Archive for the ‘ Drug Injury ’ Category

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2
Feb

Pfizer, Inc. Recalls One Million Birth Control Pill Packets

February 2, 2012

The Drug manufacturing giant, Pfizer, Inc., announced a recall of nearly one million packets of birth control pills Tuesday due to a manufacturing mix-up that could put women at an increased risk of unwanted pregnancy. Reports form WRAL News say that 14 lots of Lo/Ovral-28 tablets and another 14 lots of Norgestrel and Ethinyl Estradiol tablets had placebo tablets placed in the wrong order the tablets are to be taken in.

The mix-up was discovered last year when a customer called after noticing the pills were in the wrong order. The company fixed the problem immediately. Then, in December, Pfizer contacted pharmacies asking them to pull the specific recalled lots from the shelves. The recall was announced publicly on Tuesday only after the Food and Drug Administration (FDA) made a request that Pfizer do so. Women who have been using affected pills are advised to begin use other forms of contraception immediately.

Experts say that the manufacturing mix-up could put the drug-maker at risk of a multi-million dollar lawsuit. An article by FOX News says the lawsuit could stand on the same grounds as several lawsuits in the past that have been won after a man’s vasectomy did not take and his partner became pregnant.

The North Carolina drug injury lawyers with HensonFuerst are here to answer any questions you may have if you have been affected by a mistake or side effect of a medication prescribed to you by a doctor.

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5
Jan

More Americans Die From Drug Overdose Than From Car Crashes

January 5, 2012

Right now in the United States, more people die from drug overdoses than from car accidents, according to new research released last month. According to WECT 6 News, the study concluded that the cause of the surge in fatal overdoses could be linked to the increased use of drugs that have potential for abuse.

The study was conducted by the Centers for Disease Control and Prevention (CDC) over a 30-year time period. Over the span of three decades, researchers saw an increase of six times as many drug poisoning deaths. In 1980, there were roughly 6,000 deaths associated with drug poisonings. By 2008, that number had capped out at 36,500. That same year, nine out of ten poisoning deaths were drug related, with 77 percent of them being unintentional.

These findings correlate with earlier research that showed the number one type of drug abused in the United States today are legal pharmaceuticals.

A CDC health scientist involved with the study, Dr. Chris Jones, stated that the number of prescriptions that doctors are willing to write to patients today is a major contributing factor to the problem. “Between 1999 and 2010, the sales of these drugs increased fourfold.” he added.

The Raleigh drug injury lawyers with HensonFuerst are an experienced team of attorneys dedicated to helping victims who have been injured at no fault of their own by a prescription drug. If you or someone you know has experienced a similar scenario, call us today to discuss your case.

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30
Dec

Top Medical and Drug Stories of 2011

Medical stories are some of the most heartbreaking:  You trust your health to a doctor or hospital, and something goes wrong. Maybe you end up sicker than you were before. Sometimes, the error may result in death. Here is a round-up of the most important medical and drug stories of the year. (To read any of the blogs, click on the title and you’ll be taken directly to the story.)
Harm Done in a Hospital
A study published in the New England Journal of Medicine found that there was a “shockingly high rate of preventable injuries to patients,” specifically in North Carolina hospitals. Of patients admitted to a North Carolina hospital, 1 in 5 will be harmed by the medical care they receive, and about 14% of medically induced harms caused permanent or life-threatening injury.

Defective Hip Replacement Devices

The U.S. Food and Drug Administration (FDA) has ordered all producers of “metal-on-metal” hip replacements to study the implants after thousands of patines have had the devices fail, causing tissue damage and requiring second replacements. This serious problem started with DePuy hip replacement devices, and has be expanded. Anyone with a hip replacement should check with their physician to make sure that their devices aren’t in the process of failing.

Transvaginal Mesh

Over the past three years, the U.S. Food and Drug Administration received nearly 4,000 reports of severe complications (including 3 fatalities) associated with surgical mesh used to treat pelvic prolapse. The most frequent complications include erosion through the vaginal wall, infection, abscesses, pain, and urinary problems.

