Colorado Springs Personal Injury Lawyer - FDA & Prescription Drugs

The Heparin Debacle Part One

Linda Snyder — Tue, 22 Apr 2008 20:50:42 GMT

Remember what it felt like as a kid when you went into a candy store and you were overwhelmed with how many choices of sweets lay before you? When I read the New York Times article, U.S. Identifies Tainted Heparin in 11 Countries, I felt that same overwhelming indecision, but in a bad way. I was baffled by which angle to take. Do I blog about how the Chinese are trying to pass the buck and blame everyone else for the contaminated Heparin. Do I blog about how the FDA is dismally understaffed to even consider inspecting foreign plants. Do I blog about how huge this Heparin debacle is turning out to be or do I blog about how Baxter International, the manufacturer of Heparin, is more concerned with covering their corporate behinds and is denying that the contaminated drug has caused 81 deaths.

So, I decided to do what any smart kid in a candy store would do…sample a little bit of everything…

In a nutshell, the FDA has found the contaminated drug Heparin, a blood thinner, in 11 countries including, Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Investigators have also established a definite link between the contaminant and the severe reactions that have caused 81 deaths in the Unites States.

Heparin is made from the mucous membranes of the intestines of pigs and the process of rendering the ingredients takes place in Chinese family workshops which are for the most part, unregulated. The contaminant, oversulfated chondroitin sulfate is a cheaper substitute that was able to slip through the usual testing and was not identified until more sophisticated tests were utilized.

There has been speculation that the concentrated number of deaths in the US may be attributed to the practice of American doctors to use large, quickly infused doses of heparin. Additionally, the FDA may be better than its foreign counterparts at tracking serious side effects.

The FDA had reports as early as 2006 that some lots of heparin contained the cheaper additive, which begs the question…why did Baxter International wait until February 2008 to issue a recall?

Up next: The Heparin Debacle Part Two – Chinese Officials Play the Blame Game

Originally posted at InjuryBoard by Linda Snyder

Vytorin and Zetia Only to be Used as Last Resort

Linda Snyder — Mon, 14 Apr 2008 18:52:32 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

Contaminated Heparin Syringes Recalled

Shannon Weidemann — Fri, 04 Apr 2008 10:23:34 GMT

A second manufacturer of pre-filled Heparin syringes has issued a drug recall for 32 lots of product. The syringes were manufactured by Covidien who received components for making Heparin from the same supplier as Baxter. Baxter has recalled all of the Heparin they manufactured due to contamination with a substance that mimics Heparin.

The Mansfield, Mass., company issued the recall in response to a notification from Scientific Protein Laboratories (SPL), which is the company that supplies Covidien with the active pharmaceutical ingredient used to make heparin.

Covidien, which was formerly known as Tyco Healthcare, said there have been no reports of adverse events associated with its heparin products.

SPL is also the supplier to Baxter Healthcare, whose heparin products have been linked to serious allergic reactions and at least 19 deaths.

Some of the drug components were manufactured by a factory in China. The U.S. FDA and China's similar branch are both investigating the matter. Heparin has been recalled in Europe and Japan as well.

Originally posted at InjuryBoard by Shannon Weidemann

Trasylol Pulled From Market

Shannon Weidemann — Mon, 05 Nov 2007 13:17:24 GMT

The antibleeding drug Trasylol has been pulled from the market around the world after a study has shown there may be an increased risk of death from use. The drug is used during heart bypass surgery.

The announcement came as a Canadian study comparing the safety and efficacy of Trasylol with two others was halted. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs. The trial was to include 3,000 patients.
Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots.

The FDA panel had met last month to discuss the drug but was advised to keep the drug on the market. Possible side effects from Trasylol include heart attack, stroke, and kidney problems.

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

Originally posted at InjuryBoard by Shannon Weidemann

Avandia Gets Black Box Warning Label

Shannon Weidemann — Thu, 16 Aug 2007 10:17:24 GMT

The FDA has issued that the diabetes drug Avandia should carry a black box warning label for possible heart failure related to taking the drug. The warning labels will appear on all drugs in the thiazolidinedione class. GlaxoSmithKline is the manufacturer of Avandia.

"This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure," Steven Galson, director of the FDA's CDER, said.
The manufacturers, GSK and Takeda, agreed to add the warnings voluntarily. The other affected drugs are GSK's Avandaryl (rosiglitazone maleate/glimepiride) and Avandamet (rosiglitazone maleate/metformin HCl), and Takeda's Actos (pioglitazone HCl) and Duetact (pioglitazone HCl/glimepiride). These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with Type 2 (non-insulin-dependent) diabetes.

Doctors are being asked to watch and test their patients carefully for signs of heart failure while on Avandia. Some patients have died of heart failure while on the drug.

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

Originally posted at InjuryBoard by Shannon Weidemann

Liquid Grifulvin Recalled Due to Glass

Shannon Weidemann — Mon, 30 Apr 2007 22:59:08 GMT

Ortho-McNeil Pharmaceutical, Inc. is recalling glass bottles of GRIFULVIN V(R) griseofulvin oral suspension (liquid) due to glass fragments found in some bottles. The recall is only for the liquid form of the drug. Consumers should call their pharmarcy to see if their prescription is included in the recall.

