Prescription Drugs

March 18, 2009

Baby boomer alert: Watch out for household products that could injure or kill your child or grandchild

Each year, poisonings from consumer products found in the home kill about 30 children and result in more than two million calls to poison control centers across the nation.

More than 90 percent of the calls involve poisonings in the home. Every year an estimated 80,000 children are treated in hospital emergency rooms for unintentional poisonings.

March 15 to 21 is National Poison Prevention Week, which aims to help prevent childhood poisonings.

Poison (little girl) Children younger than age 5 account for the majority of the non-fatal poisonings. A recent review conducted by U.S. Consumer Product Safety Commission found that 70 percent of poisonings involve children 1 to 2 years of age.

Oral prescription drugs, non-prescription drugs, and supplements were involved in more than half of the incidents.

“Awareness and action are the keys to preventing unintentional poisonings,” said Nancy Nord, acting chairman of the commission. “Children act fast. So do poisons. That’s why we urge parents, grandparents, and caregivers to have layers of poison prevention protection in the home.”

The commission recommends that parents, grandparents, and caregivers immediately take these three steps.

  1. Keep medicines and household chemicals in their original, child-resistant containers.
  2. Store the potentially hazardous substances up and out of a child’s sight and reach
  3. Keep the national toll-free poison control center telephone number, 800-222-1222, handy in case of a poison emergency.

Additional poison prevention tips to check during National Poison Prevention Week are:

  • When hazardous products are in use, never let young children out of your sight, even if you must take them along when answering the phone or doorbell.
  • Keep items closed and in their original containers.
  • Leave the original labels on all products, and read the label before using.
  • Always leave the light on when giving or taking medicine so that you can see what you’re dispensing or taking. Check the dosage every time.
  • Avoid taking medicine in front of children. Refer to medicine as "medicine," not "candy."
  • Clean out the medicine cabinet periodically and safely dispose of unneeded and outdated medicines.
  • Don’t put decorative lamps and candles that contain lamp oil where children can reach them. Lamp oil can be very toxic if ingested by young children.
Copyright 2009, Rita R. Robison, Consumer Specialist

March 09, 2009

Drug company argues woman who lost her arm shouldn’t have right to sue

A musician whose arm was amputated after gangrene resulted from an improper injection with an anti-nausea drug filed a lawsuit against Wyeth Pharmaceuticals.

Wyeth argued it shouldn’t be held liable since the label had been approved by the U.S. Food and Drug Administration.

The U.S. Supreme Court ruled six to three that federal law doesn’t prevent plaintiffs from suing drug companies in state court. The ruling upheld a Vermont jury’s $6.7 million award to Diana Levine, who played the guitar until the amputation.

Levine received an injection of Wyeth’s Phenergan when she went to a local health clinic in 2000. The physician’s assistant injected the drug into an artery instead of a vein, causing the gangrene.

As a result of the decision, consumers now have greater standing to sue drug companies when drugs kill or cause severe injuries, according to the article “Supreme Court Upholds Consumers’ Right to Sue Drug Companies in State Court” on Consumer Affairs.com.

See the articles for details.

Copyright 2009, Rita R. Robison, Consumer Specialist

February 05, 2009

Tips for what baby boomers can do about urinary incontinence

Just because you’re a baby boomer and you’re getting older doesn’t mean you have to accept loss of bladder control.

There's a number of things you can do to lessen the likelihood of being affected, or at least to decrease the condition's impact on your quality of life, according to the article “Urinary Incontinence Is Common but Not Inevitable” on U.S. News and World Report.

Urinary incontinence occurs in about half of adults during their lives due to medications, urinary tract infections, or weak pelvic floor muscles.

Urinary To stop or reduce bladder leakage the article suggests:

  • Doing regular pelvic floor exercises.
  • Exercising.
  • Losing weight.
  • Scheduling regular bathroom breaks if you have diabetes.
  • Avoiding caffeine, alcohol, or spicy or acidic foods if they seem to irritate the bladder’s lining and cause you to feel like that you need to rush to the bathroom.