VIDEOS
In addition to blogs, we also create videos about important health, medical, and legal topics. To see all of our available videos, please visit our YouTube channel here:  HensonFuerst YouTube Channel.  Here are links to some of our medical videos:

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29
Dec

Studies Show Avastin® Has Weak Results Against Ovarian Cancer

December 29, 2011

New studies are showing that a drug once used to treat numerous types of cancer may not work. According to WRAL News, recent data presented to the Food and Drug Administration (FDA) not only led to the organization pulling approval for the use of the drug Avastin® in the treatment of breast cancer, but now also in the treatment of ovarian cancer.

The drug was approved last week for use in advanced ovarian cancer patients despite the findings, but the drug’s manufacturer, Genentech, has stayed mum on whether the company will seek approval for the same in the United States.

Two studies in today’s newest issue of the New England Journal of Medicine found that the drug only slowed the cancers progression for several months and did not improve mortality rates. On top of this, patients have suffered from numerous drug side effects, including:

  • Blood Clots
  • Slow Wound Healing
  • Severe Bleeding
  • Perforations Of The Gastrointestinal Tract

If you or someone you love has suffered ill effects from drugs like Avastin®, contact the experienced team of North Carolina drug injury lawyers with HensonFuerst. They are here to help their clients in every step of the process of filing a claim to get the compensation they deserve.

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16
Dec

FDA Wants Blood Clots Added to YAZ Labels

The U.S. Food & Drug Administration (FDA) has recommended that the labels for birth control pills Yaz and Yasmin, manufactured by Bayer HealthCare Pharmaceuticals, be strengthened to include more information about the increased risk of blood clots.

This is not Bayer’s first appearance at the FDA scrutiny rodeo. In 2008, Yaz was the best-selling birth control pill in the United States, pushed by an advertising campaign said to have cost hundreds of millions of dollars. You might remember these original ads:  A group of beautiful, young women in a cool restaurant or club are talking with their friend, who happens to be a doctor. She informs her friends that Yaz is birth control, but also prevents severe premenstrual symptoms and clears up acne. As the saying goes, if it sounds too good to be true, it probably is.  The FDA cracked down, and in 2009, Bayer was required to run a $20 million advertising campaign designed to correct its previously deceptive—and some might say irresponsible—commercial ads. Bayer’s new ads warned that nobody should take Yaz hoping that it would also prevent PMS or pimples.

This new problem is more serious.

According to an article in The New York Times, there has been a question of whether Yaz, which contains a synthetic form of progestin called drospirenone, is more likely to cause blood clots than other, more conventional contraceptive pills. In October 2011, the British Journal of Medicine published research showing that women taking Yaz or Yasmin had double the risk of blood clots, compared with women taking older contraceptives.

Currently more than 10,000 lawsuits have been filed on behalf of women who were harmed by Yaz or Yasmin…including about 100 fatalities. According to The New York Times:

In documents released recently in those lawsuits, David Kessler, a former F.D.A. commissioner working as an expert witness for the plaintiffs, said that Bayer researchers found increased reports of blood clots in women using Yasmin in the United States, compared with those using three other pills, but did not provide that information to the F.D.A. in a 2004 safety review.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Dr. Kessler testified. He also said the company promoted the pill for alleviating premenstrual syndrome, when it was not approved for that use.

To many experts and non-experts alike, blood clots are too great a risk. And many young women may not understand what “blood clots” really means. It sounds innocuous and minor, but the results can be devastating. If the clot lodges in the heart, it can cause a heart attack…if it lodges in the brain, it can cause a life-changing stroke. According to an article in the New York Daily News:

“I can see no real group of patients that this drug benefited over existing alternatives,” said Mark Woods of New York University School of Medicine. “Without any clear benefit, and given the potentially catastrophic risk, I voted no [to keeping the drug on the market].”

If you are a woman who has been injured after taking Yaz or Yasmin birth control pills and have questions about your rights, feel free to call the experienced attorneys of HensonFuerst. Someone is available to take your call 24 hours a day, 7 days a week at 1-800-4-LAWMED. If you have questions, HensonFuerst has answers.

