Manufacturing problems dogging Johnson & Johnson since 2009 still have not been solved. The company announced yet another drug recall because of musty odors — this time involving branded and generic forms of risperidone, the antipsychotic drug.

MedPage Today is reporting that the company’s Ortho-McNeil-Janssen subsidiary voluntarily recalled certain lost of the drug. The recall is for one lot of 3 mg Risperdal in 60-tablet bottles, lot number 0GG904, expiration May 2012, and of one lot of generic risperidone in a 2 mg dosage, lot number OIG175, sold by Patriot Pharmaceuticals.

As with several previous recalls — including the Tylenol brand of acetaminophen, Benadryl allergy medications, and topiramate (Topamax) — the company said in a statement that it had received reports from patients that the risperidone products emitted “an uncharacteristic odor.”

The two affected lots total about 40,000 bottles of risperidone.

The company advised patients with medications from these lots not to stop taking the medication. However, if they notice unusual odors, they should return the tablets to their pharmacist.

The odor in all these recalls appears to stem from a chemical preservative, 2,4,6-tribromoanisole (TBA), in wooden pallets used in shipment and storage.

No serious adverse events have been reported with the affected risperidone lots. However, according to Ortho-McNeil-Janssen, “a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.”

Source: John Gever, MedPage Today

The Food and Drug Administration doesn’t try to find out whether or not medical-device recalls are successful.

Referring to a report by the Government Accountability Office,  The Hill reports that the FDA doesn’t have clear policies in place to determine whether a recall worked and doesn’t analyze individual recalls in search of more fundamental problems, the GAO said.

According to the GAO report, the FDA doesn’t have criteria for measuring whether manufacturers actually pull every defective device during recalls. Agency officials sometimes disagree about whether similar recalls have worked, the report says.

The agency also does not document its reasons for determining that recalls are complete.

By Lucia Graves, The Huffington Post

According to a new report, industry regulators have known for years that Roundup causes birth defects.

Roundup, produced by U.S. company Monsanto, is the world’s best-selling herbicide.

The report, “Roundup and birth defects: Is the public being kept in the dark?” found regulators knew as long ago as 1980 that glyphosate, the chemical on which Roundup is based, can cause birth defects in laboratory animals.

But despite such warnings, and although the European Commission has known that glyphosate causes malformations since at least 2002, the information was not made public.

Instead European regulators misled the public about glyphosate’s safety, according to the report, and as recently as last year, the German Federal Office for Consumer Protection and Food Safety, the German government body dealing with the glyphosate review, told the European Commission that there was no evidence glyphosate causes birth defects.

The report comes months after researchers found that genetically-modified crops used in conjunction Roundup contain a pathogen that may cause animal miscarriages. After observing the newly discovered organism back in February, Don Huber, a emeritus professor at Purdue University, wrote an open letter to Secretary of Agriculture Tom Vilsack requesting a moratorium on deregulating crops genetically altered to be immune to Roundup, which are commonly called Roundup Ready crops.

Although glyphosate was originally due to be reviewed in 2012, the Commission decided late last year not to bring the review forward, instead delaying it until 2015. The chemical will not be reviewed under more stringent, up-to-date standards until 2030.

Johnson & Johnson’s troubles just get more and more stinky.

According to CNN, the pharmaceutical giant announced on Thursday a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.

The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.

The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled. However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.

J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The drug is already under fire because it has been linked to oral birth defects in infants who were exposed when their mothers took it.

Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.

Source: CNN Money

2004 Tests Found Chemical Nationwide

Some water utility representatives have protested Environmental Working Group’s report of laboratory tests that found worrisome levels of chromium-6, a suspected carcinogen, in the drinking water of 31 cities across the country.

Yet the tap water industry was worried enough about the contaminant to conduct its own extensive survey in 2004 that found clear evidence of widespread chromium-6 pollution in untreated source water. The survey, conducted by the Awwa Research Foundation (since renamed the Water Research Foundation), an offshoot of the American Water Works Association, obtained data on 341 source water samples from 189 utilities in 41 states. The conclusion: chromium-6 is common in American groundwater.

