Fractures While Taking Fosamax

In October 2010, the U.S. Food and Drug Administration (FDA) updated the label on Fosamax and other bisphosphonates to include the risk of atypical fractures. The agency has published a review in the New England Journal of Medicine after analyzing data from 2,342 post-menopausal women, concluding that there is little evidence to support the use of bisphosphonates for longer than five years.

Another recent study published in the Archives of Internal Medicine examined the risks of femur fractures with bisphosphonate therapy by comparing patients with atypical femur fractures versus classic fractures. Overall, the researchers found that 82 percent of the atypical femur fracture group had been taking bisphosphonates.

July 19, 2012 in Fosamax | Permalink | Comments (0)

New Study Warns on Increased Risk of Fracture from Nexium - Times Union

In April 2012, MHRA published an article revealing that there is recent epidemiological evidence of an increased risk of fracture with long-term use of PPIs (Proton Pump Inhibitors), including Nexium. Nexium, manufactured by AstraZeneca, is a medication that people take to prevent on-going heartburn. A recent study, published on January 31st 2012, in the British Medical Journey, showed that postmenopausal women are at a 35% increased risk of hip fractures if they regularly use PPIs, including Nexium, and that risk increases to more than 50% among women with a history of smoking.

via www.timesunion.com

In May 2010, the FDA issued a warning regarding the increased risk of fractures of the hip, wrist, and spine from Nexium and other PPIs. In March 2011, the FDA stated that the risk of low levels of magnesium in the blood (hypomagnesemia) if taken for a long time was linked to Nexium (and other PPIs). Hypomagnesemia can result in serious side effects, such as muscle spasm, irregular heartbeat, and seizures.

In April 2012, MHRA published an article revealing that there is recent epidemiological evidence of an increased risk of fracture with long-term use of PPIs (Proton Pump Inhibitors), including Nexium. Nexium, manufactured by AstraZeneca, is a medication that people take to prevent on-going heartburn. A recent study, published on January 31st 2012, in the British Medical Journey, showed that postmenopausal women are at a 35% increased risk of hip fractures if they regularly use PPIs, including Nexium, and that risk increases to more than 50% among women with a history of smoking.

May 23, 2012 in Nexium | Permalink | Comments (0)

Potential Lawsuits On Behalf Of Victims Of Zithromax Side Effects

Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, is currently evaluating lawsuits on behalf of individuals who may have suffered from Zithromax side effects, such as arrhythmia or sudden death. Zithromax, also known as azithromycin and commonly called the Z-Pak, is a widely used antibiotic manufactured by Pfizer Inc. A May 17, 2012 study published in The New England Journal of Medicine found that patients on azithromycin had one and a half times the odds of sudden death from cardiovascular causes than those on a similar antibiotic.* The odds were even higher in patients with high risk cardiovascular conditions. The study analyzed data from 350,000 Medicaid patients who took azithromycin from 1992 to 2006. The U.S. Food and Drug Administration issued a statement on the same day, announcing that it is reviewing the results of the study.

Zithromax is prescribed to treat bacterial infections, including bronchitis, pneumonia, sore throats and earaches. According to the New York Times, doctors wrote 55.3 million prescriptions for azithromycin in the United States last year.*** It was often prescribed over amoxicillin, another common antibiotic because of its easier regiment. Patients take fewer pills over fewer days, making it easier for patients to finish a course of treatment. However, according to Wayne Ray, professor of preventative medicine at Vanderbilt University and lead author of the study, "the risk of death may outweigh convenience and compliance, at least for high-risk patients."**** According to the study, there are 47 more deaths for every million people who took Zithromax instead of amoxicillin, which jumps to more than 245 deaths for those at high risks for heart problems. Individuals at high risk include those with heart failure, diabetes, previous heart attacks, prior bypass surgery or with stents implanted. In these individuals, the drug may cause potentially fatal abnormal heartbeats called arrhythmia.

