The Injury Board Commentary - FDA & Prescription Drugs - Most Popular

Pfizer Recalls Birth Control Pills

Craig Kelley — Mon, 06 Feb 2012 17:00:00 GMT

On January 31, 2012, Pfizer announced a voluntary nationwide recall of a million packs of oral contraceptives. The recall affects both the brand-name Lo/Ovral-28, and the generic Norgestrel and Ethinyl Estradiol Tablets. Both of these drugs are marketed and labeled by Akrimax Rx Products, carrying the label of that company on the packaging.

According to the FDA press release announcing the recall, Pfizer took action after their own investigation revealed that some packages of the oral contraceptive may contain the incorrect amount of active-ingredient tablets and that the tablets in the packages may be out of sequence. The problem has since been remedied, but not before 28 lots of the drug were packaged and put on the shelves. The FDA announcement includes a list of all lot numbers that were affected. That same press release also has photographs to help patients identify if their product is included in the recall.

Typically these birth control pills contain 21 white pills with an active ingredient and then seven pink pills that are inert. The effectiveness of the contraceptives depends on the pills being taken in a specific sequence. Simply taking the pills in the wrong order—which is much more likely in the recalled packages—can eliminate the contraceptive effect of the pills and increase the likelihood of pregnancy. While there are no other health risks, the FDA advises users of the product to begin using a non-hormonal contraception immediately. In addition, patients prescribed these birth control pills should immediately notify their physician and return the product to the pharmacy.

Originally posted at InjuryBoard by Craig Kelley

More Accounts of Cipro/Levaquin Side Effects

Jeff Rasansky — Mon, 14 Jul 2008 15:20:16 GMT

Last week we blogged about Cipro and Levequin, two antibiotics that have been known to cause some pretty bad side effects. The FDA released a statement on July 8, that requested black box warnings for these drugs. Talk about side effects! These drugs have been linked to a risk of tendinitis and tendon rupture!

I decided to dig around a bit and see if I could find any first-hand accounts of people who have taken these drugs and experienced the side effects. I was amazed at what I found:

I have taken Levaquin 500 mg tablets for 11 days (until 2 days ago) against pneumonia.

I have developed severe pain in my achilles tendons (mostly on the left side ). I can hardly walk in the morning. Not having had any problems before I could not figure whatever could be the reason for this problem, especially since I have been doing stretching exercises for years.

I was diagnosed in an emergency room with pneumonia after some mysterious symptoms that included blood pressure over 200 and pulse of 110 with sputum containing blood. I was given a prescription for Levaquin for the "pneumonia."

After two days, there was tremendous swelling of my right arm and left leg.

There was acute weakness and pain of the left Achilles tendon. My left leg bothers me to this day--about 8 months later.

I was in doubt about the pneumonia diagnosis to begin with, and still am. Doubly in doubt about the prescription, since I have never been allergic or had any reaction to drugs in 85 years.

I just finished taking Levaquin for 10 days for a sinus infection. After the 5th day I noticed extreme pain in my muscles through my entire body. I just finish my 10th pill 3 days ago and am still in extreme pain. I feel like I'm an 80 year old woman in a 34 year old's body.

I’m not sure if a “black box” warning will do anything for the pain these people have already experienced. What about you? Have you experienced any of these side effects with Cipro or Levaquin?

Originally posted at InjuryBoard by Jeff Rasansky

Novartis Tekturna Problems Study Cancellation

Shezad Malik MD JD — Thu, 05 Jan 2012 21:35:15 GMT

Medical side effect concerns about Tekturna, a blood pressure drug sold by Novartis, have arisen after clinical trials were canceled due to a high number of strokes and kidney problems among diabetic patients.

Novartis was running a trial of the drug to see if it could be useful in the treatment of diabetic hypertension. The drug maker found that Tekturna may increase the risk of non-fatal strokes, kidney problems and other health risks.

Read the Safety Warning from Novartis here. Direct Healthcare Professional Communication on potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular disease treated with aliskiren (Tekturna®) tablets and aliskiren-containing combination products.

As a result of the findings, a safety review of the potential Takturna problems was launched in December in Canada, where the medication is sold under the brand name Resilez.

The cancellation of the clinical trials was announced in a December 20 press release by Novartis. The trial, known as ALTITUDE, involved 8,609 patients from 36 countries. It was a randomized, double-blind, placebo-controlled study of the drug’s use in patients with diabetes and kidney problems.

