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Ethex Expands Recent Recall Even Further

Paul Kiesel — Thu, 05 Feb 2009 20:37:09 GMT

From Forbes:

Associated Press - KV Pharmaceutical Co. is issuing its fourth product recall in about three months because some of its prescription prenatal and iron supplements were made under unsatisfactory conditions.

Late Tuesday, KV said it is voluntarily pulling dozens of prescription iron supplements and prenatal vitamin capsules and tablets because the products were made under conditions that didn't comply with industry standards. The recall includes products made by its Ther-Rx and Ethex divisions.

The company also extended a recall of five drugs made by Ethex, KV's generic business. Those drugs, along with dozens of others, were recalled last week at the wholesale level because of manufacturing problems. The new recall extends to the retail level.

In afternoon trading, KV shares lost 10 cents, or 13.9 percent, to 62 cents.

KV has issued four spates of product recalls since Nov. 7, citing manufacturing problems and accidentally oversized pills. On Jan. 26, the company recalled most of its products, and stopped its manufacturing and shipping operations. It warned that the Food and Drug Administration might choose to investigate or file charges.

Originally posted at InjuryBoard by Paul Kiesel

FDA: We Need to Protect the Public Health

Paul Kiesel — Wed, 04 Feb 2009 20:27:43 GMT

From U.S. News and World Report:

WEDNESDAY, Feb. 4 (HealthDay News) -- In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration is adopting stricter standards for heparin and glycerin -- two widely used drug products at the center of recent contamination episodes.

The new standards were created by the U.S. Pharmacopeia (USP) Convention, a nonprofit health organization that sets public standards for prescription and over-the-counter medicines and other health-care products made or sold in the United States.

"These are ongoing changes for our standards for heparin, and for glycerin that might be contaminated with toxins called ethylene glycol and diethylene glycol," said USP Chief Science Officer Dr. Darrell R. Abernethy. "The reason is to protect the public health."

Starting in November 2007, there were hundreds of severe reactions among patients receiving heparin, a blood thinner, and most were patients on kidney dialysis. Some 200 people died from the reactions, Abernethy said.

"There was almost certainly a contaminate put in the heparin in China that caused these reactions," he said. "It was done in such a clever, devious way that it passed our standards."

The contaminated heparin from China was tainted with over-sulfated chondroitin sulfate, which is made from the dietary supplement chondroitin and mimics heparin's blood-thinning properties, Abernethy explained.

The USP had to fix the standard so that adulterated heparin would not be allowed to come into the United States, Abernethy said. In a first step, the USP did a "quick fix" last year, which dealt with the immediate problem from China.

Now, there will be a permanent change in the standard that takes effect in August. After that time, manufacturers and importers of heparin will have to use the new standard to test their products before they can be sold in the United States. The new standard includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before, Abernethy said.

Glycerin is a chemical used to sweeten products such as toothpaste and pancake syrup, while ethylene glycol and diethylene glycol are poisonous. Switching ethylene glycol, which is used in antifreeze, as a cheap substitute for glycerin goes back as far as 1937 when more than 107 people were killed in the United States by ethylene glycol used as a liquid base for an antibiotic, Abernethy said.

Recently, there have been cases of ethylene glycol or diethylene glycol contamination in toothpaste from China found in the United States and Panama. The latest case occurred in November, when 34 Nigerian children died after being given a tainted teething drug, according to the FDA.

With that background, the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin, Abernethy said.

Before this change, manufacturers were only required to spot test their products for these chemicals. Now manufacturers will have to test for these chemicals in all the glycerin that comes into their plants, Abernethy said. The new standard takes effect in May.

"The approach that the FDA is using to enforce these standards for heparin and glycerin means that these impurities should not happen again," Abernethy said.

Dr. David L. Katz, director of the Yale University School of Medicine's Prevention Research Center, said he wasn't convinced that these new standards will keep all tainted drugs or other products out of the country.

"In a world of global commerce, perfect defenses against tainted or adulterated drugs are achievable, but at costs few would be willing to pay," Katz said. "It would require high-volume inspection, strict quality-control standards, and a massively costly surveillance effort to let the good products through, while unfailingly filtering out the bad."

