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.

The findings — based on data for kids and adults using fluoxetine (Prozac) and for adults on venlafaxine (Effexor) — are not enough to change everyone’s view of the risks of antidepressants, especially to kids.

“The authors in this study examined the risk of suicidal thinking or behavior associated with one drug, fluoxetine,” said Jeff Bridge, a researcher at Nationwide Children’s Hospital in Columbus, Ohio. “My view is that the weight of evidence shows a small but significant increased risk of suicidal ideation/suicidal behavior in pediatric patients treated with antidepressants.”

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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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