Unsafe Drugs: October 2006 Archives

Doctors Warned of Effexor Overdose Risk

Drug manufacturer Wyeth and the U.S. Food and Drug Administration are cautioning doctors to limit the number of Effexor pills that they prescribe. There are reports of deaths and serious injuries in patients who overdosed on Effexor, especially when the drug is taken in conjunction with alcohol. Overdosing on any antidepressant can be fatal, but there is a greater risk of deadly overdose with Effexor than with other antidepressants such as Prozac, Zoloft, Paxil, and Lexapro.

Doctors warned of Effexor overdose risk

Wyeth says that it is unclear whether the increased risk of deadly overdose associated with Effexor is because of the drug's traits or the personalities of patients taking the drug.

Posted by Patricia Bowling at 10:09 PM | Permalink | Comments (0) | TrackBacks (0)

Idaho Woman Sues Over Birth Control Patch Problems

Katy McKellips Braman of Boise is suing Johnson and Johnson and Ortho McNeil, blaming its birth control patch Ortho Evra for her blood clot disorder. Braman was 17 when she began using the patch in 2004, but a little over a month on the medication, she developed a serious blood clot disorder which means she now must take anti-blood clotting drugs daily. She is asking that the company pay damages and for any further medical treatment.

Idaho Woman Sues Drugmaker over Birth Control Patch Problems

Ortho McNeil spokeswoman Julie Keenan said the company could not comment on the pending litigation. Last month, the Food and Drug Administration updated the label on the Ortho Evra birth control patch to warn women that they will have a higher risk of blood clots while on the patch.

Posted by Patricia Bowling at 10:31 AM | Permalink | Comments (0) | TrackBacks (0)

Benefits, Risks Associated with Ritalin

A recent study shows that side effects are to be expected with Ritalin use in preschoolers diagnosed with attention deficit disorder, but there also are benefits in using the drug for children with severe problems. Ritalin is not yet approved for use in children under the age of 6. The researchers involved in the study said that low dose Ritalin treatment in young children has benefits outweighing the side effects. However, not all think Ritalin should be prescribed for young children. "I hope publication of this does not lead to more overprescribing," said Dr. Sidney Wolfe of the watchdog group Public Citizen. "The safety isn't adequately established, the efficacy even less."

Study finds risks, benefits in giving Ritalin to preschoolers

Roughly 40% of the children in the study developed side effects and about 11% dropped out of the study because of problems such as irritability, weight loss, insomnia, and slowed growth. Side effects are more pronounced in older children than in younger children. About 8% of U.S. children have ADHA and about 3% of preschoolers.

Posted by Patricia Bowling at 08:46 PM | Permalink | Comments (0) | TrackBacks (0)

FDA Advisory Panel Recommends Further Warnings on Tamoxifen

A Food and Drug Administration advisory panel suggested that a warning label be added to tamoxifen, a drug used to treat and prevent breast cancer. The FDA approved tamoxifen in 1998 to reduce breast cancer risk after a study showed that women taking the drug had a 50% less chance of developing cancer. The FDA recommends that labels warn that postmenopausal women might be at a higher risk of breast cancer recurrence if they take tamoxifen. "The risk signal needs to be indicated very clearly to patients," said Howard McLeod, a panel member and a director at University of North Carolina's Institute for Pharmacogenomics and Individualized Therapy.

FDA Advisory Panel Recommends Adding Warning Label To Breast Cancer Drug Tamoxifen

Tamoxifen is sold under the brand name Nolvadex by AstraZeneca and is currently also sold by several generic drug makers. Physicians are advised to suggest tamoxifen to women who have a risk of breast cancer that is 1.67% or higher. Side effects of Tamoxifen can have side effects of uterine cancer and blood clots.

Posted by Patricia Bowling at 09:49 PM | Permalink | Comments (0) | TrackBacks (0)

Food-Drug Interactions Prove Dangerous

FlavoRx has announced its intent to mount a nationwide campaign to get the message out that food and drug interactions can be dangerous. Food and drink can have effects on some medications and FlavoRx plans to distribute information about these interactions to healthcare practitioners. "Many patients, especially young children, find medications easier to swallow when mixed with food or drink because it masks the existing taste and/or smell," said Kenny Kramm, President and CEO of FLAVORx. "Unfortunately, many common items like juices, dairy products and even fiber, can influence the body’s digestion or absorption of a medication."

FLAVORx Announces Nationwide Campaign to Address Dangers of Food & Drug Interaction

FlavoRx is a company that sells "safe, effective and scientifically-tested flavoring system for over-the-counter and prescription medications to improve taste and compliance without affecting the drug’s efficacy." Kramm says that the three ways in which food and drink can affect a drug's activity on the body are by interfering with absorption, increasing absorption, and mimicking the effect of the medication.