The study found an increase in Tekturna side effects after 18-24 months that included not only strokes and kidney complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause circulatory problems.

The clinical trial involved the use of Tekturna along with angiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result of the bad side effects, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients.

ALTITUDE was cancelled after an independent Data Monitoring Committee (DMC) overseeing the clinical trial became alarmed at the high rate of Tekturna health risks among tests subjects and recommended Novartis pull the plug.

The company has not yet released data from the study, but has told all of the clinical trial’s investigators to remove Tekturna products from their patients’ treatment regimen.

Tekturna (aliskiren) was approved in 2007 for the treatment of high blood pressure. In several countries outside the United States, it is sold under the brand name Rasilez.

In a recent statement released by the Canadian regulatory agency, Health Canada, noted that 329 of the test subjects were from Canada and the agency has expressed concerns over the risks of the clinical trial to its citizens.

Canadian officials say they are looking at available safety data and is considering taking appropriate regulatory action if necessary. The actions could include new label warnings and safety recommendations.

Originally posted at InjuryBoard by Shezad Malik MD JD

Fentanyl/Duragesic: Exposing the Truth About the Pain Patch of Sudden Accidental Death-Interview With Injury Trial Attorney James Orr

Rick Shapiro — Thu, 05 Mar 2009 22:13:04 GMT

I am on a mission to use my forum as an editor on three Injuryboard regional injury law blogs to educate consumer/patients, doctors, pharmacists and medical providers about the extreme risk of accidental overdose deaths associated with the prescription of Fentanyl pain patches, also known as Duragesic pain patches. Fentanyl patches are often being prescribed to patients who can instead be prescribed a safer alternative pain medication, and my argument is that the medical community is unaware of the epidemic of accidental overdose deaths nationwide. Does the FDA realize the truth about how many accidental fentanyl overdose deaths are really occurring nationwide?

Our firm has been investigating two accidental fentanyl patch overdose deaths in North Carolina alone, and what about the other 49 states? Based on my research of lawsuits against the manufacturers of this drug, I have officially associated with James Orr, a Texas lawyer with the firm of Heygood, Orr, Reyes, Pearson & Bartolomei, to investigate a wrongful death because of fentanyl toxicity/accidental overdose, involving one of our law firm’s North Carolina client's. I consider James Orr to be one of the foremost authorities on the dangers of fentanyl pain patches, because of at least two prior successful wrongful death trials he has participated in, representing the families of those killed by this exceedingly dangerous pain patch medication. Fentanyl toxicity death is turning up with frightening frequency. And as the public learned in the Firestone tire defect/safety cases, and many other public health & safety scenarios, who usually exposes dangerous health and safety problems first? Yes, the injury lawyers through the civil justice system. I asked Jim Orr if I could interview him for our Injuryboard injury law blog network and our interview follows:

Shapiro: Jim: Thank you for agreeing to this interview about what I consider to be the epidemic of nationwide sudden deaths/accidental overdoses of persons who were lawfully prescribed Fentanyl or Duragesic pain patches.

My first question is this--why is the fentanyl patch so dangerous in the hands of consumer/patients in your view?

Orr: It is the most potent narcotic there is. It is 100 times stronger than morphine. Everyone's skin absorbs fentanyl at different rates, as much as a 10 fold difference. Typically, if a person is starting to suffer from fentanyl poisoning, they don't get sick, they just get sleepy. If they lay down, they never wake up. Also, even if you do recognize that you may be in trouble, if you take off the patch, it does not help. The fentanyl enters the skin from the patch into what is called the "skin depot" and it takes as much as 18 hours for that fentanyl to subsequently enter the blood stream. Thus, if you take off the patch, it is too late as the fatal dose may already be in the "skin depot." This is why a leak can be so dangerous. If you have a leak, the skin depot can fill up real fast and then kill you hours later.

Shapiro: How many trials have gone to verdict that you participated in the trial as a trial attorney?

Orr: The first case was the Hendelson case which was tried in federal court in West Palm Beach Florida in June of 2007. Hendelson involved a father that lost his 28 year old son due to a defective fentanyl patch. The result of the case was a $5.5 million verdict for our client. The second case was the DiCosolo case which was tried in state court in Chicago in November of 2008, just a couple of months ago. DiCosolo involved the death of a 38 year old wife and mother of 3 children due to a defective fentanyl patch. The result was a $16.5 million verdict for our clients.

