Archive for the ‘Defective Drugs’ Category

Fosamax found to weaken bones rather than strengthen them

Wednesday, March 10th, 2010

Doctors are reporting increases in unusual bone fractures over the past 18 months in patients taking the Merck osteoporosis drug Fosamax (alendronate).

As pressure increases for the Merck or the FDA to act, doctors say they are seeing more patients coming to them with fractures that happen during normal daily activities, as Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center explained to ABC News in a recent interview.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Ego. “Very unusual, the femur is one of the strongest bones in the body.”

“Over the last 18 months we are seeing this more frequently,” Dr. Ego said.

Doctors prescribe Fosamax to treat osteoporosis and osteopenia.  The drug is supposed to strengthen bones to offset bone-weakening problems.  Instead, the mounting evidence shows it can do exactly the opposite, causing serious injury.

Fosamax scrare strikes women with osteopenia ( ABC News)

Fosamax: Is long-term use of bone strengthening drug linked to fractures? (ABC News)

Will side-effect reports scare Fosamax patients? (ABC News)

The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) is actively engaged in defective drug litigation.  For more information about patients’ legal rights, Merck Fosamax patients and their families can contact the lawyers of AWKO Law at www.awkolaw.com (888-255-2956).


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Pfizer/Wyeth ordered to pay $9.45 million for cancer caused by menopause drugs

Monday, February 22nd, 2010

In the latest victory for breast cancer patients who were injured by Pfizer/Wyeth’s Prempro menopause drugs, the company was ordered to pay $9.45 million dollars in compensatory and punitive damages.

A Philadelphia jury issued their decision Feb. 22, finding Pfizer’s Wyeth unit owes Audrey Singleton, of Alabama, $6 million in punitive damages and $3.45 million in compensatory damages for injuries Ms. Singleton suffered because of Wyeth’s menopause drug, Prempro.

This is the fifth courtroom loss in a row for Wyeth in trying to defend the company’s practices in selling a dangerously harmful drug without sufficiently warnings.  The loss is also the seventh out of only ten that have gone before juries so far. Across the nation, more than 8,000 plaintiffs have filed claims against Wyeth for injuries resulting from Prempro.

The case decided today is Singleton v. Wyeth Inc., 050102885, Court of Common Pleas, Philadelphia County, Pennsylvania.

Attorneys at Aylstock, Witkin, Kreis & Overholtz have been working on similar cases for several years and are available for consultation at 888-255-2956.

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Avandia maker hid dangers from public for years, says Senate report

Saturday, February 20th, 2010

GlaxoSmithKline, the maker of diabetes drug Avandia, knew its drug posed serious heart attack and heart failure risks, but hid that information from the public for years, according to a Senate report released Saturday, confirming legal claims made in lawsuits across the nation.

The report, which concluded two years of investigation, is harshly critical of FDA procedures that have kept Avandia (rosiglitazone) on the market, in spite of internal protests by doctors within the agency.  Senators Max Baucus and Chuck Grassley led the effort to produce the report, released Saturday by the Senate Finance Committee.

Every month, 500 people suffer heart attacks and another 300 suffer heart failure because they are taking Avandia instead of a safer diabetes drug known as Actos (pioglitazone), according to the Senate report.  Actos, marketed by Pfizer, provides at least as much diabetes protection without causing the heart attacks and heart failures linked to Avandia, according to the Senate report.

In light of the Avandia dangers, known for years within GSK and within the FDA, some doctors in the agency have been demanding that the FDA pull Avandia from the market.  An FDA safety committee came within one vote of recommending such action in 2007, after studies showed Avandia had caused 83,000 deaths between 1999 and 2007, according to the Grassley/Baucus report.

The senators are demanding that FDA Commissioner Margaret Hamburg provide some answers by March 4.  Specifically, the senators want to know why the FDA has allowed GlaxoSmithKline (GSK) to proceed with a years-long study that is designed to defend Avandia when the study itself will put participants at risk of heart attacks. 

The FDA told GSK to go ahead with a study that is supposed to compare Avandia with the competing drug Actos, marketed by Pfizer.  However, several previous scientific studies had already established that Avandia poses greater health risks without any added benefits over Actos.  The design of the study would require giving a drug known to increase risk of heart failure to some participants when doctors already know Actos provides the same benefits without the same level of risk.

The bipartisan Senate report says GSK should have warned patients years ago that Avandia was potentially deadly.  The two-year investigation concluded that:

“GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.” (Baucus/Grassley letter to FDA)

Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process.  For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).

