INTERNATIONAL
BIOPHARMACEUTICAL ASSOCIATION
Drug
Recall: Effects on consumer confidence.
AUTHOR:
Eddy
Mutumba MLT
503
Wilson Heights Blvd.
North
York
Toronto,
Ontario,
M3H
2V7
Canada
E-mail:
eddymutumba@yahoo.com
Summary:
Anybody who watches Television, cruises the Internet or flips through a magazine is very familiar with advertising for pharmaceutical drugs picturing attractive, healthy and active people. Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug.
Over the past few years, the safety of more than a dozen popular prescription drugs has been examined. In some cases, certain drugs have been recalled, cited in consumer deaths, consumers have presented significant questions and legal claims.
The recent global recall of the drug Vioxx has resulted in heightened scrutiny of certain blockbuster drugs with hearings before Congress in which at least one FDA researcher suggests that the FDA may be incapable of protecting consumers from unsafe drugs and that several other unsafe drugs currently on the market may also present unacceptable patient risk. According to a survey by the Department of Health & Human Services Office of Inspector General, about two-thirds of Food & Drug Administration scientists are less than fully confident in the agency’s monitoring of the safety of prescription drugs now being sold.
Drug warnings:
Too often, it has been observed, recalls work poorly. Instead of trusting that you’ll be notified, you might have to search for information you need to protect you and your family. Manufacturers might not tell you. Only serious drug recalls are widely publicized. Pharmacies are required to review records and contact patients only for a Class 1 recall, the most serious of the three classes in the reporting system, in which taking the drug could cause death or serious illness. Alerting patients to a potency problem, according to the FDA, might needlessly worry patients and prevent them from an incorrect dosage. All these add up to erode consumer confidence.
Pharmaceutical manufacturers should respond quickly and address safety concerns and information demands of the general public in order to sustain consumer confidence in prescription drug safety as well as advertising their benefits.
December 17, 2004-An internal survey conducted by the Food and Drug Administration
INTERNATIONAL BIOPHARMACEUTICAL ASSOCIATIONFDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
According to the Journal of the American Medical Association, adverse prescription drug reactions resulting from correctly administered Federal Food and prescription drug Administration (FDA)-approved prescription drugs are responsible for over 100,000 deaths per year in the United States, making it the fourth leading cause of death in the United States. In recent years, many prescription drugs and dietary supplements have been linked to serious health problems, clearly outweighing their potential benefits. Some drugs have raised concerns and warnings concerning their safety in the medical community. Some drugs since thought to be lifesaving have proven to have dangerous side effects and have resulted in permanent damage and death.
Alerts,
Warnings and Recalls:
The Food and prescription Drug Administration (FDA) is responsible for ensuring the safety of products, including prescription drugs, medical devices and foods.
A Recall is an action taken to remove a product from the market. Recalls are conducted by FDA request or on the initiative of the manufacturer. In many recall situations (Class I Recall) there may be a reasonable probability that the use or exposure to a product will cause serious injury or death.
A Class II Recall is a situation where use or exposure to a product may cause temporary or medically reversible injury. The recall of a defective or harmful consumer product is sometimes publicized in newspapers and in news broadcasts. This may be especially true when a recall involves prescription drugs, medical devices, and food products regulated by the FDA. The FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. Legal claims are frequently brought against recalled prescription drugs manufacturers.
A SAFETY ALERT is issued in situations where a medical device or product may present an unreasonable risk of substantial harm. In some cases, these situations are also considered recalls.
Eroding
consumer confidence:
Recent developments in the drug industry aren’t helpful to the consumer. This can only serve to erode consumer confidence. A case in point is the recent abrupt recall of blockbuster drug vioxx. The level of consumer confidence is expected to continue eroding as a result of this recall. The situation with vioxx may lead to consumer skeptism about prescription drug safety. Drug companies need to win back consumer confidence, in light of the vioxx recall, by communicating clearly the relevance, differentiation and benefits of each branded drug advertised.