Shapiro: Is it true that Johnson and Johnson and one or more of its subsidiaries have earned well over $1 billion in distributing transdermal Fentanyl patches?

Orr: Yes, their sales from just the brand name Duragesic are as follows:

2003 1.63 Billion

2004 2.08 Billion

2005 1.58 Billion

2006 1.29 Billion

2007 1.16 Billion

Shapiro: When the food and drug administration first approved Fentanyl patches for patient use, wasn't it limited to only terminal cancer patient pain cases? How did it get expanded?

Orr: No. It was originally approved in 1990 for “management of chronic pain in patients requiring opioid analgesia.” However, its use initially was primarily for cancer patients. Now, due to J&J’s marketing claims such as “Duragesic stops the pain, not the patient” and “Life uninterrupted”, it is being handed out for all kinds of pain. In fact, J&J subsidiaries have recently been found guilty by a West Virginia court of willfully publishing misleading promotional materials relating to Duragesic and were fined heavily for doing so.

Shapiro: What have some of the drug manufacturer corporate representatives stated was the need for the widespread prescription of Fentanyl patches in their defense of this product?

Orr: J&J claims that fentanyl is a potent drug and that it carries with it a risk. In fact, they have filed a pleading in a case asserting that Duragesic is unavoidably unsafe. They claim that they have not encouraged its use in situations in which it is not indicated. Unfortunately for J&J, they don’t sufficiently warn about the risk they themselves claim fentanyl patches present.

Shapiro: Are you advocating removal of Fentanyl medication from the hospital operating rooms setting, or just removing it from the hands of patients and why?

Orr: I would advocate that leaking patches getting out of the plant and sold to the public be eliminated. In terms of patches that are manufactured properly, I would advocate that doctors and patients be warned that the proper use of fentanyl patches carries with it a risk of death and that in fact many patients have died. I would advocate stronger warnings in the black box regarding use of fentanyl patches at the same time with other sedating medications. I would advocate that these warnings not only be included in the package insert, but that they be prominently displayed in any promotional materials regarding fentanyl patches.

Shapiro: What types of product defects have you proven have gone wrong with Fentanyl patches?

Orr: Manufacturing defects, i.e., that the patches have failed to perform as intended; marketing defects, i.e., the warnings were inadequate

design defect, i.e., safer alternative design existed.

Shapiro: What is your opinion about what the FDA should do to control the fentanyl patch prescription death overdose epidemic in the United States?

Orr: Require drastic changes in both the package insert, the patient information insert and J&J’s promotional materials. Also, in my view, the prescribing of this medication in a patch form should be limited to anesthesiology, pain medicine and oncology physicians.

Shapiro: Thanks so much for explaining some of these details. If this article can prevent one doctor from prescribing these fentanyl patches where it is unnecessary, or help build a groundswell to convince the FDA that the present warnings are totally inadequate, we accomplished something here. Also, I plan to send this interview to every physician or pharmacist I know to get the truth out there about this fentanyl patch accidental overdose epidemic.

Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia, with offices in northeast NC and Virginia Beach (VA), practicing primarily in the southeastern U.S. and handles only injury law, including car, truck, railroad, and medical negligence cases and more. The firm's website is: hsinjurylaw.com, the firm edits three injury law blogs: Virginia Beach Injuryboard & Norfolk Injuryboard, as well as the Northeast North Carolina Injuryboard and also hosts a video library covering many FAQ’s on personal injury subjects.

Originally posted at InjuryBoard by Rick Shapiro

FDA Request for Withdrawal of Darvon and Darvocet May Have Come Too Late

Michael Roberts — Wed, 24 Nov 2010 09:19:25 GMT

Darvon and Darvocet Recall
Failing to remove a dangerous product from the market can have severe health consequences. But it is even worse when the withdrawal effort could have come much sooner and some of the health issues prevented. Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, recently agreed to withdraw the medication from the U.S. market. The withdrawal came at the request of the FDA. The FDA sought withdrawal of propoxyphene after the agency received new clinical data that showed that propoxyphene-based drugs puts patients at risk of potentially serious or even fatal heart arrhythmia. After weighing the benefits and risks of the drug, the FDA determined that the serious heart risks, combined with the risks of suicide, addiction and death outweighed the potential benefits of the drug as a painkiller. However, despite the FDA’s decision to request the withdrawal at this time, the consumer watchdog Public Citizen blasted the FDA for waiting too long before issuing a Darvon and Darvocet recall late last week.

