Unsafe Drugs: September 2006 Archives

Evidence Kidney Drugs Correlated to Heart Attacks, Strokes

Despite growing evidence that aggressive kidney dialysis treatment can raise the risk of fatal heart attacks and strokes, doses continue to rise. Epogen, produced by Amgen, Inc., is taken by a majority of the 325,000 Americans with kidney failure. Epogen raises energy levels in patients and makes them feel healthier. However, about 20% of those taking Epogen had red blood cell levels in a concentration high enough to be of concern in a clinical trial performed last year.

As kidney drug doses rise, so do warnings

Dr. Jeffrey Ferns, an associate professor of medicine at the University of Pennsylvania said of the results "We need to be more conservative in where we target and maintain patients." Amgen says that the results are of note, but are not of particular concern because they do not represent typical administration. Epogen acts by increasing oxygen-carrying red blood cells to counteract the effects of anemia that go along with kidney failure.

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Accutane IPledge Program Impacting Drug Sales

Strict regulations of the sale of the acne drug isotretinion, marketed by Roche as Accutane, are negatively impacting sales of the drug and causing more buyers to look to the Internet. The FDA began on December 30, 2005 to register women, drug wholesalers, physicians, and pharmacists into iPledge, which requires women to submit two negative pregnancy tests before they can receive a Accutane prescription. Women must undergo a monthly pregnancy test while taking the drug, and also agree to use two forms of birth control or to abstain from intercourse for one month prior to Accutane treatment and for one month following.

Medical News Today

Studies have shown Accutane to cause severe side effects in pregnant women, such as birth defects and fetal death, and might also be associated with higher rates of suicide and depression. Since users have been subjected to the IPledge, sales of the drug have fallen 46% compared with the same time last year. To discourage people from bypassing the IPladge by purchasing online, the FDA is expected to discuss ways to change IPledge to make it more flexible. In addition, the FDA is creating a website that will pop out when Accutane is searched for on the Internet; this might discourage some from purchasing online.

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Zyprexa to Blame for Son's Diabetes?

Catherine Harrison of West Baton has filed a federal lawsuit against Eli Lilly and Co. because she claims her son developed diabetes after taking the drug Zyprexa for three months in 2003. In addition to diabetes, Harrison's son also is said to have developed severe stomach and bowel problems. Eli Lilly spokeswoman Terra Fox said of the lawsuit, “we believe the allegations linking Zyprexa and diabetes are not supported by scientific evidence.”

The Advocate

Harrison is suing Eli Lilly for an unspecified amount, but claims her child has suffered extreme pain and will have high medical costs the rest of his life. Zyprexa is the marketed name of olanzapine, an anti-psychotic drug used in the treatment of schizophrenia and bipolar disorder. In 2004, Eli Lilly began including warning labels, citing an increased risk of hyperglycemia and diabetes in people taking the drug.

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Vioxx Most Dangerous Painkiller

Two recent studies provide evidence that banned prescription painkiller Vioxx is more dangerous for users than its two rivals, Bextra and Celebrex. Bextra also has been taken off the market. All three drugs are COX-2 inhibitors. The co-author of one of the studies, Eric Ding, noted that "not all COX-2 inhibitors have the same adverse effects."

Health Day Reporter

Adverse effects from Vioxx were seen almost immediately after the drug began to be sold in 2004. Vioxx was taken off the market in 2004. COX-2 inhibitors are non-steroidal anti-inflammatory drugs. Aspirin, ibuprofen, and naproxen (Aleve) also are included in this class of drugs. Celebrex is the only COX-2 inhibitor left on the market. "It is clear that Vioxx increases the risk of heart attack. And that increase in risk begins with the first tablet a patient takes," said Dr. David J. Graham, author of one of the recent journal articles. Merck & Co., the maker of Vioxx, initially claimed that Vioxx sis not increase the risk of heart attack but actually prevented against heart attacks. Approximately 16,000 Vioxx lawsuits have been filed against Merck in the last few years.

Posted by Patricia Bowling at 01:21 PM | Permalink | Comments (0) | TrackBacks (0)

New AARP Plan: Good or Bad?

On Sunday, the AARP began a $500,000 advertising campaign asking for Senate action in allowing consumers to purchase U.S.-made prescription drugs from Canada and eventually other countries like Australia, Japan, and European Union nations. The legislation has support from 31 co-sponsors. David Certner, AARP legislative policy director, says that U.S. citizens are purchasing medications from abroad already and that something needs to be done to "make sure the system is as safe as we can make it."