For more information on incontinence, see these articles:

“Muscle and Bladder Training Ameliorate Urinary Incontinence; Other Remedies Don’t Do As Well” – Medical News Today

“Behavioral vs. Drug Treatment for Urge Urinary Incontinence in Older Women” – Journal of the American Medical Association

“Controlling Urinary Incontinence" – FDA Consumer

“Urinary Incontinence” – MedlinePlus

“Urinary Incontinence” – Mayo Clinic

Copyright 2009, Rita R. Robison, Consumer Specialist

January 22, 2009

What President Obama and Congress need to do for American consumers

In my last post, I looked at what President Obama said in his Inaugural address about consumer issues and discussed the challenges he faces in corralling the country’s strong special interests.

Obama Demo Leaders ARRA01








Here’s what I think Obama, working with Congress, needs to accomplish for American consumers:

  • Find a solution to the country’s massive financial problems.

  • Help consumers who are facing foreclosure of their homes.
  • Find effective ways to create jobs.
  • Establish a health care system that works and provides coverage for all Americans.
  • Curb the excesses of the pharmaceutical industry by putting a lid on their profits, investigating the harmful side effects of prescription drugs that are injuring and killing people, and fostering the use of less harmful alternative medicine techniques.
  • Act quickly to halt the excessive fees and interest rates being charged by banks and credit card companies.
  • Stop poor lending practices by banks and mortgage companies.
  • Establish better regulation of financial services.
  • Fund nonindustry-sponsored research on approaches for clean energy and implement programs based on the research.
  • Reestablish the White House Special assistant for consumer affairs and/or create a federal consumer protection agency.
  • Restore the budgets of federal regulatory agencies including the Federal Trade Commission, Consumer Product Safety Commission, Food and Drug Administration, and U.S. Department of Agriculture.
  • Enhance the regulatory functions of these agencies so that our food, consumer products, and drugs are safe.
  • Develop creative and effective ways for citizens to be involved in the decision-making of these agencies.
  • Restore trust in the work of the federal government and its processes.
  • Insist on transparency in all the work of the federal government including the regulatory agencies and White House staff.
  • Ban the direct-to-consumer advertising of prescription drugs on television, in magazines, and on the Internet.
  • Ban, establish a moratorium, or least require the labeling of genetically modified food.
  • Require irradiated food to be labeled.
  • Work with Congress to develop regulatory processes that will prevent the excesses under the George W. Bush administration that caused the collapse of the housing market and the stock market.
  • Enhance environmental protections.
  • Adequately fund programs for seniors including Social Security, Medicare, and Medicaid.
  • Assist local and state governments in preparing for the needs of baby boomers as they age.
  • Work to eliminate poverty and homelessness.
  • End the wars in Iraq and Afghanistan so that money will be available for domestic programs.
  • Support a congressional investigation of the crimes of the George W. Bush administration that will lead to the filing of charges against those who broke the law.
  • Review recent telecommunication laws in terms of how they meet the needs of consumers.
  • Figure out whether cell phones are safe to use and, if they’re found to be harmful, mandate that they be safe.
  • Improve mass transportation throughout the nation.
  • Work with local governments and the states to create compact, walkable communities so that Americans can walk to work and shopping areas.

I know this is a huge agenda, but American consumers are in need of drastic assistance after the gutting of consumer and environmental protections during the George W. Bush administrations.

Copyright 2009, Rita R. Robison, Consumer Specialist

January 17, 2009

Top health stories of 2008

Because baby boomers are health conscious, I’ve been looking for a listing of 2008’s best health news, but haven’t been able to find a consumer-oriented one.

“In Case You Missed It: What Happened in Health in 2008,” the cover story for the December 2008 issue of the Health Letter, arrived in the mail and solved my problem with its consumer-point-of-view article. The newsletter is produced by the Public Citizen Health Research Group, a consumer research, education, and advocacy organization.