Earlier Complaints Ignored
Propoxyphene, which is contained in Darvon and Darvocet, is an opioid used to treat mild to moderate pain. Darvon was first introduced in 1957. Now, the drug is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet’s use is not limited to a small number of people. In fact, it has been prescribed for more than 22 million people and is one of the 25 most commonly used prescriptions.

The widespread use makes the FDA’s slow reaction time even more devastating. Public Citizen released a statement this past Friday stating that the delay may have resulted in 1,000 to 2,000 additional Darvon and Darvocet deaths during the years after the FDA should have recalled all propoxyphene drugs. Public Citizen first petitioned the FDA for a Darvocet and Darvon recall in 1978. At that time, there was already evidence of the adverse health effects Darvon and Darvocet could have on the heart. But the earlier warnings did not end there. The U.K. decided to pull Darvocet and Darvon from that market in January 2005, after determining the drugs were too dangerous and had little benefit. Public Citizen petitioned the FDA for a recall again in 2006, but again to no avail. It then filed a lawsuit against the FDA in 2008 following the FDA’s refusal to act on its petition.

FDA’s Response
It was not until after that lawsuit that the FDA’s own advisory committee voted for a recall in January 2009 for the same reasons as the UK. The FDA defended its decision to wait however, saying that it only recently received enough data to justify that the risks of Darvon and Darvocet side effects outweighed its health benefits.

What the Future Holds
There is a small bright spot for some patients. “With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Dr. Sidney Wolfe, director of Public Interest’s health research wing, wasn’t focusing on the limited bright side and instead had some harsh words for the FDA. “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since [the] time the UK ban was announced,” Wolfe said. “The FDA’s pitiful excuse that it needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world – which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.”

Conclusion
Consumers who have been harmed by Darvon or Darvocet should not just accept their health issues. Whether or not the FDA or Xanodyne acted negligently remains to be determined. Public Citizen has called for a congressional investigation into the agency’s negligence, but patients should not wait for the results of that potential investigation. The time to contact a lawyer and explore all potential remedies is now.

Originally posted at InjuryBoard by Michael Roberts

How do Fosamax, Actonel and Boniva compare?

Michael Monheit — Sun, 31 Oct 2010 08:59:00 GMT

All bisphosphonate drugs have been linked to rare femur or thighbone fractures, esophageal cancer, and jawbone death.

Fosamax, Actonel, and Boniva are in a class of drugs known as bisphosponates.

According to Wikipedia, bisphosphonates prevent the loss of bone mass and are used to treat osteoporosis and similar diseases.

Bone has constant turnover, and is kept in balance by osteoblasts which create bone and osteoclasts which digest bone. Bisphosphonate drugs inhibit the digestion of bone by osteoclasts.

Fosamax or Fosamax Plus D (alendronate sodium) are taken orally once a week (70mg or 70mg/5600 IU vitamin D) at least 30 minutes before the first food, beverage, or medication of the day with 6 to 8 ounces of plain water only. People taking Fosamax or Fosamax Plus D should not lie down for at least 30 minutes after taking their weekly dose or until after eating.

Actonel (risedronate) is dosed either as one 5-mg tablet taken daily or one 35-mg tablet taken once a week. Actonel has the same dosing restrictions as Fosamax. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Calcium supplements may interfere with the absorption of Actonel and should be taken at a different time of the day.

Boniva (ibandronate sodium) is different than either Fosamax or Actonel in its dose administration. Unlike the oral tablets listed above, Boniva is a 2mg to 6mg quarterly dose-proportional intravenous injection. Boniva either binds to the bone rapidly or excretes into the urine. Boniva also has a 2.5mg oral tablet which may be taken daily.

All bisphosphonate drugs have been linked to rare femur or thighbone fractures, esophageal cancer, and jawbone death.

If you or a loved one has been harmed by bisphosphonate drugs like Fosamax, Actonel, and Boniva…please contact the Philadelphia lawyers at Anapol Schwartz law firm to find out if legal actions may be right for you and your family.

