Injuryboard Commentary - FDA & Prescription Drugs

Recent Review Shows that H1N1 Vaccine is Safe

Carrie Strasser — Mon, 07 Dec 2009 17:32:10 GMT

The New York Times reported on Saturday that the H1N1 vaccine is safe and that most people who have had side effects have only suffered side effects similar to those prevalent as a result of the seasonal flu vaccine.

This new report comes from two monitoring networks, the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink. Doctors, health care workers and the public can file a report with the Adverse Event Reporting System and these reports are then investigated. Safety Datalink has information on over 400,000 people who received the H1N1 vaccine in managed-care organizations.

According to the new report, “no substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported.”

Dr. Thomas R. Frieden, director of the CDC, said the findings were reassuring, but still preliminary. The H1N1 vaccine has only been in widespread use for about two months and certain problems might not present themselves until later when more people are vaccinated. Dr. Frieden also stated that there was no evidence that this swine flu vaccine increased the risk of Guillain-Barre syndrome that was linked to the swine flu vaccine from 1976.

As of November 24, almost 4,000 adverse events had been reported after H1N1 vaccinations. 204 of those were considered serious.

For information on the Vaccine Adverse Event Reporting System, click here.

For information on the Vaccine Safety Datalink, click here.

For information on the safety of the H1N1 vaccine, click here.

Originally posted at InjuryBoard by Carrie Strasser

Yaz / Yasmin / Ocella Side Effects: Bayer Profit Grows In Spite of Deadly Side Effects

Brett Emison — Mon, 07 Dec 2009 11:20:48 GMT

Industry site, bnet.com has reported that Bayer's profit from Yaz and Yasmin continues to grow in spite of serious -- even deadly -- side effects including heart attack, stroke, pulmonary embolism, deep vein thrombosis and gallbladder disease.

Bayer’s Yaz and Yasmin contraceptives appear to be recession- and scandal-resistant superbrands, if recent reports are to be believed. Bayer hit back at a German newspaper that reported the company was cutting back on pill production due to decreased demand.

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But Bayer said the report was wrong:

“Revenue from our Yasmin product family continues to rise as planned,” a Bayer spokesman told Reuters on Sunday.

Yasmin is Bayer’s best-selling pharmaceutical product group. In the first quarter of 2009, Bayer reported sales of 319 million euros ($443.2 million) for the Yasmin range, a 7.4 percent year-on-year gain.

Those sales gains came despite the FDA forcing Bayer to spend an extra $20 million on “corrective” advertising to rebuff claims the company previously made that Yaz cures acne and PMS (it doesn’t).

Bayer continues to increase its profits at the expense of thousands of young women across the country. Bayer needs to be held accountable for putting profits and money over safety and lives. Why doesn't Bayer have to follow the same rules as everyone else?

If you or I put out a product that killed people, we would be held accountable. Why hasn't Bayer been held accountable? How many young women must suffer a heart attack or stroke before Bayer finally learns its lesson? Bayer's lesson will be learned only after it loses what it values most . . . money.

Why Are Yaz / Yasmin / Ocella So Dangerous?

Popular birth control pills, Yaz, Yasmin and Ocella, have been linked to serious and potentially deadly side effects. This deadly side effects affect women of all ages, including teens and young women.

Yaz, Yasmin and Ocella have been linked to serious side effects, such as heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease and sudden cardiac death.

Despite these serious side effects, Bayer marketed these drugs to young women not only as a contraceptive, but to relieve symptoms of severe PMS and as an acne fighter.

The FDA reprimanded Bayer late last year for overstating the benefits and downplaying the risks of Yaz in television advertisements. The slogan for Yaz was "beyond birth control."

Bayer marketed Yaz to women in their 20s. Commercials cultivated a hip, youthful image set to rock music, and advertised Yaz as a treatment for acne and premenstrual syndrome (PMS).

The FDA called Bayer's advertisements "misleading" and reprimanded Bayer in a number of official FDA letters. Bayer's conduct was so egregious that the FDA ordered Bayer to run a $20 million "corrective" ad campaign.

"I can't think of anything even remotely as large scale as this corrective advertising," said Michael A. Santoro, an associate professor of business ethics at Rutgers University.