Daily Health Report

However, not all are supportive of the bill, largely over concerns of the purity of imported drugs. The Pharmaceutical Research and Manufacturers of America says that the AARP is endangering patients. Ken Johnson, senior president of PhRMA said "the FDA has repeatedly stressed that it cannot guarantee that imported medications from Canada are safe. And Canadian health officials have acknowledged the severity of the counterfeiting crisis within their borders."

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New ADHD Drug Warning

Health Canada is cautioning that all drugs used in the treatment of attention deficit disorder have the potential to cause psychotic reactions in children. The agency is asking that the labelling on these drugs be changed to reflect ''the potential for psychiatric adverse events.'' Health Canada concedes that ADHD drugs are "generally safe."

New Warning Over ADHD Drugs

Four months ago, Health Canada warned that ADHD drugs can cause heart problems, including a risk of sudden death. Children and adults with high blood pressure, heart disease, or heart abnormalities were advised not to take the drugs. ADHD drugs mentioned by Health Canada as cause for concern are: Adderall XR, Attenade, Biphentin, Concerta, Dexedrine and Strattera. Health Canada's advisory echoes that made by the FDA. In March, the FDA's Kate Gelperin described cases of 'hallucinations, both visual and tactile, involving insects, snakes and worms'' present in children taking ADHD drugs.

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WalMart to Sell $4 Generic Drugs

The Chicago Tribune reports that WalMart plans to begin selling some generic drugs for $4 per month. Such an action likely will have a great impact on the pharmaceutical business. The $4 test offer will begin in Florida and may be expanded to other states, depending on the success of the program. A wide selection of drugs will be offered for the low price, and the $4 offer will be available to all, whether or not they have health insurance.

Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, is skeptical of the program. He says that the cheap drugs are only drugs that are fairly cheap already and that have been on the market for a long time. "This isn't addressing what is the source of people's frustrations with drug prices," said Schondelmeyer. "This is a very limited set of drugs. It's a lot of hype and will create a lot of traffic going into Walmart stores. But I think people are going to be disappointed when they go into the stores and find out their drug isn't there."

Posted by Patricia Bowling at 12:20 PM | Permalink | Comments (0) | TrackBacks (0)

Consumers Often Overdose on Prescription Eye Drops

Despite instructions on eye drop labels to use one or two drops, Public Citizen recommends the use of only one drop because there is less chance of overdosing. The recommendation is based on information published in the June 19 issue of The Medical Letter on Drugs and Therapeutics. “By improperly applying eye drops, consumers are putting themselves at risk of overdosing the medication and causing an adverse reaction,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Applying only one drop can be more effective if that drop is applied correctly.”

By using a second drop, consumers may reduce the effectiveness of the first drop, by flushing it out. They may also be increasing the risk of an adverse reaction; there is a greater chance for the drops to enter the blood stream if more of it is present. Excess medicine has only two places to go when dropped into the eye: it can exit the body as a tear or can go through a small duct in the corner of the eye and nose where it is absorbed into the blood.

Related Links:
Legal View: Unsafe Drugs
< ahref="http://renu.legalview.com">LegalView: ReNu with MoistureLoc
WorstPills.org
Eye Drop Overdose Information

Posted by Patricia Bowling at 07:14 PM | Permalink | Comments (0) | TrackBacks (0)

No Misconduct in Vioxx Handling, Finds Merck

USA Today reports that Merck's board of directors said that a 20-month investigation funded by the pharmaceutical company found that senior management acted responsibly in its development and marketing plan of the pain reliever Vioxx. Vioxx is now off the market. The report, which is 1,700 pages long and cost $21 million, mentioned minor criticisms of employee actions but said for the most part "management acted with integrity and had legitimate reasons for making the decisions that it made, in light of the knowledge available at the time."

The report did contain criticism of Merck's marketing, public relations, and response to the doctors who mentioned concerns about Vioxx's safety. Merck reiterated that it never had knowingly put patients at risk. Vioxx was taken off the market two years ago after a study found that the drug doubled patients' risk of heart attacks and strokes. Merck faces 14,200 lawsuits that state Merck knew Vioxx's risks but sold it to the public anyway. Thus far, Merck has lost four of these lawsuits and won four.

