Monday, June 30, 2008

Dangerous Lawn Mowers

A video worth watching as summer and lawn mowing season move foward in earnest:

About 85,000 Americans land in hospital emergency rooms with injuries sustained while mowing the lawn, according to the Consumer Product Safety Commission. And the authors of a 2006 study at the Johns Hopkins Bloomberg School of Public Health concluded the number of injuries is rising, with most happening to people younger than 15 or older than 60. Source.

Thursday, June 26, 2008

Paxil: FDA In the Dark About Drug's Problems

The WSJ's Alicia Mundy has a report on how lawsuits over GlaxoSmithKline’s handling of information about the suicide risk from Paxil reveal documents "that say a lot about why the FDA often seems to be in the dark when problems with drugs" start showing up post approval. Source.

What is disturbing about the report: In the papers produced in the litigation was an exchange between lawyers suing Glaxo over Paxil and attorneys defending the company. "The upshot: FDA may not even have known all the information to ask for about Paxil. "

More at the link above. The real upshot? Once again there is another report about the FDA being left in the dark. Wow, what a surprise.

Friday, June 20, 2008

VA Will Warn Vet about Chantix

The Veterans Affairs Department will mail out notices to nearly 33,000 veterans who are taking the anti-smoking drug Chantix, warning them about possible side effects, including thoughts of suicide.

VA Secretary James Peake said VA doctors will continue to prescribe the drug because they are seeing no serious problems or trends with its use.

Source: Here.

Tuesday, June 17, 2008

New FDA Report on Heparin

The FDA updated the number of deaths of patients who took heparin, nearly doubling it to 149. The FDA reported the new death toll of patients who took heparin.

For more, go here.

Friday, June 13, 2008

Georgia Watch - Georgia State Court Annual Report

The Georgia Court Watch issued its annual report on appellate courts.

ATLANTA – Court Watch today released its first annual report analyzing consumer-related decisions issued by the Supreme Court of Georgia and the Georgia Court of Appeals. Court Watch is a project of Georgia Watch, a nonprofit and nonpartisan group committed to strengthening the rights of consumers in Georgia .

The “2007 Annual Report” identifies and profiles the most noteworthy consumer-related decisions released by the appellate courts throughout the year, and identifies emerging trends.

“Many of the decisions reached by the state Supreme Court and Court of Appeals significantly impact the rights that consumers have under law,” said Georgia Watch Executive Director Allison Wall. “Georgia Watch launched this project to provide ongoing, thoughtful, fact-based analysis.”

Notable consumer cases discussed include:

* Glenn v. State, a case in which the court upheld Georgia ’s Payday Lending Law. Two individuals convicted of issuing payday loans argued that the statewide ban on payday lending was unconstitutionally vague and did not specifically prohibit the schemes they utilized in issuing loans, such as a “sales-leaseback” of a cell phone or coffee maker. The lenders also claimed they were not subject to the ban because they were located out-of-state.

* Kaminer v. Canas, in which the court upheld the two-year statute of limitations for medical misdiagnosis, regardless of futures failures to properly diagnosis, even in the presence of a patient’s additional or significantly worsened symptoms. In Georgia , a claim must be filed within two years of the date of the first misdiagnosis, whether or not the patient knows they have been misdiagnosed. In Kaminer v. Canas, the patient unsuccessfully argued that repeated misdiagnosis over a decade of treatment by multiple medical providers should have restarted the statute of limitations.

* Dees v. Logan, in which the court established that insurance companies are prohibited from creating offset clauses to reduce the amount owed to drivers who purchased uninsured motorist (UM) insurance. Offsets deny policyholders benefits already purchased that are needed to cover medical and property damage resulting from an accident with an underinsured driver. The court ruled that insurance policies containing offsets for personal injury benefits are in conflict with Georgia ’s Uninsured Motorist Act. This year, the Georgia General Assembly responded to this decision by passing Senate Bill 276, which expressly permits insurance carriers to use offsets for workers’ compensation benefits, effectively overturning part of this decision. SB 276 also expanded drivers’ access to UM coverage.

“Generally speaking, Georgia laws are not consumer-friendly,” Wall said. “As this report demonstrates, our courts generally follow those laws unless they explicitly run afoul of the state constitution.”

