Tag Archives: Drugs

GSK pleads guilty regarding advair


GlaxoSmithKline Plc (GSK) agreed to plead guilty and pay $3 billion to resolve criminal and civil allegations that it illegally promoted prescription drugs and failed to report safety data, the U.S. said.

The settlement, the largest-ever in a health-care fraud case in the U.S., includes a criminal fine of $956.8 million, the Justice Department said today. London-based Glaxo will also forfeit $43 million, the U.S. said.

 

GSK will plead guilty to marketing the drugs Paxil and Wellbutrin for uses not approved by the U.S. Food and Drug Administration and for failing to report clinical data on Avandia, federal prosecutors said. The company has agreed to admit to the charges, which are misdemeanors, according to filings today by the U.S. in federal court in Boston…read more

Darvocet Warning Released by FDA


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..

USA, States Sue Wyeth Pharmaceuticals


US, states sue Wyeth over drug prices

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…


(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…

FDA Cites Bayer on Yaz Birth Control Pill


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)