Pharmaceutical News
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December 17, 2008
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.
Read the FDA news release
December 13, 2008
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.
Click here to read the article
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
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
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
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.
Click here to read the article
July 31, 2008
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
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
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
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
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.
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April 16, 2008
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.
Read more here
April 15, 2008
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
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.
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April 14, 2008
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."
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April 14, 2008
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.
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March 31, 2008
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. Health Law 360
March 31, 2008
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.
Click here to read more about the study
March 17, 2008
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.
Click here to read the article
March 4, 2008
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
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
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.
Click here for more information
January 31, 2008
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.
Read the Wall Street Journal article
January 24, 2008
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.
Read the full article here
January 21, 2008
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.
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