RESOURCES

To read the article in The New York Times about the 2009 advertising correction, click here: A Birth Control Pill That Promised Too Much

To read the article in The New York Times about the blood clot risk, click here: More Detail on Risk Urged for a Contraceptive Label

To read the article in the New York Daily News, click here: Yaz and other birth control pills to get harsher labels

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8
Dec

Hormone in Yaz® Linked To Higher Risk Of Blood Clots

December 8, 2011

On the heels of research suggesting newer birth control pills may pose more of a risk for blood clots than older contraceptives, regulators with the Food and Drug Administration (FDA) are requiring a warning label update be made for newer contraceptive pills, ABC 11 News reported Tuesday.

A synthetic hormone known as drospirenone is at the center of the debate. It was marketed to drug manufacturers several years ago as having fewer side effects than active ingredients previously used in the drugs. Now, several large independent studies have shown that drugs containing the hormone may put users at a greater risk of developing potentially fatal blood clots.

Although the FDA has determined that the study’s results are inconclusive, they felt that the information should be included in the warning labels. Today, the agency is asking for the opinions of experts to help determine whether or not some women should not be allowed to use the medications.

The North Carolina Yaz® Injury Lawyers with HensonFuerst often deal with cases involving drug injuries. If you have been injured by taking the drug Yaz®, contact us with questions regarding your case today.

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3
Nov

GlaxoSmithKline Agrees To Pay Federal Government $3 Billion

November 3, 2011

In an agreement reached yesterday, Drug maker GlaxoSmithKline (GSK) will pay the United States Government $3 billion to settle investigations into the company’s sales and marketing tactics regarding it’s drug, Avandia. According to WRAL News, the deal stems from 2004 allegations that the company had price irregularities with the drug and did not fully disclose the dangers of the medication posed in marketing materials.

Documents show that the settlement will cover both civil and criminal liabilities for the company. As part of the agreement though, the company had to change policy and procedure for compensation of it’s sales force. The company says that bonuses paid to representatives of the company will no longer be based on hitting individual sales targets, but will rather focus on the quality of service that customers receive.

The company is hoping that these strategic moves will put to rest much of the controversy the company has faced regarding its business practices. The company says the payment will be made in the next fiscal year and will come from its cash assets. In all, GSK says it has paid out more $6 billion in settlements surrounding the drug Avandia.

The North Carolina Drug Injury Lawyers with HensonFuerst often deal with cases involving drug injuries. If you or someone you know has been the victim of a drug injury, contact HensonFuerst for a free intial consultation today.

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25
Oct

Pharmacist Changes May Reduce Drug Injuries

Pharmacists are highly trained professionals. They are proficient in biology, chemistry, public health, and pharmacology. They are trained to dispense prescription drugs, while also advising patients and physicians about drug interactions, dosages, and side effects. Some pharmacists also compound new medicines by mixing ingredients.

But lately, these drug experts have been stuck behind the counter at local pharmacies, dealing with insurance companies or answering the phone to tell a patient whether her medication is ready to be picked up. A total waste of talent.

There may be hope. An article in The New York Times reports that Walgreen pharmacists are once again being allowed to become medical care providers. The company is slowly starting to renovate stores to take pharmacists out from behind the counter.

Pharmacists in the revamped stores are being kept away from the telephone, where dealing with insurance coverage questions and other administrative tasks occupy 25 percent of their time, Walgreen says.

“What we are seeing now is pharmacists should be using their knowledge to help consumers manage their medications appropriately,” said Nimesh Jhaveri, executive director of pharmacy and health care experience at Walgreen. “It’s not about the product but the care we give.”

If this works, it will be a great benefit to customers who buy prescription drugs. Fully 50% of all Americans take at least one prescription drug. Each year, more than 825,000 adverse events from medications are reported to the U.S. Food and Drug Administration (FDA), and pharmacists are important sources of this type of information. They can also be an important gatekeepers to prevent adverse events in the first place. But, of course, there must be financial incentives to allow pharmacists to regain their rightful role in the medication-dispensing process. According to The New York Times:

Federal Medicare drug laws allow for payment to pharmacists for “medication therapy management,” when patients have multiple chronic diseases like hypertension, diabetes and asthma and are taking multiple medications. In recent years, Walgreen and other pharmacy chains have lobbied aggressively for reimbursement and changes to rules that allow pharmacists to do more and to get paid for these additional services.

