Unsafe Drugs: December 2006 Archives

Family Seeks $50 Million in Wrongful Death Suit

The family of a Virginia man is filing a $50 million wrongful death lawsuit against Wal-Mart. Keith Scofield died 20 days after having been sold a prescription five times stronger than what he needed by the Guilfold Drive Wal-Mart in 2005. Scofield suffered from adult-onset, or Type 2, diabetes.

Family seeks $50M in wrongful death suit

The complaint accuses Wal-Mart of gross negligence in Scofield's insulin poisoning and alleges that Wal-Mart does not properly train pharmaceutical employees. Wal-Mart said that they had not yet been given legal notice of the lawsuit. Wal-Mart spokesman John Simley said that "the safety of our customers is a top priority in our pharmacy practice. The circumstances here are tragic, but we have not yet had an opportunity to see the lawsuit, so we couldn't comment on it." Scofield died after injecting himself with the medication and subsequently suffering pulmonary collapse, acute respiratory failure, and convulsions.

Posted by Patricia Bowling at 09:37 PM | Permalink

Mother Sues Ortho-McNeil

The mother of a woman who died while using Ortho-McNeil's Ortho Evra birth control patch is filing a wrongful-death lawsuit against the maker of the patch. Celena Devault, 26, of Hollow Rock Tennessee, died from a pulmonary embolism and blood clots in June 2003. She began using the patch in April 2003. Devault's mother, Mary Devault, is named as the plaintiff in the lawsuit. Brian Kabateck, lawyer for Mary Devault, says that "we believe that Ortho-McNeil knew of the dangers of the Ortho patch sold in the U.S. and choose to ignore them. "Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage. Now, young women across the country are suffering serious illness and even death."

Mother of Tenn. woman sues birth-control patch company

The lawsuit alleges that Ortho-McNeil intentionally deceived the public about the drug's risk of severe side effects, including blood clots, strokes, deep vein thrombosis, and pulmonary embolisms. In September, the FDA issued a warning that women heightened their risk of blood clots and lungs by using the birth control patch as opposed to the pill.

Posted by Patricia Bowling at 09:16 PM | Permalink

Warnings Needed on Antidepressants

A United States advisory panel said on Wednesday that antidepressant drugs need further warnings about the role they play in increased suicide risk in adults up to age 25. Antidepressants such as Zoloft, Prozac, and Cymbalta are believed to increase suicidal behavior and thoughts after children and young teenagers begin taking the drugs. The Food and Drug Administration voted that information about this be added to the current "black box" warnings on drugs.

Panel calls for antidepressant warning

Panel member Dr. Andrew Leon, a psychiatrist at Weill Medical College of Cornell University in New York, said that the desired effect of the further warnings is to "extend the age in the black box and at the same time not discourage treatment." Some say that the warnings should have been added a long time ago. Susan Gonzalez says that her 40 year old husband shot himself in the head shortly after he began taking the antidepressant Paxil. She told the advisory panel that "I hold you all responsible for his death and I always will. I keep asking myself... what was my husband thinking? How crazy did you make him that morning that he would get up... and do this to himself?"

Posted by Patricia Bowling at 08:32 PM | Permalink

Ketek Benefits Outweigh Risks

The Food and Drug Administration says that the benefits of Sanofi-Aventis's antibiotic Ketek outweigh the risks. Ketek has become controversial recently because post-marketing reports have shown several cases of liver damage and death. Warning labels on the drug have been strengthened in the wake of the reports. Additionally, a big clinical trial used in support of Ketek's application later was shown to be unreliable.

FDA Staff Supports Sanofi Drug

Recent reports suggest monitoring of Ketek patients for liver damage may be necessary and that the labelling on the drug should be further strengthened. The regulatory agency says that Ketek has been linked to "rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant."

Posted by Patricia Bowling at 03:57 PM | Permalink

Former Doctor Gets 18 Months for Botox Fraud

Jerome Lentini, a former doctor from Salem, Oregon will spend 18 months in jail for injecting patients with a Botox substitute that has not been approved by the U.S. Food and Drug Administration. Lentini pleaded guilty to using two forms of botulinum toxin and to a felony charge of misbranding a drug with the intent to defraud. Lentini also must pay $330,00 to more than 800 patients affected.

