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News Category: Product Liability

Byetta manufacturer looking to get bigger share of diabetes market

Saturday, May 18th, 2013

Drug maker Eli Lilly is increasing its efforts to get a larger share of the diabetes market, Reuters reports.

The story says Lilly is now the fourth-largest diabetes drug manufacturer, with 10.6 percent market share. That puts it behind Denmark’s Novo Nordisk , France’s Sanofi and the U.S.A.’s Merck & Co.

Lilly is looking to change that position, with dozens of medications in development. Among them is the experimental once-weekly injection dulaglutide, for which the company is seeking approval.

Dulaglutide is part of a class of medicines called GLP-1 agonists that includes the company’s widely used Byetta, and which have generated some health concerns lately. Byetta, along with Merck’s Januvia, has been linked to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer. (more…)

Lipitor maker posts lower-than-expected earnings

Friday, May 17th, 2013

Pfizer Inc. has posted lower-than-expected earnings and revenue for the first quarter, in part because of rapidly falling sales of the cholesterol drug Lipitor, Reuters reports.

Sales of the drug, formerly a cash cow for the pharmaceutical giant, plummeted 55 percent to $626 million.

The drug has been competing with cheaper generics since November. Recent health concerns about Lipitor have cropped up as well.

The U.S. Food and Drug Administration has added warnings to the labels of Pfizer’s Lipitor and other types of statins, advising that they may increase blood sugar, and therefore the risk of Type II diabetes.

Overall, Pfizer announced, the company earned $2.75 billion, or 38 cents per share, in the first quarter. A year earlier, it earned $1.79 billion, or 24 cents per share. At that time, the company took charges to boost productivity and address legal matters. (more…)

Inspection prompts medicine recalls

Thursday, May 16th, 2013

Following an inspection by the U.S. Food and Drug Administration, a Florida specialty pharmacy called The Compounding Shop is recalling all of its sterile products, ABC News reports.

According to the story, FDA inspectors were concerned about sterility problems with company drugs that could lead to bacterial contamination. The agency advised health care professionals to keep drugs produced at the company away from patients.

The FDA investigation was part of a wave of inspections at compounding pharmacies, which prepare medications from ingredients provided by other sources in response to specific physician orders.

The agency stepped up its oversight of the facilities in the wake of a fungal meningitis outbreak that has sickened more than 700 people and killed more than 50 throughout the country. That outbreak has been traced to a batch of steroid medication produced at a compounding pharmacy in Massachusetts called the New England Compounding Center. (more…)

Cholesterol levels dropping, still problematic

Thursday, May 16th, 2013

The good news is that national cholesterol levels have dropped over the last four decades. The bad news is that they still represent a “significant public health problem,” according to the National Center for Health Statistics, a branch of the Centers for Disease Control and Prevention.

KPCC Public Radio out of California says the NCHS report specifically refers to low-density lipoprotein (LDL) cholesterol, which health providers often refer to as “bad cholesterol.” High-density lipoprotein (HPL) cholesterol, or “good cholesterol,” appears to protect people against heart attacks.

But when too much LDL cholesterol circulates through the bloodstream, it can build up on the walls of the arteries, which carry blood to the brain and the heart. There, it can form plaque, which can cause blood clots that lead to strokes or heart attacks.

Some medications meant to lower LDL cholesterol carry risks of their own. For example, the U.S. Food and Drug Administration has added warnings to the labels of Pfizer’s Lipitor and other types of statins, advising that they may increase blood sugar levels, which could cause diabetes. (more…)

British regulators warn about hip implants

Thursday, May 16th, 2013

A story in The Telegraph details the advice that British health regulators are providing for U.K. residents who received a “metal-on-metal” hip implant, in light of recent findings that up to half of the devices fail within six years.

Friction between the metal surfacing on both the implants’ ball and cup causes tiny filings of cobalt and chromium to break off. According to the story, that toxic debris “can seep into the blood and cause inflammation, destroying muscle and bone.”

Health experts are also worried that the fragments could put the nervous system, heart and lungs at risk of being slowly poisoned.