In August, the FDA again warned Bayer about poor quality control at a German plant that makes Yaz's key ingredient -- drospirenone.

How Does Yaz / Yasmin / Ocella Cause Such Serious Side Effects?

Yaz and Yasmin contain the chemical, Drosperinone, which acts as a diuretic and causes fluid loss. This fluid loss decreases sodium in the blood and increases potassium. This imbalance causes irregular heartbeats and blood pooling, resulting in heart attacks, blood clots and stroke.

What Can I Do If I Have Experienced A Yaz / Yasmin / Ocella Side Effect?

Our firm has teamed up with the very best trial lawyers in the country to litigate Yaz and Yasmin lawsuits in the Multi-District Litigation (MDL) pending in the Southern District of Illinois, near St. Louis.

In fact, one of our team, Mark Niemeyer of Onder Shelton O'Leary & Peterson, LLC, is one of only three in the country to be selected by the Court to act as co-lead counsel for these Yaz and Yasmin cases.

"My role in this MDL is simply a reflection of the commitment of all us . . . to the women or families of women who suffered grave heath consequences after taking Yaz or Yasmin and just how seriously we take all our cases," said Mr. Niemeyer.

You can contact our team for a free case evaluation.

What Is An MDL? How Does An MDL Effect My Case?

You can find out more about MDLs and how they work at this recent post.

An MDL is like a class action, but with important differences. Instead of only one "case" (like in a class action), each plaintiff in the MDL maintains his or her own claim. However, because of many areas of common interest, the thousands of cases are consolidated for much of the pre-trial work up. For example, all of the cases filed in federal courts across the country will be transferred and consolidated in front of a single trial judge. The trial judge will appoint certain attorneys to represent all of the plaintiffs for various issues during pre-trial work up, such as discovery (fact-finding), motions, and scientific testing.

Lead counsel for the MDL is appointed by the trial judge. This small group of attorneys (for the Yaz MDL, there are only three attorneys appointed as co-lead counsel) will manage all of the pre-trial work up of all cases (potentially thousands) within the MDL.

If you file your Yaz or Yasmin claim in federal court, the three co-lead counsels -- including Mark Niemeyer of our team of attorneys -- will manage the work up of your case until trial.

Who Are Members Of This Team Of Attorneys?

The Onder Law Firm, based in St. Louis, Missouri has a track record of success and results for their clients in pharmaceutical litigation, personal injury claims, class actions and multi-district litigation (MDLs). Other lawyers across the country seek the firm's experience and expertise on complex litigation in specialty areas like dangerous drug cases.

Langdon & Emison, with locations in Chicago, St. Louis and near Kansas City, is one the country's premier trial firms, successfully taking on the largest corporations in the country. Langdon & Emison fought General Motors to the United States Supreme Court. . . and won. Baker v. General Motors held that corporations could not buy the silence of their employees and is taught in law schools across the country. The lawyers at Langdon & Emison actually try cases and have built a reputation for getting results for their clients with total recoveries of more than half a billion dollars. You can learn more by visiting Langdon & Emison's safety blog or profile.

Standly Hamilton, based in Dallas, Texas, litigates cases involving important social issues, dangerous pharmaceutical drugs, catastrophic personal injury, and wrongful death.

Learn More

You can learn more about the serious side effects of Yaz, Yasmin and Ocella and find out what to do if you or a loved one have suffered any of these dangerous side effects at this Yaz/Yasmin/Ocella informational and safety web site.

Originally posted at InjuryBoard by Brett Emison

Slim-Fast® Ready-to-Drink Products in Cans Recalled Due to Possible Health Risk

Paul Napoli — Mon, 07 Dec 2009 11:12:25 GMT

December 4, 2009

Unilever United States, Inc. of Englewood Cliffs, NJ, in cooperation with the U.S. Food and Drug Administration (FDA), has voluntarily recalled all Slim-Fast® Ready-to-Drink products in cans due to the possibility of contamination with the microorganism Bacillus cereus.

People infected with food borne Bacillus cereus experience diarrhea, abdominal cramps, nausea and occasionally vomiting within 1/2 hour to 15 hours after consumption of contaminated food. Symptoms persist for 24 hours in most instances.