FDA
complaints reach an all time high in 2004
-March 14, 2005
According to a published report, complaints to the FDA regarding drug side effects and other related health problems have reached an all time high in 2004. The increase of nearly 14 percent from the previous year included reports made by pharmaceutical companies, health professionals and patients.
The final number of complaints during 2004 is expected later this year, but the FDA said it does not expect it to be off from the estimate of 422,500 adverse event reports. Increase could be in response to the growing scrutiny over prescription drugs in response to safety and drug recalls that occurred due\ring the year, as well as the increase in prescription drug uses.
Just tip of the iceberg: The number of serious drug reactions and problems reported to the FDA are believed just a fraction of the actual events suffered since doctors, nurses and patients making reports do so on a voluntary basis. The majority of reports made to the FDA are from drug manufacturers, who are required by the federal agency to file details of any known adverse events involving their drugs.
Breaking
Carbolith News:
The FDA advised consumers about a Canadian recall of Carbolith (lithium carbonate) 150 mg capsule distributed in Canada by Valeant Canada Limited. Although Carbilith is not an FDA-approved product, FDA is investigating several Internet websites advertising Carbilith for sale to U.S consumers. Carbolith 150 mg capsules are used in the treatment of manic-depressive illness. U.S consumers who have taken Carbolith for the treatment of manic-depressive illness could experience adverse events associated with lowered blood lithium levels.
October
15, 2004:
The Food and Drug Administration issued a public Health Advisory, asking manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies. FDA also informed these manufacturers that it has determined that a patient Medication Guide (Med Guide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate for these drug products.
Drug
name: Rofecoxib.
Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Refecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 19999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.
Why
is Vioxx prescribed?
Rofecoxib is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by arthritis and to treat painful menstrual periods and pain from other causes. Rofecixib is in a class of nonsteroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors. It works by stopping the body’s production of a substance that causes pain and inflammation. COX-2 inhibitors may cause stomach bleeding and ulcers than similar medications.
Merck & Co., decided to recall vioxx following a new, three-year data from a prospective, randomized, placebo-controlled clinical trial, __(Adenomatous Polyp Prevention on Vioxx).
The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo.
“We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck.
Vioxx was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were$2.5 billion.
Jan. 25, 2005 - The arthritis drug Vioxx could have caused an estimated 88,000- 140,000 excess cases of serious coronary heart disease in the USA since its launch in 1999, concludes a study published online by The Lancet.
April 7, 2005__The Food and Drug Administration asked Pfizer to withdraw Bextran from the market and announced new label warnings for the non-steroidal anti –inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over- the- counter (OTC)) non-selective NSAID medications.
FDA asked Pfizer, Inc. to withdraw Bextra from the market because the overall risk versus benefit profile for the drug is unfavorable.
Celebrex
Recall:
Celebrex is a popular arthritis drug belonging to the COX-2 family of pharmaceuticals. A recent clinical study indicated that Celebrex might be linked to higher incidences of life-threatening cardiovascular problems, including heart attack and stroke. A competing drug, Vioxx, already has been withdrawn from the market after numerous clinical studies found similar problems.
Celebrex
Side Effects:
In the study conducted by the National Cancer Institute, patients taking Celebrex suffered more than twice as many heart attacks and strokes as those taking a placebo.
Those taking a 400mg daily dosage had a 2.5 times greater risk. Patients taking 800mg were 3.4 times more likely to suffer a serious cardiovascular problem.
In spite of evidence that Celebrex may be linked to life-threatening problems, Pfizer announced they would not recall the drug. The company contends that the results of this study are not consistent with earlier clinical studies and therefore a recall is not necessary. The manufacturer of Vioxx recently came under heated criticism for failing to withdraw the drug earlier. That company also disregarded and discredited clinical studies that indicated an elevated risk of heart attack and stroke.
Prozac
linked to violence?
Lilly Documents Raised Prozac Concerns, Journal Says Eli Lilly & Co. documents linking the antidepressant Prozac to violent behavior have been turned over to the U.S. Food and Drug Administration by the British Medical Journal, the publication says in its January issue.