New York Times: Research Ties Diabetes Drug to Heart Woes (Feb. 19, 2010)
http://www.nytimes.com/2010/02/20/health/policy/20avandia.html

New York Times: Senate Report – Avandia Maker Knew of Cardiac Risks (Feb. 20, 2010)
http://www.nytimes.com/aponline/2010/02/20/health/AP-US-MED-Diabetes-Drug.html

Senate Finance Committee: Baucus/Grassley announcement of Avandia danger
http://finance.senate.gov/press/Gpress/2010/prg022010.pdf

Senate Finance Committee: Senators’ Letter to the FDA, with attachments
http://finance.senate.gov/press/Gpress/2010/prg022010b.pdf

Avandia legal updates from Aylstock, Witkin, Kreis & Overholtz, PLLC (law firm handling Avandia lawsuits)
http://www.awkolaw.com/drugs_avandia.html

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Latest study shows anemia drugs Epogen, Aranesp and Procrit cause strokes, says FDA

Thursday, January 7th, 2010

Anemia drugs sold by Amgen and Johnson & Johnson have been reported to cause strokes when prescribed in high doses, according to an article from the FDA, recently published in the The New England Journal of Medicine. The law firm of Aylstock, Witkin, Kreis & Overholtz is investigating the FDA’s recent announcement.

The FDA commentary said the latest study and previous studies “raise major concerns” about the use of these drugs to treat anemia caused by kidney disease. The drugs are also used to treat anemia caused by chemotherapy. Studies over the past several years have revealed a link between the drugs and heart attacks, strokes, and other problems.

Amgen’s anemia drugs include Epogen and Aranesp. Johnson & Johnson sells anemia drug Procrit, which is produced by Amgen. The drugs are designed to raise red blood cell levels, to promote delivery of oxygen to body tissues.

According to the FDA, results from the most recent clinical trial that showed people taking one of the drugs suffered twice as many strokes as those on placebo (a substance with no effects that a doctor gives to study participants instead of a drug, for comparison with those on the drug). Study participants also showed no significant benefits from taking the drug. Those taking the drugs had just as many deaths and cardiovascular problems as those taking placebo in the study.

FDA officials said they will ask an outside advisory committee to re-evaluate use of the Amgen and Johnson & Johnson anemia drugs.

Since 2007, the FDA has held three advisory panel meetings on these drugs and has changed the labels of the drugs to warn of risks and lower the doses used.

Sales of one of the drugs, Aranesp, reached $4.1 billion in 2006, but are expected to decline to below $3 billion following the study results discussed in the FDA commentary. Use of the Johnson & Johnson and Amgen anemia drugs has been falling since 2007, when studies showed that the drugs might cause heart attacks and strokes and might worsen the condition of cancer patients.

The most recent study cited in the FDA commentary was a study called “Treat,” published Oct. 30 in The New England Journal of Medicine. The trial showed the drugs failed to help people. Trial results also shows that those taking Aranesp suffered twice as many strokes as those taking only placebo.

Doctors outside the FDA are also advising caution in use of the drugs. Dr. Ajay K. Singh of Brigham & Women’s Hospital and Harvard Medical School said because of “the remarkable observations from the Treat study,” doctors should avoid use of the drugs in any patients except those undergoing dialysis.

A Medicare advisory panel is scheduled to meet in March to discuss coverage of use of these anemia drugs.  Medicare is already changing coverage to encourage less use of such drugs, according to agency officials.

If you have any information relating to injuries sustained by a consumer as described herein, please contact the litigation team of Aylstock, Witkin, Kreis & Overholtz for an immediate, free consultation regarding your legal rights – toll free at: 877-810-4808.

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Paxil Birth Defect Claims Continue to Mount

Tuesday, November 24th, 2009

The firm of Aylstock, Witkin, Kreis & Overholtz represents dozens of families and their children relating to birth defects connected with the ingestion of Paxil. Also called paroxetine hydrochloride, Paxil is a pharmaceutical drug manufacturered by GlaxoSmithKline prescribed to treat depression and anxiety disorders. The drug belongs to a family of drugs called selective serotonin reuptake inhibitors (SSRI).

Unfortunately, many women ingested Paxil during their pregnancies and have given birth to children with varying defects including: congenital heart defects such as atrial and ventricular septal defects (i.e. holes in the walls of the chambers of the heart), hypoplastic left heart syndrome, pulmonary stenosis and tricuspid atresia. Additionally, children are shown to have suffered other birth defects such lung defects (ie. PPHN), craniosynostosis, neural-tube defects, webbed neck, infant omphalocele, congenital foot deformity (ie. club foot), anal atresia.