Originally posted at InjuryBoard by Michael Monheit

Warnings: When to Prescribe Fentanyl/Duragesic Patches

Rick Shapiro — Wed, 03 Feb 2010 17:53:55 GMT

This article briefly outlines one perspectiveon when medical professionals including doctors/physicians should consider prescribing Fentanyl or Duragesic pain patches to their patients. This article is authored by a personal injury trial attorney who is currently involved in Fentanyl/Duragesic pain patch cases, and has also researched and authored previous articles on this topic. If you are a medical professional you are mindful of legal liability issues, and must stay up to date on contra-indications and proper indicators for the prescription of these powerful Fentanyl pain patches and I think this article will be relevant to you. Here are my views:

1. The first thought should be: Do not prescribe a Fentanyl or Duragesic pain patch at all. Of course, this medication is 80 to 100 times more powerful than morphine, drop for drop, and your chances of any possibility of your patient overdosing and dying from a medication you prescribed decreases considerably if you simply do not prescribe a Fentanyl/Duragesic pain patch of any particular dosage because of the high rate of accidental overdoses and accidental deaths that have been increasingly tied to this medication.

2. As I have previously written, the FDA has issued a series of warnings and cautions to consider before the prescription of Fentanyl or Duragesic pain patches should be made and they are only proper for chronic pain patients that cannot be managed by any other suitable medication. The problem here is that there is a virtual epidemic of accidental overdoses nationwide of Fentanyl and Duragesic pain patches and, wrongful death actions have been filed nationwide against the manufacturers, including Johnson and Johnson, Mylan, and the other generic manufacturers of the pain patches. The allegations include unintended leakage from the pain patches, by those using heat pads or other possible unusual uses causing a sudden discharge of too much medication, or, what seems to be the most common, is that the patient does not understand the toxicity pain patch and places a second patch on the skin while the first patch has not discharged all of the transdermal medication, unbeknownst to the patient.

3. Who are the proper patients? - The only proper patient for these types of pain patches are chronic pain patients that cannot be managed by any other medication that has less accidental wrongful death associated with the medication. This Fentanyl and Duragesic pain medication was originally intended for cancer patients, for those patients with unfortunate terminal diseases that have incredible pain, and is not intended for persons that are suffering chronic pain that may be manageable by other medications. However, aggressive sales tactics by sales representatives with the various companies producing the Fentanyl/Duragesic pain patches has resulted in an incredible increase in the prescription of these pain patches. When the pain patches work well, the patient of course does not experience pain. This is good. However, the potential for unintended, accidental death with these pain patches is a very real and present danger and a medical professional should stay away from any prescription of such a drug based on the hypocratic oath, the basic tenet learned in medical school that above all "do no harm."

Here's a video discussing Fentanyl/Duragesic pain patches being misprescribed by doctors and nurses...

http://www.youtube.com/watch?v=Jyi3E3JFPxY&feature=related

Please review any of the prior articles that are mentioned as links in this article for further detail on the dangers of Fentanyl/Duragesic pain patches. Hopefully, as the mounting accidental deaths continue to increase, the FDA will take further action restricting the prescription of Fentanyl/Duragesic pain patches.

About the Editors: Shapiro, Cooper, Lewis & Appleton personal injury law firm (VA-NC law offices ) edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono service to consumers.

Originally posted at InjuryBoard by Rick Shapiro

Compulsive Gambling and Mirapex Verdict $8.2 Million

Eddie Farah — Sat, 02 Aug 2008 13:33:08 GMT

A drug given to treat Parkinson’s disease and restless leg syndrome is the focus of a number of trials underway in the District Court of Minneapolis. More than 200 plaintiffs are taking their case forward. But first, three cases will be heard back-to-back to determine the disposition of the remaining cases, including whether there should be a class settlement.

The cases have been consolidated against the drug Mirapex. So far it’s not good news for drug makers Pfizer and Boehringer Ingelheim. This week a federal jury agreed the drug contributes to compulsive gambling and awarded a man $8.2 million.

Many people responding to the story think this is a joke. But it’s not. Compulsive behavior can not only bankrupt you, but destroy marriages and lives. Drug makers denied they knew about the potential side effects, but attorneys for the plaintiffs have shown that the drug makers had knowledge of these compulsive side effects back into the 1990s. Apparently the jury agreed.

Mirapex was approved in 1997, but a warning of compulsive behavior was not issued until 2005. All the while, thousands if not millions of patients, trying to relieve the tremors of Parkinson’s began compulsive behavior. Not only gambling, but shopping, eating, many repetitive behaviors.

More than 10 million prescriptions have been written for Mirapex.

The drug makers blame the compulsive behavior on the patients.

