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Drugs such as Oxycontin and Percocet are commonly prescribed for severe pain. The Orange County District Attorney filed a lawsuit against several pharmaceutical companies, claiming the companies are intentionally misrepresenting to doctors and patients just how addictive these prescription painkillers can be.
Orange County Health Care Agency officials say there were 291 deaths in 2012 related to overdoses. That's almost 40 percent of all the accidental deaths in the county.
One of the companies, Janssen Pharmaceuticals, issued a statement: "Janssen is committed to ethical business practices and responsible promotion, prescribing and use of all our medications. We're currently reviewing the complaint."
The FDA approved Pradaxa in 2010 for use in patients at risk of stroke due to atrial fibrillation or other irregular rhythms. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011. The settlement follows a $931,000 fine assessed against the company in December for failing to preserve documents related to the drug's development. Pradaxa generated revenue of $1.63 billion last year.
A New Jersey jury found that the Accutane manufacturer, Hoffman-LaRoche and Roche Laboratories, failed to provide Kamie Kendall Ries from Salt Lake City with adequate warning of the health risks. Reis was prescribed Accutane in 1998, when she was just 12 years old and later had her colon removed after developing Accutane Ulcerative Colitis.
More good news for Accutane colitis victims is that the jury found the failure of adequate warnings extended to 1998, when Ms. Ries was prescribed Accutane.
Roche intends to appeal the verdict. Buchanan said that plaintiffs (of which approximately 7,000 Accutane cases are pending in New Jersey and elsewhere) will seek to streamline the litigation through motion practice and trying more cases together in the future.
Accutane was pulled from the US market in 2009. Roche said its product was removed due to a low market share and the high cost of defending personal injury lawsuits by Accutane consumers. Accutane is still available in the UK and other countries, and the generic version of Isotretinoin is still available in the US.
The recall affects 30-count and 90-count bottles of Effexor XR 150-milligram extended release capsules and 90-count bottles of Greenstone-branded Venlafaxine 150-milligram extended release capsules.
According to a press release, a pharmacist had reported that a bottle of Pfizer's Effexor XR contained one capsule of Tikosyn. There have been no other reports, but three lots that were packaged on the same line are being voluntarily recalled as a precaution.
The use of Tikosyn by someone taking Effexor or Venlafaxine could have "serious adverse health consequences that could be fatal," the press release states.
Patients should watch out for signs of abnormal heartbeat and contact their doctors if they have any problems.
The lawsuits were from women who allegedly were harmed by using Merck and Company’s NuvaRing. Under the settlement, “Merck will be paying a fraction of what at least one company has paid in a similar settlement.” Last year, Bayer AG (a German drug maker) paid $1.6 million to settle lawsuits against its Yaz and Yazmin birth control pills, which allegedly were causing women to have clots, strokes, and heart attacks.
Manufacturers of popular sleeping pills are now required to lower recommended dosages for women after simulation studies confirmed the medication could cause impaired driving among users.
Zolpidem was first introduced in the early 1990s as a safe and effective treatment for insomnia. It is sedative-hypnotic commonly sold under the brands of Ambien, Edluar and Solpimist.
While agency officials are aware that sleepwalking and residual drowsiness are common, these side effects have a greater impact on women, who metabolizes the drug slower than men. According to FDA evaluations, 33% of women taking XR(extended release) zolpidem will still have enough of the drug in their blood to influence motor skills even after eight hours. FDA officials declared that doses will be reduced by half from 10 mg to 5 mg for instant releases and 12.5 mg to 6.25 mg for extended release. The agency also suggested lower dosages for men but it will not be a requirement.
Over the years, the Food and Drug Administration have allegedly obtained an estimated 700 reported car accidents in which the driver was on zolpidem. In some cases, the driver purports no recollection of the mishap.
Four sisters whose mother took the pregnancy drug DES, or diethylstilbestrol, while pregnant are suing the Indianapolis-based drug company Eli Lilly and Co. This lawsuit is set to begin trial today, and is the first of many such claims against various pharmaceutical companies.
DES, a synthetic estrogen, was prescribed from the late 1930s to the early 1970s to prevent pregnancy problems such as miscarriage and premature births. The drug was pulled from the market in 1971 by the FDA when a study found that DES appeared to increase the risk of DES daughters developing a rare vaginal cancer.
The case going to trial today centers around the claims of these four sisters, each of whom have developed breast cancer. Additionally, each of the four sisters has had miscarriages and fertility problems as well as other reproductive tract problems. Their mother did not take DES while pregnant with their fifth and youngest sister who has not developed breast cancer nor has she had any sort of fertility issue.
The sisters’ lawyers cite a 2011 study by Dr. Robert Hoover that suggests that the risk of breast cancer in DES daughters over 40 is nearly double. The study found that the chance of developing breast cancer by age 55 in a DES daughter is about 1 in 25 while for the average woman, the chance is about 1 in 50. Thousands of lawsuits have been filed since 1971 alleging the link between DES and vaginal cancer, cervical cancer, and fertility problems and many of those cases have settled.
Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Laboratories and also India’s largest drug maker, has recalled its generic version of the drug Lipitor due to the possibility of certain lots containing tiny glass particles.
The 10, 20, and 40-milligram doses of the atorvastatin calcium tablets are being recalled while the 80-milligram doses are unaffected. This includes 41 lots of the generic cholesterol drug. The majority of the lots affected contain bottles with 90 pills in each, while three lots contain bottles with 500 pills. It is unclear how many bottles are in each lot.
This recall is the latest of many quality lapses at Ranbaxy factories over the past several years. The FDA has sanctioned the company in the past, as well as previously barring the shipment of certain drugs. Currently, Ranbaxy is operating under a consent decree with the FDA which means that it is required to improve its manufacturing procedures, ensure that the data on its products is accurate and have all of this reviewed and overseen by a third party for five years.
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