Two peer reviewed studies show that women who took Paxil during the first trimester were approximately two (2) times as likley to give birth to a child with a heart defect as women who ingested other antidepressants and women in the background who did not take any antidepressant. One study in particular shows the risk of heart defects 2 percent or 2 out of every 100. The most common defect reported was heart related including atrial and ventricular septal heart defects.

AWKO represents babies with varying defects including by way of example, a little girl, “P” who was born in early 1999 and suffered from Craniosynostosis. Paula underwent two craniotomies and additional surgeries to improve her eye function but has permenant disfiguring and debilitating injuries. Another client, “J” suffered ventral septal defects and webbed neck and was forced to undergo open heart surgery at 6 months of age to repair her heart.

Without a large scale settlement in place, the firm of AWKO remains steadfast in its fight for the rights of these girls and their families and all of AWKO’s clients who suffered at the hands of Paxil.

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FDA lists drugs under review for possible safety issues

Saturday, October 31st, 2009

The FDA has released a list of drugs the agency is reviewing drugs for possible safety issues.  Some of the drugs have been noted for safety issues previously, resulting in forced label changes.

The list includes: the cancer drug Sutent; gandolinium-based contrast agents used in MRIs; and Reclast, which is used treat post-menopausal osteoporosis. The full list is:

  • Ceftriaxone (Rocephin) – Hemolytic anemia was added to the Warnings section of labeling in June 2009
  • Diclofenac epolamine patch (Flector) – Hypersensitivity reactions
  • Didanosine (Videx) – Portal hypertension
  • Entacapone (Comtan) – Colitis
  • Gadolinium-based contrast agents – Anaphylaxis
  • Alpha interferon products – Pulmonary Hypertension
  • Mecasermin products (Increlex, Iplex) – Hypersensitivity reactions
  • Methylnaltrexone (Relistor) – Gastrointestinal perforation
  • Minocycline (Solodyn) – Autoimmune disorders in pediatric patients
  • Promethazine injection – In September 2009 FDA informed manufacturers of promethazine injection to include a Boxed Warning in the labeling to highlight the risk of serious tissue injury when this drug is administered incorrectly.
  • Sunitinib (Sutent) – Liver failure
  • Tenofovir (Viread) – Safety during pregnancy
  • Zoledronic acid (Reclast) – Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.
For the FDA safety review list, and more information: http://z-9.us/FDAwatchlist-10-09
Ceftriaxone (Rocephin) – Hemolytic anemia was added to the Warnings section of labeling in June 2009
Diclofenac epolamine patch (Flector) – Hypersensitivity reactions
Didanosine (Videx) – Portal hypertension
Entacapone (Comtan) – Colitis
Gadolinium-based contrast agents – Anaphylaxis
Alpha interferon products – Pulmonary Hypertension
Mecasermin products (Increlex, Iplex) – Hypersensitivity reactions
Methylnaltrexone (Relistor) – Gastrointestinal perforation
Minocycline (Solodyn) – Autoimmune disorders in pediatric patients
Promethazine injection – In September 2009 FDA informed manufacturers of promethazine injection to include a Boxed Warning in the labeling to highlight the risk of serious tissue injury when this drug is administered incorrectly.
Sunitinib (Sutent) – Liver failure
Tenofovir (Viread) – Safety during pregnancy

Zoledronic acid (Reclast) – Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.

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Xolair possibly linked to heart attack and stroke

Saturday, July 18th, 2009

The FDA warned on July 16 that asthma drug Xolair may be linked to increased risk of heart attacks and strokes. Xolair is sold in the U.S. by Novartis and Genentech, a division of Roche.

An ongoing study has revealed signs that Xolair (omalizumab), which is used to treat asthma and allergies, may be directly related to heart attacks and strokes suffered by study participants.  The drug may have also caused abnormal heart rhythm and heart failure in patients treated with Xolair, according to the Food and Drug Administration (FDA). For the FDA warning, see http://ow.ly/hB6L.

The law firm of Aylstock, Witkin, Kreis & Overholtz is investigating possible manufacturer and distributor liability in this case. For updates from our lawyers, see the AWKO Law “Defective Drugs” page at http://ow.ly/hB7v.

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Fleet Phospho – Soda side effects serious kidney injury

Thursday, July 2nd, 2009

Severe kidney injury has been reported following use of over-the-counter Fleet laxative products, leading to an FDA warning and a manufacturer recall of the oral sodium phosphate (OSP) products.

