Cheyenne Personal Injury Lawyer - FDA & Prescription Drugs

Hydroxycut Products Recalled Due To Risk Of Liver Injury

Chrissie Cole — Fri, 01 May 2009 00:11:00 GMT

Some Hydroxycut products have been associated with serious liver injuries and as such consumers should immediately stop taking these products.

The Food and Drug Administration (FDA) has received 23 reports of liver injury, including jaundice and elevated liver enzymes. Other adverse reports include seizures, heart problems and rhabdomyolysis, another type of muscle damage.

Hydroxycut products are dietary supplements marketed for weight loss, fat burners, energy-enhancers and water loss under the Iovate and MuscleTech brands.

Below is a list of recalled Hydroxycut products:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

* Not included in the recall are Hydroxycut Cleanse and Hoodia.

Although rare, liver injury was reported by patients at doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice and brown urine. Other symptoms can include abdominal pain, vomiting, loss of appetitie, excessive fatigue, weakness, nausea and itching.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Liver-related disorders have not been reported in all Hydroxycut products, but the company has agreed to recall all of the products listed above.

For more information and to report any adverse events related to Hydroxycut products, please visit the FDA Web site.#

Originally posted at InjuryBoard by Chrissie Cole

AIDS: Still deadly

Darin Schanker — Thu, 19 Jun 2008 15:41:12 GMT

Naturally, game 3 of the NBA Finals was a star-studded event. The classic rivalry between the Boston Celtics and the Los Angeles Lakers reigniting after 21 years attracted L.A. celebrities and NBA legends in equal numbers, and there, sitting court-side, looking hale and healthy, was Earvin “Magic” Johnson, quintessential Laker champion and one of the NBA’s all-time greats.

Seventeen years ago, very few would have predicted that Johnson would live to see the new millennium. The shock of Johnson’s November 7, 1991 announcement that he was HIV-positive is hard to fathom today: people like Johnson and others have successfully fought and lived with the disease for years. But from 1986 to 1996, over 300,000 people with AIDS died.

The precipitous decline in AIDS-related fatalities since the height of the epidemic, mainly due to the introduction of the antiretroviral drug cocktails (HAART or highly active antiretroviral theraphy) which have helped keep Magic health since 1996, has given rise to the myth that the disease can be treated and effectively cured. But Americans are still dying from AIDS.

The people who are most likely to die are the poor who can’t afford to get tested and treated (HAART can cost upwards of $1,000 a month), or who don’t get tested until they have full-blown AIDS; those made especially vulnerable to cancer or heart disease from their drug cocktails; and those long-term survivors whose earlier, pre-HAART treatment caused to virus to become drug-resistant. So while we should be optimistic about the future, we should keep in mind that there is no still magic cure for HIV/AIDS.

Thomas Connell

Summer Intern 2008

JD Candidate, 2010

University of Colorado

Originally posted at InjuryBoard by Darin Schanker

McKesson Corporation to pay $13.25 Million in Settlements

Linda Snyder — Tue, 06 May 2008 19:51:44 GMT

McKesson Corporation has reached an agreement to pay $13.25 million in civil and administrative settlements with the U.S. Drug Enforcement Administration and six U.S. Attorneys for failing to report sales of certain drugs to on-line pharmacies.

Did you ever wonder how illegal on-line pharmacies are able to obtain the drugs they sell to customers without a legal prescription? The answer is simple…they buy them from the drug manufacturers just like your regular corner drug store.

The problem is the drug manufacturers are violating the Controlled Substances Act by failing to report to the DEA any suspicious sales which include orders that are unusually large, unusually frequent, and/or deviated substantially from the normal pattern. By failing to report the sales to the on-line pharmacies, drug manufacturers are not only violating the Controlled Substances Act they are also contributing to the growing epidemic of prescription drug abuse.

"The abuse of prescription medications is a significant and growing problem, and there is an erroneous perception among our youth that the recreational use of these powerful medications is somehow safer than the abuse of illegal drugs such as cocaine, meth, and heroin,” said Deputy Attorney General Mark Filip. “Today's settlement makes clear that the Department of Justice is committed to doing its part to curtail illegal access to these dangerous drugs."

My question is what would motivate a drug manufacturer to report an upsurge in their sales? The money is pouring in, so why would they do anything to jeopardize this influx of revenue? The drug companies have no reason to comply until it hits them in the pocketbook and I suspect that while this $13.25 million dollar settlement stung a little, it was probably just a drop in the bucket compared to the profit they made before they got caught.

