Unsafe Drugs: April 2007 Archives

Lethal Injection Drugs Often Don't Kill As Intended

Drugs used in the United States to execute prisoners often do not work as intended, instead causing slow and painful deaths that likely are in violation of constitutional bans on cruel and unusual punishment. The most recent medical review of studies about the topic says that even when the drugs are given properly, the three-drug injection method looks to have caused some inmates to suffocate while they were conscious and unable to move. The drugs are supposed to stop a person's heart while he or she is sedated. No scientific group ever has said that lethal injection is humane, say the authors of the review.

Study: Lethal injection method flawed

The study says that the problem with lethal drugs is that they do not consider an inmate's weight or other such factors. Consequently, the anesthesia given to some inmates wears off before death occurs. Teresa Zimmers, a biologist who led the study, said that "you wouldn't be able to use this protocol to kill a pig at the University of Miami."

Posted by Patricia Bowling at 11:01 AM | Permalink

H S Joy of Love Recalled

Herbal Science International has begun a voluntary nationwide recall of its supplement sold under the name H S Joy of Love. The Food and Drug Administration recently said that lab samples of H S Joy of Love contain Piperadino Vardenafil, which is an analog of Vardenafil, which is an FDA-approved drug used as a treatment for male Erectile Dysfunction. Piperadino Vardenafil is similar structurally to Vardenafil, it has a similar pharmacological and adverse effect profile.

Jen-On Herbal Science Recalls H S Joy of Love, a Product Marketed As a Dietary Supplement

The presence of Piperadino Vardenafil is worrisome because consumers who take other prescription drugs containing nitrates may have to worry about drug interactions and the compound also has potential to lower blood pressure to dangerous levels. H S Joy of Love is sold across the country and those who have been taking it should stop using it immediately.

Posted by Patricia Bowling at 01:39 PM | Permalink

Does FDA, Congress Ensure Drug Safety?

More than 60 percent of U.S. adults think that the Food and Drug Administration and Congress do not do an adequate job of ensuring prescription drug safety, says a survey from Consumer Reports. The survey was conducted over the telephone and used date from 1,026 randomly chosen adults. Nine out of ten of the respondents wanted all clinical trial data made public and say that the FDA should have the authority to require warning labels and post-market trials of prescription drugs with safety issues.

Many Believe FDA, Congress Fail to Ensure Prescription Drug Safety

Jim Guest, the CEO of Consumers Union, says that "the message we're hearing from consumers couldn't be clearer- they want strong laws to ensure our prescription drugs are as safe and as effective as possible." The study also found that six out of ten respondents believe that physicians and scientists with financial conflicts of interest should not be allowed to participate in FDA advisory committees.

Posted by Patricia Bowling at 01:16 PM | Permalink

Listerine Recalls Agent Cool Blue Mouthwash

McNeil-PPC's recall of every bottle of Listerine Agent Cool Blue mouthwash has potential to ruin what appeared to be a very promising brand for the company. Last week's recall announced that approximately four million bottles of the mouthwash may have been contaminated with certain microorganisms. The recall was voluntary on the part of Mc-Neil-PPC and not initiated by the FDA. Thus far, no health effects related to the mouthwash have been reported; however, a risk could be posed to those who have weakened or suppressed immune systems.

Not Cool: Listerine Recalls Agent Cool Blue Mouthwash

Agent Cool Blue had been a profitable product for McNeil-PPC, but the recall likely will affect this. Because Agent Cool Blue is a relatively new brand, it has not established much loyalty in its customers. Jennifer Sheehey, who works for Cone Communications in Boston, says that “You don’t get three strikes and you’re out with products for children. Parents aren’t very forgiving about something like this.” The recall does not affect parent company Listerine.

Posted by Patricia Bowling at 12:55 PM | Permalink

Hormone Replacement Therapy Also Linked to Ovarian Cancer

Hormone replacement therapy, which already has been linked to increased rates of breast cancer, now also has been tied to increased risk of developing ovarian cancer. Women who take HRT are about 20 percent more likely to develop and die from ovarian cancer compared to women who never have been on HRT. This new research comes from the Million Women Study, which looked at 1.3 million British women from 1996- 2001.

Hormone replacement therapy now linked to ovarian cancer

In HRT, women take estrogen or progesterone because natural levels of these hormones decline after menopause. HRT can be beneficial in reducing menopausal problems such as hot flashes, vaginal dryness, and increased rates of osteoporosis and heart disease. The total incidence of these three cancers in the (Million Women Study) population is 63 percent higher in current users of HRT than never-users," says the study.

