LONDON, England (CNN) – More than half of children taking antiviral drug Tamiflu suffer side-effects such as nausea, insomnia and nightmares, UK researchers have said.

Two studies from experts at the Health Protection Agency (HPA) showed a “high proportion” of British schoolchildren reporting problems after taking the anti-viral drug.

Data was collected from children at three schools in London and one in south west England who were given Tamiflu earlier this year after classmates became infected.

The studies by HPA experts were carried out in the early stages of the epidemic between April and May, when everyone sharing a classroom with a child who developed swine flu was given the drug, even if they showed no symptoms.

Their research, published in the Eurosurveillance scientific journal, looked at side-effects reported by 11 and 12-year-old pupils in one school year in a secondary school in south west England.

A total of 248 pupils took part in the study; their school was closed for 10 days after a pupil there contracted swine flu during a holiday in Mexico, researchers said...read more here…

July 7, 2009 — The US Food and Drug Administration (FDA) is adding stronger warnings to pain medications that contain propoxyphene, such as Darvon and Darvocet, because of new data on fatal overdoses linked to propoxyphene products. The FDA is requiring the manufacturers of these drugs to strengthen the drug’s boxed warning and to create a medication guide for patients.

The agency is stopping short of a phased withdrawal from the market as demanded by a Public Citizen petition filed in 2006.

To reduce the likelihood of overdose, the FDA will now require that manufacturers of propoxyphene-containing medications strengthen their label and include a boxed warning on the potential for overdose. Manufacturers will also be required to develop a medication guide for patients stressing that they use the medication as directed. Propoxyphene has been on the market since 1957.

Between 1969 and 2005, an FDA database has linked a total of 91 deaths in persons taking propoxyphene related to accidental overdoses and suicide attempts, although a direct link to propoxyphene is difficult to establish because multiple drugs and other conditions were involved, the agency said.

The FDA is currently working with several organizations, including the Centers for Medicare & Medicaid Services and the Veterans Health Administration, to collect data for a new safety study that will assess the cardiotoxic effects of propoxyphene at higher doses, particularly in elderly populations; findings from this study could lead to additional regulatory action. At this time, the FDA is looking at how Americans are using medications containing propoxyphene, and in which combinations.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, told reporters during a press briefing that propoxyphene is an accepted option for pain treatment at this time. “Pain is an important issue — it’s the fifth vital sign. Millions of people suffer from pain; it is so prevalent that 1 in 10 people have chronic pain, and the FDA is committed to appropriate treatment of pain. At this time, propoxyphene is an acceptable choice for the treatment of mild to moderate pain when taken as directed.”

Dr. Woodcock noted that after last week’s advisory meeting on acetaminophen safety, the FDA heard from hundreds of patients concerned about the availability of their medications that contain acetaminophen.

“When it comes to acetaminophen or opioids, the FDA is constantly balancing benefit vs risk,” she said.

The FDA said that in cases of overdose, propoxyphene can be a fatal medicine; however, most of the deaths connected to the drug in the FDA’s database were in cases of ingestion of multiple drugs.

The consumer group Public Citizen petitioned the FDA in February 2006, asking that propoxyphene-containing products, sold primarily as a generic drug, be removed from the market. The FDA declined today to take action on the petition. The drug was withdrawn from the UK market in 2005, however, when the British government said it was unimpressed with the efficacy of the drug and that the risk of toxicity in cases of overdose — both intentional and accidental — were unacceptable.

The FDA defended its position in not removing the drug from the market, pointing out that there are not a lot of alternative drugs without similar adverse effects...read more here..

WASHINGTON (AFP) — The US Justice Department and 16 states have joined two whisteblower lawsuits against Wyeth, alleging that the drugmaker has defrauded the government of hundreds of millions of dollars.

According to the lawsuits, filed in a federal district court in Massachusetts, Wyeth avoided paying hundreds of millions of dollars in rebates due to state Medicaid programs — which provide health insurance to low-income families or people with disabilities — for its Protonix Oral and Protonix IV stomach acid drugs.

Medicaid, which is financed by the federal government and states, is qualified to obtain the lowest prices on prescription drugs. Drugmakers such as Wyeth in turn are required to pay rebates to states based on any other discounts they have offered.

But the Justice Department claimed Monday that between 2000 and 2006, “Wyeth offered steep discounts to thousands of hospitals nationwide” through the “Protonix Performance Agreement.”