"Are higher quality standards and more scrutiny for heparin and glycerin a perfect defense against drug adulteration? Surely not," Katz said. "But they are a good step in the right direction."

Originally posted at InjuryBoard by Paul Kiesel

New Democratic Legislation Calls for FDA to Investigate Heparin Plants in China

Paul Kiesel — Tue, 03 Feb 2009 20:08:22 GMT

From Reuters:

WASHINGTON, Jan 28 (Reuters) - U.S. Democratic lawmakers unveiled legislation on Wednesday to increase government inspections of food and drug manufacturing plants in an effort to keep tainted products off the market.

The measure was introduced during a salmonella outbreak traced to peanut butter and follows last year's discovery of contaminated ingredients from China that were used to make the blood-thinner heparin.

Under the bill, food producers and drugmakers would be required to pay fees to the Food and Drug Administration to help boost the frequency of plant inspections. Investigations have found the FDA's inspection staff stretched thin with a growing number of global products to oversee.

The legislation was introduced by Democrats on the House of Representatives Energy and Commerce Committee.

"Americans shouldn't have to worry about whether the food they serve their families and the medical products they use to improve their health might actually make them sick," said Representative John Dingell from Michigan.

For the rest of the article, click here.

Originally posted at InjuryBoard by Paul Kiesel

Walgreens Sends Urgent Drug Recall Information Letter Out to Ethex Morphine Sulfate Prescription Customers

Paul Kiesel — Fri, 09 Jan 2009 21:34:04 GMT

Ethex Corporation has been recalling (four times in the past year to be exact) several of its prescription drug products, due to some of the tablets being oversized (upwards of twice the appropriate level of the active ingredient).

Below is the content of Walgreens' recall letter per Ethex's Morphine Sulfate oversized tablets:

The manufacturer of Morphine Sulfate IR tables, Ethex Corp., is recalling several lots of this medication because there is the possibility that some tablets may be oversized and may contain more than the appropriate level of active ingredient. Your prescription may have included product from one of these affected lots.

We do not recommend that you discontinue taking Morphine Sulfate IR tablets without speaking to your physician. We ask that you attempt to contact your physician or other health care provider and share this information with them. You may return any remaining Morphine Sulfate tablets to your local Walgreens pharmacy for a refund. If you have any questions about this recall, you may contact the manufacturer at 1-800-748-1772 from Monday through Friday 8 a.m. to 5 p.m. C.S.T or via e-mail at customer-service@ethex.com.

*Also, anyone who wants to learn more about Ethex's recalls over the past 90 days can click here and browse several blogs that have further information.

Originally posted at InjuryBoard by Paul Kiesel

CDC: U.S. Dodged a Bullet with Heparin

Paul Kiesel — Tue, 09 Dec 2008 15:44:54 GMT

The Centers for Disease Control and Prevention is receiving praise from several recently published medical journals for successively tracking down the deadly contaminant that had been used in the blood thinner heparin, earlier this year.

The New England Journal of Medicine details how the CDC identified the adulterated product, which found its way around the world, "into at least 21 dialysis facilities and some heart clinics in at least 11 states," (U.S. News and World Report, 12/4/08), prompting Baxter Healthcare to recall the heparin products. Unfortunately, this was only after an abundance of adverse drug reactions and more than 100 deaths occurred.

Since many ingredients found in American drugs come from China or elsewhere around the world, it is important for the Food and Drug Administration to be able to provide the regulatory standard that applies to drug-making facilities in the United States, over in these oversea plants. If the FDA is unable to scrutinize foreign plants and these plants face the bare minimum when it comes to inspection and oversight, the U.S. will likely face an even greater tainted drug problem than the recent heparin scare.

Baxter sold more than 10 million doses of the drug to distributors over a three-month period, and, fortunately, the number of lots contaminated and people harmed was relatively small considering the prolific amount of heparin used throughout the marketplace. But the reason there were only a small number of people affected by the drug has more to do with the effort of the CDC working with local and state public health officials to stop the problem, than it does with the FDA's ability to prevent it.

