March 22, 2010
Reuters: Saudi Arabia suspends Avandia for Six Months
Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has become the first healthcare regulator to suspend GlaxoSmithKline’s (GSK) controversial diabetes drug Avandia, citing that the drug’s potential risks outweigh its benefits. The SFDA decided this month that it will suspend Avandia, along with any detailing or advertising of the drug, for six months. According to the SFDA, this decision is based on growing scientific evidence against Avandia, or rosiglitazone, which indicates that the drug can lead to severe cardiovascular risks, including heart attacks. The suspension is not permanent and will give GSK six months to provide reasons to keep the drug on the market and supply data that demonstrates Avandia’s safety.

March 4, 2010
Wall Street Journal:  FDA’s Office of Criminal Investigation to Boost Prosecutions of Executives
The Food and Drug Administration’s criminal division has announced plans to increase prosecutions of pharmaceutical and food industry executives. The announcement coincides with a report set to be released on March 4, 2010 by the Government Accountability Office which criticizes the FDA’s Office of Criminal Investigations (OCI). The government report states that the OCI has operated autonomously for some time with very little accountability to top FDA officials. The report added that the agency’s criminal division has fallen short in performance standards compared to other agencies, although its budget rose 73 percent between 1999 and 2008.

FDA officials said they agree with the report’s findings and hope to refocus the agency’s criminal office with increased prosecutions. The FDA wrote a letter to Sen. Chuck Grassley (R., Iowa) which stated that the FDA will “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.” The FDA declined to specify which kinds of wrongdoing its criminal office will pursue.

January 5, 2010
Wall Street Journal: Antidepressants May Not Help the Mildly Depressed, Study Finds
A new meta-analysis released on Tuesday suggests that patients with less-severe depression see little or no benefit from antidepressant medications while those with severe symptoms do see benefits.  Researchers analyzed the results of six studies which involved 718 patients ranging from mildly depressed to severely depressed and evaluated their reactions to antidepressant drugs, like GSK’s Paxil.  The findings, published in this week’s Journal of the American Medical Association, stated that "There is little evidence to suggest that [antidepressants] produce specific pharmacological benefit for the majority of patients with less severe acute depression."

November 30, 2009
Law 360:  Court Rules Generic Drug Makers Must Provide Adequate Labeling
A three-judge panel of the U.S. Court of Appeals for the Eight Circuit has ruled that generic drug manufacturers must provide adequate warnings on the labels of their medication.  The significant ruling is the first federal preemption case of this kind to be decided on the appellate level. The ruling reverses an earlier decision by the U.S. District Court for the District of Minnesota. While finding the generic drug makers responsible, the appellate court also found that the plaintiff had no claim against brand-name manufacturers since she had not ingested any of their medication.

The plaintiff originally sued Wyeth Inc., and others after developing a disabling neurological disorder called tardive dyskinesia four years after taking a generic form of the drug Reglan (metoclopramide). According to the plaintiff’s complaint, the risk of tardive dyskinesia was not clearly indicated on the label. The complaint also alleged that the drug was promoted for long-term use, although the FDA only approved it for short-term use since the risk of tardive dyskinesia grows significantly with use longer than 12 weeks. According to court documents, 70 percent of metoclopramide prescriptions are now filled by generics.

September 25, 2009
Reuters: Study Finds SSRI’s Taken Early in Pregnancy Double Risk of Birth Defect
Researchers from Denmark’s Aarhus University were surprised to find that taking certain antidepressants in the early stages of a pregnancy may lead to double, and in some cases triple, the risk of certain birth defects.  The study, published in the September 25th Online First issue of BMJ, tied the use of selective serotonin reuptake inhibitors (SSRI) such as Prozac and Zoloft with a heart defect involving a piece of tissue that separates parts of the heart.  According to the study, taking Prozac doubled the risk of this defect, taking Zoloft more than tripled it and taking more than one SSRI pushed the risk of having a baby with this particular heart defect to nearly five times more likely.

August 19, 2009
The Globe and Mail:  New Study Finds Avandia more Dangerous Than Counterpart
A new study published in the British Medical Journal has led Canadian scientists to conclude that continued use of the diabetes drug Avandia may not be justified.  In the latest blow to GlaxoSmithKline’s blockbuster drug, new findings show that diabetics who take Avandia are more likely to suffer heart failure or death than those taking its counterpart, Takeda Pharmaceutical’s Actos.  Both Avandia and Actos are used to treat patients suffering from type 2 diabetes and both medications pose a risk of fluid retention and heart failure in some patients.  According to the new research, however, Actos may be a much safer alternative.  According to the findings, for every 120 diabetics taking Avandia instead of Actos, one additional hospitalization due to heart failure would occur and for every 269 patients taking Avandia instead of Actos, there would be one additional death.