The documents appear to suggest a link between Indianapolis-based Lilly’s Prozac and suicide attempts and violence, the Journal said. The papers “went missing “during a product liability lawsuit 10 years ago and were recently sent to the medical Journal by an anonymous source, according to the Journal’s account.
“I am glad that they took the action they did,” said Richard Kapit, a former FDA doctor who reviewed the application for Prozac’s approval in 1987. “I am sorry it took so long” to add the warning of suicide risk.
Lilly officials weren’t immediately available to comment on the report or provide a copy of the documents cited. The company ‘s shares fell 73 cents, or 1.3 percent, to $56.77 at the New York Stock Exchange composite trading.
Prozac was Lilly’s best-selling drug and the world’s top-selling antidepressant until it lost exclusive marketing rights in 2001. The drug’s global sales peaked at $2.8 billion in 1998 and were $448.2 million in 2003,according to the company.
FDA
Enforcement Report Index:
The FDA Enforcement Report Index is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities.
President Bush has asked all federal agencies to streamline communications with the public and improve interagency information sharing in order to enhance public security.
“Americans
demand top-quality service from the private sector. They should get the same
top-quality service from their government.”—President
George W. Bush
Therefore, to provide better service in alerting the American people to unsafe, hazardous or defective products, six federal agencies with vastly different jurisdictions have joined together to create www.recalls.gov--a “stop shop” for U.S. Government recalls.
FDA continually assesses the safety of the products it regulates and responds to safety reports by taking action such as, providing important product safety information to the public, making changes in labeling, requiring a product design change, or withdrawing a product from the market. FDA promptly issues Safety Alerts, Public Health Advisories, Recalls, Talk Papers, and Notices in an effort to inform the public about patient safety issues as they are identified.
Blood
component recalls in the United States:
Background: United States blood suppliers are required to recall marketed blood components later found to be in violation of Food and Drug Administration (FDA) regulations for safety, purity, and potency. Many recalled units have already been transfused.
In the wake of the AIDS epidemic and the tragedy of transfusion-transmitted HIV, the FDA now regulates the production of blood products not only as biologicals, but also as pharmaceuticals, requiring strict adherence to current Good Manufacturing Practice regulations as set forth in the Code of Federal regulations. However, blood products are arguably the most complicated “drugs” to produce. Physicians who prescribe blood components are generally aware of the risks of virus transmission, currently estimated in the United States at 1 in 680,000 units for HIV, 1 in 63,000 units for hepatitis B virus (HBV), 1 in 100,000 units for Hepatitis C virus.
Study design and methods: Each blood component recall was examined for the number of units; recall reason, and hazard class.
Results: In 8 years, an estimated 241,800 blood components were recalled, or approximately 1 in 700 units available to US hospitals. The most common reasons were incorrect testing for syphilis (57%of units) or viral markers (19%), reactive or previously reactive donor viral markers (6-11%), and inadequate donor-history screening (4%). Over 43,900 units had HIV-related problems, but only 3 units involved HIV transmission?
CONCLUSION:
Although high-risk recalls are rare, many blood component recalls pose medical concerns for Physicians and patients. The recent decline in large recalls may be due to increased FDA oversight, stricter accreditation standards for quality improvement, and more centralized donor testing in large specialized laboratories.
A
SICK AGENCY IN NEED OF A CURE?
When David Graham got his medical degree from Johns Hopkins University, he figured he’d opt for the comforts of an academic career in neurology. But he couldn’t shake his other infatuation, with public health, so instead of heading to the lab he began what would become a 20-year government career at the U.S. Food and Drug Administration: “At the FDA”, he says,” there seemed to be the possibility that you could have an effect that would benefit patients to a greater extent than at any University.
Today that dream has turned sour. Indeed, Graham is now the center of a national controversy over the FDA’s ability to protect the public against unsafe medicines. As associate director for science and medicine in the FDA’s office of Drug Safety, Graham told Congress last month that FDA’s problems with ensuring drug safety were “immense in scope” and left the nation “virtually defenseless” against the chance that unsafe drugs will reach consumers.