Requip is also in the same class as Mirapex- so-called “dopamine agonists” that stimulate the brain’s movement and coordination centers by overactivating the brain’s pleasure centers. When you stop the drug, the behaviors stop.

With so many people involved in behavior they cannot stop, and no clue that theirs may be a drug-induced state, the drug makers deserve all the scrutiny these trials are now bringing.

They are being charged with liability for design, manufacturing and warning; breach of warranty; and negligence.

Originally posted at InjuryBoard by Eddie Farah

Popular Painkillers Darvon/Darvocet Yanked From Pharmacies Due to Heart Risk

Jamie G. Goldstein — Fri, 07 Jan 2011 17:08:35 GMT

Propoxyphene (PPX), a prescription painkiller sold under the names Darvon and Darvocet, has been linked to heart complications and removed from the market. Darvon is pure propoxyphene while Darvocet combines propoxyphene with acetaminophen. Propoxyphene was first placed on the market in 1957 and by the 1970s had become one of the most popular prescription drugs.

The U.S. Food and Drug Administration (FDA) decided in late last November to pull Darvon and Darvocet off the market after both drugs were linked with reports of heart problems and the agency concluded in a memorandum that “the benefits of PPX no longer outweighed its risks.” The drugs, produced by Xanodyne Pharmaceuticals, were found to cause cardiac damage or fatality even when taken in the recommended doses. The FDA’s action was prompted by the results of a clinical trial showing that the drug altered the electrical activity of the heart, which can cause rhythmic disturbances. The results of the study showed the dangerous risk of heart abnormalities far outweighed the benefit of the drug in reducing pain. In 2009, propoxyphene was prescribed to around 10 million Americans for pain relief.

The drug was completely banned in the UK in 2005 and in Europe in 2009. Why was the United States the last to act? The ban hardly comes to a surprise to some, especially the Public Citizen’s Health Research Group who advocated pulling PPX from pharmacies years ago. They estimate that around 1,000-2,000 Americans have died from taking PPX. These numbers are drawn from Florida statistics that show around 400 deaths occurring from the drug over a 4 year span.

In 2009 an FDA panel voted 14-12 against continued marketing of PPX. As a result, the FDA included a new warning label including the risk of fatality. A study on the effects of recommended doses of 600 mg and 900 mg on the heart showed a severe risk of arrhythmia and a greater risk of death than similar pain killers like hydrocodone and tramadol. Other alternatives to taking Darvon or Darvocet include anti-inflammatory drugs such as Advil, Aleve, Cataflam, and Celebrex. Experts say that once one stops taking PPX, the risk of heart problems will disappear. However, many may have to be slowly weaned off of the drug or have it replaced with another opiate for pain management. Still others may not yet be aware of the ban.

Originally posted at InjuryBoard by Jamie G. Goldstein

FDA Warns of Cylert Side Effects

Bob Carroll — Wed, 26 Oct 2005 05:25:17 GMT

FDA Alert Re Cylert, a drug used to treat ADHD. Coming a mere 10 years after Canada and Great Britain pulled the drug from their markets and and 5 months after the manufacturer, Abbott Labs, stopped making and marketing the drug due to declining sales, the question is why did the FDA bother at all.

Does anyone need more evidence that the FDA is dysfunctional? Exhibit A: its recent Alert about Cylert, a drug used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Coming a mere 10 years after Canada and Great Britain pulled the drug from their markets and 5 months after the manufacturer, Abbott Labs, stopped making and marketing the drug due to declining sales, the question is why did the FDA bother at all.

FDA ALERT [10/2005]: Liver Injury Risk and Market Withdrawal:

The Agency has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (Pemoline tablets and chewable tablets). Cylert is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This product is considered second line therapy for ADHD because of its association with life threatening hepatic failure (see BOXED WARNING in product label and patient package insert).

The rest of the story from Chicago Injury Law Blog:

Cylert Withdrawn From Marketplace Due To Liver Toxicity
The FDA announced today that Cylert, and all similar generics, be removed from the market. Cylert, made by Abbott Laboratories, is a treatment drug for ADHD on the market since the 1970's.
In 1995, Canada and Great Britian removed the drug from their respective markets citing a study that indicated a 45 fold increase in childrens' liver failure. The FDA did not force the withdrawal, and the drug remained on the market for another 10 years.
Abbott Labs stopped marketing and making the drug in May, 2005, citing declining sales.

Originally posted at InjuryBoard by Bob Carroll