August 18, 2009
Milwaukee Journal Sentinel:  FDA to Determine BPA safety by Nov. 30,
Based on Pending Review of New Research
The Food and Drug Administration announced that it will determine by Nov. 30 whether bisphenol A is safe for use in food and beverage containers.  The FDA announced their timeline on Aug. 17, stating that the decision will be based on a pending review of new studies on the controversial chemical.  Many environmental activists have criticized the timeline, accusing the FDA of delaying the decision.  Numerous recent studies have linked the chemical to heart disease, diabetes and breast cancer.  The new FDA analysis will include more than 100 new studies, including those that included low doses of BPA.

July 30, 2009
Bureau of National Affairs: House Passes Food Safety Bill Requiring FDA Assessment of BPA
On July 30, 2009, the House of Representatives passed a food safety bill that would potentially compel the FDA to make a determination about the safety of the controversial chemical Bisphenol A.  If passed, Section 215 of the Food Safety and Enhancement Act of 2009 will require the FDA to inform Congress whether there is reasonable certainty of no harm associated with BPA, according to available scientific data.   The FDA will have to decide, by the end of 2009, if the available data supports the conclusion that infants, young children, pregnant women and adults are not in danger when using polycarbonate plastic and epoxy resin containing BPA.  The bill would further require the agency to propose restrictions on the chemical if the determination is not made.  The Senate does not currently have a companion bill

May 11, 2009
FDA:  A-S Medications Solutions LLC Announces Nationwide Digoxin Recall
On May 11, 2009, A-S Medications Solution LLC announced a nationwide recall of all lots of digoxin tablets 0.25mg due to size variability.  The voluntary recall pertains to Caraco brand Digoxin tablets, USP, 0.25 mg, that were distributed before March 31, 2009, which are not expired and are within the expiration date of August, 2011.  The recalled tablets may differ in size, having more or less of the active ingredient, digoxin.  Excessive digoxin intake can lead to digoxin toxicity, which can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, slow heart rate and even death.  Also, a lower than labeled digoxin dose can lead to heart failure or abnormal heart rhythms, the very two ailments that digoxin is meant to treat.

April 29, 2009
Healthcare Finance News: Proposed Bill Seeks More FDA Oversight of Foreign Medical Cos.
Sens. Chuck Grassley, R-Iowa, and Edward Kennedy, D-Mass., have proposed a bill that would give the FDA more authority in their scrutiny of foreign medical device and drug manufacturers.  The bill, called the Drug and Device Accountability Act of 2009, was presented on April 23.  It will potentially allow the FDA to hold foreign drug Class II and Class III device manufacturers accountable for unsafe manufacturing practices.  It would also require these companies to receive FDA certification and submit to more frequent inspections.  The bill comes after recent “troubling findings” regarding the agency’s handling of foreign drug companies.

April 27, 2009
Chemical and Engineering News:  FDA Sends Warning Letters to Chinese Suppliers of Heparin
The FDA has cited two Chinese suppliers of the blood thinner, heparin, for failing to follow safe drug manufacturing practices.  In warning letters sent to Shanghai No. 1 Biochemical & Pharmaceutical and manufacturer Qingdao Jiulong Biopharmaceuticals, the FDA continued its probe into contaminated Chinese-made heparin, which last year was linked to 80 deaths in the U.S. The letters reinforce the FDA’s investigation into the companies’ involvement with the manufacture and marketing of the faulty heparin.

March 31, 2009
Sun Herald: Caraco Pharmaceutical Laboratories, Ltd. Voluntarily
Recalls All Lots of Digoxin Tablets Due to Variability in Pill Size
Generic pharmaceutical company Caraco Pharmaceutical Laboratories, Ltd. has voluntarily recalled all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.  According to the company’s press release, the recalled tablets may differ in size and could have the wrong amount of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.  The recall caused concern since digoxin toxicity, caused by excessive digoxin intake, can cause nausea, low blood pressure, cardiac instability and death.  Consumers are urged to return the recalled product to their pharmacy or place of purchase.

March 10, 2009
Philly.com: U.S. Supreme Court Resuscitates Antidepressant Lawsuits
On March 9 , 2009, the U.S. Supreme Court revived two lawsuits blaming Pfizer Inc. and a GlaxoSmithKline P.L.C. unit for failing to warn that their antidepressants might cause suicidal tendencies in adults.  In light of the previous Supreme Court decision giving patients more ability to sue drug makers, the justices asked the U.S. Court of Appeals for the Third Circuit in Philadelphia to reconsider the suits, which they had previously rejected.  The lawsuits are being pushed by survivors of a woman and a man who killed themselves after taking Glaxo’s Paxil and Pfizer’s Zoloft, respectively.

February 25, 2009
Law 360: Manhunt Underway for President of Company Accused
of Shipping Bacteria-Laden Syringes
There is currently an international manhunt for the president of AM2PAT, a company who is accused of knowingly shipping bacteria-laden pre-filled syringes that have led to at least five deaths and sickened hundreds of people.  The former president of Raleigh, N.C.-based AM2PAT, Dushyant Patel, is believed to be hiding out in his native India, although this is not confirmed.  Patel has been charged with fraud and adulterating medical devices.  Two others who worked at AM2PAT, a manager and quality control inspector,  pled guilty and were sentenced to 54 month prison terms.  AM2PAT syringes were pulled from the market in 2007 after reports linked the syringes to infections of the urinary tract and circulatory system.  Sales of AM2PAT pre-filled syringes were at $6.9 million in 2006 and 2007.