The two reports of glass fragments are believed to be the result of bottle breakage during shipping and handling. A plastic over-wrap placed on bottles of this medicine for protection might have made it difficult to detect breakage that occurred during shipping and handling, and action is being taken to change the over-wrap to prevent this possible occurrence in the future. In the unlikely event that a damaged bottle has been dispensed, a potential exists for injury due to accidental ingestion of glass fragments. There have been no reports of adverse events from the reported glass fragments in broken bottles.
The lots were shipped to distributors in the United States only between August 23, 2005 and March 14, 2007. Lot numbers are listed at the end of this press advisory and posted on http://www.aboutgrifulvin.com/. Lot numbers can be found on the back of the product label only on four-ounce (120 mL) glass bottles filled by the manufacturer. Consumers with pharmacy-dispensed bottles, which were filled at the pharmacy and do not contain lot numbers, should contact the pharmacy where they purchased the medicine to determine if they are in possession of product that has been recalled.

The griseofulvin oral suspension may have a Patriot Pharmaceuticals, L.L.C., label. For more information you may call 1-800-426-7762 or 1- 800-510-0383.

Originally posted at InjuryBoard by Shannon Weidemann

Lyrica added to Worst Pills do not use list

Staff Writer — Mon, 05 Feb 2007 10:17:50 GMT

WorstPills.org posted in January an alert saying that consumers should not used Lyrica to treat neuropathic pain because of the potential risks and side effects.

Lyrica (pregabalin), manufactured by Pfizer, is often used to treat epilepsy. WorsPills.org specifically recommends not to use this drug until 2012, or seven years after FDA approval. This means that they believe the drug needs more testing before it will be considered safe.

If you or someone you know has suffered injuries or side effects as a result of a defective drug, you may want to consult with a personal injury attorney. For a free case evaluation, click on the form to the right of this page.

Originally posted at InjuryBoard by Staff Writer

"Black-Box" Antidepressant Warning Still Debated

Staff Writer — Wed, 19 Jul 2006 18:32:55 GMT

According to a report by the United Press International, the debate continues over the antidepressant's "black box" label, warning of the increased risk for suicidal thoughts and behavior, especially among adolescents. Supporters of the warning see it as necessary and are upset that some doctors are needlessly prescribing these treatments to children. Critics of the warning believe that it scares people needing treatment away from the drug. While it is true that doctors are prescribing antidepressants less often, the cause for this decrease is still unclear.

The FDA did not place this warning on antidepressants to prohibit their use among children, but to remind and warn doctors and parents of the elevated risk of suicidal thoughts and behavior among children who take these drugs. The FDA hopes that the warning increases awareness of the potential risks among health providers, parents and patients. Only 10 other products approved for children carry the "black box" warning, the most serious FDA warning displayed on prescription medicine. Prozac is the only antidepressant that approved by the FDA to treat depression in children 18 and under

Originally posted at InjuryBoard by Staff Writer

Pharmacists Care Important to Patients

Staff Writer — Thu, 06 Jul 2006 09:33:00 GMT

A recent study documents that the quality of care provided by pharmacists is important to the outcome for particular patients. The study, which was conducted on in-patient conditions, determined that the involvement of a pharmacist in patient care is a valuable addition to the patient's health care process. This is consistent with the obligation of pharmacists to do more than "just fill prescriptions".

For many years the standard of care for pharmacists required pharmacists to "counsel" patients and take an active role in their health care. This recent study, published recently in the scholarly journal Archives of Internal Medicine, documented that pharmacist who take a proactive role in patient care can improve the level of care for the patient. The study concluded that the addition of clinical pharmacist services in the care of inpatients generally resulted in improved care, with no evidence of harm. Interacting with the health care team on patient rounds, interviewing patients, reconciling medications, and providing patient discharge counseling and follow-up all resulted in improved outcomes.

Based on This study and the standard of practice, patients would be well advised to seek pharmacist counseling and involvement in their health care.

Originally posted at InjuryBoard by Staff Writer

Ketek May Increase Possbility of Liver Injury Four Times Over Other Antibiotics

Staff Writer — Fri, 30 Jun 2006 17:33:24 GMT

Today the Food and Drug Administration (FDA) warned that use of the antibiotic Ketek could cause dangerous and even fatal liver injury. While all antibiotics carry some risk of liver injury, Ketek appears to be 4 times as likely to cause liver damage as other antibiotics. At least 14 people experiencing liver failure following their use of Ketek, four of which died because of their injuries. 23 others experienced mild to severe liver injuries. Ketek is a drug known as telithromycin and is prescribed for conditions such as bronchitis, bacterial sinusitis, and pneumonia.

The manufacturer of Ketek, Sanofi-Aventis announced that an updated warning label on Ketek that advises doctors and patients that they must be vigilant for any indication of liver problems while taking this product. Unfortunately, some argue that serious damage from Ketek can occur within only a few dosages. This would not reasonably leave many people time to see the symptoms before it is too late. Senator Charles E. Grassley, charged with investigating the FDA's policies with Ketek, indicated that this is an example of the FDA making accommodations to drug makers, ignoring serious safety concerns. The FDA has committed to engage in further research in order to evaluate Ketek's safety to consumers and take further steps if necessary.

Originally posted at InjuryBoard by Staff Writer