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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.

FDA warns Lunesta sleeping pill users: Take half the dosage

From The Washington Times:

The Food and Drug Administration warned that anyone prescribed the sleeping medication Lunesta might want to start their dosages at half strength, to about 1 milligram.

The federal agency ordered the manufacturer, Sunovion Pharmaceuticals, to change its warning labels to reflect the new FDA recommendations, which are a scale-back of the current 2 milligram dose, The New York Times reported.

The FDA’s latest recommendation comes in part from research that involved 91 adults at the Surrey Clinical Research Center in Britain. The study found that 3 milligrams of Lunesa impairs memory and motor skills the next day and that the recommended 2 milligrams could prove a challenge for driving, memory and fine-motor skills for up to 11 hours after ingesting.

Posted: 5/16/2014 9:44:00 AM

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FDA Approval of Paroxetine for Menopausal Hot Flushes

From The New England Journal of Medicine:

The recent approval by the Food and Drug Administration (FDA) of paroxetine (Brisdelle, Noven) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause was distinctive for at least two reasons. First, it offered the first nonhormonal option to women who cannot or do not want to use hormonal medications to treat their menopausal vasomotor symptoms. Second, the approval ran counter to the recommendation of the FDA Reproductive Health Drugs Advisory Committee, which had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of Brisdelle did not support approval.

For decades, hormonal therapy had been the only FDA-approved treatment for menopausal vasomotor symptoms. Hormonal therapy is highly effective for treating vasomotor symptoms, but health risks in some women became apparent about a decade ago, with the release of reports from the Women's Health Initiative. Owing to these reports, many women either have chosen not to use hormonal therapy to treat their symptoms or have not been offered such therapy because of coexisting conditions. Overall, use of hormonal therapy has decreased considerably in the past decade — a trend that underscores an unmet need for a nonhormonal treatment option for vasomotor symptoms.

The efficacy of Brisdelle was established in two randomized, double-blind, placebo-controlled, multicenter clinical trials. More women who used Brisdelle than women who used placebo considered the reduction in frequency of their hot flushes to be clinically meaningful. In addition, Brisdelle remained efficacious at 6 months, the latest time point assessed. This is an important finding, because a lack of efficacy at 6 months after treatment initiation would call into question its usefulness for this fairly chronic condition.

Brisdelle's modest efficacy and concerns about suicidal ideation certainly influenced the advisory committee's 10-to-4 vote against approval. But recognizing that no hormone-free drug product had been approved to treat vasomotor symptoms, and after careful review of the efficacy results, the FDA concluded that Brisdelle offers a clinically meaningful benefit for some menopausal women. In addition, the Brisdelle clinical trials did not identify any new safety concerns regarding paroxetine.

Posted: 5/8/2014 1:39:00 PM

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FDA approves first generic drugs for schizophrenia

From FOX News:

The Food and Drug Administration has approved the first generic versions of a drug used to treat schizophrenia, the government organization announced Wednesday.

People who suffer from schizophrenia now have the option of treating their symptoms with the generic version of Seroquel (quetiapine) tablets. Quetiapine is also used to treat or prevent episodes of mania or depression in patients with bipolar disorder.

According to the FDA, the generic tablets are expected to be manufactured in several different strengths.

Posted: 4/12/2012 12:53:00 PM

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FDA: Novartis recall may also affect painkillers

From The Bellingham Herald:

The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.

The issue stems from manufacturing problems at a Lincoln, Neb., facility which triggered a recall Sunday of 1,645 lots of Novartis' over-the-counter drugs, including Excedrin, Bufferin, NoDoz and Gas-X.  Consumers are advised to stop using the products and contact the company for a refund.

FDA officials warned Monday that some of Novartis' over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it is not aware of any confirmed product mix-ups that reached patients or caused any injuries. A spokeswoman for Novartis said late Monday that only Gas-X is produced on the same manufacturing line as the opioid drugs.

FDA officials say they are not recalling the painkillers because they are essential medications for many patients and the risks of stray pills are low.

Posted: 1/10/2012 11:51:00 AM

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FDA OKs Generic Zyprexa for Schizophrenia, Bipolar Disorder

From WebMD:

The FDA has approved the first generic versions of the drugs Zyprexa and Zyprexa Zydis for the treatment of schizophrenia and bipolar disorder.  The generic name for the two drugs is olanzapine.

Keith Webber, PhD, deputy director of the FDA's Office of Pharmaceutical Science, says the approval of generic olanzapine "offers greater access to a widely used treatment for mental illness."

He says that having "affordable treatment options is good for patients with long-term illnesses that must be carefully managed."

Zyprexa can cost more than $300 a month, while generic versions can substantially cut the cost.

The FDA says olanzapine must be dispensed with a medication guide that describes the risks and possible adverse reactions patients may experience. Olanzapine is not approved for treating psychosis in the elderly with dementia.

The drug can have side effects leading to high blood sugar and high blood fat levels and weight gain.

Posted: 10/26/2011 2:20:00 PM

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Afinitor Approved for Rare Pancreatic Cancer

From HealthDay News:

U.S. Food and Drug Administration approval of Afinitor (everolimus) has been expanded to include people with progressive neuroendocrine tumors of the pancreas (PNET) that have spread to other parts of the body or cannot be removed by surgery, the agency said Friday.

PNET is slow-growing and rare, affecting fewer than 1,000 new patients in the United States each year, the FDA said in a news release.

Afinitor was previously FDA-approved for advanced kidney cancer and certain brain tumors that cannot be treated surgically.

Posted: 5/6/2011 12:41:00 PM

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New Birth Defect Warning for Topamax

From WebMD:

Taking the epilepsy drug topiramate (Topamax) during pregnancy raises the risk of oral cleft birth defects such as cleft lip and cleft palate, according to a new warning issued by the FDA.

New drug registry data show that the risk of oral birth defects is up to 16 times higher among women who took topiramate or its generic equivalents during pregnancy.

Topiramate is approved by the FDA for treating seizures associated with epilepsy and to prevent migraines. But it is also sometimes used on an off-label basis to treat other conditions, such as obesity, bipolar disorder, and alcoholism.

Posted: 3/7/2011 8:56:00 AM

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FDA Warns GERD Drugs May Deplete Magnesium

From MedPage Today:

Use of proton pump inhibitors (PPIs) regularly for a year or longer may lead to low levels of circulating magnesium, which may increase the risk of leg spasms, arrhythmias, and seizures, according to an FDA warning.

The latest alert from the FDA says physicians "should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time."

Posted: 3/3/2011 10:06:00 AM

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New FDA warnings against use of terbutaline to treat preterm labor

From Bioscience Technology:

The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

Posted: 2/21/2011 10:21:00 AM

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