All Slim-Fast RTD (Ready to Drink) products in cans, regardless of flavor, Best-By date, lot code or UPC number are recalled. The products are packaged in paperboard cartons that contain four; six or 12 steel cans of 11 FL OZ (325 mL) each and distributed nationally. Certain retail outlets also sold individual cans.

Unilever United States, Inc. initiated the recall after it conducted quality testing on Slim-Fast RTD products in cans. The company is in the process of identifying and correcting the production issue and will resume production and shipment of the product when the issue has been addressed and corrected.

Consumers who have purchased Slim-Fast® RTD products in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open Monday – Friday, 8:30 AM – 6:00 PM ET.

If you or someone in your family has suffered adverse reactions resulting from a food or drug product, please contact the experienced attorneys at Napoli Bern Ripka, LLP by calling 1-888-529-4669. You may be entitled for compensation for your injury, medical expenses or a loved one’s death.

Originally posted at InjuryBoard by Paul Napoli

SJS, TENS and EM

Greg Jones — Mon, 07 Dec 2009 10:56:00 GMT

As with all illnesses, skin diseases can often be hard to diagnose. This article will help distinguish between three often confused disorders: Erythyma Multiforme (EM), Stevens Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

Erythyma multiforme often occurs as a result of an allergic reaction or infection. It’s fairly common, and mostly affects people between 20 and 40 years of age. EM appears as a rash. The rash looks like several pink/red blotches, each one symmetrical is shape, usually on extremities such as hands. The individual blotches consist of a white center surround by a red ring. Irritation will cause the rash to spread. Fortunately, the rash is ‘self limiting,’ which means that it will eventually disappear by itself.

The most serious form of EM is possibly related to and often confused with Stevens Johnson Syndrome. SJS is also a reaction to medication or infection, but its consequences are generally more serious than those of EM. SJS first manifests itself with flu-like symptoms, such as fatigue, sore throat, and fever. A painful purple/red rash follows, causing the top layer of the patient’s skin to blister and then fall off. Anyone suffering from SJS should be immediately taken to the hospital, where they will be taken off of all previous medications and receive similar treatment to burn victims. The best method of physical therapy and treatment is still under contention.

Most dangerous of the three disorders is Toxic Epidermal Necrolysis. As with the other two, TEN often stems from adverse drug reactions. After 1-2 weeks of fever, the patient will develop a warm, red rash over large swaths of their body. The most strongly affected areas are the mouth, which can develop blisters that make it difficult to eat, the eyes, which can become swollen, crusted, and blind, and the vagina. Eventually the patient’s skin will fall off in large pieces. Diagnosis is often difficult, and treatment, which includes several different levels of intensity based on the progression of the disorder, is far from foolproof; TEN has a mortality rate of 30-40%.

Before you get too concerned, remember that all three of these disorders are rare – TEN affects approximately only 1 out of every million cases per year. Just keep an eye out, and if you develop any of the symptoms be sure to contact your doctor right away.

Originally posted at InjuryBoard by Greg Jones

Yaz, Yasmin and significant health risks

Greg Jones — Mon, 07 Dec 2009 10:54:54 GMT

If you ever watch TV, then you've probably seen at least one commercial for Yaz, a birth control pill that boasts the unique side effect of alleviating the symptoms of Premenstrual Dysphoric Disorder (PMDD). PMDD is a medical condition that is similar to Premenstrual Syndrome (PMS), but the difference is that the symptoms of PMDD are severe enough to affect your daily life.

Bayer HealthCare Pharmaceuticals, the makers of Yaz and its sister Yasmin, have marketed these products as being the solution to PMDD (as well as moderate acne) because of a chemical called drospirenone. Drospirenone is a type of hormone that Bayer uses in its birth control to help reduce bloating and alleviate the symptoms of PMDD.

Unfortunately, drospirenone also causes dehydration, which, in certain women, can have dangerous health effects. Allegedly, as a result of the drospirenone in Yaz and Yasmin, many women (of all ages and walks of life) have suffered from blood clots, strokes, and heart attacks, some of which have been fatal. Many of the victims had no pre-existing heart conditions, and some were as young as 16 years old.

