FDA FINDS SHADY INGREDIENTS IN WEIGHT-LOSS SUPPLEMENTS

(CTVNEWS-Health) reported that (FDA) scientists spotted an amphetamine-like compound, called beta-methylphenethylamine, in nine of the 21 supposedly all-natural supplements tested.  An athlete competing in canoeing qualifiers for the 2012 London Olympics was disqualified after traces of the compound were found in his system.

It goes on further to say that the FDA is currently inspecting weight-loss and energy boosting products made by a company called Hi-Tech Pharamceuticals. Another company, iForce Nutrition, lists Acacia rigidula as an ingredient in its Dexaprine XR diet supplements. Dutch officials have also released safety warnings about Dexaprine.

U.S. could bring more common drugs over the counter

(Reuters) – March 08, 2012 Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators.

In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March.

The goal is to ensure people take drugs as needed, while still understanding safety issues.

Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States.

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Certain Antipsychotics Up Risk of Death for Patients With Dementia

THURSDAY, Feb. 23 (HealthDay News) — Compared to other antipsychotic drugs, haloperidol (Haldol) raises the risk of death in elderly patients with dementia, a new study finds.

One outside expert believes the finding should aid in dementia care. “This data provides much-needed guidance and reassurance for the ever-increasing number of health care practitioners treating older demented patients,” said Dr. Gisele Wolf-Klein, director of geriatric education at the North Shore-LIJ Health System in New Hyde Park, N.Y.

The study was published online Feb. 23 in the British Medical Journal.

In 2005, the U.S. Food and Drug Administration warned that certain antipsychotic drugs are associated with an increased risk of death in elderly patients with dementia. This warning was expanded to include conventional antipsychotics in 2008, according to a journal news release.

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Vivus obesity drug has safety risks

(Reuters) – February 17, 2012Vivus Inc’s obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.

Food and Drug Administration staff will ask an advisory panel to consider whether the drug’s benefits for obese patients will outweigh its risk of birth defects and heart problems.

The FDA staff, in documents posted online on Friday, said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

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Study questions antidepressant-suicide link

(Reuters Health) – February 17, 2012 – The Food and Drug Administration has a blanket warning on antidepressant medications stating they increase the risk of suicidal thoughts and behaviors among kids and young adults, but a new review of clinical data finds no link between suicide and at least two of the medications.

The new analysis, based in part on previously unpublished data, also concludes that treatment with antidepressants decreases the risk of suicide among adults of all ages.

“These results have to instill some additional confidence that prescribing these medications is not necessarily going to lead to suicidal thoughts or behavior,” said Robert Gibbons, a professor at the University of Chicago and lead author of the study, published in Archives of General Psychiatry.

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Buyer, Beware of Over-the-Counter Thyroid Supplements

FRIDAY, Nov. 4 (HealthDay News)Over-the-counter “thyroid support” supplements commonly used for weight loss and to fight fatigue are mostly ineffective and may pose a health threat, a new study warns.

The supplements contain widely varying amounts of two kinds of thyroid hormonestriiodothyronine (T3) and thyroxine (T4) — apparently derived largely from chopped up animal thyroid glands, according to senior investigator Dr. Victor Bernet, an endocrinologist at the Mayo Clinic in Florida.

These two hormones are regulated by the U.S. Food and Drug Administration and intended for use only in prescription drugs because they can cause serious health problems, including increased heart rate, heart irregularities and palpitations, nervousness and diarrhea, he explained.

The researchers analyzed 10 commercially available OTC thyroid supplements and found that nine contained T3 and five of them would deliver 50 percent or more of the total amount of T3 produced by the body daily.

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Studies show no extra risk with Pfizer smoking drug

(Reuters) – October 24, 2011 –  Smokers who take Pfizer‘s pill Chantix to help them quit do not have a higher risk of being hospitalized for psychiatric events such as depression, compared with nicotine patches, according to studies reported on Monday.

Users of Pfizer’s non-nicotine pill have reported agitation, depression and suicidal thoughts, and, in clinical trials, the pill was linked to nightmares.

Psychiatric symptoms have occurred in people without a history of mental illness and have worsened in people who already had mental illness, the FDA has said.

Although investors initially had high hopes for the drug, called Champix in Europe, reports of psychiatric effects have hampered sales growth.

The Food and Drug Administration released its review of two studies which compared Chantix to standard nicotine replacement therapy such as the Nicoderm nicotine patch from GlaxoSmithKline.

