Utah Personal Injury Blog - FDA & Prescription Drugs

Eli Lilly Will Pay Utah 24 Million to Settle Zyprexa Suit

Bret Hanna — Wed, 11 Nov 2009 18:17:31 GMT

Utah Attorney General Mark Shurtleff announced today that the state has settled a 4-year-long battle with Eli Lilly over its marketing unapproved uses, so-called "off-label" uses, of its anti-psychotic drug Zyprexa. His news release indicates that the pharmaceutical giant will pay 24 million to resolve the matter:

Attorney General Mark Shurtleff recently reached a $24,000,000 civil settlement with pharmaceutical manufacturer Eli Lilly and Company for its "off-label" marketing of the anti-psychotic drug Zyprexa. The nearly 4-year investigation conducted by the Utah Attorney General's office revealed that Lilly concealed its knowledge of Zyprexa's association with significant weight gain and obesity, and that its sales force illegally promoted Zyprexa for uses not approved by the FDA.

"Drug companies are an important part of our health care system," says Shurtleff. "But when they engage in illegal marketing practices they are endangering the health and safety of patients."

It is a crime for pharmaceutical manufacturers to market their drugs for uses that are not approved by the FDA. Zyprexa was only approved for the treatment of schizophrenia and certain types of bipolar disorder in adults, but in 1999, Lilly's long-term care sales force, its marketing branch that focuses on doctors who treat the elderly, began encouraging doctors to prescribe Zyprexa for dementia, Alzheimer's, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. The Attorney General's investigation showed that there were 1,769 Medicaid patients over the age of 65 who took Zyprexa but never had a diagnosis of either schizophrenia or bipolar disorder.

"Lives are endangered and costs are unnecessarily increased when pharmaceutical companies interfere with the FDA's mission to insure that drugs are used safely," says Robert Steed, Assistant Attorney General and Director of the Utah Medicaid Fraud Control Unit. "Today's announcement should send a clear message that those who would put corporate profits ahead of patient safety will be held accountable."

In October 2000, Lilly began instructing its general sales force to recommend Zyprexa to primary care physicians for the treatment of behavioral symptoms like agitation, aggression, hostility, sleep disturbances, depression and mood disorders even though schizophrenia and bipolar disorder are not conditions normally treated by these doctors. Lilly also trained its sales teams to avoid discussions with health care professionals about the weight gain side effect.

"I would like to commend the Department of Health and the Attorney General's office for their work on this critical public health issue," says Representative David Clark, Speaker of the Utah House of Representatives. "The State Legislature will work to make sure this money is put to the best possible use to benefit all Utahns and particularly those that may have been affected by the off-label marketing of this drug."

"Today's announcement should not be considered an indictment against the pharmaceutical industry in general," says UDOH Executive Director Dr. David Sundwall. "The pharmaceutical industry is a key partner in treating illness and preventing complications from diseases. Appropriate use of drugs can save a great deal of money by controlling unnecessary hospitalizations and surgeries. Further, we count on our nation's pharmaceutical companies to fund research and development of the drugs we need to prevent, treat, and when possible, cure disease."

Assistant Attorney General Robert Morton, who assisted with this litigation stated, "This is by far the largest recovery ever in the State of Utah from our efforts to hold pharmaceutical companies accountable for their unlawful conduct. We are grateful to Director Sundwall and the excellent staff at the Utah Department of Health for the time, resources and expertise they provided during this litigation."

The Utah Attorney General's Office oversees the Medicaid Fraud Control Unit to protect the integrity of Utah's Medicaid program. The public can learn more about Medicaid fraud or report abuse at: http://www.attorneygeneral.utah.gov/145.html.

Utah's House Speaker David Clark, R-Santa Clara, has indicated that the legislature will work to use the money to benefit those affected by off-label marketing. Let's hope he follows through with this promise because this is a big victory for the people of Utah.

Originally posted at InjuryBoard by Bret Hanna

Local Infectious Disease Specialist Supports Recommendation of Gardasil for Boys

Bret Hanna — Mon, 14 Sep 2009 23:15:40 GMT

On September 9th, a Food and Drug Administration committee issued a recommendation that the Gardasil vaccine manufactured by Merck be given to males between the ages of 9 and 26 to prevent genital warts. John Kriesel, an infectious disease specialist at the University of Utah School of Medicine approves of the recommendation according to a report in the Salt Lake Tribune.

Kriesel believes that more consistent widespread use of the vaccine offers the potential of reducing cervical cancer in females and, perhaps, eliminating genital warts in both sexes over a couple of generations. Gardasil is a vaccine aimed at preventing human papillomavirus infections that cause genital warts and related cervical, vulvar and vaginal cancers. Girls and women are screened the infections but males are not because there is no easy and effective method of doing so. A vaccine eliminates the need for the screening.

