Category Archives: Drugs

Low Vitamin D intake increases risk of stroke

DALLAS, May 24, 2012 (GLOBE NEWSWIRE) — Japanese-American men who did not eat foods rich in vitamin D had a higher risk of stroke later in life, according to results of a 34-year study reported in Stroke, an American Heart Association journal.
“Our study confirms that eating foods rich in vitamin D might be beneficial for stroke prevention,” said Gotaro Kojima, M.D., lead author of the study and geriatric medicine fellow at the John A. Burns School of Medicine at the University of Hawaii in Honolulu.

Vitamin D is an essential nutrient that helps prevent rickets in children and severe bone loss in adults, and researchers believe it has the potential to lower the risk of a host of diseases including cancer and diabetes.

Sunlight is generally the greatest source, but synthesizing vitamin D from the sun gets more difficult as we age, Kojima said, so older people are advised to eat more foods rich in vitamin D or take supplements. Good sources include fortified milk and breakfast cereals, fatty fish and egg yolks.

Study participants included 7,385 Japanese-American men living on Oahu, Hawaii. All were participants of the Kuakini Honolulu Heart Program, a study of stroke and coronary heart disease in Japanese-American men that began in 1965 which was conducted at the Kuakini Medical Center.

Participants were 45 to 68 years old in the mid- to late-1960s when they were first examined and interviewed about what they had eaten in the previous 24 hours. Food models and serving utensils were used to help participants determine their portions accurately.

Researchers separated the participants into four groups of approximately 1,845 each depending on how much vitamin D they had consumed. They then analyzed their records through 1999, roughly 34 years after the initial exams, to determine the incidence of stroke. New strokes occurred in 960 men during the follow up period.

Researchers calculated risk while adjusting for age, total calorie intake, body-mass index, hypertension, diabetes, cigarette smoking, physical activity, cholesterol levels and alcohol intake. Men who consumed the least dietary vitamin D had a 22 percent higher risk of stroke and a 27 percent increase risk of ischemic (blood-clot related) stroke compared to those consuming the highest levels of vitamin D. There was no difference for hemorrhagic stroke.

Stroke ranks fourth among the leading causes of death in the United States. New or recurrent strokes strike about 795,000 Americans annually. Ischemic strokes account for 87 percent of all strokes, and 10 percent are from an intracranial hemorrhage (bleeding in the brain). The remaining 3 percent result from bleeding in the subarachnoid space between the brain and the tissues covering it.

Kojima said it is unclear whether the study results could be applied to different ethnic groups or to women.

While previous studies focused on blood concentrations of vitamin D, this investigation used dietary intake.

Co-authors are Christina Bell, M.D.; Robert D. Abbott, Ph.D.; Lenore J. Launer, Ph.D.; Randi Chen, M.S.; Heather Motonaga, M.D.; G. Webster Ross, M.D.; J. David Curb, M.D.; and Kamal Masaki, M.D. Author disclosures are on the manuscript.

The National Heart, Lung, and Blood Institute and the National Institute on Aging funded the study.

The American Heart Association offers information on Diet and Lifestyle Recommendations. For information on stroke visit strokeassociation.org.
Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association’s policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.

Plavix to go generic

The FDA announced the approval of generic versions of Plavix (clopidogrel bisulfate; Bristol-Myers Squibb and Sanofi) tablets. Plavix helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

Currently, Dr. Reddy’s Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300mg clopidogrel tablets. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75mg clopidogrel tablets.

Plavix is a platelet aggregation inhibitor indicated in reduction of atherosclerotic events in: recent myocardial infarction (MI) or stroke, established peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-ST-elevation MI) or ST-elevation MI.

For more information visit here

New drug approved for erectile dysfunction

 

FDA NEWS RELEASE

For Immediate Release: April 27, 2012
Media Inquiries: Stephanie Yao, 301-796-0394stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Stendra for erectile dysfunction

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

Erectile dysfunction is when a man has trouble getting or keeping an erection. An estimated 30 million men in the United States are affected by erectile dysfunction.

Stendra is a pill that patients take on an as-needed basis 30 minutes before sexual activity. Doctors should prescribe the lowest dose of Stendra that provides benefit.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Stendra belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. As with other PDE5 inhibitors, Stendra should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure.

PDE5 inhibitors may rarely cause color vision changes. In rare instances, men taking PDE5 inhibitors have reported a sudden loss of vision in one or both eyes. Sudden loss or decrease in hearing has also been reported in patients taking PDE5 inhibitors. Patients who experience a sudden loss of vision or hearing should stop taking PDE5 inhibitors, including Stendra, and call a doctor right away.

The most common side effects reported in greater than 2 percent of patients in the clinical studies of Stendra include headache, redness of the face and other areas (flushing), nasal congestion, common cold-like symptoms (nasopharyngitis), and back pain. In rare cases, patients taking Stendra and other PDE5 inhibitors may get an erection lasting four hours or longer that will not go away (priapism). If this happens, patients should seek immediate medical care.