Frankly, the FDA doesn't have the money, people or resources (information systems) at this time to meet the global challenges of drug regulation, especially when the drug's used in America are not made in America. But the FDA should be adequately armed in all of the former categories. If the heparin panic and recall was a warning to our drug regulatory system, and it's clear that this wasn't the first time a product from China had caused a widespread recall in the U.S., then what other contaminated ingredient could find it's way into our sometimes porous (it only takes one ingredient, one drug, one mistake, etc.) drug manufacturers' and distributors' hands and how efficient would the CDC or FDA be a second time around at discovering and recalling a "heparin-like" drug?

The key: put more resources into preventing the problem and the probability of further contaminated products reaching the United States will diminish over time.

Originally posted at InjuryBoard by Paul Kiesel

Henry Waxman vs the FDA?

Paul Kiesel — Fri, 05 Dec 2008 19:59:13 GMT

Will incoming House Energy and Commerce Committee chairman Henry Waxman take on the FDA like his predecessor, John Dingell?

Rep. Dingell (D-Mich), unfortunately, was very conservative when it came to energy and auto emissions (and it's likely that's one of a handful of reasons why Waxman was able to take Dingell's chair), but, fortunately, he had been a big supporter for change at the FDA and the industries it regulates.

The House Energy and Commerce Committee has currently more than a dozen ongoing investigations of issues drug, food and FDA-related issues that have made their targets sweat, according to The Wall Street Journal. In May, a hearing went so poorly for Merck, Schering-Plough and Pfizer that PhRMA's chief Billy Tauzin warned his members to volunteer DTC restrictions or they'd have to face the hand Dingell and his committee deal them.

The HEC committee pointed to, in that May hearing, a number of bad decisions that were made at the FDA involving food and drug safety, and, as well, the committee put FDA executives under a microscope, lambasting their ill-advised handling and regulation of medical devices, such as the wide-spread problems with contaminated heparin from 2007 and early 2008.

FDA executives may feel they can breath a sigh of relief now that Dingell isn't barking them up a tree, however, they need to first wisely look at two recurring factors:

1. Bart Stupak, the tough-as-nails chair of the Investigations Subcommittee, formerly under Dingell and now Waxman, will stay in that positions, meaning those investigations that were taking place last spring will continue and, if the FDA doesn't get its act together in regards to tougher regulation, accelerate;

2. "Waxman is in the middle of pending legislation that would allow lawsuits against medical device makers, which would undo this year's Supreme Court preemption decision affecting them," (online.wsj.com, 11/20/2008).

Therefore, the FDA can and should work to strengthen its ability to regulate the industries it oversees, and the agency should do what it can to work with Waxman to help keep Americans safer.

Originally posted at InjuryBoard by Paul Kiesel

Washington Post: Report Confirms Source of Contaminated Heparin

Paul Kiesel — Thu, 04 Dec 2008 20:38:54 GMT

From HealthDay News and the Washington Post:

WEDNESDAY, Dec. 3 (HealthDay News) -- A final report on the deadly contamination of the blood thinner heparin confirms that the problem was caused by a man-made chemical that was added to batches of the drug imported from China, U.S. investigators report.

The crisis, which began last November, resulted in 152 adverse reactions and as many as 81 deaths in the United States. The Chinese heparin, contaminated with the chemical oversulfated chondroitin sulfate, was found in at least 10 countries, according to federal officials.

"The last case was reported on January 31," said Dr. Priti R. Patel, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention, and a member of the investigation team that wrote the report.

Published in the Dec. 4 issue of the New England Journal of Medicine, the report "describes the adverse reactions caused by the contaminant" and links it to a specific substance, Patel said. The reactions included a drastic drop in blood pressure, nausea and shortness of breath, starting within 30 minutes after the administration of the heparin.

"There is a definite link between this contaminant and the patients who had these reactions," she said.

The first reports of such reactions among hospital patients given heparin came in November 2007. Eventually, cases were reported in 13 states. Investigators found a common thread in those cases: heparin marketed by Baxter Healthcare, of Deerfield, Ill., which got its supplies from China.