Here are the Public Citizen Health Research Group’s the top health stories:

  • A study showed that Vytorin (combining Zetia and Lipitor) worked no better than Zocor alone – which costs 1/16 as much in its generic version simvastatin – in reducing artery plaque that can lead to heart attacks.
  • A California meat company was forced to order the largest beef recall in U.S. history. “Downer” cows, which are unable to walk, were being slaughtered. The use of these cows as food for humans is banned by the U.S. Department of agriculture.
  • The deaths of 81 people from heparin, a blood thinner, imported from China drew attention to the problem of contaminated drugs from China. As a result of the problems with imported drugs, the U.S. Food and Drug Administration received additional funding for monitoring. In 2007, the FDA had only conducted 14 inspections in China although 714 establishments there sell drugs to U.S. firms.
  • The clotting drug Trasylol was taken off the market by Bayer after the FDA wasn’t able to identify any group in which the benefits of the drugs were outweighed by the risks. The drug is used during heart surgery.
  • The vote by the New York City Board of Health to list calories on menus and menu boards was reaffirmed.
  • The number of physicians in the U.S. who favor national health insurance has increased to 59 percent. It was 49 percent five years ago.
  • Canada banned the use of BPA in baby bottles. BPA is a widely used chemical in hard plastic food containers. After convening a task force to develop recommendations, the FDA released a draft report upholding the current safety standards for BPA in food. The agency’s recommendation was based on two studied conducted by the food industry.
  • Life expectancy declined between 1983 and 1999 in certain U.S. counties. Among women, the decline was due to increases in diabetes and lung cancer. For men, HIV infection and homicide were the cause.
  • Problems with the U.S. system for monitoring food safety were revealed when tainted tomatoes and jalapeno peppers affected more than 1,200 people in 43 states in a salmonella poisoning outbreak.
  • The FDA was given authority by Congress to regulate tobacco products.
  • The FDA guidelines for using experts on its advisory committees with potential conflicts of interest were tightened.
  • Infant formula tainted with melamine, an industrial chemical used to artificially increase the protein content of products, caused several deaths and more than tens of thousands of cases of illness in China. The Chinese government kept journalists from publicizing the story until after the Olympic Games.
  • A provision in the bailout package will require health care insurers to provide the same coverage for mental health services that are provided for physical health services beginning in 2010. An estimated 113 million people will be affected.
  • The American Diabetes Association is advising against the use of Avandia – generic name rosiglitazone – because of the drug’s serious risks, including liver failure and an increased risk of heart attacks, heart failure, bone fractures, anemia, and macular edema with vision loss.

To obtain a copy of the December 2008 issue of Health Letter, send a check for $3, payable to Public Citizen, to Health Letter, 1600 20th Street N.W., Washington, DC 20009 or call 202-588-1000 for more information or to order by credit card. An annual subscription for 12 issues of the Health Letter is available for $18.

Copyright 2009, Rita R. Robison, Consumer Specialist

January 15, 2009

Big pharma uses attractive, ex-cheerleader reps to hawk prescription drugs

Drug representatives have one mission: to convince your doctor to prescribe their overpriced, brand-name medications instead of more cost-effective generic drugs, according to the Web site Mr. Med Saver, a site that offers information to consumers to help them save money on prescription drugs.

One of the greatest weapons that female representatives have is their sexuality, says the Jacob Milbradt, PharmD, founder and president of Mr. Med Saver. Sex sells, Milbradt says in his article, adding “You’ll never meet an ugly drug rep.”

It’s actually been documented that big pharma heavily recruits college cheerleaders to be drug reps. See the article "Gimme an Rx! Cheerleaders Pep Up Drug Sales" on The New York Times Web site.

So be an alert, aware boomer consumer. Take the time to learn about all of your medications, what they’re for and what the side effects may be.

Be in charge of your health care. Don’t give up your power to your doctors and other health care providers. Do research to learn about your health problems and make decisions in cooperation health care providers. Don’t let them dictate all your health care needs if you don’t understand the reasons for the treatments.

Copyright 2009, Rita R. Robison, Consumer Specialist

 

January 14, 2009

If you're a baby boomer who takes erectile dysfunction medications, read this warning

Baby boomers who take three well-known erectile dysfunction medications should be extremely careful if they also take any of 56 other drugs, including many commonly prescribed anti-angina and certain blood pressure medications, grapefruit juice, and St. John’s Wort, warns Public Citizen.