January 30, 2009
Wall Street Journal Health Blog: GSK takes $400M hit
pending investigation into "off-label" drug marketing
GlaxoSmithKline is taking a $400 million legal charge in the fourth quarter because of an investigation into the sales and marketing practices from 1997 to 2004 of nine of its blockbuster drugs, said the company. The Colorado U.S. Attorney's Office are said to be looking into the "off-label" marketing of GSK’s best selling antidepressants Wellbutrin SR and Paxil, amongst others. According to the Wall St. Journal, Glaxo didn’t specify whether it was moving toward a settlement, but said its decision to take the charge “reflects the current status of the investigation, and is based upon the company’s most recent evaluation of the matter.”

January 30, 2009
CNN Money: Pharmaceutical giant Eli Lilly pleads guilty in Zyprexa case
Pharmaceutical giant Eli Lilly and Company (LLY, Fortune 500) pleaded guilty Friday to a misdemeanor charge of ‘off-label’ marketing of their anti-psychotic drug Zyprexa. According to federal prosecutors, the company illegally promoted the drug for uses not approved by the Food and Drug Administration. As a part of the plea agreement and civil settlement, Eli Lilly was ordered to pay a total penalty of over $1.4 billion. A portion of the penalty is a fine of $515 million, which is the largest criminal fine ever imposed in a U.S. criminal prosecution for an individual corporation.

January 28, 2009
Reuters.com: Study finds BPA may stay in body longer than previously believed
According to a new government health survey, bisphenol A, or BPA, a controversial chemical used in many plastic products, may remain in the body longer than previously thought. The study, conducted by Dr. Richard Stahlhut of the University of Rochester and colleagues, found that significant BPA levels remained in the body even in people who had fasted for 24 hours. Researchers also believe that people may be ingesting the potentially dangerous chemical from sources other than food, such as tap water or house dust. The precious belief was that BPA quickly and completely exited the body through urine. The FDA has no immediate plans to stop the use of the chemical in products such as baby bottles and food cans.

January 9, 2009
FDA News: FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC
The Food and Drug Administration reached an agreement with Generic-drug maker Actavis Group regarding the company’s Actavis Totowa LLC subsidiary. The Consent Decree requires Actavis to halt production and distribution of products manufactured at its U.S. subsidiary’s New Jersey plant in order to upgrade the facilities to meet the FDA’s manufacturing standards. The consent decree follows a lawsuit filed in November by the U.S. Department of Justice which claimed that a series of regulatory inspections had exposed problems with the company's manufacturing practices. The complaint also sought a permanent injunction to block the company from manufacturing and distributing drugs. Actavis Totowa makes the heart failure drug digoxin (Digitek), which was recalled in April after tablets made double thick and twice as potent were released to the market.

December 17, 2008
FDA News: FDA Announces New Recommendations on Evaluating Cardiovascular Risk
in Drugs Intended to Treat Type 2 Diabetes
On December 17, 2008, the US Food and Drug Administration announced new recommendations regarding the evaluation and approval of drugs for type 2 diabetes, urging drugmakers to provide evidence that their product will not increase the risk of cardiovascular events such as a heart attack. The recommendation is effective immediately and specifically calls for manufacturers to demonstrate that developing antidiabetic therapies do not increase cardiovascular risks in comparison with existing therapies. The FDA also recommended stronger and more adequate design data and collection approaches in clinical trials than were previously expected. The FDA also warned that longer trials are likely under the new guidelines.

December 13, 2008
Los Angeles Times: Meta-analysis of clinical trials finds Avandia
doubles bone fracture risk in women
According to a new analysis of large clinical trials, long-term use of diabetes drugs such as Avandia and Actos can double the risk of bone fractures in women. The meta-analysis of clinical trials was reported online on Wednesday, December 10, 2008 in the Canadian Medical Association Journal. Experts say that since women are already at a higher risk of fractures, the doubling of this risk is alarming. This evidence adds to the growing list of risks associated with Avandia, including heart attack and death. According to the study, the fracture risk did not increase for men.

November 21, 2008
Federal judge orders GSK to release ad campaign documents
Federal Judge J.P. Stadmueller has ordered detailed information from GlaxoSmithKline PLC regarding the Wisconsin advertising of their antidepressant drug Paxil. The order comes as a part of a product liability case filed by Baum Hedlund Aristei & Goldman PC and Cramer Multhauf & Hammes LLP on behalf of Gary L. Forst, who claims the drug was a factor in his March 2004 suicide attempt. The judge said the documents requested "are relevant to the Forsts’ claims that GSK acted negligently when it failed to adequately warn physicians and consumers about increased suicide risk."