Raw heparin is derived from pig intestines. It is given intravenously to prevent blood clots during certain kinds of surgery, and also is used by people with kidney disease requiring dialysis. In China, heparin often is made by small, unregulated companies.

Chondroitin sulfate is a natural substance extracted from animal cartilage that can be used in supplements to treat arthritic joints. Oversulfation results from processing of the substance. Most of the reactions reported in the United States occurred in dialysis centers among people given high initial doses of heparin, the report found.

The heparin incident illustrates the importance of health providers reporting untoward incidents to regulatory authorities, Patel said. "Public health always relies on providers to make these reports," she said. "If they don't report, we have no way of finding what is wrong and correcting it. We are always asking people to be on their toes and communicate any problems."

Meanwhile, a letter in the same issue of the journal described a much easier way of identifying oversulfated chondroitin sulfate (OSCS) contamination in heparin -- should it occur again.

The two tests now mandated to detect contamination -- capillary electrophoresis and nuclear magnetic resonance spectroscopy -- are "technically challenging, not widely established and not easily applicable in clinical practice," said the letter from researchers at Christian-Albrechts University in Kiel, Germany.

That letter reported successful identification of OSCS contamination in heparin by use of one of the most common tests in medical practice --measuring prothrombin time, the time required for blood to clot, or coagulate. Studies show that coagulation time goes down as the amount of OSCS in a blood sample goes up, the letter said.

The test is widely available because many people, such as those taking the blood-thinning drug Coumadin for conditions such as atrial fibrillation, must have their clotting time assessed periodically.

"This test is applicable for any clinical laboratory, in the United States and Europe," said Susannne Alban, a professor of pharmacy and co-author of the letter. "It could be used as a pre-test, to detect the problem before any symptoms are seen."

Originally posted at InjuryBoard by Paul Kiesel

Morphine Overdose Killed Army Soldier

Paul Kiesel — Thu, 04 Dec 2008 20:30:06 GMT

Earlier this year, a Fort Huachuca soldier died of a morphine overdose at the Army base's medical barracks, an investigation concluded this week, and authoritites are trying to determine who provided the drug, according to the Associated Press.

Pfc. Eli Baker, 22, had just finished boot camp and was still in the process of training at the Central Arizona Army base when he was found dead on January 28 in Fort Huachuca's Warrior Transition Unit.

The unit provides medical and mental-health support for soldiers wounded in action or for troops recovering from other medical conditions.

Chris Gray, a spokesman for the U.S. Army Criminal Investigation Command, said," We have reason to believe that someone supplied him with that morphine, but he was not prescribed that morphine."

That statement issued by the Army must be disappointing to the family of Eli Baker, as 1. It'd be immediately obvious, particularly in the military, to find out whether Mr. Baker had been prescribed morphine (and it took them 11 months to figure this out?) and 2. Unless Mr. Baker had been prescribed the morphine, naturally, someone would have had to given it to him.

The most interesting aspect of the Army's investigation into what is ostensibly a case of negligent homicide, is what they've omitted. They have not suggested or disclosed that the morphine table came from the Warrior Transition Unit. And they have not connected the morphine overdose to the FDA's three recalls on Ethex Morphine Sulfate tablets, which occurred four months after Mr. Baker's death. (*Two of the recalls were voluntarily made by Ethex, after the FDA issued the first; the FDA then issued, simultaneously, two more recalls on 17 other Ethex generic products.)

The FDA doesn't typically mandate a recall on a product unless the agency is fearful of life-threatening consequences, and the FDA has yet to receive any of the recalled lots of Ethex Morphine Sulfate. Does this mean that Mr. Baker's death was the result of an oversized tablet? No, but unless the Army investigates the Warrior Transition Unit's stock of medication (and who may have been prescribed morphine at the Army base upon or before Mr. Baker's arrival), and examine whether or not the facility was stocked with any Ethex products, Eli Baker's family will lack the closure it deserves and this case will likely go unsolved.

Originally posted at InjuryBoard by Paul Kiesel

How Do You Say Heparin Recall in Mandarin?