The problem is exacerbated by the fact that the FDA hasn't approved the use of these birth control pills as cures for either PMDD or acne. This is dangerous marketing that lures girls and women into buying a product that could easily kill them.

If you know a woman who is using Yaz or Yasmin, for whatever reason, make sure she knows the risks involved, and has talked to her doctor about other options that are available to her.

Originally posted at InjuryBoard by Greg Jones

Merck Knew Vioxx Risks YEARS Before Pulling from the Market

Mike Ferrara — Sun, 06 Dec 2009 17:43:03 GMT

By now, it’s hard to be surprised by bad news about drug giant Merck, maker of the painkiller Vioxx, who “voluntarily” withdrew the drug from the market in September 2004 after it had caused thousands of heart attacks, strokes, and deaths.

Being outraged at Merck, on the other hand, is easy—and now we have even more reason to do so. Just before Thanksgiving, the Archives of Internal Medicine published an article finding that Merck had “clear evidence” that Vioxx increased the risk of heart attack and stroke as early as December 2000—three and a half years before it pulled Vioxx from the market.

The peer-reviewed study analyzed both published and unpublished research into Vioxx to discover when Merck could have reasonably concluded that the drug raised the risk of stroke and heart attack. During the time Merk was marketing Vioxx, it did not make most of the data used in this study publicly available to independent researchers, but instead, hired ghostwriters to promote Vioxx’s positives while grossly downplaying its negatives.

For its own part, Merck has denied any wrongdoing, surprise surprise. I sincerely hope that something similar is not going on with Merck’s HPV vaccine Gardasil right now. Just a few years ago, Vioxx was all the rage with doctors, hospitals, and patients all over the country. Now, Merck is paying out nearly $5 billion in lawsuits for the strokes and heart attacks it negligently, greedily caused. The way Merck is now aggressively marketing its HPV vaccine Gardasil to America’s young people (before adequate testing has been performed) feels frighteningly similar to the way it handled Vioxx. Please read more about Gardasil’s adverse effects and Merck’s blockbuster ad campaigns if you are considering getting vaccinated or vaccinating your child.

Originally posted at InjuryBoard by Mike Ferrara

FDA Watch List on Potentially Dangerous Pharmaceutical Drugs Recently Updated

Randy Appleton — Sat, 05 Dec 2009 19:50:00 GMT

A list of drugs which may present potential health hazards was recently published by the FDA and can be accessed at the FDA's website. The list includes some antidepressants which have been widely prescribed and may lead to suicidal ideations.

The following are just a few of the drugs that have landed on the FDA’s list:

Prozac, Zoloft, Lexapro, Celexa, Able, Maprotiline, Atomexitine, Bupropion, Ablify

Drugs which are under investigation have been identified as having potential side effects. Physicians who prescribe any medication engage in a balancing approach in which they try to insure the patient receives the intended benefit from the medication without an adverse reaction. If a patient begins to experience an adverse reaction while taking a medication it is important to work with the physician to address the side effects and, if possible, avoid any potential harm.

Many times simple changes in dose or the frequency of taking a medication may relieve side effects while still providing the benefit of the medication. The best source of information describing symptoms which a patient suspects are side effects of any medication is the patient. If a patient suspects they are experiencing an unusual reaction while taking any medication, a full description of the symptoms should be reported to the treating doctor. It may be helpful to make notes describing the symptoms including when they began, how long they lasted and whether any other medication had been taken when the symptoms began. In cases of visible symptoms such as hives or rashes, a photo to show the doctor is a good idea. It is also important that a patient being treated by multiple physicians be sure each physician is aware of all the medication being prescribed by other doctors.

Prescription medications are intended to produce beneficial effects for the patient and should generally be taken specifically as instructed by a doctor. The FDA investigation should warn the public of some risks associated with the medications under investigation. If you, or someone you know, are concerned about the use of any medication, consult with the prescribing physician and discuss your concerns thoroughly. Physicians are concerned about the well being of their patients and such discussions provide an opportunity to address issues which directly deal with a patient's care.