Former Salem Doctor Gets 18 Months for Botox Fraud

Lentini is the first doctor to be imprisoned because of his medical actions as far back as officials are able to recall. Lentini used two drugs made in China and in Arizona that have not been approved for human use instead of FDA-approved Botox. Lentini's prison sentence was justified because he betrayed the trust of his patients, according to the federal prosecutor in the case, assistant U.S. Attorney Dwight Holton. "It's pure good fortune that no one was injured, but they're very serious toxins," said Holton.

Posted by Patricia Bowling at 12:09 PM | Permalink

FDA Says Drug-Coated Stents Create Clot Risk

Health officials caution that those who have drug-coated stents implanted to hold open their clogged arteries have a slightly higher, but significant, risk of blood clots. A new study recommends that patients with stents take anti-clot medications indefinitely. The Food and Drug Administration says that it is unknown whether there is an increased risk of death or heart attack in patients with drug-eluting stents, but that the patients definitely have an increased risk of blood clots a year or more after surgery than those who have bare-metal stents implanted.

FDA: Drug-coated stents create blood-clot risk

The FDA is debating whether to update the labels on drug-eluting stents with new warnings, identify patients for whom the stents are not appropriate, and to possibly change federal recommendations on how long people should take blood thinners while the stents are in place. Dr. Robert Califf, a Duke University cardiologist, said that the evidence of increased clot risk says that "the bottom line from our paper, for doctors and patients, is these results tilt the balance to the fact you should stay on clopidogrel if you have a drug-eluting stent indefinitely until further data tell us how long you should be on it."

Posted by Patricia Bowling at 11:57 AM | Permalink

FDA Warns Topical Cream Makers About Blending

Five companies that distribute topical anesthetic cream are being warned by the Food and Drug Administration to stop compounding and distributing standardized versions of their creams. Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, and New England Compounding Center have been instructed make creams that are more specific to needs of patients. Companies that do not fix the problem face injunctions against continuing violations and seizure of illegal products.

FDA Warns Topical Cream Makers on Blends

The FDA says that it is concerned about health risks posed by compounded anesthetic creams. Exposure to high concentrations of local anesthetics found in topical anesthetic creams can cause reactions including seizures and irregular heartbeats. Two deaths have been connected to the topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy.

Posted by Patricia Bowling at 11:28 PM | Permalink

Baxter Warns Drug Can Cause Blood Clots

Doctors have been notified by the Food and Drug Administration and Baxter International Inc. that the drug Heparin could possibly be the reason for thrombosis or blood clots in patients who stop taking the drug. Heparin is a blood thinner. "Thrombotic events may be the initial presentation for heparin-induced thrombocytopenia and thrombosis which can occur up to several weeks after the discontinuation of heparin therapy," said the FDA in a statement.

Baxter warns drug could cause blood clots

Baxter spokeswoman Erin Gardiner said that the company asked that the FDA reflect current research on the drug in its revised labelling. Gardiner said that the move was not brought about because of any recent increase in adverse effects from the drug. Heparin is sold in generic form by other companies as well.

Posted by Patricia Bowling at 06:26 PM | Permalink

Merck's Vioxx Fight Paying Off

Plaintiff lawyers reacted with excitement when Merck pulled Vioxx, its best-selling painkiller, from the market in September 2004. Merck's decision to withdraw was an invitation for lawsuits, especially since rumors about Vioxx being linked to heart attacks and strokes. The New England Journal of Medicine published an editorial in the wake of the withdrawal saying that Merck had concealed information about increased heart attacks suffered by those on the medication and in August 2005 a Brazoria County judge awarded $253 million in the country's first Vioxx trial. Vioxx's prospects did not look good.

Merck's Battle-all-the-way Legal Strategy In Vioxx Cases Seems To Be Paying Off

However, Merck's strategy of taking every Vioxx suit to court has led to more victories for the company than losses. "You can never predict what one individual jury will do — there are some ups and downs — but we like our chances before a jury,” said Ted Mayer, who is supervising Merck's Vioxx litigation. “We do believe strongly in our message. We're encouraged that some of the juries are responding.” Merck's wins have come from cases where Vioxx use was not consistent or for a long duration. Because heart attacks can be caused by many factors, Merck has better chances of winning court causes than, for example, asbestos cases, because asbestos exposure has a more signature effect.

Posted by Patricia Bowling at 11:39 AM | Permalink

Vioxx Killed Mom?