May 18, 2012 in Zithromax | Permalink | Comments (0)

First Pradaxa Side Effects Lawsuits Filed | Houston Chronicle

The FDA is now investigating post-marketing reports of serious bleeding events and deaths in patients taking Pradaxa (dabigatran etexilate).

Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most comm

via www.chron.com

Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most common heart rhythm condition in the world. Patients with this condition typically require blood-thinning medications such as the well-known warfarin. Pradaxa was the first alternative to warfarin approved in nearly 60 years. Problems were quick to follow. In November 2011, Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa.

Pradaxa side effects have prompted safety advisories in Japan and Australia and have led to labeling updates in Europe and the United States. The FDA recently required the German pharmaceutical manufacturer Boehringer Ingelheim to update its Pradaxa label after receiving a large number of adverse event reports from consumers. The January 2012 label change added minimal information regarding the dangers of bleeding events and the lack of a reversal agent for Pradaxa. The drug remains devoid of a “black box warning” or an FDA recall.

March 30, 2012 in Pradaxa | Permalink | Comments (0)

FDA reviewing safety of Propecia | Examiner.com

FDA spokesperson Sandy Walsh wrote in an email that, “The focus of the current review is the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use. This review was prompted by routine drug safety surveillance.”

FDA’s safety investigation comes as a growing number of men say Propecia’s severe side effects have caused them to suffer persistent and permanent sexual dysfunction. While several European countries have required Propecia’s maker, drug-giant Merck & Co., to issue warnings regarding the drug’s irreversible side effects, this marks the first time the FDA has acknowledged it is reviewing the drug’s safety here.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar. The FDA approved Propecia in 1997 and reports that Merck’s annual Propecia sales are over $400 million

via www.examiner.com

Last year, researchers from the George Washington University and Boston University medical schools published separate studies in the Journal of Sexual Medicine that reported Propecia’s persistent and permanent side effects. Those side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast.

Last year, the FDA issued a new warning regarding Propecia’s link to high-grade prostate cancer -- the most aggressive and deadly form of the disease

March 27, 2012 in Propecia | Permalink | Comments (0)

Rare Fractures Linked To Drugs For Weak Bones : NPR

Schneider was one of the first women to suffer from one of these unusual fractures among patients who've been taking osteoporosis drugs called bisphosphonates for years. Or at least her case was one of the first reported in a medical journal, back in early 2006.

Since then, orthopedic surgeons and bone specialists have been seeing more of these unusual fractures among long-term users of bisphosphonate drugs such as Fosamax, Actonel, Boniva and Reclast.

There have been conflicting studies about the possible association between long-term use of such drugs and the risk of atypical fractures. The latest and largest study, a Canadian report published last week in the Journal of the American Medical Association, suggests that women who've been on bisphosphonates for more than five years have a nearly three times higher risk of the unusual fractures than those with only transient exposures to the drugs.

"Although the number of fractures, these unusual fractures, was pretty small — they're pretty rare — (the study) nonetheless did show a relationship with longer-term use," says Dr. Gillian Hawker of St. Michael's Hospital in Toronto, an osteoporosis specialist and study author.

via www.npr.org

Schneider has led an effort to restrict the use of the bone drug Fosamax, saying extended use can lead to femur fractures like the one she had in 2001.  Other Osteoperosis drugs include Actonel, Boniva and Reclast

March 27, 2012 in Actonel, Boniva, Fosamax, Reclast | Permalink | Comments (0)

Contraceptives Causing Health Risks

Artificial birth control makes pharmaceutical companies a bundle, whereas self-control preserves the family, and, thereby, the culture. Self-control also preserves health.

While first-generation Enovid, with 10 times the estrogen needed, caused thousands of women to die or be maimed by stroke, current contraceptives nearly double stroke risk.

The once-a-month NuvaRing is fighting 730 lawsuits filed in state and federal courts. The first, filed in 2008, alleges NuvaRing led to death by stroke after the company hid the risks.

Likewise, Yaz, the Yasmin/Yaz Lawsuit Center reports, is linked to "blood clots including pulmonary embolism, DVT (deep vein thrombosis) and stroke."