The three erectile dysfunction drugs are Viagra, chemical name sildenafil; Cialis, chemical name tadalafil; and Levitra, chemical name vardenafil.

The 56 drugs fall into three categories: (1) those that can cause a life-threatening drop in blood pressure when taken with erectile dysfunction drugs; (2) those that prevent the body from eliminating erectile dysfunction drugs, thereby leading to an overdose; and (3) those that speed up the metabolism of the erectile dysfunction drugs, thereby reducing their effectiveness.

Grapefruit juice also is listed in the second category because it acts like a drug in this circumstance.

"Those who take erectile dysfunction drugs are generally older men, who are more likely to be taking other medications as well," said Sidney Wolfe, M.D., director of the Health Research Group at Public Citizen, in a statement about the drugs. "It is critical that they be aware of the potential for dangerous interactions."

Erectile dysfunction drugs cause blood vessels to dilate, an effect that is magnified when taken with blood pressure medications, which also dilate blood vessels. Men who take blood pressure medications such as Flomax and Cardura should avoid erectile dysfunction drugs, Wolfe said. The combination can cause a dangerous drop in blood pressure that could lead to a heart attack or stroke.

Other drugs, such as erythromycin and nefazodone, inhibit an enzyme that metabolizes erectile dysfunction medications, thereby causing a build-up of the erectile dysfunction drugs to higher levels. Other medications, such as nafcillin, phenobarbital, and 13 other drugs, increase the activity of the enzyme, rendering the erectile dysfunction drugs less effective.

St. John’s Wort, an herbal supplement, also is included in this third category because it has a negative, drug-like effect when used with erectile dysfunction drugs.

The complete list of 56 drugs is at Public Citizen’s WorstPills.org.

Copyright 2009, Rita R. Robison, Consumer Specialist

 

November 06, 2008

Reforms a must in next four years for baby boomer consumers

Under the presidency of George W. Bush, the interests of the business community often superseded those of consumers. And time after time, scandals such as the Enron energy debacle and the sub-prime mortgage crisis, flashed across the front pages of American newspapers.

What public policies are needed to get the federal government back on track so it’s working for consumers rather than special interest groups?

Public Citizen, a consumer advocacy group, wants President-Elect Barack Obama to restore the role of citizens in government. It calls on Obama and Congress to:

  • Govern the financial bailout to ensure that homeowners receive some benefits, that financial companies don’t take advantage of the taxpayers’ largesse, and that the financial markets are reregulated.
  • Ensure that the regulatory agencies make health, safety, and the environment the No. 1 priority, instead of corporate profits.
  • Repeal the subsidies that Congress lavished on the fossil fuel and nuclear industries and instead invest in alternative and renewable energy and mass transit.
  • Ensure that the next elections for president and Congress will be publicly financed, so we can rid the government of the corrupting influence of money.
  • Reverse the dangerous trend to curbing citizen access to the courts through preemption and mandatory arbitration clauses.
  • Repeal the Prescription Drug User Fee Act, wherein drug companies pay more than $500 million directly to the U.S. Food and Drug Administration to fund drug review and other programs related to prescription drugs, creating a direct conflict.
  • Change the status-quo model of globalization and the “trade” agreements now implementing it; ensure that the Colombia, Korea, and Panama agreements aren’t implemented and that future agreements meet basic criteria designed to promote the public interest.

"One of the worst outcomes of the past eight years has been the erosion of democracy and the phasing out of the people's voice in the government," said Joan Claybrook, president of Public Citizen, in a statement the day after the 2008 presidential election. "It is imperative that this be reversed."

Under the Bush administration, Claybrook said Americans saw:

  • An emergency management agency that couldn’t provide needed aid after a devastating hurricane.
  • A mine safety agency that coddled mining companies at the expense of worker safety.
  • The dominance of politics over science at the Environmental Protection Agency and the FDA.
  • An energy policy written by and for the fossil fuel industry.
  • An economic meltdown after the deregulation of the financial services industry.

President-Elect Obama has a unique opportunity to improve the lives of consumers in America. I look forward to seeing Obama put together a team and begin working for policies to support the public interest.