Originally posted at InjuryBoard by Linda Snyder

Vytorin and Zetia Only to be Used as Last Resort

Linda Snyder — Thu, 03 Apr 2008 13:15:52 GMT

The American College of Cardiology has recommended that the popular drugs Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail. The panel's spokesman, Harlan Krumholz of Yale University, said: "Our strongest recommendation is that people need to go back to statins. … If you were put on this drug before you were fully treated on a statin, you should go back."

The panel based its findings on detailed evidence from a controversial study showing Vytorin worked no better than a statin drug currently being sold as a cheap generic.

Zetia was approved in 2002 and Vytorin in 2004 based on research showing that they dramatically reduce levels of LDL. High LDL levels can raise heart attack risk, however these drugs were not proven to actually save lives. Both Zetia and Vytorin are made up of a drug, ezetimibe, which blocks the absorption of bad cholesterol, LDL, in the gut. Vytorin also contains the cholesterol-lowering drug simvastatin. Statins work by blocking LDL synthesis in the liver.

The two-year trial, sponsored by the drugmakers Merck and Schering-Plough, involved 720 patients who had a severe form of inherited high cholesterol. Half were given simvastatin, also sold as Zocor, and a placebo. The rest were treated with the combo sold as Vytorin.

The drugs' performance was evaluated by measuring fatty deposits in the carotid arteries that supply the brain and femoral arteries in the legs. Researchers found no differences between patients who took simvastatin alone and those who took Vytorin.

"There is absolutely no difference … between the two treatment groups," said lead investigator John Kastelein of the Academic Medical Center in Amsterdam at the group's annual scientific session.

What makes this study particularly interesting is, in a second study published in the New England Journal, Krumholz and his co-workers scrutinzed prescribing practices in the US, where a $200-million-a-year consumer advertising campaign helped build Vytorin and Zetia into best-sellers. This marketing effort helped drug makers Merck and Schering-Plough gain a 15 percent market share for cholesterol lowing drugs in the US. In Canada, where direct-to-consumer advertising is banned, the market share was 3 percent.

Furthermore, earlier studies have shown that pharmaceutical companies spend almost twice as much on marketing a drug than they spend on research and development for that same product.

So, the question is…did the drug companies know about or suspect the effectiveness of Vytorin and Zetia before they put these drugs on the market, knowing they could make a large profit before the truth caught up with them? Did they choose to put profit over consumer safety by spending more money on the marketing campaigns instead of research and development?

Appropriately enough, shares of Merck (MRK) and Schering-Plough (SGP), the companies that market Vytorin, plunged this week to their lowest levels in years.

Originally posted at InjuryBoard by Linda Snyder

Dennis Quaid Sues Baxter for Heparin Overdose

Linda Snyder — Tue, 18 Mar 2008 15:07:11 GMT

Actor Dennis Quaid and his wife Kimberly Buffington filed a lawsuit in December 2007 against Baxter Healthcare Corporation, claiming the drug maker was negligent when packaging different doses of the same drug in similar packaging. Both heparin and the lower dose version, hep-lock are packaged in similar vials with blue backgrounds and very small print on both labels.

Quaid's newborn twins, who were hospitalized for staph infections, were both administered multiple near fatal dose of the blood thinner Heparin at Cedars-Sinai Medical Center in Los Angeles last November. Zoe Grace and Thomas Boone were given 10,000 units of Heparin, rather than the 10 units they were prescribed. Babies typically get Heparin in their IV catheters to prevent clotting because their IV lines are so tiny. It's necessary for the babies to survive.

In 2006, a similar incident in Indiana involving 6 newborns which resulted in the death of 3 babies, motivated Baxter to redesign the packaging and issue a warning to hospitals. There were also at least two other incidents in 2001 involving infants, both of which recovered. What Baxter didn't do was recall the old stock that was sitting in hospitals all over the country, including Cedars-Sinai in Los Angeles

Quaid and his wife are in the process creating a foundation to fight the epidemic of hospital errors. Quaid told 60 Minutes, he hoped that Cedars-Sinai would also take a lead in fighting hospital errors.

In an interview with "60 Minutes," Baxter executive Debra Bello explained in an interview with "60 Minutes", "the product was safe and effective, and the errors were preventable and due to failures in their system,"

The argument could be made that it's not Baxter's fault because they changed the labeling. The argument could be made that it's not the nurse's fault because the packaging was so similar, you couldn't tell the difference. The argument could be made that it's not the pharmacy's fault because they couldn't tell the difference between the adult dosage and the infant dosage because the print on the label was so small . The argument could be made that mistakes happen. The argument could be made that Pharmaceutical Companies and hospitals won't take steps to correct those mistakes until someone files a lawsuit and it hurts them in their pocketbooks.