Marc Golin is filing a lawsuit against Merck, claiming Merck's Vioxx was the cause of this mother's heart attack two years ago. "My mom was a fighter and her heart really failed," Golin said of his decision to file the lawsuit. "The sad thing is, she never had a problem with her heart before." Goulin's mother was 80 years old when she died. Goulin's lawyer says that charges are being filed for wrongful death damages because Merck did not post warnings about the dangers of the drug, despite possibly having known as early as 1997 that Vioxx was a dangerous drug.

Suit: Vioxx maker liable for mom's death

Merck has won four of the seven cases thus far to have reached verdicts, but still faces more than 21,000 Vioxx lawsuits. More Vioxx lawsuits still could potentially be filed, though the statute of limitations has run out in many states. Goulin is angered by Merck's possible cover up of the dangers posed by Vioxx: "It wasn't fair what they did and now they're trying to do the big cover-up."

Posted by Patricia Bowling at 11:56 AM | Permalink

Physician Testifies Vioxx Hid Dangers

Dr. Jerome Avorn testified that Merck & Co. downplayed the risks of Vioxx, even after a study by the Harvard Medical School professor linked that Vioxx increased the risk of heart attacks. Avorn said that Merck salespeople were told not to tell doctors about his findings. "I can think of no legitimate reason why it would ever be appropriate to suppress negative findings about a drug risk," Avorn testified to jurors in a federal court in New Orleans.

Physician testifies Merck hid Vioxx's high heart attack risk

Avorn said that Merck hid the medical risks of their drugs before the drug was withdrawn in 2004, when a study showed that the drug doubled risk for heart attacks. Merck also allegedly hid the known risks of the drugs in literature, advertisements, and statements made to doctors by sales representatives. Merck lawyer Phil Beck says that the plaintiffs' attorneys shaped Avorn's testimony and that he overstated his findings.

Posted by Patricia Bowling at 08:41 PM | Permalink

An Answer to Why Vioxx is Dangerous?

Recent evidence conducted by the Imperial College London and Queen Mary's School of Medicine and Dentistry suggests why Vioxx may increase risks of heart attacks and strokes. Vioxx also suppresses prostacyclin, a blood vessel protector that prevents blood clots, consequently increasing risk of a heart attack. Tim Warner, one of the professors who made the discovery said that "it is essential that we have a true understanding of their sites of action so that we can produce new, safe, and effective drugs for years to come."

Study may reveal cause of Vioxx side effects

The researchers say that the results are exciting because they suggest that Cox-2 inhibitors could possibly be altered so that they no longer would affect prostacyclin. Merck's Vioxx caused an increased risk of heart attacks and strokes.

Posted by Patricia Bowling at 07:49 PM | Permalink

Should Celebrex be Prescribed for Children's Arthritis?

A Food and Drug Administration review of Pfizer's application to sell Celebrex as a treatment for juvenile rheumatoid arthritis questions whether the drug will be of use to those with the pediatric disease. Celebrex was approved by the FDA as a treatment for adults with osteoarthritis and rheumatoid arthritis in 1998. Celebrex is of the same class of drugs as Vioxx and Bextra; both these drugs were pulled from the market after concerns were raised that they drastically raised the risk of heart attacks and strokes in adults.

FDA questions Celebrex for kids' arthritis

Pfizer provided results of a study that showed Celebrex (celecoxib) works as well as naproxen in treating young rheumatoid arthritis patients. The FDA responded to this study by saying that the study was limited in its scope and "raised questions about whether it provides adequate evidence of efficacy of celecoxib" in children. Concerns over potential heart dangers also have been raised.

Posted by Patricia Bowling at 10:16 PM | Permalink

Asthma Drugs Cause Immune Cell Build Up

The use of beta-agonist inhalers, used in the treatment of asthma and including drugs such as Proventil (albuterol,) is linked to the accumulation of type 2 T cells, according to a recent report in the Journal of Allergy and Clinical Immunology. Authors of the study say that the results stress the importance of including anti-inflammatory steroids with use of these drugs. One of the authors of the study, Dr. Raymond B. Penn, says that "Our findings that suggest beta-agonists promote preferential type 2 T-cell accumulation are consistent with clinical findings that continuous beta-agonist therapy leads to deterioration of control in some asthmatics."