Gardasil is not cheap so cost is will remain an issue. It is administered in a three shot series over the course of six months and the series runs in the neighborhood of $375. While many insurance plans cover the vaccine, many do not. And then, of course, there are the uninsured who have little hope of receiving the vaccine. Perhaps that will change if meaningful health care reform comes to pass.

Originally posted at InjuryBoard by Bret Hanna

Death By Prescription Drugs - Be Careful

Bret Hanna — Wed, 17 Jun 2009 06:00:00 GMT

Natural News, relying on data from the CDC, reported that prescription drug deaths shot up 68 percent in a five year period. Statistics show that for the reporting period, prescription drug deaths were the second leading cause of unintentional deaths in the United States. The percentage increase translates to increase from 11,000 deaths to 20,000 deaths between 1999 and 2004. The largest increase was in the age range of 15 to 24, but all age groups other than the 75 year old plus set saw increases of at least 35 percent. The one variable in the data that is hard to pin down is the number of reported deaths that were unrecognized suicides, but it does not appear that such deaths were a large number. It is also possible that some prescription drug deaths during the study period that were reported as suicides or intentional deaths may have, in fact, been unintentional. Regardless, the problem is significant.

But there are some bright spots in the realm of prescription drug deaths. The Utah Department of Health recently reported that prescription drug overdose deaths are down 12.6 percent in the state between 2007 and 2008. Although that number translates to 40 fewer deaths in that one year period, there were still 277 deaths from what public health officials see as a preventable cause of death. The numbers are encouraging insofar as this data points to the largest decrease in reported prescription drug deaths since 1994, but Dr. Todd Grey, Chief Medical Examiner for the Utah State Office of the Medical Examiner, has indicated that drug overdoses are still the leading cause of death in Utah.

To combat the situation in Utah, the Utah Department of Health launched the "Use Only As Directed" campaign in May 2008. The resource offers the following tips when it comes to prescription pain medication:

Help prevent these types of deaths by following these tips:

1) Never take prescription pain medication that is not prescribed to you.

2) Never adjust your own doses.

3) Never mix with alcohol.

4) Taking with other depressants such as sleep aids or anti-anxiety medications can be dangerous.

5) Always keep your medications locked in a safe place.

6) Always dispose of any unused or expired medications.

Prescription drugs are the silent killer in the medicine cabinet - don't let them unintentionally take your life or that of a loved one.

Originally posted at InjuryBoard by Bret Hanna

Deadly Heparin? Drug Investigated in Two Deaths

Bret Hanna — Thu, 14 May 2009 23:43:16 GMT

A hospital in Delaware and the Federal Drug Administration are investigating two deaths and other complications that may be related to the use of the anti-coagulant heparin according to a report in the Chicago Tribune. The Beebe Medical Center in Lewes, Delaware, is investigating adverse reactions from the use of heparin in five patients. Meanwhile, the facility has suspended the use of the drug pending the results of the investigation. An independent laboratory is conducting the investigation.

Baxter International manufactures the the commonly used blood thinner which has had a checkered safety track record. Baxter issued a vast recall of a form of the drug distributed in vial form last year after a number of complications were reported from its administration, including the widely publicized case involving twins born to actor Dennis Quaid and his wife, Kimberly Buffington. The heparin at issue in the Beebe Medical Center cases was administered in pre-mixed bags and is a different product than that involved in the recall.

Baxter claims that the recalled product was the result of the use of an adulterated product from a Chinese supplier referred to as oversulfated chondroitin sulfate. The heparin at issue in the current investigation was formulated with active ingredients supplied by North American based Pfizer, Inc. Such active ingredients are generally described as being derived from pig intestines.

Originally posted at InjuryBoard by Bret Hanna

FDA Alerts Doctors to New Suicide Warnings for Epilepsy Drugs

Bret Hanna — Fri, 08 May 2009 11:07:20 GMT

The Boston Herald reports that the U.S. Food and Drug Administration is alerting doctors that there is an increased risk of suicidal tendencies associated with anti-seizure medications. Such drugs are commonly prescribed for seizure disorders, certain psychiatric disorders and nerve pain. Last December, the FDA announced that the warning would be required for the drugs, but it is now informing doctors of the specific warning which is increased "risk of suicidal thoughts or behavior in patients taking these drugs for any indication."

The new labeling requirements apply to approximately 20 medications including GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica. The FDA does not believe that the risk is significant but it is sufficient enough to trigger the new labeling. In addition, the FDA has posted the warning on its website and it is alerting doctors by letter. The drug manufacturers will be required to notify patients by pamphlet of the new warning, but the FDA stopped short of requiring that manufacturers issue the most serious alert, a "black box" warning.

Originally posted at InjuryBoard by Bret Hanna

Over the Counter Drugs Bad for Children Under Age 2

Amy Schauers — Thu, 17 Jan 2008 09:24:33 GMT

The FDA is issuing a parental warning today. It warns parents to avoid over the counter cold medicine for children under the age of two. They say that these drugs may be harmful and cause serious and potentially life threatening side effects. The concern is that parents may purchase over the counter cold medications for their older children and then give them to their toddlers.