Posted by Patricia Bowling at 12:05 PM | Permalink

Decline in Breast Cancer Rates Linked to Less HRT

Researchers say that a sharp decrease in breast cancer occurrence corresponds to a decline in the use of hormone replacement therapy. After the Women's Health Initiative study regarding HRT was stopped in 2002 because of HRT safety concerns, many women stopped taking hormone replacement drugs over fears of increased risk of breast cancer. The combination of estrogen and progestin used in the drugs likely is to blame for the greatly heightened risk for invasive breast cancer. Although the most recent data does not establish a cause-and-effect relationship, a 6.7% decline in breast cancer was shown in 2003.

Sharp decline in breast cancer linked to HRT, study shows

Senior author of the study, Dr. Donald Berry, said that "I was surprised by the precipitous drop in breast-cancer incidence that started immediately after the announcement of the Women's Health Initiative results and the consequent decrease in the use of HRT. But when I realized that stopping a cancer's fuel could slow its growth, it seemed quite reasonable."

Posted by Patricia Bowling at 11:05 AM | Permalink

FDA Confirms Boston Scientific Defibrillator Recall

The U.S. Food and Drug Administration has confirmed that Boston Scientific Corporation did recall some of their cardiac defibrillators earlier in the month. Boston Scientific recalled approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of a flaw in the devices that can lead to the batteries dying sooner than expected. Boston Scientific says that most patients are not affected by the recall, but should be in touch with their physicians about possible action.

FDA Confirms Boston Scientific Defibrillator Recall

Boston Scientific says that as of March 30, they had confirmed 19 cases of patients being affected by the defibrillators being recalled. However, no serious injuries or deaths have been linked to the battery problem.

Posted by Patricia Bowling at 12:35 PM | Permalink

Listerine Agent Cool Blue Rinse Recalled

The U.S. Food and Drug Administration has announced a voluntary recall of all lots of Listerine Agent Col Blue Plaque-Detecting Rinse. The mouthwash is believed to have been contaminated by microorganisms. McNeil-PPC Inc., a Johnson & Johnson, subsidiary and the maker of Listerine, plans to recall approximately four million bottles. The FDA says that the risk of the microorganisms causing illness in healthy people is very low; however, it could pose a serious threat to those with weakened or suppressed immune systems.

Listerine Agent Cool Blue Rinse Recalled

Consumers are advised to stop using the product. Listerine Agent Cool Blue is available in Glacier Mint and in Bubble Blast flavors and is marketed toward children. Anyone who has a bottle can get a refund by calling the company. No other Listerine products are affected by the recall. Additional information can be found at Agent Cool Blue's website.

Posted by Patricia Bowling at 12:01 PM | Permalink

Man Drops Suit Against Merck Over Vioxx

Lowell Berwick dropped his lawsuit against Merck for a heart attack that he allegedly suffered as a consequence of having taken Merck's drug Vioxx. Los Angeles Superior Court Judge Victoria Chaney allowed Berwick's motion to dismiss his case because he was worried about the effects that the trial could have on his health. Berwick's lawyer was not available for comment.

Man Drops Suit Against Merck & Co. Over Vioxx

Berwick, a retired auto repairman, took Vioxx for 10 months before he suffered a heart attack in March 2004 at the age of 61. Berwick had had a prior heart attack and bypass sugery several years before he began taking Vioxx. However, he said that Merck did not warn his doctor about the dangers of the drug to patients who had a history of heart ailments.

Posted by Patricia Bowling at 02:52 PM | Permalink

Consumer Group Says Celebrex Ad Downplays Risk

Pfizer Inc. was accused on Monday of downplaying the risk of Celebrex and its other painkillers in a new advertisement. Pfizer is the world's largest drugmaker. They began running television advertisements for Celebrex last week for the first time in two years. Sidney Wolfe, the director of the health group at Public Citizen, said that "the overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than other drugs." Wolfe added that the ad may lead consumers to take more expensive, riskier Celebrex over "equally effective, safer alternatives such as naproxen."

< href="http://www.sciam.com/article.cfm?alias=consumer-group-says-celeb&chanId=sa003&modsrc=reuters">Consumer Group Says Celebrex Ad Downplays Risks

Celebrex, like Vioxx and Bextra, is a COX-2 inhibitor. COX-2 inhibitors have been promoted as being more gentle on the stomach than other painkillers such as naproxen and ibuprofen. However, COX-2 inhibitors have been linked to an increased risk of heart attacks and strokes in those who take the drugs for an extended period of time. Vioxx was pulled from the market two years ago.