Tap water industry representatives made no mention of their study when they testified alongside EWG at a Feb. 2 Senate environment committee hearing on chromium-6 pollution. There is no indication that customers of the 189 participating utilities were advised of the chemical’s presence in source waters in their communities.

Chromium-6, also known as “hexavalent chromium,” is often called the “Erin Brockovich” chemical, after the crusading legal assistant who helped residents of tiny Hinkley, Calif, win a $333 million settlement from Pacific Gas & Electric Co, accused of dumping the chemical in local ground water. Actress Julia Roberts won an Oscar for her portrayal of Erin Brockovich in the 2000 film of the same name.

The 2004 industry study, which EWG obtained from a source and cited in its December 2010 report, “Cancer-causing Chromium-6 Pollution in U.S. Tapwater,” demonstrates that chromium-6 pollution was not confined to California.

“The tap water industry’s 2004 study is unmistakable proof that it has known about extensive chromium-6 contamination for at least seven years,” said Jane Houlihan, EWG senior vice president for research. “Water utilities should tell their customers any time they know that a suspected carcinogen has polluted local waters. People have a right to know what they and their families may be drinking.”

Pollution levels in untreated and treated water are not directly comparable. Even so, the two studies, read together, paint a picture of coast-to-coast chromium-6 pollution.

The industry research group provides its report Occurrence Survey of Boron and Hexavalent Chromium to water utilities and their consultants, who pay four or five-figure subscription fees and a document fee of about $300. (The report can now be bought online for $200 or more.)

EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.

After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

An earlier Class I recall of saline flush syringes has now prompted a secondary FDA recall of venous catheter trays that included the defective syringes.

Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of defective central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.

The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9 percent sodium chloride) manufactured by Excelsior Medical Inc.

Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.

After learning of the problem with this defective medical device, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.

The recalled defective medical devices include 123 individual catheter products, which come packaged in trays containing different sizes. The catheters are used to monitor a patient’s pressure in a vein, for blood sampling, and administration of drugs and fluids.

Source: John Gever, Senior Editor, MedPage Today

A judge accepted a guilty plea by a division of Boston Scientific on charges that it hid defects in heart defibrillators. In addition, the judge  placed the company on three years’ probation.

Posted on behalf of Cappolino Dodd Krebs LLP.

That pharmaceutical companies occasionally manufacture a dangerous drug or that a defective drug slips through the system isn’t really news.

We’ve known for some time that there were serious problems with dangerous drugs like Paxil and Avandia.

Now, we’re learning that GlaxoSmithKline, a British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant made in their Puerto Rico plant, despite warnings from their own quality control manager that the plant had problems.

Cheryl D. Eckard, GlaxoSmithKline’s quality manager, asserted in her whistle-blower suit that she had warned of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.

In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care.

Ms. Eckard’s role in the case began in August 2002 when GlaxoSmithKline sent her to Cidra, south of San Juan, to lead a team of 100 quality experts to fix problems cited by an F.D.A. warning letter a month earlier.

This was GlaxoSmithKline’s premier manufacturing facility, producing $5.5 billion of product each year. But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

She complained to top company executives, but she was ignored even after warning that she would call the F.D.A. So she called the F.D.A. and sued. The agency began a criminal investigation and used armed federal marshals in 2005 to seize nearly $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GlaxoSmithKline closed it in 2009.

If you or someone you love has been harmed by one of these defective drugs, you may be entitled to financial compensation. Please contact an experienced defective drugs attorney for professional insight.

Source: GARDINER HARRIS and DUFF WILSON of The New York Times.

Agency working with trade associations to increase company vigilance and protect public

In a letter sent to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

The FDA has noted the three most common categories of these illegal products:

* Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
* Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
* Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Source: U.S. Food and Drug Administration