Posted by Patricia Bowling at 12:45 PM | Permalink | Comments (0) | TrackBacks (0)

Beware Drug Combinations!

People taking two high blood pressure medications, usually an ACE inhibitor taken with a diuretic, and a non-steroidal anti-inflammatory drug (NSAID) can potentially suffer from renal failure resulting from drug interactions, which can kill. Examples of NSAIDs include ibuprofen or Celebrex. A recent online survey showed that 9% of patients were taking a potentially dangerous combination of drugs and one half of those surveyed could remember being warned by their doctor or pharmacists about the dangers of adding anti-inflammatories to the drugs they already were taking.

Beware the 'triple whammy' drug combo

The survey was conducted by Kidney Health Australia.

Posted by Patricia Bowling at 12:29 PM | Permalink | Comments (0) | TrackBacks (0)

CDC Funds Large Study to Find Autism's Cause

The autism. It is unusual for the CDC to fund such a study: Diana Schendel, the CDC's lead health scientist said of the study: "the CDC hasn't funded a study like this (before.)"

CDC funds largest study of autism's cause

However, the president of the National Autism Association says the CDC is not to be trusted because it promotes childhood vaccines. Vaccines are believed to be a possible cause of autism, though it should be noted that no scientific research has established such a link and that the benefits of childhood vaccines have drastically improved life since their widespread use. Autism is a disorder not general diagnosed in children until after the age of three. Symptoms can include head-banging, avoiding physical or eye contact with others, and communicating with gestures instead of words.

Posted by Patricia Bowling at 09:22 PM | Permalink | Comments (0) | TrackBacks (0)

New Schizophrenia Drugs No Improvement?

The new anti psychotic drugs may not be significantly more effective than older drugs used in the treatment of schizophrenia, report British researchers. Older schizophrenia drugs are less expensive than the newer drugs and this recent study suggests that the widely held belief that newer drugs have less side effects and therefore are better may be false.

Newer Schizophrenia Drugs May Be No Better

The study had 118 patients take first generation drugs and 109 patients take second-generation drugs. After twelve weeks, quality of life scores for those taking first generation drugs was 49.2, compared with 46.6 for those taking the second generation drugs. After 26 weeks, the scores were 49.2 for the first generation drugs and 50.4 for the second generation. After one year, the scores were 53.2 for the first generation and 51.3 for the second generation. Study authors said that "participants reported no clear preference for either drug group; costs were similar."

Posted by Patricia Bowling at 11:25 AM | Permalink | Comments (0) | TrackBacks (0)

New Weight Loss Drugs Hope to Take Place of Fen-Phen

A new drug, in clinical trials, shows promise for weight loss. Similarly to its predecessor Fen-Phen, which was pulled from the market because it proved unsafe, the trial combines two drugs already approved by the FDA in which one of the side effects has been weight loss. Wellbutrin, an anti-depressant, is combined with an anti-seizure drug; the combination of drugs affects both dopamine and seratonin to signal fullness to the brain.

Health Alert: Weight-loss drugs

So far, the side effects from the new drug cocktail are numbness, tingling, and a feeling of fogginess. Maria Lightford, who was one of the participants in the trial said that she is happy with the results: "If it'll help you lose weight, why not?" Another phase of the trial will begin in a few months.

Posted by Patricia Bowling at 11:12 AM | Permalink | Comments (0) | TrackBacks (0)

Xanax for Fun? Bad Choice.

Abuse of the prescription drug Xanax is becoming more popular, leading to dangerous consequences. On the club scene, the white, rectangular pills are referred to as "bars," "ladders," and "French fries." Two young adults recently died in Florida, likely as a result of having mixed alcohol use with Xanax use. Sargeant Barry Fox said that "the investigations in both cases reveal the common link was alcohol and Xanax bars."

Police Warn of Popular But Deadly Combo

In many college towns, Xanax has become a popular drug among young adults. Xanax mixed with binge drinking of alcohol has "proven to be fatal or deadly in some cases," said Fox. Xanax is used to treat anxiety and is manufactured by Legal View: Unsafe Drugs
Drugs.com: Xanax

Posted by Patricia Bowling at 09:59 PM | Permalink | TrackBacks (0)

Xylitol Unsafe for Dogs

Xylitol, a commonly used sweetner, has been further linked to liver failure and death in dogs. Xylitol is cound in many sugar-free gums, candies, baked goods, and in toothpaste. In the study, eight dogs who had eaten xylitol containing products were looked at. Each of the dogs had become sick, and five had ended up dying from liver failure, possibly from the xylitol. "People don't think sugar-free gum can kill their dog. I didn't before I got into this. But this is something people should be aware of," said Sharon Gwaltney-Brant, a coauthor of the study.

