Archive for August, 2009

FDA Investigating Alli, Xenical Liver Injury Reports

Alli and Xenical are undergoing a safety review because of reports linking the drugs to liver injuries.  Alli, which is sold over-the-counter,  and prescription Xenical are versions of orlistate.

Despite the ongoing safety review, the Food & Drug Admnistration (FDA) is not advising healthcare professionals to change their prescribing practices with orlistat. The agency said consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed. However, users of either drug should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite. (more…)

Qualitest Recalls Accusure Insulin Syringes

Users of Accusure Insulin Syringes should be aware that two lots of these devices have been recalled.

This recall involves Accusure Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-2. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico).   The recall also includes Accusure Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21  This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico).  The  lot number can be found on the white paper backing of each individual syringe. (more…)

Teeth Staining Prompts Crest Pro-Health Mouthwash Lawsuit

Popular  Crest Pro-Health mouthwash is the subject of a Michigan lawsuit that claims it causes unsightly stains to form on teeth.  The lawsuit seeks class action status.

The plaintiff in the Michigan lawsuit claims to have “always taken exemplary care of his teeth”. Before he had used 3/4 of a bottle of Crest Pro-Health, unsightly brown stains – not present before he began using the rinse – had appeared between his teeth.  The lawsuit claims Proctor & Gamble does not warn about the Crest Pro-Health staining issue, and alleges that the company knows that if it did so, many people would not buy the product.   The lawsuit also alleges that Proctor & Gamble had knowledge of the staining issue, and violated the Michigan Consumer Protection Act by not putting a warning regarding tooth discoloration on the Crest Pro-Health label. (more…)

CPSC Says No Radiation in Chinese Drywall

Chinese drywall does not pose a radiation hazard, according to the Consumer Products Safety Commission (CPSC). Investigations aimed at determining what other hazards might be posed by Chinese drywall are ongoing.

Consumers in 24 states have filed a total of 1046 Chinese drywall complaints with the CPSC. Gases emitted from the drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor, similar to fireworks or rotten eggs, that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode. (more…)

FDA Warns Firms Marketing Unapproved Ibuprofen Pain Gels

The Food & Drug Administration has sent warning letters to 8 firms for marketing uapproved over-the-couter (OTC) topical ibuprofen pain gels.

While orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation, there are no approved applications for topical ibuprofen products. (more…)

CASPPER Used by Glaxo to Ghostwrite Paxil Articles

GlaxoSmithKline used a sophisticated program known as CASPPER to prepare ghostwritten Paxil articles for publication in medical journals, according to the Associated Press.

Documents detailing the CASPPER program were uncovered by attorneys representing plaintiffs in  Paxil lawsuits, according to the Associated Press.  Lawsuits allege that Glaxo downplayed Paxil’s association with serious side effects, such as suicide and birth defects. (more…)

Eli Lilly Settles W. Va Zyprexa Lawsuit for $22.5 Million

The state of West Virginia has struck a $22.5 million settlement with Eli Lilly over claims the drug maker improperly marketed Zyprexa.  West Virginia was seeking reimbursement for Medicaid money spent on the Zyprexa.

Under the terms of the West Virginia Zyprexa settlement, Eli Lilly will pay $15.75 million to West Virginia and $6.75 million to lawyers representing the state.  Of the state’s share, $14.75 million is to be used to fund behavioral mental health services and $1 million for consumer protection purposes in the state, Bloomberg.com said. In addition to the payment, the West Virginia Zyprexa settlement also imposes restrictions on Eli Lilly regarding Zyprexa marketing.  (more…)

Canadian Study Raises More Concerns Over Avandia

Elderly diabetics taking Avandia face a higher risk of heart failure and death than those taking  Actos, a new study conducted by Canadian researchers has found.  According to a Reuters report, the findings prompted the authors of the study to question the continuing use of Avandia.

“Given the accumulating evidence of harm with rosiglitazone (Avandia) treatment and the lack of a distinct clinical advantage for the drug over pioglitazone (Actos), it is reasonable to question whether ongoing use of rosiglitazone is justified,” the study authors wrote in the British Medical Journal. (more…)

Seeking Answers to Drywall Problem, Senator Visits China

A U.S. Senator was in China last week seeking more cooperation in solving the massive   defective Chinese drywall problem.  According to a press release from his office, Senator Bill Nelson’s (D-FL)  China stop was part of a twelve-day trip he took as a member of the Senate Intelligence Committee.

In February, Nelson called on the CPSC for an investigation of problems in homes constructed with the imported drywall, and for an interim ban on the product.  He and Sen. Mary Landrieu, a Louisiana Democrat, then filed legislation aimed at initiating a recall of defective Chinese drywall, as well as a ban on the material. (more…)

“Fume Events” on Airplance Could Result in Toxic Exposure

Could airplane air be exposing people to toxic chemicals? Evidence is accumulating that it may.

Critics of the airline industry claim that the system used to re-circulate air in airplanes does not remove fumes or vapors from the engine. The process involves combining re-circulated existing cabin air with air bled off the engines. The air pulled into the engines is cooled and compressed before it is pumped into the cabin. If this system malfunctions, chemical contaminants can  end up circulating through the airplane, creating a so-called fume event. (more…)