More than 40,000 patients in Britain received metal-on-metal implants. That includes 10,000 who received two types of implants made by Johnson & Johnson subsidiary DePuy Orthopaedics, which were recalled in 2010. (more…)

Johnson & Johnson shareholders unhappy with management

Wednesday, May 15th, 2013

A story in the Washington Post says that several Johnson & Johnson shareholders spoke of their dissatisfaction with the company during their annual meeting recently. Their complaints focused on a long string of product recalls, ethical lapses and excessive executive pay.

In 2010, the company’s McNeil Consumer Healthcare unit recalled more than 280 million packages of over-the-counter medications, which included Motrin, children’s Tylenol liquid and Benadryl.

Also in 2010, Johnson & Johnson’s DePuy Orthopedics unit recalled two popular all-metal artificial hip replacement models, which have subsequently been the basis of about 10,000 lawsuits. A jury recently awarded $8.3 million to a man injured by one of those implants, which have a tendency to break down and require replacement after only a few years, and to shed toxic metal debris in patients’ bodies.

In another high-profile case involving a Johnson & Johnson medical device, a jury awarded $11.1 million to a woman injured by a vaginal mesh implant from the company’s Ethicon division. That case represented the first of more than 11,000 lawsuits about the devices to go to trial, filed by women complaining of health problems that include infection, organ perforation and chronic pain. (more…)

Man regains eyesight lost to Stevens Johnson syndrome

Tuesday, May 14th, 2013

The Hindu, an English-language newspaper out of India, describes the case of a 37-year-old man who regained his eyesight after 18 years of blindness.

According to the report, the man initially lost his eyesight when he suffered a bout of Stevens Johnson syndrome after taking some tuberculosis medication.

Stevens Johnson syndrome usually occurs as an extreme allergic reaction when the skin and mucous membranes react severely to a medication or infection. It’s considered a medical emergency and can cause the top layer of skin to shed and die.

In addition to severe scarring, the condition often leaves patients with permanent eye damage, including total blindness.

According to The Hindu, the man had undergone 14 different surgeries over a span of nearly two decades. Doctors eventually performed “keratoprosthesis” surgery, in which a custom-made optical cylinder was inserted into his right eye. After that, he found he could see from his right eye. (more…)

Israeli doctors cautioned about diabetes medication

Tuesday, May 14th, 2013

An article in the Jerusalem Post says the Israeli Health Ministry’s pharmaceutical division is cautioning doctors to be vigilant for cases of pancreatic infections and pancreatic cancer among people taking a class of diabetes drugs that includes Byetta and Januvia.

The story says the announcement followed similar warnings by both the U.S. Food and Drug Administration and its European counterpart about the drugs.

A number of studies have linked both Byetta and Januvia to pancreatitis (an inflammation of the pancreas) and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

According to the Jerusalem Post, both drugs are classified as “incretins.” Those are gastrointestinal hormones that increase the amount of insulin released from the islets of Langerhans – the parts of the pancreas that contain hormone-producing cells. (more…)

Study links Agent Orange, deadly prostate cancer

Monday, May 13th, 2013

A study has found a link between U.S. veterans’ exposure to Agent Orange, and deadly forms of prostate cancer, according to a story in U.S. News and World Report.

Previous research has suggested that Agent Orange, a chemical spray used as a defoliant in Vietnam, increases the risk of prostate cancer. But the new study is the first to demonstrate a specific link between the defoliant and more dangerous forms of the disease.

The story says that Agent Orange was often contaminated with the carcinogen dioxin.

Researchers examined data on more than 2,700 U.S. veterans who underwent a prostate biopsy. Of that group, 33 percent were diagnosed with the disease, including 17 percent with a high-grade form. (more…)

Different types of birth control evaluated

Monday, May 13th, 2013

A story on EmpowHer evaluates the pros and cons of different types of birth control available to women, including pills and intrauterine devices, or IUDs. Both options carry different side effects, the report says.

The IUD is a small T-shaped device inserted into the uterus during a procedure that requires only local anesthesia. A type called ParaGard does not have any hormone in it, instead relying on the copper wrapped around the T-frame to create an inhospitable environment for the egg and sperm. Mirena and Skyla, on the other hand, both contain the hormone progestin.