That pricing arrangement provided up to 94 percent discounts off the Protonix Oral list price and 80 percent off that of Protonix IV.

“Our complaint charges that Wyeth created the Protonix bundle so they could increase their market share at the expense of the Medicaid program — a program to provide the least advantaged Americans with necessary medical care and services,” Assistant Attorney General Tony West said in a statement.…read more here…

Studies have also  shown that statin medications lower inflammation, as measured by high  sensitivity C Reactive Protein. After the JUPITER trial  was published,  many healthcare professionals beleived that this is possibly the mechanism by which statin medications such as lipitor, zocor, pravachol  and crestor decrease risk of death and exert their health benefits.

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By Rob Waters

April 29 (Bloomberg) — Patients who reduced their cholesterol and blood pressure by taking Pfizer Inc.’s Lipitor after suffering a stroke were less likely to have a second attack, researchers reported today.

People who lowered their blood pressure, cholesterol and blood fats called triglycerides to recommended levels with the drug cut their risk of a second stroke by 65 percent, according to the study funded by New York-based Pfizer. They also cut their risk of heart attack and other cardiovascular damage by 75 percent. Researchers presented results today at a meeting of the American Academy of Neurology in Seattle.

All cholesterol-lowering drugs knows as statins are likely to have a similar effect, said Samuel Hunter, a neurologist at the Advanced Neurosciences Institute in Franklin, Tennessee, in an interview yesterday in Seattle. Stroke is the third leading cause of death in the country and causes more serious long-term disabilities than any other disease, according to the National Institutes of Health.

“It is a message of hope for patients,” said Pierre Amarenco, a researcher at Denis Diderot University in Paris and the lead author of the study. “We can now tell them that if they are adherent to treatment, they may reduce the risk” of strokes and of major cardiovascular events...read more here…

I have received a list of medicines that will be going generic during the first quarter of 2009. This is great news at a time when so many are on a limited budget.  Remember to always ask your physician for generic alternatives.  At this point in time, almost every class of medicine out there has generic equivalents, including blood pressure medicines.  Places like Wal-mart and Target offer the medicines  for as cheap as $4 per month or $10 for 3 months.

1.  Topamax (topiramate)  : Seizure  medicine and migraine prevention/

2. Prandin (repaglinide): diabetes medicine

3. CellCept (mycophenolate mofetil): Organ transplants

4. Prevacid (lansprazole): acid reducing medicine

5. Pulmicort Respules (budesonide): asthma medicine

6. Flomax (tamsulosin): prostate medicine

(NaturalNews) The herbal supplement St. John’s Wort has long been promoted as an effective alternative for treating depression. Unfortunately, St. John’s Wort has proven ineffective for people suffering severe clinical depression. In fact, the results of a recent study revealed that St. John’s Wort is completely ineffective at treating severe depression. There is another effective natural alternative, however, and it is called SAM-E (S-adenosylmethionine).

Symptoms of Depression:

•Feelings of sadness and emptiness
•Feelings of helplessness, hopelessness, guilt, or worthlessness
•Loss of interest in previously enjoyed activities
•Excessive sleeping or insomnia
•Fatigue
•Lack of energy
•Difficulty concentrating and in decision-making
•Headaches or digestive disorders
•Crying and tearfulness
•Overeating or under eating

In the aforementioned study, St. John’s Wort was tested for eight weeks on 200 patients who were suffering a degree of depression that made daily functioning difficult. St. John’s Wort was no more effective than a placebo.

In a significant number of previous studies, however, St. John’s Wort was found effective for mild to moderate cases of depression. There is some evidence that points to the fact that St. John’s Wort can help with some symptoms of depression. In Germany, in fact, St. John’s Wort is available by prescription.

There have been questions about the quality of some of this research, though. One such criticism cites a lack of studies using a placebo and another drug such as Zoloft. Zoloft is classified as an SSRI (selective serotonin reuptake inhibitor) and these are commonly used drugs for treating depression. These newer drugs also have numerous side-effects, however, and while many claim to be “non-habit forming,” this does not seem to be the case.

To satisfy these criticisms about the St. John’s Wort studies, researchers gave participating patients either St. John’s Wort, Zoloft, or a placebo for up to 26 weeks. When the study concluded, researchers found that neither the prescription drug nor the St. John’s Wort was more effective than the placebo. Almost 33% of the placebo patients showed a large response to their treatment and this was compared to approximately 24% of both the Zoloft group and the St. John’s Wort group.….read more here…

Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains

WASHINGTON — Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government.