The Court Watch Fellowship is a collaborative effort of the 2007 Court Watch Fellowship recipient and primary researcher, Nathan Gaffney, and the Court Watch Advisory Committee, which includes three members of the Executive Committee of the State Bar of Georgia Board of Governors.

“Any contention that our appellate judges are activists who stray from the letter of the law is not supported by these decisions concerning consumer rights,” said Tom Stubbs, Court Watch Advisory Committee member. “Indeed, even when statutes can reasonably be interpreted in different ways, our courts have a pronounced bent not to interpret them so as to enhance protection of consumers in our state.”

Did Glaxo Suppress Paxil Safety Data and "Bamboozle" the FDA?

A U.S. Senator thinks so.

From various reports: GOP Senator Grassley has asked the FDA to study an overseas report issued several months ago that concluded that Glaxo suppressed Paxil data going back to 1998. Glaxo had said risks came to light in in 2006.

``It looks like GlaxoSmithKline bamboozled the FDA,'' Grassley said this week. speech. ``We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public." Per Bloomberg.

Well Senator, we do and it's not going to change unless there is a seismic shift in the way the FDA does business.

Thursday, June 12, 2008

FDA's Abysmal Failures

This time, tomatoes.

From various reports:

"As foodborne illness outbreaks continue, FDA is missing valuable opportunities to reassure Congress and the public that it is doing all it can to protect the nation's food supply," said the report by the investigative arm of Congress. Source.

One word used by Bart Stupak, chairman of the House subcommittee on oversight and investigation aptly describes this mess. "Pathetic."

This is an agency that is supposed to address safety when it comes to unsafe drugs, but can't even get to the source of bad vegetables. "Too bad that the federal government and the FDA have bowed to big corporate interests in refusing to fund or implement U.S. law requiring country-of-origin labeling for produce: labeling that could have nipped this latest outbreak in the bud." So says Mr. Dobbs. The FDA may "never" find the source.

Video here.

Monday, June 09, 2008

Epilepsy Drugs (Topamax and others) to get Suicide Warning

The FDA is in the final states of including language warning about suicidal behavior on labels of 11 epilepsy drugs. Sales of the affected drugs, widely used for nonepilepsy problems such as chronic pain, topped $8 billion last year.

From various sources, including the WSJ Blog.

The drugs include:

* Carbatrol, Equetro, Tegretol, Tegretol XR,
* Felbatol,
* Neurontin,
* Lyrica,
* Gabitril,
* Topamax, and
* Depakote

Regranex Warning from the FDA

Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

For more, go here.

Thursday, June 05, 2008

News on Tumor Necrosis Factor Blockers

Tumor Necrosis Factor blockers like Remicade, Enbrel, Humira, and Cimzia may be impacted by a recent FDA investigation.

From the FDA:

The FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases. JIA is the new name for what was called Juvenile Rheumatoid Arthritis (JRA).

Source here.

Tuesday, June 03, 2008

More Bad News on Chantix

Hundreds of accidents have been linked to Chantix according to a study by outside researchers. The report was issued by the Institute for Safe Medication Practices.

The researchers say the number of convulsions for people taking Chantix is at least 86 since the drug went on the market in 2006. (Per the WSJ Blog).The WSJ Blog is worth a read.

Monday, June 02, 2008

FDA: Baby Formula Recalled

Two lots of baby formula have been recalled.

Abbott Laboratories says it is voluntarily recalling two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder.

The formula is specially designed for infants and children with hypercalcemia - high levels of calcium - in their blood.

The FDA web site says the formula was distributed in Canada and the U.S. between June 6, 2006 and April 17, 2008. It is only available by special order.

The recall is limited to Calcilo XD in 400g cans, with stock code number 00378 and lot numbers 39973RB or 47239RB6 printed on the bottom of the cans. No other Calcilo XD powdered infant formulas are affected.

The company says small amounts of air may have entered the can, resulting in oxidation of the formula, which can often be detected by an off odour.

The FDA says consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. If parents have questions or concerns, the release says they should contact a health care professional.

Source here.

Depo Provera Class Action in Canada

From Bloomberg:

Pfizer's being sued by Canadian women who claim the company failed to provide proper notice the contraceptive Depo-Provera causes loss of bone density. The pending case won a broad (for Canada) national class-action certification.

For more go here.