Posted by Patricia Bowling at 07:00 PM | Permalink | Comments (0) | TrackBacks (0)

500 Ortho-Evra Users Sue Johnson & Johnson

Johnson & Johnson faces 500 lawsuits related to deaths and injuries caused by its birth control patch, Ortho-Evra, according to the company's latest SEC filing. Claimants "seek substantial compensatory and, where available, punitive damages." Legal analysts say that the 500 claims are nothing compared to what Johnson & Johnson can expect to face once more women across the country realize that the blood clots, heart attacks, and strokes that they have suffered might be a consequence of their having used Ortho Evra.

500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson

In 2005, doctors wrote 9.4 million prescriptions for Ortho Evra, according to IMS Health. Attorneys handing the lawsuits say that Johnson & Johnson plans to settle lawsuits as quickly and as quietly as possible because the symptoms provoked by Ortho Evra are very rare in the demographic group who takes birth control. Attorney Ray Chester says that "Johnson & Johnson is going to lose most of these cases. The cost to defend them and the public relations hit they would take if they tried the cases has tilted them toward settling."Johnson & Johnson does not plan to take the patch off the market.

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Price Hike on Birth Control

Ortho-McNeil has lowered its prices on birth control products for public health services. The price change is good news for public health providers who had purchased birth control and other contraceptives at discounted prices. The recent increase in price had left the state of Virginia looking to find money to cover the difference between the new price and the old price. Barbara Parker, nurse consultant with the Virginia Department of Health said, "It's still an increase, but it's better than it was before. We're still going to need extra money."

The Wytheville Enterprise

Without health insurance, a pack of Ortho-Tricyclen pills costs about $45 dollars. The state price reduction will allow states to purchase packs for about $3.20 a pack as opposed to the $20 packs were being sold for immediately after Ortho Mc-Neil's price increase. Ortho Mc-Neil released the following to explain the price decrease: "This action follows additional information provided to us from numerous public health service agencies indicating that Ortho Women's Health and Urology has been relied upon as the primary source for subsidizing contraceptives to underprivileged women," it reads. "While the company has consistently followed a mandated formula to public health services as a result of participation in the federal government's Medicaid program, the organization has decided to further lower pricing to meet the needs of women and insure access to contraceptive choices and work with under-funded public health services."

Posted by Patricia Bowling at 06:47 PM | Permalink | Comments (0) | TrackBacks (0)

Prempro Cited in Another Lawsuit

CNNMoney.com reports that drug manufacturer Wyeth faces yet another lawsuit, with still thousands of unresolved lawsuits to go, citing its drug Prempro as a cause of breast cancer. Plaintiff Jenny Nelson, 61, says that five years of taking Prempro to treat her menopause caused her breast cancer. Nelson was forced to have a double mastectomy as treatment. Jon LeCroy, analyst for Natexis Bleichroeder, says that Prempro remains on the market because "the FDA believes that they're safe enough for the market" and suggests that the drug's links to breast cancer are not "clear cut or severe."

This will be the second case filed against Wyeth; the first case filed by Linda Reeves is ongoing. Wyeth faces upwards of 4,000 more lawsuits from former patients who took Prempro. In 1999, Wyeth agreed to pay a $3.75 billion settlement to former fen-phen patients. Prempro is a menopausal drug.

Posted by Patricia Bowling at 07:28 PM | Permalink | Comments (0) | TrackBacks (0)

Miscarriage Blamed on Ortho Evra

According to a

Johnson & Johnson, the manufacturer of the birth control patch, did not comment on the case.

Posted by Patricia Bowling at 06:39 PM | Permalink | Comments (0) | TrackBacks (0)

Effects of Epilepsy Drugs May Wane

Patients being treated for epilepsy develop a tolerance to anti-epileptic drugs, according to a review of published studies. "Convincing experimental evidence indicates that almost all first-, second-, and third-generation AEDs lose their antiepileptic activity during prolonged treatment, although to a different extent," said Dr. Wolfgang Losher from the University of Vetrinary Medicine in Hannover, Germany, and co-author Dr. Dieter Schmidt from the Epilepsy Research Group in Berlin. The study says that development of a tolerance is a reason for the failure of drugs to work well in treatment of epilepsy, but that tolerance can be reversed by taking the patient off the drugs.

Effect of epilepsy drugs may wane over time

Loscher and Schmidt conclude that there is a need for more studies assessing tolerance and "and determining the impact of tolerance for long-term seizure outcome and the health of patients with epilepsy."

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Weight Loss Drug Bad for Moms to Be

A study out of Vanderbilt University Medical Center in Nashville, Tennessee suggests a key chemical affected by the drug rimonabant is needed for normal implantation of embryos into the womb. This is of concern to women of childbearing age. Studies also showed that the drug affects other molecules needed for normal development of embryos.
Weight Loss Drug May be Bad for Moms to be

Acomplia is the weight loss drug that contains rimonabant and works by interacting with anandamine to reduce appetite. Anandamine is essential for embryo development and a drug interacting with it has enormous potential to act as a teratogen.

