TMJ 'dysfunction' - Health implications

Latest FDA Watch List: 2 Drugs, All Acetaminophen Products
Robert Lowes
Disclosures May 06, 2013

The US Food and Drug Administration (FDA) has added a drug for multiple sclerosis (MS), another drug for a blood disorder, and all acetaminophen-containing products to its quarterly list of products to monitor because of possible signals of serious risks or new safety information.

The agency received reports of possible adverse events for these products in the FDA Adverse Event Reporting System (FAERS) database during the fourth quarter of 2012. Making the watch list does not mean that the FDA has determined that the drug poses the specific health risk reported through FAERS. What it does mean is that the FDA will investigate whether there is a causal link. If the answer is yes, the agency would consider a regulatory move such as gathering more data to better describe the risk, revising the drug's label, or requiring a risk evaluation and mitigation strategy.

By putting a drug on the watch list, the FDA is not suggesting that clinicians should stop prescribing it or that patients should stop taking it, the agency says.

All products containing acetaminophen appear on the latest watch list because of reports of severe skin reactions. Dermatologic disorders are known adverse reactions associated with these analgesics.

Fingolimod (Gilenya, Novartis Pharmaceuticals), indicated to reduce relapses and delay disability progression in patients with MS, was added to the list after FAERS received reports of hemophagocytic syndrome, a rare and potentially fatal disease of normal but overactive histiocytes and lymphocytes.

The FDA also added anagrelide (Agrylin, Shire), approved for thrombocythemia secondary to myeloproliferative disorders, because of reports of torsades de pointes, a rare and life-threatening heart arrhythmia.

Potential Signals of Serious Risks/New Safety Information Identified by FAERS, October to December 2012

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information
Acetaminophen-containing products Severe skin reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action
Anagrelide HCl (Agrylin, Shire) Torsades de pointes FDA is continuing to evaluate this issue to determine the need for any regulatory action
Fingolimod (Gilenya, Novartis Pharmaceuticals) Hemophagocytic syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action
More information on FAERS and its quarterly watch list is available on the FDA Web site.

http://www.medscape.com/viewarticle/803 ... c=168179CY

Pfizer to pay $142M for drug fraud

Sales of drug total $300M annually in Canada

CBC News

Posted:Mar 26, 2010 11:00 AM ET
Last Updated:Mar 26, 2010 3:28 PM ET

Pharmaceutical giant Pfizer has been ordered to pay $142 million US in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin.

A federal jury in Boston ruled Thursday that Pfizer fraudulently marketed the drug and promoted it for unapproved uses. The jury sided with California-based Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals, the first to try a gabapentin case against Pfizer.

Data revealed in a string of U.S. lawsuits indicates the drug was promoted by the drug company as a treatment for pain, migraines and bipolar disorder — even though it wasn't effective in treating these conditions and was actually toxic in certain cases, according to the Therapautics Initiative, an independent drug research group at the University of British Columbia.

The trials forced the company to release all of its studies on the drug, including the ones it kept hidden.

A new analysis of those unpublished trials by the Therapeutics Initiative suggests that gabapentin works for one out of every six or eight people who use it, at best. The review also concluded that one in eight people had an adverse reaction to the drug.

"The much larger majority of people will not get any benefit and many of them will have chronic neurotoxicity or poisoning of the brain," said Dr. Tom Perry of the Therapeutics Initiative.

Dr. Harry Pollett, a pain specialist in North Sydney, N.S., calls gabapentin a so-so drug with potentially serious side-effects for patients. These include drowsiness, balance problems, fogginess and edema, or swelling.

"Weight gain is a very common problem and I see that a lot," Pollett said.

The drugs represent a waste of money for Canada's health-care system, said Perry, who questioned why some doctors continue to encourage people to take the drug even though the patients are not benefiting.

"We have been using probably somewhere in the order of around $300 million a year in Canada recently and this drug has been overused since the late 1990s," Perry said. "So, do the math. It's probably well in excess of a billion dollars."

Pfizer defends its actions and its drug. The company has already been hit with $430 million in penalties and fines for fraudulently promoting gabapentin in the U.S.