Posted by Patricia Bowling at 01:42 PM | Permalink

Bottles of Ziagen May Have Been Mislabeled

The U.S. Food and Drug Administration said that bottles of the HIV drug Ziagen may have been mislabeled as Combivir, another HIV drug. GlaxoSmithKline, the manufacturer of both Ziagen and Combivir, said that the bottles likely were mislabeled by someone else who used fake labels to mislead consumers about pill contents. Thus far, no consumers are believed to have been injured by the tampering. However, Ziagen's active ingredient has potential to cause hypersensitivity reactions in some patients that could lead to death.

FDA Warns of HIV Drug Mix-Up

The FDA says that thus far "these incidents appear to be isolated and limited in scope to one pharmacy in California." The labels on the affected bottles were identified as Lot No. 6ZP9760. Combivir tablets are white and have "GX FC3" engraved on one side, while Ziagen tablets are yellow and read "GX 623" on one side.

Posted by Patricia Bowling at 01:17 PM | Permalink

Arcoxia Raises Heart Attack Risk

Merck & Co.'s new arthritis drug, Arcoxia, which was being promoted as the successor to Vioxx, likely will not be approved in the U.S. because studies suggest that it raises the risk of heart attacks. Merck's research thus far has not adequately shown that the drug will not cause the same risks that eventually caused Vioxx to be pulled from the market. Trevor Polischuk, an analyst with Orbimed Advisors LLC in New York, said that expectation for Arcoxia approval are at "super-low" levels.

Vioxx Successor's Heart Risks Raising Doubts

U.S. rejection of Arcoxia would affect Merck's plans to regain some of the $2.5 billion in annual sales that were lost when Vioxx was withdrawn from the market in 2004. If Arcoxia were approved, it could have sales of $1 billion a year; analysts say that this would indicate that Merck has recovered from its Vioxx setback. Merck's request to sell Arcoxia will be evaluated April 12 by the Arthritis Advisory Committee.

Posted by Patricia Bowling at 01:11 PM | Permalink

Questions Surround Death of Girl

Rebecca Riley, 4, died on December 13, 2006 after an overdose of prescription medications and her parents are being charged in her murder and accused of having overmedicated their daughter in order to keep her docile. While many people who were in contact with Rebecca, including teachers, social workers, and other professionals, realized something was out of the ordinary, none of them did enough to save Rebecca's life. Dr. Jon McClellan, the medical director of the Child Study and Treatment Center in Lakewood, Washington, said that while giving medications to children with behavior problems is "the easiest thing to do, it's not always the best thing to do. At some level, I would hope that you'd also be teaching kids ways to control their behavior."

Girl's overdose death raises questions

The medical examiner says that Rebecca died of a combination of Clonidine, a blood pressure medication used to treat ADHD, Depakote, an anti-seizure and mood-stabilizing drug for bipolar disorder, a cough suppressant, and an antihistamine. The medical examiner said that the amount of Clonidine alone that Rebecca had been given was enough to kill her. Rebecca's parents, Michael and Carolyn Riley, say that they were simply following doctor's orders. The Rileys' attorney says that Rebecca's psychiatrist, Dr. Kayoko Kifuji, should be held responsible for Rebecca's death because she overprescribed medication. Kifuji did not comment and refuses to be interviewed. Tufts-New England Medical Center, where Kifuji works, has issued a statement in support of Kifuji, says that her care of Rebecca was "appropriate and within responsible professional standards."

Posted by Patricia Bowling at 12:33 PM | Permalink

Pain Relievers Don't Guard Against Colon Cancer

A federal task force has determined that not enough scientific evidence supports the idea that taking aspirin and other pain relievers prevents colorectal cancer. Taking pain relievers in doses higher than 300 milligrams on a regular basis causes more harm than good, the task force says, and increases stroke risk, internal bleeding, and kidney failure. The recommendation is a part of the new US Preventive Services Task Force guideline.

