Pharma

FDA Okays Naloxegol Movantik in Opioid-Induced Constipation

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If you read the source article you’ll never look at constipation the same way ever again. Better dig deeper to find out why your applicant is constipated.  It may not be just a horrible diet and lack of dietary fiber.

And yet another FDA approved drug to counteract adverse effects from another FDA approved drug.

FDA Okays Naloxegol Movantik in Opioid-Induced Constipation.

The US Food and Drug Administration (FDA) has approved naloxegol (Movantik, AstraZeneca Pharmaceuticals), a peripherally acting opioid receptor antagonist, for the treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain.

OIC is a common adverse effect of opioid use. An estimated 40% to 80% of patients receiving long-term opioid therapy experience OIC, which can be severe enough to cause discontinuation of opioid therapy.

FDA Approves Bupropion/Naltrexone Contrave for Obesity

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FDA Approves Bupropion/Naltrexone Contrave for Obesity.

If I’m understanding this correctly we now have an anti-depressant combined with a drug originally approved for treating opioid, then alcohol addiction, approved by the FDA to treat obesity.

This will be interesting.

UPDATE

Obesity drugs have side effects. The reason it’s taken three years for the FDA to approve NB32/Contrave is that obesity drugs have serious side effects. So serious, in fact, that several major diet drugs have been yanked from the market, making doctors, regulators and yes, investors shy away. Cardiovascular disease and mood problems are just two of the potentially serious side effects associated with Qsymia and Belviq. Older drugs Xenical  and Alli carry a risk of permanent liver and kidney damage.  And those weight loss supplements you buy over the counter? Some are deadly.

via Contrave: Is This The Weight Loss Drug We’ve Been Waiting For?.

Like I said, this will be interesting.

Many Meds Taken by Seniors Can Raise Risk of Falls

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Many Meds Taken by Seniors Can Raise Risk of Falls.

After adjusting for the number of medications a person was taking, the researchers found men and women taking opioid painkillers as well as men taking antidepressants were more than twice as likely to have a fall injury as seniors who were not taking those drugs. Women taking antidepressants were 75% more likely to have a fall injury.

More on Sleeping Pills and Older Adults – NYTimes.com

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More on Sleeping Pills and Older Adults – NYTimes.com.

Now the C.D.C. has reported that a high number of emergency room visits are associated with psychiatric medications in general, and zolpidem — Ambien — in particular. They’re implicated in 90,000 adult E.R. visits annually because of adverse reactions, the study found; more than 19 percent of those visits result in hospital admissions.

Blood-Thinner Pradaxa: What You Should Know

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Blood-Thinner Pradaxa: What You Should Know.

Concerns about Pradaxa surfaced 2 years ago, he says, when doctors began reporting a larger number of serious and sometimes fatal bleeding problems in older patients on the drug.

The claim by the company that the drug needs no blood-level monitoring is misguided, Moore says. “It turns out the company has had data for several years, showing the amount of anticoagulation [blood thinning] varied [from patient to patient] more than five-fold.”

That means, Moore says, that “the same dose could produce widely varying effects on blood clotting. Some patients would be at extremely high risk of bleeding. Others would not get a strong enough blood clotting effect to serve its purpose, reduce the risk of stroke.”

Do the phrases “serious and sometimes fatal bleeding problems”  combined with the drug maker’s withholding of data bother anyone?  And yet another example of putting profits before people.

Update 07.27.14

I found another fine article on the Pradaxa mess.  Follow the link to The Poison Review. There you will find more details on this story and more links for further reading, including a link to the full text BMJ article.

The Institute for Safe Medication Practices reported that in 2011 there were 3781 serious adverse effects and 542 patient deaths reported in the United States in association with dabigatran. In comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period. – See more at: http://www.thepoisonreview.com/2014/07/27/must-read-marketing-vs-medicine-in-the-case-of-pradaxa-dabigatran/#sthash.tpAapuE6.dpuf

Must-read: marketing vs. medicine in the case of Pradaxa dabigatran | The Poison Review.

Update 08.22.14

Getting the dabigatran Pradaxa story right… Correcting four common mistakes..

If you’re not totally confused by now you should be.

Most Emergency Room Super Frequent Users Have Addiction Disorder – MedicalResearch.com

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Most Emergency Room Super Frequent Users Have Addiction Disorder | Medical Research News and Interviews: MedicalResearch.comMedical Research News and Interviews: MedicalResearch.com.

MedicalResearch: What are the main findings of the study?

 

Answer: We found that within our group of 255 known Emergency Department “super-frequent users,” 77% had with some type of addiction disorder, and 47 percent visited the Emergency Department seeking narcotics for pain. Women were more likely to be narcotic seeking. Using our individualized Electronic Medical Record care plan intervention, created and overseen by our multidisciplinary team (comprised of Emergency Department staff physicians, a psychologist, residents, nurses and support staff), we found that our plan significantly decreased annual rates of visits by these super-frequent users and those who sought pain-relief narcotics and other super-frequent users.

Safety Alerts – Pradaxa dabigatran – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

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Safety Alerts for Human Medical Products > Pradaxa dabigatran: Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin.

ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.

Safety Alerts – Eszopiclone Containing Sleep Aids Can Cause Next-Day Impairment

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Safety Alerts for Human Medical Products > Eszopiclone Containing Sleep Aids: Drug Safety Communication – Can Cause Next-Day Impairment.

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.