November 19, 2008
Morningstar: Rep. Barton Calls for Review of FDA's Handling Of Heparin Scandal
Dow Jones:  Rep. Joe Barton, R-Texas, raised questions concerning conflicting statements the Food and Drug Administration made regarding the number of deaths linked to contaminated batches of the blood thinner heparin. Mr. Barton, the ranking member of the House Energy and Commerce Committee, sent a letter to the Government Accountability Office on Wednesday, November 19, 2008, stating concerns that the FDA misreported deaths tied to the blood thinner and failed to thoroughly investigate the problem. The manufacturer of the tainted heparin, Baxter International Inc., conducted its own investigation and maintains that their product was not the cause of three cases.

October 17, 2008
Health Canada: Canada bans polycarbonate baby bottles that contain Bisphenol A
On October 17, 2008, the Government of Canada became the first country in the world to take regulatory action against bisphenol A (BPA) when it announced that it will draft regulations prohibiting polycarbonate baby bottles containing the dangerous chemical from being imported, sold or advertised. Canada said it will also take action in limiting the amount of BPA currently released into the environment. The ban came after some studies raised concerns about the potential risks associated with low levels of bisphenol A on infants and young children. The Canadian Government allotted $1.7 million to fund research on BPA for the next three years.

September 2, 2008
Huntington News: Double Strength Federal Digitek Suits Consolidated to West Virginia
All federal lawsuits related to defective, double strength Digitek will be moved to the U.S. District Court for the Southern District of West Virginia, per the order of the United States Judicial Panel on Multidistrict Litigation.  All lots of Digitek were recalled in April 2008 after inspectors discovered that some of the tablets were twice as thick as normal and contained double the amount of medication.  Sixty lawsuits have been filed in federal courts across the country.  Seventeen of the pending lawsuits have been filed in the Southern and Northern District of West Virginia, Cleveland, Ohio, New Orleans, LA, Chicago, IL, Kansas City, MO, and Ft. Myers, FL.  Fifty related actions had been filed at the time of the transfer order.  If the motion that has been filed regarding overdose cases filed in West Virginia state courts is granted, the cases would be consolidated under one state court judge.

July 31, 2008
Chicago Tribune: Heparin taint tied to deaths
Deaths from heparin have been conclusively linked by the U.S. Food and Drug Administration (FDA).  The FDA completed the review of 93 deaths that were reported during January 1, 2008 to March 31, 2008.  This was a dramatic surge in deadly allergic reactions from patients who had been injected with heparin.   Three of the ten reports of death from severe shock could be traced to lot numbers of Baxter products that tested positive for oversulfated chondroitin sulfate, an animallike substance.  For the remaining seven deaths, lot numbers were not available and therefore could not be traced.  Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research said, "We know they got contaminated heparin, and they died.  This is one of the final links in the chain."  Baxter would not comment on the analysis, stating they had not reviewed it.  The company recalled their heparin products in February 2008 when the spike of the number of allergic reactions occurred.  There were more than 90 reports of deaths and more than 1,000 adverse reactions to the heparin products, including, bleeding, pneumonia, sepsis and kidney failure.

July 14, 2008
KWTX Channel 10 News: Patients Sue Maker Of Recalled Heart Drug
Actavis Totowa, the manufacturer of Digitek, is facing nine federal lawsuits in New Jersey.  The lawsuits are filed in U.S. District Court in Newark, N.J.   Actavis Totowa started a nationwide recall of all strengths of Digitek tablets on April 25, 2008.  Some of the recalled tablets contained double doses.   Lawsuits in West Virginia and California have also been filed.  The lawsuits state the recalled drug was dangerous, defective and caused injuries and death.

June 30, 2008
Trading Markets: Heparin linked to 149 deaths
Heparin was recalled in January after reports of allergic reactions began in November. Initial reports of approximately 81 deaths have been linked to the contaminated heparin.  Now, there have been at least 149 deaths linked to the contaminated heparin which is a large increase.  Baxter International hasn't re-entered the marked selling heparin and now another company has been selling heparin, which is free of contamination.  The plant which supplied the raw heparin, SPL, in China remains closed.

June 4, 2008
In April 2008, Actavis Totowa recalled their Digitek tablets because some of the medication contained twice the active ingredient than is normally found in the tablet.  In early 2006, the FDA (Food and Drug Administration) issued a warning letter to Actavis for failing to provide periodic safety reports at their plant in Little Falls, New Jersey.  According to some reports, some of the faulty Digitek came from that plant.  When Actavis recalled the tablets,  the FDA considered it a Class I recall, meaning the defective tablets could cause death or serious health problems.   There have been several reports of illnesses and injuries in patients taking the recalled tablets.

May 9, 2008
Forbes: Medtronic pulls some heparin-coated devices
Medtronic is recalling some devices that are used in heart bypass surgery.  The devices include tubing packs, blood oxygenators, pumps, reservoirs and cannulae (a metal tube for insertion into the body to draw off fluid or to introduce medication).  These devices are coated with small amounts of contaminated heparin.  Heparin is a blood thinner that has been linked to at least 81 deaths.  The majority of the heparin that was recalled in the past was administered in large doses for patients getting heart surgery or dialysis.  However, heparin is also used in smaller quantities as a coating on stents or catheters.