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U.S. advisers urge FDA to address antipsychotics in kids

(Reuters) – Sept. 22, 2011 – U.S. pediatric health advisers on Thursday urged drug regulators to continue studying weight gain and other side-effects of antipsychotic drugs as they are increasingly taken by children.

Significant numbers of U.S. children are receiving drugs to tame aggression, attention deficit disorder and other mental problems, even though there is little conclusive data to show exactly how the medications work or whether they damage kids’ health.

The pediatric advisory panel on Thursday listened to preliminary results of a study sponsored in part by the FDA that, inconclusively still, compared whether some antipsychotic drugs put children at a higher risk of developing diabetes than others.

Similar to the recommendations the panel has made in previous years, it voted 16-1 to support the U.S. Food and Drug Administration‘s routine safety monitoring of the new generation of antipsychotics.

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FDA warns of allergy risk with Merck antipsychotic

(Reuters) – September 02, 2011 – The Food and Drug Administration warned on Thursday that serious allergic reactions have been reported with the use of Merck & Co Inc’s antipsychotic drug Saphris.

The agency said the drug’s label has been revised to include information about the risk.

Saphris, first approved in 2009, is used to treat symptoms of schizophrenia and bipolar disorder.

Doctors should closely monitor patients for reactions including anaphylaxis, swelling, low blood pressure and swollen tongue, the FDA said in a notice on its website.

The agency said Saphris should not be used in patients with a known hypersensitivity to the drug and patients should seek emergency medical attention if they develop any signs and symptoms of a serious allergic reaction while taking Saphris.

http://www.reuters.com/article/2011/09/02/us-lundbeck-sycrest-idUSTRE7811F820110902

Approval Received For Generic Version Of Effexor XR® Capsules

(Medical News Today) – June 3, 2011 – Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base), the generic version of Wyeth’s Effexor XR® Capsules, which are used in the treatment of major depressive disorder and social anxiety disorder. Mylan is launching these products through a previously announced settlement and license agreement entered into with Wyeth, which is now part of Pfizer.

Venlafaxine HCl ER Capsules had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. The product is being shipped to customers.

Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.

http://www.medicalnewstoday.com/releases/227399.php

Information Overload in Drug Side Effect Labeling

ScienceDaily (May 24, 2011) — The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging 70 reactions per drug, a number that can overwhelm physicians trying to select suitable treatments for their patients, according to a new study of drug labels.

Long lists of drug side effects — whether found in magazine advertisements or in package inserts — are a familiar sight to patients and doctors. Now researchers from the Regenstrief Institute and the Indiana University School of Medicine have quantified just how complex drug labels have become.

In the study, appearing in the May 23, 2011 issue of the Archives of Internal Medicine, the researchers found that the average label contains 70 different side effects, with more commonly prescribed drugs averaging around 100 side effects. The upper range was remarkably high, with a single label containing as many as 525 reactions. The study involved analysis of more than 5,600 drug labels and more than half a million labeled effects.

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Gastric bypass better than Lap-Band

(Reuters) – February 22, 2011 –  A study of the two most popular weight-loss surgeries found obese diabetics who had gastric bypass surgery lost 64 percent of their excess weight after a year, compared with 36 percent in those treated with Allergan Inc’s Lap-Band device, researchers said on Monday.

Complication rates were about the same with both procedures.

“It’s a dramatic difference,” said Dr. Guilherme Campos of the University of Wisconsin School of Medicine in Madison, and formerly of the University of California, San Francisco, whose study appears in the Archives of Surgery.

Weight loss surgery is becoming increasingly popular as obese people struggle to lose weight and avoid the health complications that accompany the extra pounds — including diabetes, heart disease, joint pain and some cancers.

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Cymbalta Approved for Chronic Joint and Muscle Pain

FRIDAY, Nov. 5 (HealthDay News) Cymbalta (duloxetine hydrochloride) has received expanded approval from the U.S. Food and Drug Administration to treat chronic musculoskeletal pain, stemming from conditions including lower back pain and osteoarthritis.

Since its approval as an antidepressant in 2004, some 30 million people in the United States have used the drug, the agency said in a news release. The FDA also has sanctioned Cymbalta for the treatment of diabetic pain, generalized anxiety disorder and fibromyalgia.

The most common side effects from Cymbalta use include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. More serious adverse reactions have included liver damage, allergic reaction, pneumonia, depressed mood, and suicidal thoughts and behavior, the agency said.

