Remove Potentially Fatal Drug from the Market


Target: Margaret A. Hamburg, Commissioner of the Food and Drug Administration

Goal: Demand that officials rescind approval of the dangerous new drug Zohydro ER

The Food and Drug Administration (FDA) recently approved Zohydro ER, a new non-tamper resistant drug related to opium that is up to five times more powerful than any related drug on the market. It is now available with a prescription, despite the clear disapproval by the FDA Advisory Board who voted against the drug 11-2. In the report, the advisory board stated concerns about potential abuse of the drug, and predicted that it will be abused at a higher rate than other similar drugs because of its high potency and because it can be crushed.

The number of drug poisoning deaths in the United States has more than quadrupled since 1999, and this powerful new product could have a highly negative impact on the prescription drug abuse epidemic. According to the Zohydro ER warning label, if the capsule is chewed and not swallowed completely it can cause “rapid release and absorption of a potentially fatal dose of hydrocodone.” With this high potential for overdose, if someone makes a small mistake it could cost them their life.

In 2010, about 12 million Americans abused prescription painkillers. The non-tamper resistant nature of Zohydro ER makes it easier for users to abuse it because it can be crushed. This fact alone will make it more appealing to people who misuse prescription painkillers, which is especially dangerous because of this drug’s high potency. People without a prescription will likely still have access to the drug due to the weak regulations on prescription drugs in some states.

By signing this petition, you will help urge the Commissioner of the Food and Drug Administration to remove Zohydro ER from the market because of its high potential for overdose and abuse.


Dear Commissioner Hamburg,

The recently approved drug Zohydro ER must be removed from the market. The Advisory Board warned of its high potential for abuse because of its non-tamper resistant nature and high potency, but it is now available for the public. Not only is the drug potentially fatal if not swallowed whole, but it can be crushed, which is likely to lead to abuse and misuse. Even though it is available by prescription only, due to the weak regulations on prescription drugs in some states, it is likely that it will get into the hands of people who are not prescribed the drug.

The approval for the release of Zohydro ER may have negative consequences on the high rate of prescription drug abuse that exists across the country. The number of Americans who have died from drug poisoning has quadrupled within the past two decades, and this is likely to add to the problem.

I am urging you to rescind your approval of the release of Zohydro ER to the public and follow the advice of the Advisory Board. Please take action to prevent this drug from adding to the high rate of prescription drug abuse in the United States.


[Your Name Here]

Photo Credit: ‘OpenIcons’ via Pixabay

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64 Signatures

  • Amy Wilson
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