Dog owners warned over sugar-free items

Xylitol can cause significant insulin release in dogs, which drops their blood sugar levels to potentially fatal levels. Gwaltney-Brant says that a 22 pound dog who eats only one gram of xylitol should be taken to a vetrinarian for treatment.

Posted by Patricia Bowling at 02:11 PM | Permalink | Comments (0) | TrackBacks (0)

Nasutra Dietary Supplements Recalled

Nasutra LLC said Wednesday that it is recalling all Nasutra-brand dietary supplements being sold to enhance male sexual performance. The Food and Drug Administration showed Nasutra contains acetildenafil, which is a similar compound to sildenafil, the active ingredient in Viagra. Viagra is sold only by prescription in the U.S.

Acetildenafil has the ability to interact with other prescription drugs to lower blood pressure to unsafe levels. In July, the FDA warned consumers against buying Nasutra after it was shown that they contained compounds similar to those in prescription drugs.

Posted by Patricia Bowling at 01:54 PM | Permalink | Comments (0) | TrackBacks (0)

Flood of Vioxx Lawsuits as Deadline Nears

September 30 marked the deadline for many Vioxx users to sue manufacturer Merck because many US states have a time limit of two years on personal injury lawsuits. Merck continues to fight each lawsuit, a strategy most experts say is preventing an even larger number of lawsuits from being filed. Merck already faces more than 21,700 suits and 190 potential class action lawsuits by Vioxx users and Merck shareholders. Merck, however, is not allowing the flood of lawsuits to bring down its morale. Merck chief executive Richard Clark said, "if you compare the company's focus and energy and morale with where we were two years ago, the focus and energy is back."

Legal View: Vioxx
Last-minute lawsuits bombard Vioxx creator
Surge of Vioxx lawsuits swamp courthouses

Posted by Patricia Bowling at 12:55 PM | Permalink | Comments (0) | TrackBacks (0)

Continued Controversy over Ephedra

Nutraceutical Corporation has filed a petition to the U.S. Court of Appeals, asking that the ban on its herbal supplement Ephedra be reversed. Ephedra is a sports performance and weight loss supplement. Nutraceutical's petition blames the three-judge federal appeals panel for using "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved for pre-market review of drugs."

Nutraceutical Corp again challenges Ephedra ban

Controversy over Ephedra has been ongoing ever since Ephedra was linked to adverse health effects. While pharmaceuticals must go through pre-market approvals, herbal supplements are not subject to such controls. The lack of testing is of concern to many.

Related Links:
Legal View: Ephedra
Consumer Advisory:Ephedra
Nutraceutical Press Release

Posted by Patricia Bowling at 12:49 PM | Permalink | Comments (0) | TrackBacks (0)

Deadly Consequences When Medication Stopped Early

Many patients stop taking their medications before they should and, in doing so, put themselves in danger when those drugs are being used to treat heart disease or diabetes. One of eight heart attack patients out of the hospital for one month stopped taking the life-saving drugs prescribed to them, found a study of 1,521 patients. "One month is very surprising," said Dr. Michael Ho, a co-author of the study.

Many Patients quit medicine too early

Heart attack patients who stopped taking their medicine early were found to be three times more likely to die during the next year than their counterparts who continued to take their medications. The study did not look at why patients stopped taking medication, but found those who discontinued use to be older, single, and less educated.

Posted by Patricia Bowling at 09:21 PM | Permalink | Comments (0) | TrackBacks (0)

Doctors Need to Provide More Drug Info

Physicians need to be more vigilant when prescribing patients with new information, say investigators in California."Physicians stated the specific medication name for 74% of new prescriptions and explained the purpose of the medication for 87%," said Dr. Derjung M. Tarn from the David Geffen School of Medicine in Los Angeles. Doctors only mentioned how long the medication should be taken 34% of the time and described possible adverse effects only 35% of the time.

Docs often fall short when prescribing new drugs

The lack of adequate patient-doctor communication may be part of the reason that patients do not comply with treatment. Furthermore, patients who are unable to read medication labels are greatly impacted when drug information is not verbally conveyed.

Posted by Patricia Bowling at 08:50 PM | Permalink | Comments (0) | TrackBacks (0)

Epilepsy Drug Linked to Cleft Palate

GlaxoSmithKline's epilepsy drug Lamictal during the first three months of pregnancy may increase the chances of having a baby born with a cleft palate, says the Food and Drug Administration. In an alert posted on its website, the FDA said "more research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal."

U.S. says Glaxo drug may be linked to birth defect

The FDA recommends that women who are pregnant or who are considering becoming pregnant not take Lamictal without discussing it with their doctor. A Glaxo spokesman said that the safety and efficiency of Lamictal are not in dispute, but that the decision to take any drug brings risks.