Asthma Drugs Cause Immune Cell Build Up

Penn and his colleagues found that under some circumstances, treatment with the beta agonist isoproterenol led to accumulation of type 2 T cells. The drug caused this affect by increasing production of these cells and also increasing their survival rates. Penn said that these findings should not be reason to disrupt treatment for those having success treating their asthma with beta-agonists. "It is important that physicians and lay people not reject beta-agonists as an asthma therapy, as beta-agonist inhalers save thousands of lives each year by preventing or rescuing people from fatal asthma attacks," Penn said.

Posted by Patricia Bowling at 07:56 PM | Permalink

Did Eli Lilly Shape Drug Guidelines?

Several government doctors say that they believe drug manufacturer Eli Lilly & Co. affected medical guidelines for the treatment of an often lethal blood infection to help improve their sales of a drug whose value is being debated. Concerns are being raised because the involvement of drug companies in decisions about medical guidelines could become another arena for corporate interests; this is problematic because it does not take the best interests of patients into consideration. Dr. Naomi O'Grady, from the National Institutes of Health, says that “this company is trying to insinuate its drug into many aspects of patient care that industry really shouldn’t be involved in."

Eli Lilly accused of shaping drug guidelines

Eli Lilly spokeswoman Judy Kay Moore said that Eli Lilly's involvement was beneficial because the company provided money to help "advance understanding of patient care." Lilly's anti-clotting drug Xigris is the drug in question. It is useful in sepsis cases because it directly attacks the disease and a $6,800 treatment can help protect organs destroyed by infection. Later studies have sparked concern about Xigris' effectiveness, bleeding risk and a higher mortality rate.

Posted by Patricia Bowling at 01:23 AM | Permalink

Oral Contraceptives to Blame for Brain Blood Clot?

A 15 year old Swedish girl is believed to have suffered a blood clot in her brain because of taking oral contraceptives. According to doctors, the girl became seriously ill and experienced numbness and still has problems with her vision. Ingemar Persson of the Medical Products Agency, said that "the case must be investigated because we need to see if there are unknown risk factors involved. If so, we must act."

Contraceptive pills could have caused blood clot on brain

Although the girl had a hereditary predisposition to migraines, she was healthy before she had the blood clot. The girl was taken to the hospital after falling in the shower and doctors initially believed the problem to be the result of a migraine attack. However, the girl continued to have problems with her vision and further tests showed the presence of the blood clot.

Posted by Patricia Bowling at 02:15 PM | Permalink

Vioxx Class Action Claim Refused

A judge denied a motion for class action status for personal injury and wrongful death cases involving Merck's withdrawn painkiller Vioxx. Class action status would have allowed the Vioxx plaintiffs more leverage in their lawsuits against Merck by allowing attorneys to sue on behalf of all individuals alleging harm. Judge Eldon Fallon said of his decision: "In this case, the difficulties in class management overwhelm any efficiencies that could be secured through classwide adjudication. Indeed, the predominance of individual issues relating to plaintiffs' claims for compensatory and punitive damages detracts from the superiority of the class action device in resolving these claims."

Vioxx Class Action Claim Refused

About 24,000 federal and state lawsuits have been filed by people who say they were harmed by the drug, which was withdrawn by Merck in 2004. Merck plans to fight the lawsuits individually rather than agree to a more costly group settlement.

Posted by Patricia Bowling at 10:46 AM | Permalink

Benzocaine Dangerous?

Health Canada is questioning the safety of benzocaine, a local anesthetic used in surgical and dental procedures. Health Canada says that benzocaine has been linked to higher rates of methemoglobinemia, a potentially serious blood condition. Methemoglobinemia reduces the ability of red blood cells to deliver oxygen in the body. It can lead to bluish discoloration of the skin, nausea and fatigue, and has the potential to lead to death.

Benzocaine bad, Health Canada says

Health Canada suggests that patients about to undergo a procedure involving benzocaine should be advised of the risks and the possible side effects. Benzocaine is applied to the skin surface or the mucous membranes of the mouth or nose to cause numbness. Nine cases of methemoglobinemia associated with benzocaine have been reported to date; none of these cases has been fatal. Most of the cases were associated with a high concentration form of benzocaine, 14% to 20%.