Graham was called before the Senate Finance Committee to explain why it took the FDA years to acknowledge that the pain reliever Vioxx increased cardiovascular risks. Merck, Vioxx’s manufacturer, removed the drug from the market in September because of Vioxx-related heart attacks and strokes, which Graham and other researchers say may surpass 100,000 in the United States alone. The FDA has known of the risks since 1999, yet a warning was not added to the drug’s label, which the FDA regulates, until 2002.
According to Sandra Kweder, the deputy director of the office of New Drugs, the FDA did not have enough leverage to force Merck to include a warning about heart risks; the agency negotiated with the company for some 14 months after the problem was first identified. When the warning was included, it was not a “black box” type, which might have reduced the flood of advertising directed at consumers. Vioxx remained a top seller for two more years.
High stakes. Product liability lawsuits, according to Merill Lynch, may run as high as $18 billion, from patients and their families. “Vioxx is a terrible tragedy and a profound regulatory failure”. Graham told the Senate committee. It illustrates troubles at the FDA “that will make future Vioxxes Inevitable.” Graham, who is expressing his opinion, not that of the FDA, paints a picture of “an agency in denial,” where bureaucratic wrangling has replaced scientific debate and a climate of fear stifles healthy dissent.
Vioxx
Recall Lawyers Canada
Canada Lawyers Representing hundreds of People Injured by Vioxx. Health Canada is urging patients who have taken Vioxx to discuss other treatment options with their Physician.
Greg Monforton and Partners is handling legal claims against Merck on behalf of Canadians injured by the drug Vioxx. Over the next few months Greg Monforton and Partners expect to file hundreds of Lawsuits on behalf of clients injured by Vioxx.
Dangerous
Drug Legal Cases
In recent years, there has been an alarming increase in the number of product liability cases, especially drug product cases, which involve injuries or ill health caused due to defective or dangerous drugs and medicines.
Interactive
Voice Response Eases Drug Recall:
October 7, 2004-When Ed Mercadante saw the news that Pharmaceutical giant Merck & Co. Inc. was recalling its popular arthritis drug Vioxx, he knew he was in for a challenge.
Mercadante, the CEO of an 80-store pharmacy chain based in Farmington, Conn., needed to get the word out to his customers in a hurry. In the past, the practice for this sort of thing would be to have pharmacists call each of their customers who used the drug and inform them of the recall, and then see if they had questions or needed more information. But this could take weeks.
Fortunately, the chain was already using an IVR (Interactive Voice Response) application service. Before the recall, the system had received only a lukewarm response. But now came the challenge. It was necessary to get the word about the recall out as soon as possible, both to help manage the customers’ health care and to make sure that any concerns were dealt with promptly.
Silverlink, the IVR service provider, designed the calls so that they would inform each patient of the Vioxx recall, and then ask them if they wanted their primary care physician to contact them to determine an alternative means of treatment.
Because Silverlink can make thousands of calls an hour, the recall notices were completed very quickly_in less than two hours, in fact. Over 3000 vioxx patients did exist, and nearly all of them were contacted in less than a day. Doing it the old way would mean that pharmacists would still be calling patients for days or weeks to come.
References:
1. Drug-warning.com www.drug-warning.com copy right: New Tech. Media
3. U.S Food and Drug Administration (Recalls, Market withdrawals and Safety Alerts)
4. GregMonforton And Partners (http://www.celebrex.lawsuit.ca)
5. FDA Center for Drug Evaluation and Research
6. Adrugrecall.com (http://www.drugrecalls.com)
7. drugdanger.com
8. Wayne Rash (http:www.eweek.com/article 2/%2c) October 7, 2004.
9. Spake, Amanda U.S. News & World Report 12/13/2004
10. G. Ramsey and L.A. Sherman. Department of Pathology, North Western Medical School, Chicago, Illinois U.S.A. g-ramsey@nwu.edu
Author:
Eddy Mutumba
503 Wilson Heights Blvd.
North York
M3H 2V7
Toronto, Ontario.
Canada
E-mail: eddymutumba@yahoo.com