Paul Kiesel — Tue, 02 Dec 2008 18:12:27 GMT

The FDA, after years of criticism for its responses to food-sickness outbreaks and contaminated imports, unveiled a report on Monday that summarizes what officials call a "hugely ambitious" campaign to reshape its food and drug inspection channel.

Dr. David Acheson, the FDA's associate commissioner for foods, told The New York Times, " The goal is to radically redesign the process." Meaning, instead of waiting until the food or product hits the U.S., the goal would be to try and detect the tainted products during the production process.

The last thing the FDA needs is another product coming from China or anywhere in Asia for that matter, and causing thousands upon thousands of consumers to fall ill. First there was tainted pet food, then came contaminated heparin and just recently milk containing melamine.

And, likely, due to the scrutiny the FDA's faced over the past year, just under two weeks ago, the agency set up shop in Beijing to protect Americans from similar threats like the aforementioned.

According to the Wall Street Journal, "It's the agency's first overseas office and is part of the regulator's effort to better scrutinize the large and growing number of foods and drugs that China ships into the U.S. 'The FDA is a global regulatory body and expanding their footprint outside the U.S. is the first step in becoming more active in the global market,' Patrick Ronan, a former chief of staff at the FDA, tells the Health Blog."

However, how is one, two or three FDA outposts in China going to blanket an enormous Chinese food industry that lacks adequate food safety controls? Health and Human Services Secretary Mike Leavitt optimistically thinks the FDA's arrival in China marks the start of a "new era" and is a first step of many that will allow the FDA to work more closely with manufacturers and regulators abroad.

At the end of the day, whatever the FDA is able to do in China will come down to money, personnel and outside resources, three factors that it grapples with already in the United States. And, on top of that, the FDA still has a dull eye when it comes to spotting material that is imported from China and used to manufacturer products like Heparin. Heparin recalls will continue to occur in the U.S. due to this lack of oversight and will only be abated once the FDA can permeate itself throughout the Chinese food and drug industry, which, not to sound too pessimistic, is doubtful since the FDA has a hard enough time regulating food, drugs and appropriate product labels within the U.S.

Originally posted at InjuryBoard by Paul Kiesel

Texas Congressman to GAO: FDA Needs to Improve Its Drug Safety System

Paul Kiesel — Wed, 26 Nov 2008 15:25:21 GMT

From CNN: WASHINGTON -(Dow Jones)- Rep.

Joe Barton, R-Texas, on Thursday raised questions about the adequacy of the Food and Drug Administration's handling of a scandal involving a contaminated blood thinner amid concerns the agency misreported deaths tied to the product and didn't thoroughly investigate the problem.

At issue are what appear to be conflicting statements the FDA made to the public and Congress about the number of deaths tied to contaminated batches of heparin, a widely used blood thinner for cardiac surgery.

In May, the FDA said it completed a review and linked three deaths to contaminated heparin. Last month, the FDA told congressional staff that only two of the deaths were possibly linked to contaminated heparin, while one was " unassessable," according to a letter Rep. Barton sent Wednesday to the Government Accountability Office, the investigative arm of Congress. Rep. Barton is also ranking member of the powerful House Energy and Commerce Committee.

But a company involved in the heparin scandal, Baxter International Inc. (BAX), did its own investigation of the deaths and concluded the blood thinner likely wasn't the cause in the three cases, according to the letter. Baxter's investigation included obtaining medical records from the patients, interviewing pharmacists and nurses, and visiting a hospital where one of the patients had gone before dying.

The FDA didn't follow up with clinical staff at the hospitals or talk with Baxter to find out further information about the deaths. The FDA also didn't access other medical databases it acknowledges enhance its ability to evaluate drug safety problems.

Based on this information "there is a serious and potentially troubling question about whether FDA availed itself of all of its tools to conduct comprehensive surveillance of heparin deaths," Rep. Barton said in the letter.

The FDA began investigating heparin earlier this year after receiving hundreds of reports of allergic reactions and dozens of deaths in patients who had taken the blood thinner, which is essential during procedures like cardiac surgery. Contaminated heparin from China was eventually found in batches of the blood thinner owned by Baxter.

Originally posted at InjuryBoard by Paul Kiesel