Posted by Patricia Bowling at 03:24 PM | Permalink

Drug's Use Could be Dangerous

A blood-coagulating drug which is typically is used to treat hemophilia is being given to critically wounded U.S. troops in Iraq; this is problematic because there is evidence that this drug can cause clots that lead to strokes, heart attacks, and death in patients. The drug, Recombinant Activated Factor VII, is manufactured by the Danish pharmaceutical company Novo Nordisk, and has been approved in the U.S. for treating forms of hemophilia that affect fewer than 3,000 Americans. It costs $6,000 a dose.

Drug's use sparks criticism

Physicians in Iraq say that the drug is important in saving lives of troops who have been severely wounded. "When it works, it's amazing," said Col. John B. Holcomb, an Army trauma surgeon"It's one of the most useful new tools we have." However, not everyone agrees. "It's a completely irresponsible and inappropriate use of a very, very dangerous drug," said Dr. Jawed Fareed, from Loyola University in Chicago.

Posted by Patricia Bowling at 12:50 AM | Permalink

FDA Reapproves Silicone Breast Implants

The Food and Drug Administration has again decided to allow silicone breast implants on the market, 14 years after they were pulled from the market over questions of safety. Thus far, approved implants only come from two companies: Inamed Aesthetics and Mentor. The FDA says that these implants are suitable for "breast reconstruction in women of all ages and breast augmentation in women of ages 22 and older."

FDA allows silicone breast implants back on market

In 1992, the FDA took silicone breast implants off the market, citing concerns over their safety. Silicone has potential to rupture in a woman's body. After then ban, silicone implants were available only to women who were in clinical trials who needed them after surgery, particuarly breast cancer surgery. Inamed and Mentor both claim their implants have low rupture rates and are safe for women. Public Citizen has long opposed silicone implants and still disapproves of the FDA's decision, citing the fact that the FDA has not opposed silicon gel testicular implants because of inadequate testing.

Posted by Patricia Bowling at 09:20 PM | Permalink

Anemia Drug May Raise Risk of Heart Problems

High doses of Epogen, Procrit, and Aranesp may be linked to increased heart problems and deaths, according to a new study. Amgen and Johnson & Johnson manufacture the drugs, which are used in the treatment of anemia in dialysis and in cancer patients. Dr. Ajay Singh, a Harvard Medical School associate professor and lead author of the study, said that the results were unexpected and suggest that doctors should treat anemia less aggressively. The drug also is known as epoetin or darbepoetin.

Study Suggests Anemia Drug May Raise Risk of Heart Problems

The study reinforces the increasing concern that kidney patients may be given too much epoetin, in part because dialysis clinics make larger profits for providing bigger doses. The amount of epoetin given to the average American dialysis patient has nearly tripled since the early 1990s. Epoetin's introduction marked an important advance in the treatment of anemia. Prior to epoetin's introduction, blood transfusions were the only effective way to treat anemia. “The drug in and of itself has really advanced care for patients, so that they’re able to go back to do the things that they previously couldn’t,” says Kris Robinson, the executive director of the American Association of Kidney Patients, of the drug.

Posted by Patricia Bowling at 08:09 PM | Permalink

December 29, 2006

Family Seeks $50 Million in Wrongful Death Suit

December 28, 2006

Mother Sues Ortho-McNeil

December 27, 2006

Warnings Needed on Antidepressants

December 26, 2006

Ketek Benefits Outweigh Risks

December 25, 2006

Former Doctor Gets 18 Months for Botox Fraud

December 22, 2006

FDA Says Drug-Coated Stents Create Clot Risk

December 21, 2006

FDA Warns Topical Cream Makers About Blending

December 20, 2006

Baxter Warns Drug Can Cause Blood Clots

December 19, 2006

Merck's Vioxx Fight Paying Off

December 18, 2006

Vioxx Killed Mom?

December 15, 2006

Physician Testifies Vioxx Hid Dangers

December 14, 2006

An Answer to Why Vioxx is Dangerous?

December 13, 2006

Should Celebrex be Prescribed for Children's Arthritis?

December 12, 2006

Asthma Drugs Cause Immune Cell Build Up

December 11, 2006

Did Eli Lilly Shape Drug Guidelines?

December 08, 2006

Oral Contraceptives to Blame for Brain Blood Clot?

December 07, 2006

Vioxx Class Action Claim Refused

December 06, 2006

Benzocaine Dangerous?

December 05, 2006

Drug's Use Could be Dangerous

December 04, 2006

FDA Reapproves Silicone Breast Implants

December 01, 2006

Anemia Drug May Raise Risk of Heart Problems