April 23, 2008
GovernmentExecutive.com: FDA chief defends agency's work before House panel
Andrew von Eschenbach, the U.S. Food and Drug Administration's commissioner, was questioned for two hours during the hearing of the U.S. House of Representatives Committee on Energy and Commerce subcommittee April 22, 2008.  He was asked what financing and procedure changes were needed to avoid national scares in the future like the ones last year involving tainted pet food, toothpaste and contaminated blood thinner.  He told the committee the solution is complex and will need extra funding and an overhaul of the inspection system.  The hearing examined the FDA's failures to inspect foreign manufacturers that produce products that are imported into the U.S and the agency's plans to increase its efforts in overseeing pharmaceuticals coming from hundreds of overseas facilities.  Each U.S. based manufacturer is inspected, on the average, every 2.7 years.  Each foreign manufacturer is inspected every 13 years.  Approximately 80% of active pharmaceutical ingredients in the U.S. are imported.  The FDA is only able to inspect about 10 to 20 of the more than 700 Chinese firms that are registered to export drug products to the U.S. and it would take the FDA more than 30 years to inspect each firm one time.  Eschenbach said the FDA should be given the authority to bar a product from entering the U.S. if it believes it poses a danger and be allowed to levy penalties for counterfeiting.  The FDA would need approximately $70 million to check the 3,200 foreign manufacturers that send products to the U.S.

April 16, 2008
Pharmalot: Vioxx Studies: Ghostwriters And Merck Sponsorship
 The Journal of the American Medical Association (JAMA) stated today that two new reports involving the painkiller Vioxx raise concerns about how drug companies influence the publication and interpretation of medical research.  Merck is the manufacturer of Vioxx and the claim made by JAMA is that they frequently paid academic scientists to take credit for research articles that were prepared by company hired medical writers or commonly known as ghostwriters.  Also in the reports, it's contended that Merck tried to minimize deaths in two studies that showed Vioxx did not work at preventing or treating Alzheimer's.  Merck calls the reports misleading and false.  Even though Merck is singled out in the reports, the practice is not uncommon.  The Alzheimer study was published in the journal Neuropsychopharmacology in 2005.  It's new editor said their policies have been strengthened to ban ghostwriting.

April 15, 2008
Associated Press: FDA Plans to Open China Office in May
The Food and Drug Administration (FDA) is opening an office in China in May 2008. It is part of their strategy to improve product safety that will involve more inspections, increase capacity and strenghten relationships with regulators. Washington is still waiting for final approval from the Chinese government on opening the office, but they will begin working in May before the official opening of the office in October. Toothpaste, pet food, heparin and other products and drugs have been recalled from China. Approximately 80% of the chemical ingredients in drugs are imported as well as 40% of pharmaceutical ingredients. The office will be headed by Christopher Hickey, who is currently the director of the Asia and the Pacific offices at the Department of Health and Human Services.

April 15, 2008
Medical News Today: GlaxoSmithKline Confirms Receipt Of FDA Letter On Regulatory Reporting
The US Food and Drug Administration (FDA) sent a warning letter to GlaxoSmithKline related to reporting requirements for approved medicines. The FDA inspected GSK's reporting processes conducted last year, specifically, in relation to Avandia. There were omissions from periodic reports to the FDA, such as summaries of final data from some clinical trials and the start and progress of the clinical trials. GSK initiated a review of processes and reporting systems after the inspection.

April 14, 2008
Royal Society of Chemistry: Psychiatric drug ads 'frequently misleading'
Claims made in psychiatric drug advertisements, including ads for antidepressants, are often misleading and impossible to verify, according to a new study by Chemistry World. When the team, which included psychologist Glen Spielmans of Metropolitan State University, analyzed the advertisements, they found over 35% of the claims were not supported by their cited sources. This included the New England Journal of Medicine.

Researchers also found that nearly 80% of the ads made at least one claim that was not supported by the data source. GlaxoSmithKline, Pfizer, Shire and AstraZeneca did not reply to the researchers. Wyeth refused to send their trial data. Antidepressant sales are close to $13.5 billion in US sales and $20.6 billion worldwide in 2006. Spielmans claims that 21 Food and Drug Administration officials at the agency's Division of Drug Marketing, Advertising and Communications were charged with reviewing over 39,000 ads aimed at doctors in 2005.

"When I saw how many ads they have to review, it's mind boggling," said Spielmans. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America said, "Federal safeguards are in place to help assure that the advertising and promotional material disseminated by America's pharmaceutical research companies in US publications is accurate and well substantiated."

April 14, 2008
In-PharmaTechnologist.com: Heparin death tally worsens; FDA issues device warning
Deaths from allergic/hypotensive symptoms after using heparin has shot up from 19 to 62. Forty seven of these deaths were reported when the first evidence of heparin contamination was discovered. Recalls were issued. The U.S. Food and Drug Administration (FDA) has sent a letter to drug device manufacturers warning them to examine the sources of heparin used in their products. The recalled heparin which is normally derived from pig's intestines was contaminated with oversulfated chondroitin sulphate, which is made from animal cartilage and a less expensive alternative. Nineteen of the 62 deaths have been linked to Baxter's heparin, however, Baxter states that only four deaths have been linked. The FDA is still investigating how the heparin was contaminated in the supply chain in China.