We’ll take anything that reduces the numbers of drug injuries in this country.

To read the full article in The New York Times, click here:  Out from behind the counter

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12
Sep

Strong Cautions on Bone-Building Drugs

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[photo from The New York Times

About 4 million women in the United States—more than 10 percent of women over age 50—take medications called bisphosphonates as a treatment for osteoporosis or osteopenia (pre-osteoporosis). Unfortunately, many of those women may not have been informed about the risks of these so-called bone-building drugs. There are serious risks associated with these medications…risks that aren’t always adequately explained when the drugs are prescribed.

Bones are not static; they are made of living cells, and like all other cells in the body, they are constantly dying and being reformed. With bone, the process is called remodeling. Old cells are resorbed—they leave the bone and are absorbed by the body. One of the earliest bisphosphonate medications was used to treat Paget’s disease, a condition in which bone resorption happens faster than formation of new bone cells. The drug slowed the resorption of bone.

In his book Worried Sick, Dr. Nortin M. Hadler, professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, noted that in high doses or during prolonged treatment bisphosphonate medications can actually cause–rather than thwart–osteopenia. He writes:

In fact, one has to be wary of all bisphosphonates as double-edged swords. For example, there was one agent that was withdrawn from the market because leukemia was a side effect.

Other serious side effects that have been documented are:

  • Osteonecrosis (bone death) of the jaw. This painful side effect is the total destruction of bone tissue in the jaw. This degenerative condition involves soft-tissue swelling in the mouth, infection, loosening of the teeth, drainage, and exposed bone. It is often the result of blood not properly reaching the bone.
  • Fractures of the hip and/or the femur (the long bone of the thigh). These fractures have occurred with no apparent trauma in patients taking bisphosphonates. They can occur after tripping (not falling) over a rug, or from simply walking down stairs. Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center, said these bone fracture patients had X-ray results that looked like those of car accident victims.

FDA Urges Stronger Cautions

In November, the U.S. Food and Drug Administration (FDA) will issue a revised label for bone-building medications, including Fosamax, Actonel, and Boniva. It is expected that there will be stronger cautionary language on the product labels. According to an article in The New York Times, the FDA’s safety review was:

…prompted by concerns over a relatively small number of long-term users who had suffered unusual thigh fractures or a serious jaw disease. The benefits of the drugs have only been proven for three to five years, not longer, F.D.A. staff members said, warning about links to those rare conditions after longer use….

The committee also called for more study of the overall effectiveness of the drugs in their desired goal of preventing fractures. And the advisers recommended that the F.D.A. take a close look at why the drugs are prescribed as preventive medicine for women who do not even have osteoporosis.

There is the possibility that the FDA might recommend a “drug holiday” for some women, with the hope that it might prevent the effects that happen with long-term use.

“In my opinion, after five years in most cases it ought to be stopped,” [Dr. Susan M. Ott, an associate medical professor and bone specialist at the University of Washington] said in an interview. She prescribes the drugs for shorter periods, but said evidence shows growing risks and no proven benefits after five years.

“The longest anybody could have taken this drug is 15 years now,” Dr. Ott said. “It’s an ongoing experiment, and there are a few million women in the country who are participating in it. I keep wanting to say, ‘You’re all guinea pigs after five years because that’s when the studies stopped.’ ”

Right now, Merck, the pharmaceutical company that manufactures Fosamx, is facing more than 1,600 lawsuits over serious bone and jaw injuries. A woman in Florida was awarded $8 million by a jury after Fosamax destroyed her jaw and caused significant pain. The jury concluded that Fosamax was “unreasonably dangerous due to defective design, and that its defective design was a legal cause of Mrs. Boles’ injury.”

WHAT TO DO

Most importantly, do not discontinue taking any medications without first consulting your physician. If you have concerns about the side effects of taking bisphosphonate drugs, talk with your doctor. Seek immediate care if you are taking these drugs and experience pain in your thigh—this symptom has been a precursor to fracture in some women.