Laxative products marketed as “Fleet Phospho-soda,” “Fleet ACCU-PREP,” “Fleet EZ Prep,” and “Fleet Phospho-soda E-Z Prep Bowel Cleansing System” have been recalled by the manufacturer after the U.S. Food and Drug Administration (FDA) warned that use of the products has led to more than 20 reports of acute kidney injury caused by OSP products.  The FDA instructed healthcare professionals to stop using of the products for bowel cleansing.

The FDA reports that use of the oral laxative Phospho-soda products made by C.B. Fleet Company can cause serious kidney damage known as “acute phosphate nephropathy,” a form of acute renal failure. The condition is also known as “nephrocalcinosis.”  Acute phosphate nephropathy is a build-up of calcium-phosphate crystals, which can create permanent renal impairment requiring chronic dialysis.

Symptoms of acute kidney injury include: malaise, lethargy, drowsiness, decreased urine volume, and swelling of the ankles, feet, and legs, according to the FDA.

The FDA has issued a warning to healthcare professionals to alert them to this problem with the use of the Fleet “Phospho-soda” and “ACCU-PREP” oral sodium phosphate (OSP) products for bowel cleansing.

According to the FDA, the OSP products associated with the kidney damage problems “are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery.”  Fleet marketed these products as over-the-counter medications.  However, the FDA has recently stated that this type of medication should only be issued with a prescription when used for bowel cleansing.  It was this warning about over-the-counter use that led to the recall of the Phosph-soda

Doctors and other healthcare providers have been using the Fleet laxative products associated with these problems in spite of published reports of acute phosphate nephropathy as early as 2003. More than 20 incidents were reported in a published case series in 2005. FDA warnings were first issued in May 2006, and continued, with increasing urgency, through the latest warning of serious adverse events in December 2008, which led to the manufacturer recall.

Fleet began pulling the laxative products from store shelves shortly after the December 2008 FDA warning, but is considering options for putting the products back on the market, according to a statement by Fleet’s chief scientific officer, Chris McDaniel, in a June 29 article in The News & Advance newspaper in Lynchburg, Virginia.

Those most at risk of developing kidney failure problems after using the Fleet laxatives, according to the FDA, include patients who are:

  • age 55 and above, or
  • have kidney disease, or
  • suffer from bowel obstruction, or
  • have active colitis, or
  • are dehydrated, or
  • are taking “diuretics, ACE inhibitors, ARBs, and possibly NSAIDS”

(more…)

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FDA Issues “Black Box” Warning For Anti-Smoking Drugs

Thursday, July 2nd, 2009

In July 2009, the Food and Drug Administration (FDA) issued a “black box” warning, its sternest warning short of a recall, for two of the top smoking cessation prescription medications, Zyban and Chantix. The warning follows reports that the anti-smoking drugs caused unusual changes in behavior, including aggression, agitation, depression and suicidal thoughts.

Chantix, Zyban and Suicide

Since Chantix’s release in 2006, the drug has been linked to 98 reports of suicide and 188 reports of attempted suicide. In addition, Zyban has been connected to 14 reports of suicide 17 attempted suicides.  The FDA has received more than 1,000 reports of serious injury in Chantix users; this exceeds the number of reports levied against the top ten best-selling drugs combined.

Chantix and Zyban, manufactured by GlaxoSmithKline and Pfizer Incorporated respectively, are prescription smoking cessation medications that help smokers break their nicotine addiction by blocking dopamine release, thus eliminating the feeling of pleasure smokers usually experience while smoking. Many believe the neuroreceptor manipulation has led to suicidal ideation, suicidal behavior, depression, aggression and other neuropsychiatric symptoms.

The FDA has also extended this warning to the anti-depressant, Wellbutrin, which is the same medication as Zyban, marketed under a different name.

Chantix, Zyban Lawsuits

Defective drug manufacturers, like GlaxoSmithKline and Pfizer Inc., are responsible for thoroughly testing their products before releasing them to the market. If the drugs cause damage to consumers, they may be held liable and can be subject to personal injury litigation.

The lawyers of Aylstock, Witkin, Kreis and Overhotlz hold advanced experience and expertise in filing defective drug claims against pharmaceutical companies. They can help you identify key components to build a strong case that can potentially award you millions of dollars. To learn more about filing a Chantix lawsuit or Zyban lawsuit, contact AWKO Law today at (888) 255-2956.

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