Posted by Patricia Bowling at 09:06 PM | Permalink | Comments (0) | TrackBacks (0)

Drug Pump Production Stopped

Cardinal Health has stopped producing four of its Alaris drug infusion pumps. The decision was spurred by the FDA requested that U.S. marshalls confiscate 1,300 pumps from the company's facility. The pumps have been linked to at least two deaths because of an oversensitive keypad.

Cardinal Stops Production of Defective Drug Pump after FDA has U.S. Marshalls Confiscate Devices

The FDA says that the keypad in the pump causes "key bounce;" this leads to a number that has been entered into the keypad being recorded more than once. For example, if the intended dose was 3.5 mL/hour, this would be erroneously recorded into the machine as 33.5 mL/hour, thus causing huge potential for severe overdose. The FDA has not recalled defective pumps already in hospitals. Approximately 140,000 Alaris pumps have been distributed worldwide over the last 12 years and many of these pumps remain in use.

Posted by Patricia Bowling at 08:57 PM | Permalink | Comments (0) | TrackBacks (0)

FDA Urges Testing for Tissue Recipients

Forbes reports that the FDA is urging doctors whose patients may have received tissues from a human tissue supply company in Raleigh, North Carolina. The company was closed several weeks ago because of "serious deficiencies" in the way it operated. The FDA's ongoing investigation into the company has "heightened concern," according to the Associated Press.

Tissue from the company was used in patients across the country and the FDA recommends these recipients be tested for HIV, hepatitis B and C, and syphilis. Many companies are voluntarily recalling tissues supplied by Donor Referral Services, the AP reported. They include: Alamo Tissue Services of San Antonio, Texas; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando, Fla.; and U.S. Tissue of Cincinnati, Ohio.

Posted by Patricia Bowling at 08:43 PM | Permalink | Comments (0) | TrackBacks (0)

FDA: Beware of Canadian Drugs

The FDA is warning consumers to be cautious of drugs being sold on Canadian Internet sites. Fake drugs include versions of Lipitor, Diovan, Acetonel, Nexium, Hyzaar, Ezetrol, Crestor, Celebrex, Arimidex, and Propecia. In 2005, an FDA sweep found that 85% of drugs said to be "Canadian" came from 27 countries other than Canada.

FDA Warns of Bogus Drugs

RxNorth.com, Canadiandrugstore.com,Rxbyfax.com, Canada-pharmacy.com, NLRX.xom, Canampharmacy.com, Canadian-safe.com were all identified as being sales outlets for two providers. The FDA recommends that drugs from these providers be disposed of because they could be dangerous.

Posted by Patricia Bowling at 08:30 PM | Permalink | Comments (0) | TrackBacks (0)

Voluntary Recall of HCl Injection

Luitpold Pharmaceuticals, Inc. and the FDA are announcing a voluntary recall of Hydralazine HCl Injection (20 mg/mL, 1 mL single dose vials) because the products may contain particulates. According to the recall letter, "recall of this product was initiated because some vials may contain particulates."

Pharmalive

The urgent voluntary recall letter was sent to pharmacy buyers and directors all over the country. Further use and distribution of the product should be discontinued as a precautionary measure.

Related Links:
Legal View: Unsafe Drugs
Drug Guide
FDA

Posted by Patricia Bowling at 07:55 PM | Permalink | Comments (0) | TrackBacks (0)

Asthma Drugs Could be Dangerous

WebMD reports that medications used for long-term control of asthma, beta agonists, may be too widely prescribed. Drugs such as Advair, Serevent, and Foradil act to relieve asthma by relaxing smooth muscles in the airways. Last year, however, the FDA advised that these drugs carry a black box warning because they may increase the risk of severe, life-threatening asthma flares in some people. Despite concerns, the drugs still are marketed to doctors who may be unaware of the threats they pose. Asthma specialist Miles Weinberger, MD, says, "these drugs are being used too much and patients who are on them are often not monitored as they should be."

Advair and Serevent both are manufactured by GlaxoSmithKline. Studies on the drugs have revealed a greater number of asthma-related deaths in patients taking these drugs than in those taking a placebo. However, the overall number of asthma-related deaths was small: 13 deaths in 13,176 patients.