The FDA has also warned that Cymbalta should never be used in patients who have recently taken a type of antidepressant called an MAOI, or Mellaril (thioridazine), or who have uncontrolled glaucoma.

http://health.yahoo.net/news/s/hsn/cymbaltaapprovedforchronicjointandmusclepain

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FDA approves Botox to treat chronic migraines

(Reuters) – October 17, 2010 – The Food and Drug Administration on Friday approved Allergan Inc’s anti-wrinkle injection Botox to treat chronic migraines.

Botox injections would be given to adult sufferers of chronic migraines around the head and neck every 12 weeks in an attempt to dull future headaches, said the FDA in a statement.

Chronic migraine sufferers have a headache on most days of the month. Botox has not been shown to work for people who suffer headaches 14 days or less per month, the FDA said.

The United Kingdom was the first country to approve the use of Botox for migraine treatment in July.

The approval comes just over a month after Allergan agreed to pay $600 million to settle a federal probe into its marketing practices for Botox.

Allergan Inc’s shares rose 7 percent in after-hours trading to $73.90.

http://www.reuters.com/article/idUSTRE69F03I20101017

FDA Suicide Warnings Change Antidepressant Prescribing

FDA Suicide Warnings Change Antidepressant Prescribing Patterns, but Physicians Ignore Monitoring Recommendations

January 27, 2010 — (Medscape Today) – Physicians have responded to US Food and Drug Administration (FDA) warnings about a link between antidepressant use in children and suicidality by adjusting their prescribing patterns but have failed to heed specific safety recommendations about follow-up monitoring in their young patients taking these medications.

“Although we found changes in prescribing patterns, the FDA’s recommendation regarding increased physician monitoring appears to have been largely ignored,” the study authors, led by Susan H. Busch, PhD, Yale School of Public Health, New Haven, Connecticut, write.

This finding, say the study authors, “highlights the limited power of the FDA to directly affect the care received by patients.”

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Antiepileptic Drugs Not Linked to Suicide Among Those With Bipolar Disorder

ScienceDaily (Dec. 10, 2009) — Despite government warnings about an increased risk of suicidal thoughts and actions while taking antiepileptic drugs, these medications do not appear to be associated with increased risk of suicide attempts in individuals with bipolar disorder, and may have a possible protective effect, according to a report in the December issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

Antiepileptic drugs are life-saving for those with seizure disorders and are also used to treat many other conditions, including mood disorders and nerve pain, the authors write as background information in the article. The 11 antiepileptic drugs include gabapentin, pregabalin, topiramate and carbamazepine. “On Jan. 31, 2008, the Food and Drug Administration issued an alert regarding increased risk of suicidal thoughts and behavior related to use of antiepileptic drugs,” the authors write. “On July 10, 2008, a Food and Drug Administration scientific advisory committee voted that, yes, there was a significant positive association between antiepileptic drugs and suicidality but voted against placing a black box warning on antiepileptic drugs for suicidality.”

Individuals with bipolar disorder — often treated with antiepileptic drugs — have a higher risk of attempted and completed suicide than the general population. “That makes this a population of interest in detecting the effect on suicide risk of antiepileptic drugs compared with a no-treatment control group,” the authors write. Robert D. Gibbons, Ph.D., of the University of Illinois at Chicago, and colleagues studied a cohort of 47,918 patients with bipolar disorder who had at least one year of data before and after their diagnosis in a national database of medical claims.

A total of 13,385 patients received one of 11 antiepileptic drugs and 25,432 received neither antiepileptic medications nor lithium. After treatment, those taking antiepileptic medication had similar rates of suicide attempts (13 per 1,000 patients per year) as those taking lithium (18 per 1,000 patients per year) or those who did not receive treatment (13 per 1,000 patients per year).

Among those taking antiepileptic drugs, the rate of suicide attempt was significantly lower after treatment (13 per 1,000 patients per year) than before treatment (72 per 1,000 patients per year). In patients who were not receiving treatment with another antiepileptic, an antidepressant or an antipsychotic medication, taking any antiepileptic mediation appeared protective against suicide attempts relative to no pharmacologic treatment (three per 1,000 suicide attempts per patient per year vs. 15 per 1,000 per patient per year).

“Our analysis also reveals that there is a selection effect, in that the pretreatment suicide attempt rate is five times higher than the rate in untreated patients,” the authors write. “If pretreatment suicide attempt rates reflect the severity of illness, it is the more severely impaired patients who receive treatment with an antiepileptic drug or lithium. Nevertheless, the post-treatment suicide attempt rate is significantly reduced relative to their elevated pretreatment levels to the level found at or below patients not receiving treatment. This finding suggests a possible protective effect of antiepileptic drug treatment on suicidality.”