Originally posted at InjuryBoard by Linda Snyder

Some Antidepressant Use May Lead to Bone Loss

Jenny Albano — Tue, 17 Jul 2007 14:44:58 GMT

Selective serotonin reuptake inhibitors (SSRIs), a commonly prescribed class of anitdepressants, have been linked to bone loss in older men and women in three new studies.

Researchers studied 2,722 women with an average age of 78, following them for an average of 4.9 years. After adjusting for weight, diet, smoking and other health behaviors, they found that S.S.R.I. users had an average hip bone density decrease of 0.82 percent per year, compared with 0.47 percent per year in nonusers.

In a second study, of 5,995 men 65 and older, bone mineral density was 3.9 percent lower at the hip and 5.9 percent lower at the lumbar spine in men who used the drugs compared with those who did not.

Researchers realize that these findings do not prove that SSRI use causes bone loss, but doctors should still be aware of the potential risk. This new found risk should have physicians being more aware of who they prescribe SSRIs to. Doctors should also have an annual scan for older patients who use SSRIs.

The findings also illustrate the need to treat depression and osteoporosis in older patients. Doctors do not want patients to stop using their antidepressants due to these findings. Researchers do not have a full understanding of the results yet.

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

Originally posted at InjuryBoard by Jenny Albano

Anemia Drugs Will Now Carry Warning Label

Shannon Weidemann — Thu, 29 Mar 2007 14:11:14 GMT

Three very popular anemia drugs have had "black box" warning labels added to them by the FDA. Procrit, Epogen, and Aransep are usually given to cancer and kidney patients. Patients that take them have a higher risk of death or life-threatening side effects though.

The new boxed warning states that Erythropoiesis-stimulating agents (ESAs) increased the risk of death and serious cardiovascular problems when given at higher than recommended doses. The FDA also suggested that higher doses of the dangerous drug could lead to blood clots.
Director of the FDA's Center for Drug Evaluation and Research, Steven Galson said "The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting."

The FDA advises doctors to use the drugs at the lowest possible level on their patients. If you are taking any of these drugs, please contact your doctor for more information.

Originally posted at InjuryBoard by Shannon Weidemann

Adverse effects and deaths reported with Methadone

Staff Writer — Mon, 05 Feb 2007 09:32:12 GMT

An article posted on WorstPills.org this month details new FDA warnings to consumers and health care professionals about the adverse effects of pain managing drug methadone.

Deaths and life-threatening changes in heart beat and breathing have been reported in association with methadone.

The professional product label, also known as a package insert, for methadone carries a black-box warning about respiratory depression and fatal heart rhythm disturbances. That warning accompanies this article. A black-box warning is the strongest type of warning that the FDA can request from a drug manufacturer and is usually reserved for those drugs that have caused death or serious injury to patients.
The full text of the FDA's public health advisory is available on the agency's Web site at http://www.fda.gov/cder/drug/advisory/methadone.htm.

Originally posted at InjuryBoard by Staff Writer

Fired Johnson & Johnson VP expressed safety concerns

Staff Writer — Wed, 27 Dec 2006 08:44:31 GMT

A former executive for Johnson & Johnson subsidiary Ortho-McNeil has filed a civil lawsuit against his former company for firing him. He alleges that the company unlawfully terminated him in May because of his repeated complaints about the safety of certain drug products, including the Ortho Evra contraceptive patch.

An Associated Press article details the suit against J&J:

The lawsuit alleges Lippman's problems with his employer began when he complained about inadequate safety data on a hormonal menopausal product called Ortho-Prefest and about serious health concerns over the Ortho Evra patch, "which released dangerously high levels of estrogen into patients."
This September, the Food and Drug Administration required J&J to add a warning to the Ortho Evra package insert stating the risk of dangerous blood clots in the legs and lungs may be higher for women on the patch instead of birth-control pills.

Originally posted at InjuryBoard by Staff Writer

Birth Control Patch Label Warning

Staff Writer — Wed, 20 Sep 2006 16:00:16 GMT

According to the latest news from the FDA, Ortho and FDA notified healthcare professionals and patients about
changes to the available prescribing information to inform them of the results of two separate epidemiology studies evaluating the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive.

The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho
Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.

In the second study, the increased risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen was nearly double. The results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboemboli disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.

Originally posted at InjuryBoard by Staff Writer