March 31, 2008
Health Law 360: FDA Demands Safety Plans For 25 Drugs, Biologics
Twenty five medications and biologics has been targeted by the U.S. Food and Drug Administration as posing risky side effects. The FDA has directed the manufacturers to prepare safety plans to ensure they are prescribed properly. The drugs include the acne medication, Accutane and two chemotherapy medications, Thalomid and Revlimid. A medication guide, patient package insert, elements to assure safe use, a communication plan and an implementation plan will all have to be included in the safety plan. The deadline is September 21, 2008. If the manufacturers miss this deadline, the FDA can choose to impose civil penalties.

March 31, 2008
Daily News: Study makes doctors wary of new cholesterol drugs Vytorin and Zetia
A panel of four cardiologists told an audience of over 5,000 at a major cardiology conference that the medications Vytorin and Zetia may not work to lower cholesterol and the drugs should only be prescribed as a last resort. Statins, which are older cholesterol lowering drugs, have proven benefits and are probably less expensive and should be relied on more heavily. Lipitor and Zocor are also statins. The manufacturers of Vytorin and Zetia, Merck and Schering-Plough, disagree with the recommendations and state they are valuable treatments for patients. Preliminary results that were disclosed in January were also discussed at the conference and prescriptions for Vytorin and Zetia have dropped about 15% since January.

March 17, 2008
The New York Times: Tainted Drugs Put Focus on the F.D.A.
The Food and Drug Administration (FDA) has admitted that it violated its own policies by failing to inspect the Chinese plant that has been linked to as many as 17 deaths in the United States after contaminated Heparin was imported. William Hubbard, a former FDA deputy commissioner, said "This heparin problem has happened before with other drugs and it's going to keep happening until Congress fixes the problem." The amount of drugs coming from China has soared, while the FDA's inspections of overseas drug plants has dropped. There are at least 566 plants in China that export drugs to the United States, but only 13 were inspected by the FDA last year. The Bush Administration has no plans to fix the most basic of problems, which is the money to inspect more plants. However, the Senate passed a budget resolution on March 14, 2008 to allocate an additional $375 million. Julie Zawisza, an FDA spokeswoman said, "The agency is opening an office in China to conduct audits and inspections." Eighty percent of the ingredients in drugs consumed in the United States are manufactured abroad, with 40% being made in China and India.

March 4, 2008
NewsInferno.com: FDA to Review Safety Notification Procedures
The Food and Drug Administration (FDA) has been criticized for not doing a thorough job protecting Americans from unsafe drugs. They are now reviewing their safety notification process regarding prescription drugs, medical devices, foods and other products it regulates. Warnings are issued by the FDA about defective medical devices, drug side effects and recalls of tainted food. The agency often issues press releases to the media or it releases statements on its web site. Representative Bart Stupak 's 17 year old son, committed suicide while using Accutane. Stupak said, "If Americans knew how little the FDA does to assure the food and drug supply, if the truth ever came out, people would be marching in the street." Stupak is an eight term Democratic congressman and chairman of the Subcommittee on Oversight and Investigations of the House's Energy and Commerce panel. The panel has jurisdiction over the FDA. The subcommittee is investigating the FDA's handling of Heparin, manufactured by Baxter International, Lipitor, manufactured by Pfizer, Vytorin, manufactured by Schering-Plough and Merck. Anemia drugs sold by Amgen and Johnson & Johnson are also under review.

February 26, 2008
Financial Times: Study casts doubt on anti-depressants
Psychologists from the University of Hull, located in the UK, reviewed approximately 50 antidepressant clinical trials. They found that antidepressants worked no better than placebo in mildly depressed patients. Even trials that suggested some benefit to severely depressed patients wasn’t very great. Researchers focused on four of the widely prescribed antidepressants, including Prozac, Effexor and Paxil (Seroxat). Mind, a mental health charity, is urging General Practitioners to consider alternative therapies, for example, exercise, outdoor exercise especially, since it believes it has shown to be very effective in fighting depression.

February 1, 2008
Fox News: FDA: Epilepsy Drugs May Increase Risk of Suicidal Thoughts
A Food and Drug Administration (FDA) investigation started in 2005 has found that people taking epilespy drugs are at higher risk of committing suicide than those taking a sugar pill.  The FDA analyzed approximately 200 studies of 11 anti-seizure medications.  Medications were given to almost 28,000 people and another 16,000 were given placebo medications.  Drug treated patients who experienced suicidal thoughts or behavior was .43%, compared with .22% of patients given a placebo.  Four people in the drug treated groups committed suicide while none did in the placebo groups. Drug treated patients were at twice the risk of experiencing suicidal thoughts whether or not they actually suffered from epilepsy, however, per the FDA, the risk is highest for epilepsy sufferers.  The FDA analyzed data from 11 well-known anti-seizure drugs including Pfizer's Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote.  The FDA said it expected the risk applies to every epilepsy drug and will work with manufacturers to add the warning to product labels.

