FDA Approves Extended-Release Hydrocodone

FDA Approves Extended-Release Hydrocodone 

The FDA has approved the first single-entity hydrocodone product (Zohydro ER, Zogenix) for management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved product containing the opioid analgesic hydrocodone not combined with another nonopioid analgesic such as acetaminophen, as well the first extended-release (ER) hydrocodone product.
   Zohydro ER is in the class of ER/long-acting (LA) opioid analgesics, which carry with them the risk for addiction, abuse and misuse, even at recommended doses. The FDA recently revised mandatory labeling for these agents. Labels now must state that these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or otherwise would be inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.
   The approved labeling for Zohydro ER makes it the first drug in its class to conform to the updated labeling requirements for all ER/LA opioid analgesics, which were announced by the FDA on Sept. 10, 2013.The new class labeling and stronger warnings more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications.
   Schedule II drugs can only be dispensed through a physician’s written prescription and no refills are allowed. There are also stringent recordkeeping, reporting and physical security requirements for Schedule II controlled substances.
The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks associated with long-term opioid use. These studies also will be required for other ER/LA opioid analgesics.
   The safety of Zohydro ER is based on clinical studies of more than 1,100 individuals living with chronic pain. The efficacy of Zohydro ER is based on a clinical study that enrolled more than 500 patients with chronic low back pain who showed significant improvement with Zohydro ER compared with placebo.
   Zohydro ER will be part of the ER/LA opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the REMS for ER/LA opioid analgesics requires companies to make educational programs on how to safely prescribe ER/LA opioid analgesics available to health care professionals and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of these agents.
   The most common side effects of Zohydro ER are constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).
     For more information, including full prescribing information, go to www.zogenix.com

Based on a press release from the FDA.

Chakra Healing anyone?

Have you ever received unsolicited email that is just so funny, you never want to “unsubscribe” to it? I have!

Some time ago (about a month) I started receiving email from people who call themselves *Chakra Healing. They were doing some sort of survey and asked me if I would be so kind as to participate.

The survey started off with an easy question: your name and surname. Because I’m rather shy and introverted, I gave them a nom de plume pseudonym, or as it is known nowadays: a secret anonymous avatar.

I called myself: **Vrot Poeper, seeing that I’m often referred to as “an old fart.”

I decided on Vrot Poeper because it’s nice and short – and easy on the ear in any language. I completed the survey; and that was that – or so I thought.

This morning I received another email from these guys. I’d like to share it with you:

Dear Vrot Poeper,

I need to clear the air on this. (I peed myself – clear the air, geddit?)

You see, I get a LOT of emails with questions on Chakra Healing. Some people don’t really understand what Chakras are about. The buck stops here. You deserve the truth.

Eight Chakra questions you were afraid to ask:

Your 8 questions (my answers in bold):

1.    Are Chakras real? You’d better believe it!

2.    How come I’ve never heard of it? You don’t live with me.

3.    What impact will it have on my life? Your spouse will hate you and you will sleep in the spare room.

4.    Will there be any pain or discomfort? Only if you duck too late, or keep it bottled up.

5.    Will Chakras interfere with my religious beliefs? Contrary to popular belief, ALL religion is based on Chakras.

6.    I’m a busy person. Will I have time for Chakras? You’ll always be able to squeeze a Chakra in.

7.    What if I already practice something, like meditation? You can Chakra and meditate at the same time.

8.    What is the best way to get started? Start with very little pressure and build up to a full force, hurricane-type, mass destruction.

What Chakras can do for you?

You’ll be more confident and intuitive. You’ll attract more abundance. You’ll improve your relationships with your friends and family. Your sex life will sizzle like never before. And whatever challenges life can throw at you, you’ll always have the answer.

Always ready to lend a healing hand,

Regards,

Carol Tuttle.

OK. I sent my answers to the Chakra Healing Centre by email.

Now we wait…

*Chakra(s) – from Hindi, meaning: fart(s)

**Vrot Poeper – from Afrikaans, meaning: Rotten Farter

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