If you have experienced fractures, osteonecrosis of the jaw, or other serious side effect after taking Fosamax, Actonel, Boniva, or other bisphosphonate medications, and you want to explore your legal options, feel free to contact one of our experienced drug injury lawyers. Someone is available to take your call 24 hours a day, 7 days a week. Contact us by phone at 1-800-4-LAWMED, or fill out an online request on our website http://www.lawmed.com. The initial consultation is free. We will put our considerable resources behind all cases in which pharmaceutical drugs have harmed innocent victims.

If you have questions, HensonFuerst has answers.

RESOURCES

To read the full article in The New York Times, click there:  Stronger Cautions Backed on Bone Drugs for Women

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2
Sep

Health Risk from Improper Medication Storage

Where you store your family’s medications could mean the difference between cure and relapse. Too much heat or humidity can alter the way a medication works, making them lose their potency. If a life depends on proper dosage of a specific medication, this could have serious consequences.

An article in The New York Times outlines the causes, risks, and solutions to improper medication storage.

Pharmacists suggest that most drugs be stored at room temperature, no lower than 58 degrees, no higher than 86 degrees. Temperatures above or below that range can cause medicines to physically change, lose potency or even threaten your health.

For patients with such chronic illnesses as diabetes or heart disease, a damaged dose of a crucial medicine, like insulin or nitroglycerin, can be life-threatening. But even common medicines can break down with potentially harmful effects, and you can’t always tell by looking at the pill or liquid that a problem has occurred, said Janet Engle, a pharmacist and past president of the American Pharmacists Association.

Examples of what can happen if a specific medication decays or undergoes other dangerous changes:

  • Antibiotics–if they decay, they can cause stomach or kidney damage.
  • Aspirin–can cause stomach upset (more than the usual).
  • Hydrocortisone cream–can separate and become useless in the heat.
  • Diagnostic test strips–like those used to test for blood sugar levels, pregnancy or ovulation, are extremely sensitive to humidity. If moisture sticks to the strips, it will dilute the test liquid and possible give a false reading.
  • Hormone pills–thyroid, birth control and others, are especially susceptible to temperature changes. These are often protein-based, and when protein gets hot it changes properties.
  • Insulin, seizure medicines and anticoagulants–small changes in doses in some medicines like these can make a big difference to your health.

HOW TO STORE MEDICATIONS

According to The New York TImes:

  • Don’t store medicines in the medicine cabinet… or anyplace in the bathroom. The high heat and humidity of a bathroom is dangerous for drugs.
  • Choose to store medicines in a cool, dry place, such as a hallway linen closet, bedroom closet, or even a kitchen cabinet (as long as it is away from the stove.) If children have access to the medicines, consider storing them on a high shelf or in a lock box.
  • Packaging doesn’t protect drugs. Just because you haven’t opened the package doesn’t mean the drugs are safe.  HOWEVER, drugs become even more vulnerable to alterations if they are taken out of their original packaging. (It is okay to use a day-by-day pill box if necessary.)
  • When traveling, keep medications in a handbag or separate bag that you can carry with you. Even 10 minutes in a hot car can expose medications to dangerously high temperatures.
  • If you must carry emergency drugs with you for long periods or in hot locations, store them in a small cooler with a cool pack.
  • When you travel on a plane, keep the medications with you. Baggage holds aren’t temperature-controlled. Make sure to keep prescription medications in their original bottle or packaging (to make it easier to go through checkpoints).
  • If you notice that a medication has changed color, smell, taste, or consistency, don’t take it. Also, throw away pills that stick together, are chipped, or are harder or softer than usual.

Before discarding any medicine that you think may have been damaged by extreme temperatures, call your pharmacist. Some will replace the drugs free of charge. If the medicine was covered by an insurer, check with the company as well. It may reimburse you for a replacement dose.

Check with the manufacturer of the drug, too. Many have programs to replace certain damaged medicines.

And one last thing: If you do need to throw medication away, read our previous blog about the proper way to discard drugs. Click here:  News About Old Drugs

To read the full article in The New York Times, click here:  Mistakes in Storage May Alter Medication

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