Stendra’s safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients were randomly assigned to take Stendra for up to 12 weeks at doses of 50 milligrams (mg), 100 mg or 200 mg, or a placebo as needed about 30 minutes before sexual activity.

At the start of the studies and every four weeks thereafter, patients completed questionnaires to evaluate erectile function, vaginal penetration and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all three endpoints for all three doses of Stendra studied.

To further evaluate Stendra’s safety, a subset of patients from two of the studies were enrolled in another trial to receive up to an additional 40 weeks of treatment. Patients were initially given Stendra at the 100 mg dose, but could have their dose increased to 200 mg or decreased to 50 mg based on their individual response to treatment. Results showed that the side effects commonly reported in patients using Stendra did not worsen over time.

Stendra is marketed by Mountain View, Calif.-based VIVUS Inc.

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FDA Approved Drugs: Questions and Answers

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Do sinus infections need antibiotic treatment?

Sinus infections are a common reason a patient goes to their doctor’s office. Symptoms may  include nasal stuffiness, ear pressure, facial pressure, teeth pain, post nasal drip and a cough.   However, asking your physician for an antibiotic the first few days may not be the best thing for you. Studies show that using an antibiotic, such as amoxicillin or Z-pak (azithromycin) may not be needed for most patients, especially in the first week of symptoms.

A study from Washington University School of Medicine in St. Louis showed that patients with sinusitis who were given Amoxicillin vs a placebo (sugar pill) were no better at day 3 or day 10.  In other words, antibiotics did not improve the situation. (JAMA)

Most sinus infections start as a viral infection.  Antibiotics do NOT kill viruses, they only kill bacteria.   About 10% of people may ultimately develop a bacterial sinus infection,  this occurs  7 to 10 days after the symptoms start. This  occurs as a secondary infection, that is  if the viral sinusitis does not clear up.

90% of people with a sinus infection will improve by day 7 to 10.  If they happened to be given an antibiotic, they will assume this is the reason they improved.  However, this is not the case. They would have become better anyway.

Treating the symptoms may be the best therapy during the first week.  Using a saline sinus rinse netipot, such as those made by SinuCleanse can help prevent and treat sinus infections by rinsing away mucous buildup. Consider  antihistamine medications (Claritin, Allegra, Zyrtec or the generic equivalent) or nasal steroids (Flonase, Nasonex, etc.) or even Sudafed to help control your symptoms.  Only if the pain persists or if a fever starts after 7-10 days should an antibiotic be taken.

To those patients who come into my office within 48 hours of an infection, I frequently will provide them with a prescription,  recommending they wait a week until taking it to their pharmacy.  This saves my patient a return trip back to my office.

 

Keeping Your Immune System Strong

With the winter season quickly approaching,  keeping your immune system strong  is important .  There are several things you can do which will help minimize your risk of developing a cold  or the flu over the next several months.

First, eating a diet high  in fruits and vegetables will help optimize your immunity.  Consuming plant based foods which vary in color, such as red tomatoes, purple grapes or  orange carrots,  can  ensure a diverse intake of antioxidants.  A healthy diet  will give the body the tools necessary to fight off  bacteria and viruses.

Sleeping  at least 7 to 8 hours of each night is crucial  for a healthy immune system.   It is during the sleeping hours that the body repairs and heals itself from the damage done on a daily basis.  Poor sleep contributes  to poor health.

Keeping stress under control is also very important. When our body is mentally and physically stressed, cortisol, the primary stress hormone, is released in excess into the bloodstream.  Cortisol, a natural steroid,  suppresses the immune system  making one more susceptible to infection.

Studies show vitamin C  can reduce the duration of the common cold by up to 12% in adults and  21% in children.  Supplementing with 500 mg to 1000 mg of vitamin C  daily should be considered.

The Cochrane Collaboration, an independent research group,  has shown that  the mineral  zinc reduces risk of contracting a cold when taken within 24 hours of exposure.  Daily supplementation also appears to help prevent the need of  developing an  infection requiring antibiotic treatment.

Vitamin D supplementation also helps reduce the risk of developing influenza according to scientists.  The lack of sunshine, and ultimately blood levels of vitamin D,  likely accounts for the higher  incidence of upper respiratory infections during the winter months.  Ask your doctor to check your vitamin D levels before supplementing with doses higher than 2,000 IU per day.

Lastly, some people may also benefit from the influenza vaccine. Interestingly, the studies are not as overwhelmingly favorable as expected.   However, the best evidence reports that between 33 to 100 people need to be vaccinated  against the seasonal flu in order to prevent one extra infection with the virus. Even when vaccinated, one is never 100% protected from developing the flu.

As always, prevention is always the best medicine. Please talk with your healthcare provider before making and changes to your healthcare regimen.