About the Editors: Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia (VA), near the NE North Carolina (NC) border and handles car,truck,railroad, and medical negligence cases and more. Our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono public information service. Lawyers licensed in: VA, NC, SC, WV, DC, KY.

Originally posted at InjuryBoard by Randy Appleton

Valproate Sodium Products Linked to Risk of Birth Defects

Scott Kappes — Fri, 04 Dec 2009 14:42:00 GMT

Yesterday the FDA notified healthcare professionals about an increased risk of neural tube defects and other major birth defects. Healthcare professionals should warn women of child bearing age about these potential birth defect risks and consider possible alternative therapies for the treatment of migraines and other non-life-threatening conditions.

Valproate should only be used in women of childbearing when it is necessary to manage their medical condition.

Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.

Pregnant women using valproate should enroll in the North American Antiepileptic Drug Pregnancy Registry at www.aedpregnancyregistry.org

Originally posted at InjuryBoard by Scott Kappes

GE and Omniscan Face More NSF Trouble

Jamie Sheller — Fri, 04 Dec 2009 14:33:44 GMT

New analysis suggests that 3 MRI contrast agents may be risker than initially thought, leading the FDA to consider further regulation of the drugs. The drugs are linked to a rare, but potentialy fatal disease called nephrogenic systemic fibrosis (NSF). The drugs being examined are Bayer HealthCare's Magnivest, Mallinckrodt's Optimark and GE Healthcare's Omniscan. According to FDA reviewers, Omniscan had a disproportionately high number of NSF reports, compared to its peers. Magnevist, Optimark, and Omniscan are contrast agents, containing the metal gadolinium, which are injected during magnetic resonance scans. Contrast agents are linked to NSF in patients with impaired kidney function. According to researchers, one possible cause is an inability to eliminate gadolinium from the body.

NSF causes a thickening and hardening of the skin around the joints, leading to limited movement and possible incapacitation. Also, internal organs may be affected, potentially resulting in a lung embolism or other life-threatening condition. There is no known cure for NSF. In the U.S., more than 500 NSF cases have been filed, with a majority of those cases involving GE and Omniscan. Further, Omniscan is the contrast agent most cited in reports of NSF filed with the FDA and European regulators. In an FDA review, Omniscan was rated as the least chemically stabale of the contrast agents.

If you or a loved one has had an imaging study with a gadolinium contrast agent, and developed NSF, contact Sheller, P.C., to discuss your potential legal claims. The Sheller firm has a long history of successfully representing people injured by pharmaceutical products and medical devices. Sheller is currently accepting cases of patients who have developed NSF.

Originally posted at InjuryBoard by Jamie Sheller

Big Award In Pfizer HRT Case

Jamie Sheller — Fri, 04 Dec 2009 10:40:11 GMT

Recently, a breast cancer survivor won her hormone replacement lawsuit against Pfizer. Plaintiff, Donna Kendall asserted that three of Pfizer's hormone replacement drugs contributed to her breast cancer, and a jury in Philadelphia agreed with her. The jury found that the drug company failed to adequately warn consumers of the risks of Premarin, Prempro, and Provera, and ordered Pfizer to pay Ms. Kendall $6.3 million in compensatory damages and $28 million in punitive damages. Pfizer became responsible for this and thousands of other hormone replacement lawsuits, when it acquired Wyeth and Pharmacia & UpJohn.

The FDA approved Premarin in 1942 and Prempro in 1994, and they are used to treat moderate to severe symptoms of menopause. Provera was approved in 1959 to treat abnormal uterine bleeding, secondary amenorrhea and endometrial hyperplastia in post-menopausal women who are taking estrogen pills. A study of Premarin and Prempro by the Women's Health Initiative, revealed an increased risk of cardiovascular disease, stroke, and breast cancer. After that study, the use of hormone therapy decreased. One later study linked hormone replacement therapy to a signifcant increase in stroke risk. Hormone therapy was linked to an increased risk for ovarian cancer by a more recent study.

In October, another Philadelphia jury ordered Pfizer to pay $75 million to another plaintifff, whose breast cancer was connected to Prempro. Pfizer says it will challenge both verdicts.

Originally posted at InjuryBoard by Jamie Sheller