohydro’s maker, Zogenix, claim that the drug’s benefits outweigh the risks.

Zohydro is intended to be prescribed solely for patients dealing with severe pain, according to advocates for the drug. Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, stated that the company will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.

Despite these intentions, many are expecting the narrow patient group to eventually expand to patients with less serious pain issues. If Zohydro follows in the footsteps of its opioid-containing predecessors, the drug will become more and more available to those who are likely to abuse it. It seems not everyone is comfortable with the FDA’s “risk-benefit” way of thinking.