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Confusion & Controversy Surround Blood Thinner Pradaxa

From Health Feed at the University of Utah:

If you take the blood thinner Pradaxa, recent news may have left you concerned about its safety.

Pradaxa’s manufacturer, Boehringer Ingelheim, may have knowingly withheld information about risks associated with it, according to published reports in medical journal The BMJ.

Pradaxa, prescribed to people at risk for stroke due to atrial fibrillation, was originally touted as having a lower risk than the standard treatment, warfarin, known by the brand name Coumadin. The Food and Drug Administration approved its use without the need for frequent blood tests. But new evidence suggests frequent testing may reduce the risk of serious, sometimes fatal, bleeding events.

"Boehringer Ingelheim has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible," Deborah Cohen, The BMJ’s investigations editor, wrote in the report.

Gregory Hawryluk M.D., Ph.D., a neurosurgeon at University of Utah Health Care, says Pradaxa may now be a less attractive option than Coumadin.

“The fact that monitoring wasn’t recommended for Pradaxa was one of the main reasons that physicians prescribed it in the face of the difficulties reversing or neutralizing it,” he explains, noting a reversal agent for Pradaxa is currently in clinical trials. Coumadin, meanwhile, is readily reversible.

People taking Pradaxa who are thinking of stopping because of the controversy should speak to their doctors first. “It is very important that patients who are taking Pradaxa continue taking it as prescribed by their physician,” Hawryluk says. “It is very clear that although there are unavoidable risks inherent to Pradaxa, Coumadin and similar agents, the risks of treatment with these drugs as they are currently prescribed and monitored is lower than the risk of stroke that patients would face without them.”

The FDA agrees. A spokeswoman tells WebMD that the agency still believe that Pradaxa provides an important health benefit and recommends that health care professionals follow the recommendations on the approved drug label.

“Treatment with either Pradaxa or Coumadin is clearly better than no treatment,” Hawryluk says.

Update: Boehringer Ingelheim released a statement regarding the report in The BMJ. Read it here.
 

DEA Further Restricts Hydrocodone Combination Products

From: Medscape

The US Drug Enforcement Administration (DEA) voted today (Aug 21) to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to hand HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.