The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.

Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications.

Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.

Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients’ breathing problems or the inhalers has proved difficult.

The stakes for drug makers are high. Advair sales last year were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline’s biggest seller and one of the biggest-selling drugs in the world. Glaxo also sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil by Novartis.

Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’s drug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonary disease, nearly all of whom are elderly.

Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency’s drug-safety division as “not supported by their own data.” Dr. Knobil said that Advair was safe and that Serevent was safe when used with a steroid.

Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.’s safety division improperly excluded most studies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increase the risks of death or hospitalization.

Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics’s committee on drugs, said that he was treating children with Advair and that his committee had recently discussed the safety of the medicines.

“Most of us felt these were pretty good drugs,” Dr. Frattarelli said. “I’m really looking forward to hearing what the F.D.A. committee decides.”

About 9 percent of Advair’s prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could not provide similar figures for Symbicort.

In 1994, Serevent was approved for sale, and the F.D.A. began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.

In 1996, Glaxo began a study of Serevent’s safety, but the company refused for years to report the results publicly. In 2001, the company introduced Advair, whose sales quickly cannibalized those of Serevent and then far surpassed them.

Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine were more likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossible to interpret.

Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but have a longer duration than albuterol and were intended to be taken daily to prevent attacks.

Advair contains Serevent and a steroid. Symbicort, introduced last year, contains Foradil and a steroid. In the first nine months of this year, Symbicort had $209 million in sales.

The problem with albuterol is that it seems to make patients’ lungs more vulnerable to severe attacks, which is why asthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have the same risks.

But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels that accompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.

Become informed- talk to your doctor about  vaccinations and your children… I do not recommend anyone avoid vaccinations- simply make informed choices.  Evidence shows that vaccinations have great public health benefits but some children may be sensitive to added preservatives put in the vaccines. Fortunately, these preservatives are not required for the vaccine to work.

Two television commercials for Bayer AG’s birth control pill Yaz give a misleading impression of its benefits, U.S. health regulators warned the company in a letter released on Tuesday.

The ads wrongly suggest the pills are approved for relieving premenstrual syndrome, the U.S. Food and Drug Administration said in a letter dated October 3. The ads also minimize the drug’s risks, the agency said.

Bayer will stop running the only one of the two ads currently in use, company spokeswoman Rose Talarico said. The other campaign ended in 2007.

The commercial no longer being broadcast featured women singing “We’re not gonna take it” and kicking, punching and pushing balloons with words such as “irritability,” “moodiness” and “bloating.”

Those symptoms are common with PMS. Yaz, however, is cleared for a more serious condition called premenstrual dysphoric disorder (PMDD), which causes anxiety, tension, persistent anger and other symptoms.

“The TV ads misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD,” the FDA letter said.

A second ad featured the song “Good-Bye to You” with women releasing balloons labeled with symptoms. The commercial suggests “women are saying ‘goodbye’ to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA said.

Bayer will pull that ad and work with the FDA regarding other promotions for Yaz, Talarico said.

The FDA said both commercials “suggest that Yaz is approved for acne of all severities when this is not the case,” the agency said.

In addition, the FDA said the ads distracted viewers with fast-moving images and background music, while information about potential side effects was described.

“These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the agency said.

Blood clots are among the potential side effects.

The letter was posted on the FDA Website at http://www.fda.gov/cder/warn/2008/YAZ_wl.pdf.

(Reporting by Susan Heavey and Lisa Richwine, editing by Bernard Orr and Andre Grenon)

WASHINGTON (AP) — If there ever is another anthrax attack, a letter carrier may deliver antibiotics to those who might be infected.

Federal health officials are beginning a project in Minneapolis-St. Paul to let letter carriers stockpile personal supplies of emergency antibiotics so they are protected and ready to deliver aid to the rest of the city.

The project seeks to overcome a big hurdle of emergency planning. The government has many drugs stockpiled in case of bioterrorism but few ways to get them quickly to people who need them.

Carriers could provide “a front-end quick strike,” said William Raub, senior science counselor to Michael O. Leavitt, health and human services secretary.

Test projects in Seattle, Philadelphia and Boston over the past two years paired carriers with police officers on holidays. Carriers volunteered to do double routes, delivering empty pill bottles along with fliers explaining what was happening. In Philadelphia, 50 carriers reached about 53,000 households in eight hours, Mr. Raub said…...read rest of story……