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CPSC, Chinese Regulators Meet Over Chinese Drywall

Officials from China’s General Administration for Quality Supervision, Inspection and Quarantine (ASIQ) arrived in the U.S. the week of June 15 to investigate problems with drywall made in their country.

According to heraldtribune.com, officials from the Consumer Products Safety Commission (CPSC) met with  the ASIQ regulators earlier this month to discuss technical issues involving Chinese drywall.  The Chinese officials also traveled with a CPSC investigative team to observe inspections and sampling conducted by our agency in one home in Florida and two homes in Louisiana. A spokesperson for the CPSC told heraldtribune.com that discussions with the Chinese delegation were “preliminary”, and had not reached any conclusion.  The discussions will continue over the coming weeks. (more…)

Health Canada Announces Recall of PMS-Phenobarbital Tablets

Potentially over-sized pms-Phenobarbital tablets are being recalled in Canada.  According to Health Canada, the pms-Phenobarbital may pose an overdose risk.

Symptoms of a Phenobarbital overdose may include uncontrolled eye movements, lack of muscle coordination, impaired speech, extreme drowsiness, decreased breathing and heart rate and may begin within 1-2 hours after taking a Phenobarbital overdose. An overdose may be life threatening and can result in a coma and/or cardiac arrest, Health Canada warned. (more…)

European Studies Point to Possible Lantus Cancer Risk

Several European studies have raised concerns that patients taking the insulin analogue Lantus could be at a higher risk of developing cancer.

The Lantus cancer risk was seen in three of four retrospective studies involving a total of 301,136 insulin-treated patients in Germany, Sweden and Britain, Reuters said.  According to a Wall Street Journal report, The Swedish study found double the risk of breast cancer among Lantus patients.  Ae German study found that patients taking Lantus for an average of 18 months had a 9% higher risk of being diagnosed with cancer.  Those taking a higher dose of Lantus had a 31% higher risk, the Journal said.   (more…)

Roche Pulls Accutane

Following  years of controversy and lawsuits, Roche AG has decided to pull Accutane from the market.

Roche said Accutane will be pulled in the U.S. and 11 other countries. The last date for distribution in the United States was June 25. According to Reuters, Accutane is now no longer available from Roche directly but patients may still be able to get it from pharmacies. (more…)

Drug Co. MSLs Can Discuss Off-Label Use

The Wall Street Journal has an interesting article about one of the ways drug companies could legally circumvent rules against off-label drug promotions.   The use of  medical science liaisons (MSLs) – personnel considered to be part of a drug firm’s medical staff – could allow companies to communicate information about off-label uses  to doctors in ways that traditional drug reps cannot.

While doctors are free to prescribe approved drugs in any way they see fit,  drug companies are not allowed to promote off-label uses.  However,  according to The Wall Street Journal,  the firms  may respond to unsolicited requests for information from doctors, including off-label data, if they provide truthful, nonpromotional material. (more…)

Generators Recalled

About 450 PowerPlus Generators are being recalled by Big Muddy Sport.   According to the recall notice,  the 220-volt receptacle  on the generators can fail to produce power correctly and cause power surges that can damage appliances. This poses a risk of fire and possible injury to consumers.

The generators were sold at Buchheit retail stores in Illinois and Missouri during May 2009 for about $700. Consumers should immediately stop using the recalled generators and return them to any Buchheit store for an exchange or full refund. (more…)

Report Says Nestle Plant at Center of E. Coli Outbreak Refused FDA Records Requests

The Wall Street is reporting that during some inspections conducted over the last five years, a Nestle USA manufacturing facility at the center of a multistate E. coli outbreak refused  to allow the Food & Drug Administration (FDA) access to records regarding customer complaints, pest control and contamination prevention programs.  What’s more, officials at the Nestle USA facility in Danville, Virginia were legally allowed to do so.

According to the Journal, in most instances, companies  are not required to show those types of records to the FDA, and such refusals are not uncommon. The FDA can only compel food firms to turn them over if it invokes a bioterrorism law, and can show that foods made at a facility pose a serious health threat.  The only exception to this are facilities that produce infant formula, seafood, juices and low-acid canned food, the Journal said. (more…)

Health Canada Revises Piroxicam Label

A piroxicam safety review conducted by Health Canada has resulted in a labeling change for the drug in that country.  The revised Canadian piroxicam label will reflect an increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs, the agency said.

According to Health Canada, its safety review determined that the risks associated with the  use of piroxicam as a treatment for acute, short-term pain no longer outweigh the benefits relative to other non-selective NSAIDs. Piroxicam can still be prescribed for the symptomatic relief of chronic pain and inflammation in patients suffering from certain types of chronic arthritis (osteoarthritis, rheumatoid arthritis and ankylosing spondylitis). (more…)

Breast Growth in Boys Linked to Risperdal

Male breast growth, a condition known as gynecomastia, has been seen in boys taking the drug Risperdal. The condition  is usually permanent, and in most cases, boys with Risperdal-associated gynecomastia must undergo breast reduction surgery or  mastectomy to correct theproblem.

These surgical procedures are painful.  And the psychological problems suffered by many of these Risperdal victims can be even more difficult.  That is why many families of these boys have chosen to file  lawsuits against Janssen, the maker of Risperdal.  According to a recent CBS News report, such lawsuits claim Janssen marketed Risperdal for unapproved uses in children, and downplayed serious side effects.   These lawsuits point out that  breast growth wasn’t even mentioned under the “Warnings” section of the Risperdal label, but was only listed under “Precautions.”   They also allege that the language regarding gynecomastia in the Risperdal label was worded in “obscure” terms. (more…)

Group Says Gardasil Side Effects Getting Worse

A conservative group claims that Gardasil side affects appear to be getting worse.  According to Judicial Watch, there were 28 deaths following Gardasil injections reported to the Food & Drug Administration (FDA), up from 19 deaths in 2007.  In total, there have been  47  deaths reported since 2006 Judicial Watch said.

The group said it obtained Gardasil  side effect report information from the FDA’s Vaccine Adverse Event Reporting System (VAERS).   Of the 47  deaths reported to VAERS since 2006,  Judicial Watch said 41 occurred within a month of receiving the vaccine, and of those 17 were within two weeks of receiving the vaccine. In most of the deaths the cause is still unknown. (more…)

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