Posted by Patricia Bowling at 08:18 PM | Permalink | Comments (0) | TrackBacks (0)

Bayer Failed to Disclose Drug Data

German drug maker Trasylol before an advisory panel met and ruled that the side effects were acceptable, said the company Friday. The Food and Drug Administration said records from 67,000 patients may suggest that Trasylol increases the risk of death, serious kidney damage, congestive heart failure and strokes. Bayer apologizes from not being more open about the study: Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21 advisory committee meeting ... This was a mistake on the company's part," said a Bayer statement.

Bayer says mistakenly failed to disclose drug data

The FDA said of the new study: "Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure and stroke." The FDA plans to review the data to determine how they should advise doctors in prescribing Trasylol in the future.

Posted by Patricia Bowling at 07:52 PM | Permalink | Comments (0) | TrackBacks (0)

LA Man Alleges Zyprexa Caused Diabetes

A Lousiana man has filed a lawsuit against Eli Lilly, manufacturer of atypical antipsychotic drug Zyprexa, alleging he developed diabetes as a consequence for having taken the drug for two years. The lawsuit states that Eli Lilly did not give adequate warning that Zyprexa use was linked to diabetes.

Louisiana Man Files Lawsuit Against Eli Lilly Alleging Zyprexa Caused Diabetes

Zyprexa is also known as olanzapine and was approvedin 1996 as treatment for schizophrenia and bipolar disorder. In 2004, Eli Lilly began including warning labels with Zyprexa, stating that there is an increased risk of developing hyperglycemia and diabetes associated with taking the drug. In 2005, Eli Lilly settled Zyprexa claims by awarding plaintiffs with $690 million.

Posted by Patricia Bowling at 07:35 PM | Permalink | Comments (0) | TrackBacks (0)

FDA, Duke to Look at Drug-Heart Interactions

The U.S. Food and Drug Administration will partner with Duke to investigate the effects of drugs on the heart. The research will look at a database of more than 200,000 electrocardiograms (EEGs) to flag cardiac risks that may be associated with new drugs and medical devices that the FDA approves for the market. Andrew von Eschenbach, the FDA's acting commissioner said that "for years, we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient's heart. Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we are now able to identify biological measures that will help to predict which patients are at an increased risk for cardiovascular side effects. This will ultimately lead to the development of safer and more effective treatments."

The partnership also will allow better access to data associated with academia, patient advocacy groups, government and non-profit groups.

Posted by Patricia Bowling at 10:35 PM | Permalink | Comments (0) | TrackBacks (0)

Actavis Warned by the FDA

Icelandic Drug manufacturer Actavis Group has been warned by the FDA that it has violated the law by not reporting the adverse reactions experienced by patients taking its drugs. Actavis has more than 600 products on the market at this time. The FDA reports on that Actavis failed to report six "serious and unexpected adverse drug events," as long ago as 1999.

FDA Warns Icelandic Drug Maker Actavis

The FDA also says that Actavis left out important information, such as previous conditions of patients and follow-up information from physicians, in the adverse reactions that it did report. Actavis also never has filed a periodic safety report for its Little Falls, N.J. plant. Actavis responds to the charges by saying it has since revised its reporting procedures and has submitted a response to the FDA's accusations.

Posted by Patricia Bowling at 10:09 AM | Permalink | Comments (0) | TrackBacks (0)

October 29, 2006

Doctors Warned of Effexor Overdose Risk

October 25, 2006

Idaho Woman Sues Over Birth Control Patch Problems

October 24, 2006

Benefits, Risks Associated with Ritalin

October 23, 2006

FDA Advisory Panel Recommends Further Warnings on Tamoxifen

October 18, 2006

Food-Drug Interactions Prove Dangerous

October 17, 2006

Beware Drug Combinations!

October 16, 2006

CDC Funds Large Study to Find Autism's Cause

October 15, 2006

New Schizophrenia Drugs No Improvement?

October 14, 2006

New Weight Loss Drugs Hope to Take Place of Fen-Phen

October 13, 2006

Xanax for Fun? Bad Choice.

October 12, 2006

Xylitol Unsafe for Dogs

October 11, 2006

Nasutra Dietary Supplements Recalled

October 10, 2006

Flood of Vioxx Lawsuits as Deadline Nears

October 09, 2006

Continued Controversy over Ephedra

October 08, 2006

Deadly Consequences When Medication Stopped Early

October 07, 2006

Doctors Need to Provide More Drug Info

October 06, 2006

Epilepsy Drug Linked to Cleft Palate

October 05, 2006

Bayer Failed to Disclose Drug Data

October 04, 2006

LA Man Alleges Zyprexa Caused Diabetes

October 03, 2006

FDA, Duke to Look at Drug-Heart Interactions

October 02, 2006

Actavis Warned by the FDA