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Crestor Sales Soar

According to The News Journal, initial concerns about the safety of the cholesterol-lowering drug Crestor have proven false. While initially Crestor seemed to have a higher risk of muscle and kidney damage than drugs already in the field, such as Pfizer's Lipitor, the AstraZeneca drug is seeing marked increase in the profits of Crestor. Mike Tilron, cardiovascular vice president at AstraZeneca, attributes Crestor's success to its effectiveness: "It's all directly tied back to the clinical effectiveness of Crestor that patients see and physicians see," he said.

Not all, however, are convinced of Crestor's safety: Public Citizen's website lists Crestor on its worst-pills list, and Dr. Sidney Wolfe, director of Public Citizen's Health Research Group says that other drugs are as effective at lowering cholesterol as Crestor, with less risk of muscle and kidney damage.

Posted by Patricia Bowling at 10:50 PM | Permalink | Comments (0) | TrackBacks (0)

An Answer to Why Vioxx Causes Heart Problems?

According to Forbes, Merck will soon release results from a study that will reveal whether the follow-up drug to Vioxx, Arcoxia, caused heart attacks and strokes. If Arcoxia also causes heart attacks and strokes, scientists, patients, lawyers, and drug companies will have a better idea of what caused Vioxx's problems in the first place. Vioxx was a widespread treatment for arthritis and no other drugs have been able to take its place since Vioxx was pulled off the market. "There's a lot of confusion," says Christopher Cannon, a cardiologist at Brigham & Women's Hospital in Boston, who is heading the Arcoxia trial for Merck. "What's the right treatment for the 20 million or so patients with arthritis?"

Other arthritis drugs, such as Celebrex and ibuprofen, also have shown evidence of causing heart problems. More than 11,000 Vioxx lawsuits threaten to cost Merck billions of dollars in settlement costs. Vioxx, Celebrex, and Arcoxia are known as Cox-2 inhibitors. Cox-2 inhibitors act to ease joint pain without causing ulcers, as aspirin, ibuprofen, and naproxen are known to do. However, blocking Cox-2 may be the key to what causes these drugs to put patients at higher risk for heart attacks and strokes.

Posted by Patricia Bowling at 10:32 PM | Permalink | Comments (0) | TrackBacks (0)

No to Modafinil for Treatment of ADHD

According to Pharma Leader, the FDA has ruled that Cephalon will not be allowed to market its drug Sparlon (modafinil) for the treatment of ADHD in children and in adolescents. While modafinil currently is sold under the name Provigil to treat narcolepsy and idiopathic hypersomnia, Cephalon had hoped to market the drug for ADHA treatment to help offset the effect of generic competition to modafinil on revenues.

The FDA's rejection comes as a result of concerns that modafinil use may be related to the onset of Stevens-Johnson syndrome, a hypersensitivity complex that affects the skin and mucous membranes. Cephalon likely now will focus its lab efforts on its modified version of modafinil, Nuvigil (r-modafilin.)

Posted by Patricia Bowling at 10:18 PM | Permalink | Comments (0) | TrackBacks (0)

September 29, 2006

Evidence Kidney Drugs Correlated to Heart Attacks, Strokes

September 28, 2006

Accutane IPledge Program Impacting Drug Sales

September 27, 2006

Zyprexa to Blame for Son's Diabetes?

September 26, 2006

Vioxx Most Dangerous Painkiller

September 25, 2006

New AARP Plan: Good or Bad?

September 24, 2006

New ADHD Drug Warning

September 23, 2006

WalMart to Sell $4 Generic Drugs

September 22, 2006

Consumers Often Overdose on Prescription Eye Drops

September 21, 2006

No Misconduct in Vioxx Handling, Finds Merck

500 Ortho-Evra Users Sue Johnson & Johnson

September 20, 2006

Price Hike on Birth Control

September 19, 2006

Prempro Cited in Another Lawsuit

Miscarriage Blamed on Ortho Evra

September 18, 2006

Effects of Epilepsy Drugs May Wane

September 13, 2006

Weight Loss Drug Bad for Moms to Be

September 12, 2006

Drug Pump Production Stopped

September 11, 2006

FDA Urges Testing for Tissue Recipients

September 08, 2006

FDA: Beware of Canadian Drugs

September 07, 2006

Voluntary Recall of HCl Injection

September 06, 2006

Asthma Drugs Could be Dangerous

September 05, 2006

Crestor Sales Soar

September 04, 2006

An Answer to Why Vioxx Causes Heart Problems?

September 01, 2006

No to Modafinil for Treatment of ADHD