Ganley cited surveys that suggest many parents don't believe over-the-counter cold remedies pose a problem, especially if they've used them with an older child who seemed to get better.

In October the FDA announced that over the counter drugs specifically targeted to small children don't work and shouldn't be given to anyone under age 6. All medications for children under age 6 were pulled from store shelves.

Originally posted at InjuryBoard by Amy Schauers

Children's Vaccine Recall

Amy Schauers — Thu, 13 Dec 2007 20:39:26 GMT

Merck announced today that they are voluntarily recalling one million vaccines that are normally given to children under age five.

Merck is pulling 11 lots of PedvaxHIB and two lots of COMVAX. PedvaxHIB is a vaccine that protects against infection with haemophilus influenzae type B (Hib), the bacteria that causes meningitis, pneumonia, and blood stream infections. The COMVAX vaccine protects against haemophilius b and hepatitis B, a virus that can cause liver disease.

The vaccines are being pulled because a routine inspection was done of the manufacturing facility and it was contaminated with a bacteria. However, officials at the CDC and FDA say that there is no health risk. If your child was vaccinated with the affected drugs they most likely will not get sick. Merck decided to pull the vaccines as a precaution. Your doctor will know if you child may be affected.

If your child does get sick from the vaccine, the symptoms of a bacterial infection -- redness at the injection site, swelling, fever -- will likely appear within the first few days after receiving the shot. "Any problems should appear in the first several days, and by the end of a week if there are no symptoms he should definitely be out of the woods," says Dr. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases.

The CDC also says that if your child did receive the affected vaccine there is no need to re-vaccinate them. The potency of the drug was not affected by the bacteria.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Amy Schauers

Heartburn Drugs Do Not Pose Risk

Amy Schauers — Mon, 10 Dec 2007 16:14:19 GMT

In May, the pharmaceutical company that makes Prilosec and Nexium, gave the FDA findings from small preliminary trials. During the trials, some cardiac "events" were seen showing a possibility that long-term use of Prilosec and Nexium could increase the risk of heart attack, heart failure and heart-related sudden death, the FDA said at the time.

Due to these findings, AstraZeneca, maker of the two drugs, gave the FDA more detailed data from the two initial studies as well as findings from 14 other studies. Government officials announced today that the drugs are safe.

Dr. Paul Seligman, associate director of the FDA's Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, told reporters that the agency "had completed our safety review, and our current assessment is that studies do not show a risk for heart attack or heart-related problems."

The FDA further recommended that physicians continue to prescribe the drugs and patients and the public may continue to use them as directed. However, the FDA continues to investigate the possibility that Prilosec and Nexuim increase the risk of hip fracture in patients over fifty (50) years old.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Amy Schauers

Diabetes Drug Actos Looking to Rival Avandia

Amy Schauers — Thu, 15 Nov 2007 17:31:40 GMT

Just days after the FDA hit the diabetes drug Avandia with new safety warnings the pharmaceutical company GlaxoSmithKline PLC, makers of Avandia, decided to take out full-page ads to run in 60 newspapers and in several magazines. The main messages is as follows:

"If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke," according to a copy of the ad provided by Takeda.

The FDA also said it would ask makers of other diabetes drugs, including Takeda maker of Actos, to put on their labels that their drugs haven't been proven to reduce cardiovascular risk. Takeda is trying to turn this into a positive by telling customers that Actos at least doesn't increase their risk of having a heart attack or stroke. Before concerns about Avandia arose the two drugs were selling at nearly the same rate.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Editorial note- Actos is owned by Takeda Pharmaceuticals.

Originally posted at InjuryBoard by Amy Schauers

Diabetes Drug Avandia May Cause Heart Attack

Amy Schauers — Wed, 14 Nov 2007 15:08:21 GMT

On Wednesday, November 13, 2007, the U.S. Food and Drug Administration made public that they will require the diabetes drug Avandia to carry a "black box" warning saying that the drug could cause chest pain or heart attacks. The company will begin trial comparing Avandia to other rival drugs and placebo to see if the risk is unique to Avandia.

FDA's Dr. Janet Woodcock told reporters that they are keeping the drug on the market because there is not enough evidence that the risk of heart attack is higher than that of other diabetes drugs. However, the following was also reported:

The top-selling diabetes drug has been under scrutiny since a U.S. analysis last May linked Avandia to a 43 percent higher risk of heart attack in patients.

It seems clear that further testing must be done quickly to determine whether or not Avandia is a safe drug. The FDA is advising doctors to closely monitor their patients in the meantime.

For more information on this subject, please refer to the section on Drugs, medical Devices, and Implants.

Originally posted at InjuryBoard by Amy Schauers