Federal Panel: Don't Use Pain Relievers to Guard Against Colon Cancer

The group warns against the regular use of aspirin and other non-steroidal anti-inflammatory drugs for prevention of colorectal cancer in people of average risk for contracting the disease. Eric J. Jacobs, PhD, and a senior researcher for the American Cancer Society's department of epidemiology and surveillance, agrees with the findings of the task force. "Although not as easy as swallowing an aspirin, getting adequate exercise and maintaining a healthy weight are effective ways to reduce the risk of both heart disease and colorectal cancer," Jacobs says. "In addition, all Americans 50 and older should begin to get screened for colon cancer, which can result in the detection and removal of colon polyps before they turn into cancer."

Posted by Patricia Bowling at 12:12 PM | Permalink

Hormone Heart Risk Overstated for Women in 50s?

A recent review suggests that the risks of taking hormones for women in their 50s may have been overstated. A study from five years ago caused millions of women to stop taking hormone treatments to help relieve menopausal symptoms such as hot flashes and night sweats. However, Dr. Jacques Rossouw, a government researcher who led the original research and the new review of the original research, says that hormones look to be a good short-term option for women in their 50s.

Analysis: Hormone Heart Risk Overstated for Women in 50s

Many critics of the original study are happy with the results of the review. They had originally argued that the results of the study were off because more than half of the women in the original study were past the normal age when hormones are started. However, hormone pills are not receiving a complete approval because they still increase the risk for strokes and for breast cancer. Dr. Debra Judelson, a Beverly Hills cardiologist, says that "If you go back to the original WHI results, women were too old, they had too much disease, there was no breakdown by years or time since menopause." Dr. Joseph Carnardo, of Wyeth Pharmaceuticals Inc., the maker of the hormone pills studied, was pleased with the results of the study: "Hormone therapy is an individualized choice. This actually should help women and doctors to make that kind of decision."

Posted by Patricia Bowling at 01:54 PM | Permalink

Fewer Children Given Antidepressants After FDA Warnings

The number of children and teenagers who are prescribed antidepressant medications looks to have been affected by warnings that such drugs increase suicidal behavior in this age group. Additionally, antidepressants are now more often prescribed to these age groups by psychiatrists than primary care physicians. The U.S. Food and Drug Administration released a public health advisory on October 27, 2003 that cautioned that children and teenagers who took antidepressants had an increased risk of suicidal behavior.

Fewer Children, Teens Received Antidepressants After FDA Warnings

Since the advisory, conflicting information has made it unclear as to whether prescription patterns were affected. The data that led to the conclusion that fewer drugs were being prescribed to this age group was collected by Charles B. Nemeroff, M.D., Ph.D., from the Emory School of Medicine. Prescription data looked at about 55 percent of all U.S. retain pharmacy claims. Based on the data, researchers concluded that "the growth in total antidepressant prescriptions seemed to begin to slow around the timing of the public health advisories in October 2003 and March 2004 about pediatric suicidality."

Posted by Patricia Bowling at 03:38 AM | Permalink

FDA Begins Webpage to Discourage Online Accutane Purchases

The Food and Drug Administration has begun a webpage that they hope will discourage consumers from buying isotretinoin, sold by Roche under the name Accutane, over the Internet. Pregnant women who take Accutane risk birth defects and fetal death and Accutane also can raise rates of depression and suicide. "Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely," says the FDA.

FDA Launches Web Page To Discourage Consumers From Purchasing Acne Drug Accutane Online

The Food and Drug Administration has worked to increase awareness of the teratogenic effects of Accutane. In late 2005, the FDA began to require registration of physicians, prescription drug wholesalers, pharmacists, and women into iPledge, which demands that women submit two negative pregnancy tests before they will be prescribed Accutane. Additionally, women must undergo a pregnancy test before each monthly refill and must use either two forms of birth control or restrain from sexual intercourse while taking the drug. About 165,000 people have registered so far with iPledge.

Posted by Patricia Bowling at 12:57 PM | Permalink

FDA Debates Anesthesia Risk for Children

Studies on animals suggest that anesthesia can be harmful to the developing brain; however, there is no evidence that anesthesia affects brain growth in humans. Food and Drug Administration scientists stress that because there is no evidence of humans being affected, there is no cause for immediate alarm.

FDA debating anesthesia risk for kids

Numerous studies have shown that many of the drugs used to induce a state of unconsciousness in children before surgery kill brain cells in young rats, in mice, and, preliminary results suggest, in rhesus monkeys. Dr. Arthur Simone, an FDA medical officer, says that "a safety signal has been identified in animals for many drugs used to provide sedation and anesthesia. This database is growing. The relevance of the animal findings to pediatric patients is unknown."