Adapted from materials provided by JAMA and Archives Journals, via EurekAlert!, a service of AAAS.

http://www.sciencedaily.com/releases/2009/12/091207164852.htm

News coverage of antidepressants for kids uneven

NEW YORK (Reuters Health) – Dec 07, 2009 – Media coverage of the warnings on antidepressants and children’s risk of suicidal behavior often failed to give the public the whole story, according to a study published Monday.

The study, by researchers at the Yale University School of Public Health, concludes that many print and TV news stories did not give enough information on the actions the U.S. Food and Drug Administration (FDA) took in 2003 and 2004 on pediatric antidepressant use.

Safety concerns about the medications first surfaced in 2003, when research linked the drug paroxetine (Paxil) to an increased risk of suicidal thoughts and behavior in children and teenagers.

After an investigation, the FDA in 2005 added a so-called “black box” warning — the agency’s strongest warning — on the use of all antidepressants in children and teens to draw attention to the possible risks. In 2007, it extended the warnings to adults between the ages of 18 and 24.

Many psychiatrists have criticized the warnings, saying that they scare people away from effective treatment for depression, which is the leading cause of suicide. And studies have suggested that the warnings triggered not only a drop-off in pediatric antidepressant use, but may also have contributed to an 8 percent rise in suicide among minors in 2004, the biggest one-year gain in 15 years.

Critics have also charged that media coverage of the FDA warnings played a primary role in the declining use of antidepressants in children.

For the new study, published in the journal Pediatrics, Drs. Colleen L Barry and Susan H. Busch analyzed the quality of media stories on the issue when it was at its height — after three separate FDA actions in 2003 and 2004.

Looking at 167 stories from major newspapers and TV networks, the researchers found that 98 percent correctly stated that pediatric antidepressant use was linked to suicidal thoughts and behavior, and not to the risk of suicide itself.

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Extreme caution with antidepressant Norpramin

WASHINGTON (Reuters) – French drugmaker Sanofi-Aventis SA has warned that its antidepressant Norpramin should be given with extreme caution to patients with a history of certain heart problems, the U.S. Food and Drug Administration said on Wednesday.

The label for Norpramin (desipramine hydrochloride tablets USP) will also warn that seizures precede abnormal heart rhythms and death in some patients. The heart conditions include a family history of sudden death, abnormal heart rhythms, and heart conduction disturbances.

The company’s letter to FDA and health professionals also said an overdose of Norpramin has shown a higher death rate than overdoses of other tricyclic antidepressants.

http://www.nlm.nih.gov/medlineplus/news/fullstory_92576.html

Makers of Powerful Painkillers Present Safety Plans

FRIDAY, Dec. 4 (HealthDay News) — The makers of 24 different prescription painkillers on Friday presented federal regulators with plans to curb the abuse of these opioid drugs.

The pharmaceutical companies have been under pressure from U.S. Food and Drug Administration officials to find a way to stop the hundreds of fatal overdoses that occur with these medications each year, the Associated Press reported.

 Executives from Johnson & Johnson, King Pharmaceuticals and other drug makers proposed using patient medication guides, letters to doctors and additional physician training to end the misuse and inappropriate prescribing of painkillers, according to the wire service.

In February, FDA officials sent letters to 16 companies ordering them to design risk-management plans for their drugs. The drug makers presented their joint proposal to the agency after several months of discussion.

 The painkillers in question include morphine, oxycodone and methadone.

 This marks the first time the agency has required a risk-management plan for an entire class of drugs, the AP reported.

 However, the problem is significant: a 2007 survey found 5.2 million people in the United States reported using prescription painkillers inappropriately.

 Such drugs are typically approved for people requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients.

But, significant harm can occur if patients are uninformed about how to properly take the drugs, doctors inappropriately prescribe the drugs, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. John Jenkins, director of the FDA’s Office of New Drugs, part of the Center for Drug Evaluation and Research, said during a news conference back in February.

 Jenkins said then that the agency was taking this step to implement “a relatively massive new program,” because “the rates of misuse and abuse [of opiates] have risen over the past decade.” He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.

 This is “our attempt to try and ensure that the benefits of the products outweigh their risks,” Jenkins said in February.

 In addition to patient misuse, the FDA has documented many cases of physicians prescribing the potent painkillers for people with migraines, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an accidental overdose of the drug.

http://health.yahoo.com/news/healthday/makersofpowerfulpainkillerspresentsafetyplans.html