January 31, 2008
The Wall Street Journal: Article on Avandia Study Was Leaked to Glaxo
Steven Haffner, an internal medicine professor at the University of Texas Health Science Center in San Antonio, broke confidentiality rules and faxed a copy of the article he was peer-reviewing last year for The New England Journal of Medicine (NEJM) regarding Avandia and the risk of heart attacks, to an employee of GlaxoSmithKline.  Haffner knew the employee from working with him on an earlier clinical trial of the drug.  He faxed the article which he reviewed 17 days before it was to be published.  The NEJM published the article on May 21, 2007 which led to a sharp drop in Glaxo's stock and plunging sales of Avandia.  Dr. Haffner states, "Why I sent it is a mystery.  I don't really understand it.  I wasn't feeling well.  It was a bad judgment."  Haffner has financial ties to Glaxo, which includes getting paid for giving speeches for the company.  Per FDA documents, Glaxo has paid him approximately $75,000 in consulting fees and speaking engagements since 1999.   

The NEJM considers the peer-review process as confidential and deals with any breach of ethics privately.  Glaxo did not inform the NEJM that they had a copy of the study but have since confirmed that they received a copy and that Haffner wanted Glaxo to provide input.  Ms. Pekarek, Glaxo's spokeswoman, confirmed that Haffner had sent a copy to the employee and that no senior Glaxo executives traded stock based on the advance notice of the publication.  Medical journals do not give drug companies advance copies of papers concerning their drugs.

January 24, 2008
New York Times: F.D.A. Requiring Suicide Studies in Drug Trials
The Food and Drug Administration (FDA) is now requiring drug companies to look for suicidality as an adverse event during clinical trials.  Companies who make drugs for the treatment of obesity, urinary problems, epilepsy, cessation of smoking, depression and many other conditions are now, for the first time, being asked by the FDA to put a comprehensive suicide assessment into their clinical trials using a new questionnaire called the Columbia Suicide Severity Rating Scale.  FDA officials admit that since suicidal events emerged in pediatric antidepressant data, which now carry a black-box warning, that they should look for this event in other drug trials.

When French drug-maker Sanofi-Aventis applied for an application for the obesity drug, Rimonabant, researchers discovered the drug could cause psychiatric problems.  Also, this month, the results of a trial of Taranabant, also an obesity drug made by Merck, were published and showed similar psychiatric problems.  Acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia drugs can all cause psychiatric problems.  Many companies and academic research programs have adopted the new questionnaire, which has been translated into 80 different languages.

January 21, 2008
Newsday.com: List of problem prescription drugs is growing
More than 40% of the U.S. population is taking at least one prescription medication.  The growing list of medication concerns is alarming consumer watchdogs and drawing public attention.  Research this month raised concerns regarding the effectiveness of Vytorin over other cholesterol lowering medicine and now a congressional investigation is underway into Schering-Plough and Merck's questionable advertising of the drug. Antidepressants took another hit when a recent analysis was published in the New England Journal of Medicine  suggesting doctors and patients may have been misled about the effectiveness of antidepressants.  During the summer of 2007, studies revealed heart failure risks associated with  the diabetes drugs,  Avandia and Actos. Now, both drugs carry a black box warning.  Patients often learn about problems with medications inadvertently and discover them sometimes before their doctors.  Eric Heifetz was prescribed Vytorin and learned via media about the negative study before his doctor did.  His doctor switched him to Lipitor.

January 17, 2008
Antidepressants, Lack of Efficacy Finally Exposed
The effectiveness of a dozen popular antidepressants has been exaggerated by drug manufacturers and therefore misleading doctors and consumers, according to a new study published in the New England Journal of Medicine.

December 16, 2008
DiabetesHealth: Doctors Say Avandia Warning Label Should Tout Vegan Diet
The Physicians Committee for Responsible Medicine has petitioned the Food and Drug Administration (FDA) to require that Avandia's warning label include a statement that a low-fat vegan diet is safer and a more effective approach to lowering blood sugar levels than the drug itself.  The group's request comes after a recent FDA decision to require a "black box" warning on Avandia warning users to the increased risk of heart attacks.  The committee says the benefits of the diet, which include lowering of blood pressure and cholesterol levels and weight loss, as well as the prevention of heart disease, should be made clear to Avandia users.

December 20, 2007
WDDTY: Avandia: New study confirms it’s a high-risk drug
A new study published from the University of Toronto confirms that Avandia can dramatically increase the risk of congestive heart failure and fatal heart attack.  The study covered health profiles of 159,026 patients who were given the drug or a different one to treat Type II Diabetes.  Nineteen per cent, or 30,265 died from congestive heart failure while 7.9% also had congestive heart failure and survived with a similar number having heart attacks.

December 6, 2007
Medline Plus: Diabetes Drug Avandia Could Weaken Bones
Long time use of Avandia may contribute to bone loss, speeding of osteoporosis and thinning of the bones leading to fatal and/or dangerous fractures.  The study was conducted by the Salk Institute for Biological Studies in La Jolla, California.  There are over 3.5 million U.S. patients taking Avandia.