Copyright 2008, Rita R. Robison, Consumer Specialist

September 09, 2008

Boomer consumer alert: List of 20 potential problem prescription drugs now available from FDA

The U.S. Food and Drug Administration is offering listings of prescription drugs under investigation for potential safety problems. This information is helpful to the Baby Boomer Generation because nearly one-third of baby boomers take four or more prescription drugs for chronic conditions, according to a 2003 prescription drug survey by Knowledge Systems & Research Inc.
 
The FDA is releasing the information to keep health care providers and patients informed about possible problems earlier. Its first list was issue on Friday.
 
Twenty medications are included in the FDA’s chart, with a potential issue for each. No indication is provided of how widespread or serious the problems may be, according to an Associated Press article “FDA Posts List of Potential Problem Drugs.”

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008

Product Name: Active Ingredient (Trade)
or Product Class
Potential Signal of Serious Risk/New Safety Information
Arginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane) Cardiac arrest
Duloxetine (Cymbalta) Urinary retention
Etravirine (Intelence) Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
Heparin Anaphylactic-type reactions
Icodextrin (Extraneal) Hypoglycemia
Insulin  U-500 (Humulin R) Dosing confusion
Ivermectin (Stromectol) and Warfarin Drug interaction
Lapatinib (Tykerb) Hepatotoxicity
Lenalidomide (Revlimid) Stevens Johnson Syndrome
Natalizumab (Tysabri) Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin) Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity) Cardiopulmonary reactions
Phenytoin Injection (Dilantin) Purple Glove Syndrome
Quetiapine (Seroquel) Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka) Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults


Some consumer advocates question usefulness of the brief information, and the drug industry worries that patients may stop taking a medication if they see it listed, according to the article.

At least five of the drugs on the list had problems that already have been publicized, the article states. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in children and young adults.
 
Each quarter, a new report will be posted on FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified based on reports the FDA receives from hospitals, doctors, and patients.
 
The appearance of a drug on this list doesn’t mean that the FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk, the FDA said in a statement about the new listing. It’s on the list only because FDA has identified a potential safety issue.

"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.
 
Congress directed the FDA to develop the quarterly report of potential safety issues under the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. Patients and health care professionals told Congress that they want to be informed about possible safety problems with prescription drugs sooner.

Copyright 2008, Rita R. Robison, Consumer Specialist

September 05, 2008

Manufacturers must strengthen warnings for four arthritis drugs: Cases of serious fungal infections being missed by health care providers

Knowing about the possible dangers of prescription drugs is important to the Baby Boomer Generation.

Manufacturers of four drugs used to treat arthritis and other serious illnesses must strengthen the existing warnings on the risk of developing fungal infections in guides to prescribing medications developed for health care providers, the U.S. Food and Drug Administration announced recently.

Some patients with invasive fungal infections who were taking the drugs have died, according to the FDA.

The drugs

The drugs are Humira, Cimzia, Enbrel, and Remicade. Known as tumor necrosis factor alpha blockers (TNF-alpha blockers), they work by suppressing the immune system to keep it from attacking the body. The four drugs are approved to treat rheumatoid arthritis, juvenile arthritis, certain types of psoriasis, Crohn's disease, and other immune system disorders.

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by the FDA, health care providers aren’t consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Symptoms of fungal infections

Patients taking TNF blockers should be aware that they’re more susceptible to serious fungal infections, the FDA said in its statement. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention.

To assist in the diagnosis, those being treated with TNF blockers should tell their health care providers where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover, according to the FDA.

Reports of deaths

The FDA reviewed 240 reports of histoplasmosis, an infection caused by the fungus Histoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys where the fungus is commonly found. In at least 21 of the reports, histoplasmosis wasn’t initially recognized by health care professionals, and antifungal treatment was delayed, the FDA reports. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The agency also has received reports of cases of two other types of fungal infection – coccidioidomycosis and blastomycosis – that have resulted in deaths in patients treated with TNF blockers.

The labeling process

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the medication guides to the FDA within 30 days or to provide a reason why they don’t believe labeling changes are necessary.

If they don’t submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

The manufacturers for the four drugs also will be required to educate prescribers about the risks.

Copyright 2008, Rita R. Robison, Consumer Specialist