And, the Ortho Evra patch, releasing 60 percent more estrogen and progestin than typical, has caused, it's believed, 23 deaths, prompting a massive campaign for its recall.

According to National Cancer Institute, the pill is linked, as well, to an elevated risk of breast cancer. An NCI-sponsored study published in 2003 concluded "the risk was highest for women who used oral contraceptives within five years prior to diagnosis."

via washingtonexaminer.com

March 26, 2012 in Orthro Evra, Yaz | Permalink | Comments (0)

FDA Approval of Obesity treatments, Qnexa

Manufacturers of obesity treatments may need to study the heart risks of their therapies before regulators weigh approval, the Food and Drug Administration said in a report Monday.

Three California companies are competing to bring the first weight-loss pill to market in 13 years: Vivus Inc., Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc.

The FDA is set to decide on Vivus’s drug Qnexa by April 17. Arena’s medication faces an advisory panel May 10.

An advisory panel will hold a hearing on the drugs in starting Wednesday. The FDA doesn’t have to follow the panel’s recommendations.

via www.kansascity.com

March 26, 2012 in Qnexa | Permalink | Comments (0)

Risperdal trial scheduled in Arkansas' lawsuit over anti-psychotic drug

LITTLE ROCK, Ark. — A jury trial is scheduled to begin Monday over accusations that a pharmaceutical company illegally marketed Ripserdal, an anti-psychotic medication in Arkansas.

Arkansas Attorney General Dustin McDaniel filed a lawsuit against Johnson & Johnson, claiming that its Janssen Pharmaceuticals subsidiary concealed the potential health risks of the drug Risperdal. The suit also alleges that the company promoted it for unauthorized uses in violation of Arkansas' Deceptive Trade Practices Act and the Medicaid Fraud False Claims Act.

Risperdal is used to treat schizophrenia and bipolar disorder.

It's the fourth time Johnson & Johnson has gone to trial over a state's complaints about Risperdal since they first arose in 2004. The most recent trial, in Texas, ended with a $158 million settlement.

Arkansas is accusing the drugmaker of risking the lives and health of thousands of residents by deliberately hiding the drug's potential to cause serious weight gain and inflict diabetes and related ailments, as well as cause circulatory problems that increase the risk of strokes.

McDaniel alleges Johnson & Johnson, through its Janssen Pharmaceuticals subsidiary, concealed Risperdal's potential health risks and promoted it for unauthorized uses in violation of Arkansas ' Deceptive Trade Practices Act and the Medicaid Fraud False Claims Act.

State attorneys, in describing Risperdal as the most widely prescribed antipsychotic medication of its kind, allege that its "blockbuster success" was due in large part to the company hiding or downplaying its risks, even to the point of concealing negative results of studies.

The lawsuit also alleges that Risperdal was prescribed for purposes other than its labeled, federally approved purpose. The drugmaker promoted it for the treatment of dementia and Alzheimer's disease, according to the suit, despite testing that showed the drug increased the risk of death in elderly users.

March 25, 2012 in Risperdal | Permalink | Comments (0)

Pfizer Settled About Half of Prempro Cases | Bloomberg

Pfizer Inc. (PFE), the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.

Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.

“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.

Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill.

At the height of the litigation, Pfizer faced more than 10,000 claims that its menopause drugs caused breast cancer, according to lawyers for former users. Those lawsuits included more than 8,000 cases consolidated in federal court in Arkansas and suits in state courts in Pennsylvania, Nevada and Minnesota.

Pfizer in May disclosed the $772 million reserve and said it had resolved a third of the cases, or about 3,300. The November filing indicates Pfizer officials have now settled almost 5,000 of the suits.

“Pfizer continues to have a strong record of success in defending these cases,” Chris Loder, a company spokesman, said in an e-mailed statement. “While we will continue to look for opportunities to enter into favorable settlements where appropriate, we will also continue to vigorously defend these medicines in litigation.”

via www.bloomberg.com

March 23, 2012 in Prempro | Permalink | Comments (0)