November 20, 2007
FDA News: Senate Report Alleges GSK Intimidation Over Avandia Concerns
GlaxoSmithKline (GSK) tried to intimidate and silence university professor John Buse after he raised concerns on Avandia and cardiovascular events.  Buse spoke about the intimidation at a House Oversight and Government Reform Committee hearing, and stated that at one point a company employee of GlaxoSmithKline told him that he could be held liable for a $4 billion drop in the company's stock.  GlaxoSmithKline, per Buse, then composed a letter for him to sign that stated he was no longer worried about the increased risk.  Max Baucus, Senate Finance Committee Chairman, and Chuck Grassley, Ranking Member, sent letters to GSK and the University of North Carolina asking for contacts, documents and communications between the organizations related to Avandia (rosiglitazone maleate).  It was found that high ranking executives, including CEO Jean-Pierre Garnier, were involved in discussions to silence Buse.

November 19, 2007
Canada.com: Painkillers, antidepressants a risky combination
According to a report in the October issue of Alimentary Pharmacology and Therapeutics, anyone taking an SSRI-antidepressant such as Paxil, Prozac or Zoloft and also taking a nonsteroidal anti-inflammatory drug (NSAID), such as Motrin, Aspirin or Celebrex, should be aware that this combination of drugs can cause an adverse reaction and increase the risk of upper gastrointestinal bleeding.  Physicians should carefully review their patients' charts.  Patients should keep an eye out for any unusual bleeding. 

November 16, 2007
Chicago Tribune: FDA toughens label warning on Avandia
Short of recalling the drug, the Food and Drug Administration has placed a black box warning, the agency's strongest warning, on the diabetes drug Avandia stating the drug could cause chest pains or heart attacks.  GlaxoSmithKline will conduct a study comparing Avandia and another popular diabetes drug, Actos, manufactured by Takeda beginning next year. The study will be completed by 2014, but the Food and Drug Administration will be reviewing data as the study progresses.  Avandia has been under scrutiny since an analysis last May linked it to a 43% higher risk of heart attack in patients.

November 9, 2007
Wall Street Journal: Merck's Tactics Largely Vindicated As It Reaches Big Vioxx Settlement
Merck and Company has agreed to pay out $4.85 billion to settle thousands of lawsuits over their arthritis painkiller Vioxx. The company faced approximately 26,600 lawsuits representing 47,000 plaintiffs and in addition, 265 potential class action cases, making it one of the largest civil cases ever.  The agreement will affect cases filed in federal and state courts.  Payments will vary, depending on injuries and the length of time Vioxx was used. Under the settlement plan, plaintiffs will have to show that Vioxx was taken for at least 30 days, and must have suffered a heart attack or ischemic stroke within 14 days of using the drug. Merck, headquartered in Whitehouse Station, New Jersey, is still facing a number of government investigations at both state and federal levels.

November 7, 2007
LawyersAndSettlements.com: Avandia Second Black Box Warning Urged
GlaxoSmithKline (GSK) introduced Avandia as a treatment for Type II Diabetes in 1999.  It came under attack when a prominent cardiologist went public that it had the potential for serious problems with the heart.  GSK downplayed the risks.  It has been a back and forth battle ever since.  In August 2007, the Federal Drug Administration announced that Avandia would have a black box warning with regard to increased risk for heart failure.  The Federal Drug Administration is now pushing for a second black box warning in regard to the increased risk of heart attacks.  A black box warning is the strongest warning the Federal Drug Administration can impose. 

October 24, 2007
Yahoo News: FDA eyes new boxed warning on Glaxo's Avandia: WSJ
The FDA (Food and Drug Administration) is pushing GlaxoSmithKline to place a black box warning on their diabetes drug, Avandia.  The warning will be for the risk of heart attacks.  Last year, global sales of Avandia were $3.24 billion.  Sales have plummeted this year since a study in May links Avandia to an increased risk of heart failure. 

October 18, 2007
New York Times: V.A. Is Limiting Use of Diabetes Drug
The Department of Veterans Affairs issued 1,389,497 Avandia prescriptions for 161,096 patients from September 2006 to August 2007.  They conducted their own review of GlaxoSmithKline's drug, also known generically as rosiglitazone, and decided to remove it from their formulary on October 5, 2007.  The decision came after the department's conclusion that for some patients, Avandia did not have the same safety margin as other possible treatments. Eight percent of Avandia's sales are contributed to the Veterans Affairs.  The FDA is still reviewing Avandia's safety since the New England Journal of Medicine published an analysis suggesting Avandia increases the risk of heart attack by more than 40 percent.

Sept. 24, 2007
Bloomberg.com: Glaxo's Avandia Increases Bone-Fracture Risk, Study Confirms
According to a company funded study by GlaxoSmithKline, Avandia increases the risk of bone fractures in women who take it.  The bone fracture injuries first were linked several weeks ago when Baskent University in Andara completed a study.  Medical journal reports this year have stated that Avandia increases the risk of heart attacks by more than 40%