Posted by Patricia Bowling at 12:27 PM | Permalink

FDA Pulls Parkinson's Drug From the Market

Eli Lilly's Parkinson's disease drug pergolide, sold under the name of Permax, has been withdrawn from the market. The Food and Drug Administration says that the decision was made because the drug has a history of causing potentially fatal heart valve damage. Reports indicate that pergolide can cause heart problems similar to those caused by the diet drug fen-phen. Because Permax is not any more effective at treating Parkinson's than any other available medication, "it doesn't really have a place in therapy any more," said Dr. Robert Temple. Temple is the head of the FDA's office of drug evaluation.

FDA yanks Parkinson's drug from market

Permax is not in wide use and only is prescribed to about 12,000 to 25,000 patients a year, said Temple. Parkison's patients who are taking the drug should not immediately stop taking it, but should switch to different medications. Pergolide was approved in 1988 and is a dopamine agonist that usually is used with other medicines to control symptoms of Parkinson's.

Posted by Patricia Bowling at 11:50 AM | Permalink

Supplements, Herbs, and Drugs Don't Mix

Dr. George Grossberg, from the St. Louis University, cautions those who are taking both prescription drugs and herbal remedies to be cautious. Grossberg is the author of "The Essential Herb-Drug-Vitamin Interaction Guide." Grossberg says, "people think if it doesn't require a prescription, it's got to be safe, and that's not true. There could be life-threatening effects."

Supplements, Herbs, Drugs Don't Mix

St. John's Wort, the herb often taken to treat anxiety and depression, can cause serotonin syndrome if mixed with anti-anxiety medications, such as Prozac, Zoloft, or Paxil. Symptoms of serotonin syndrome include agitation, rapid heart beat, flushing, and heavy sweating. Some herbs also have been linked to health problems, even if not taken in conjunction with prescription medications. Caution should be used in taking all medications.

Posted by Patricia Bowling at 11:34 AM | Permalink

Drug Interaction Killed Anna Nicole Smith

Anna Nicole Smith was killed by an "accidental overdose of powerful sedative that became lethal when mixed with nine other prescription drugs," according to the Broward County, Florida coroner's report. Smith was taking sleeping medications, chloral hydrate, and several other drugs, including Valium, Klonopin, and Ativan. Smith's death highlights the dangers of mixing drugs; adverse drug reactions are one of the leading causes of death in health care. According to the Food and Drug Administration, about 100,000 people die each year from adverse drug reactions.

Drug Interaction Kills Anna Nicole

Complications from drug interactions are the most comoon cause of iatrogenic illness. Drug-related deaths and illnesses have recently been estimated to cost more than $130 billion each year in the United States. Online drug interaction checkers can be of benefit to those who take many drugs; the online tool also checks for interactions with certain foods, alcohol, and other drugs.

Posted by Patricia Bowling at 11:12 AM | Permalink

April 30, 2007

Lethal Injection Drugs Often Don't Kill As Intended

April 27, 2007

H S Joy of Love Recalled

April 26, 2007

Does FDA, Congress Ensure Drug Safety?

April 25, 2007

Listerine Recalls Agent Cool Blue Mouthwash

April 24, 2007

Hormone Replacement Therapy Also Linked to Ovarian Cancer

April 23, 2007

Decline in Breast Cancer Rates Linked to Less HRT

April 20, 2007

FDA Confirms Boston Scientific Defibrillator Recall

April 19, 2007

Listerine Agent Cool Blue Rinse Recalled

April 18, 2007

Man Drops Suit Against Merck Over Vioxx

April 17, 2007

Consumer Group Says Celebrex Ad Downplays Risk

April 16, 2007

Bottles of Ziagen May Have Been Mislabeled

April 13, 2007

Arcoxia Raises Heart Attack Risk

April 12, 2007

Questions Surround Death of Girl

April 11, 2007

Pain Relievers Don't Guard Against Colon Cancer

April 10, 2007

Hormone Heart Risk Overstated for Women in 50s?

April 09, 2007

Fewer Children Given Antidepressants After FDA Warnings

April 06, 2007

FDA Begins Webpage to Discourage Online Accutane Purchases

April 05, 2007

FDA Debates Anesthesia Risk for Children

April 04, 2007

FDA Pulls Parkinson's Drug From the Market

April 03, 2007

Supplements, Herbs, and Drugs Don't Mix

April 02, 2007

Drug Interaction Killed Anna Nicole Smith