All three IUDs carry risks of side effects including pain with insertion, back pain, and spotting or irregular cycles for the first three to six months during the adjustment period. Mirena also carries a risk for ovarian cysts and acne.

A number of women who used the Mirena IUD have also filed lawsuits claiming the company overstated the device’s benefits in its advertising while trying to conceal some potentially dangerous side effects. Those side effects include the possibility that the device will embed itself in the uterine wall and move from its implantation site, causing organ perforation or scarring. In some cases, according to the lawsuits, surgery is necessary to remove it. (more…)

FDA chief says more authority needed on compounders

Sunday, May 12th, 2013

Food and Drug Administration Commissioner Dr. Margaret A. Hamburg has admitted that her agency wasn’t aggressive enough in investigating compounding pharmacies, such as the one responsible for a deadly, nationwide meningitis outbreak.

But in a hearing before a House Energy and Commerce subcommittee, Hamburg also said the agency needs stronger legal authority if it’s going to make such pharmacies conform to stricter safety standards, the New York Times reports.

The compounding pharmacy in question, the New England Compounding Center, has since shut down after a contaminated batch of steroid medication it produced was identified as the outbreak’s source. Since it was reported late last year, the outbreak has sickened 733 people and killed 53 in 20 different states.

Inspectors subsequently found unsanitary conditions at the NECC.

Compounding pharmacies are supposed to make specialized medications from ingredients provided by other sources, in response to individual physician orders. But since they’re not subject to the same restrictions as other drug manufacturers, some regulators have accused them of using regulatory loopholes to manufacture drugs on a large scale for less cost. (more…)

FDA approves new cholesterol medication

Sunday, May 12th, 2013

Nature World News reports that the U.S. Food and Drug Administration has approved the anti-cholesterol drug Liptruzet.

According to the story, Liptruzet is a combination of Merck’s Zetia, which lowers low-density lipoprotein (LDL), and a generic version of Pfizer’s Lipitor, which lost its patent protection in 2011.

Lipitor has recently generated some health concerns.

The U.S. Food and Drug Administration has added warnings to Lipitor’s label, advising that the medication may increase the risk of Type II diabetes. The new label also warns that Lipitor may raise blood sugar levels, and could cause memory loss.

According to Nature World News, Liptruzet has also been the subject of criticism among cardiologists, who argue that studies haven’t shown it to be effective in lowering patients’ chances of developing heart disease. (more…)

Woman thought mesh would be easiest treatment

Saturday, May 11th, 2013

A report on News Channel 4 out of Oklahoma tells the story of a woman who received a vaginal mesh implant in the belief that it was the most advanced, minimally invasive technique available to cure her urinary incontinence.

Instead, she ended up in extreme pain, and trying unsuccessfully for three years to get the surgery necessary to remove the device. The story says she has joined hundred of other women from Oklahoma in seeking redress against the mesh’s manufacturers.

According to the story, “the outcome for some patients included the mesh tearing their body apart from the inside.”

Women throughout the country are taking similar legal action. In the first of about 11,000 of those lawsuits to go to trial, a New Jersey jury recently awarded $11.1 million to a woman who received a vaginal mesh implant manufactured by Johnson & Johnson’s Ethicon subsidiary. (more…)

Analysis says diabetes drugs carry risks

Saturday, May 11th, 2013

Diabetes

A report on FiercePharma says an analysis by safety watchdog group Institute for Safe Medication Practices found the class of diabetes drugs that includes Merck’s Januvia and Bristol-Myers’s Byetta may increase the risk for pancreatitis and pancreatic cancer.

The analysis found that reports of pancreatitis (an inflammation of the pancreas) and pancreatic cancer were about 25 percent higher for the class of drugs known as GLP-1, compared to older treatments.

FiercePharma notes that the analysis is only the latest among a series of warnings about the drugs to emerge lately.

An analysis of insurance records published two months ago in the medical journal JAMA Internal Medicine concluded that diabetics hospitalized with pancreatitis were twice as likely to be taking Januvia or Byetta than a control group of diabetics without the condition.

Based on that analysis, the U.S. Food and Drug Administration announced that it’s reviewing data on Januvia and Byetta.

Previous studies had linked Januvia and Byetta to a higher risk of pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer. (more…)

FDA releases warning about migraine treatment

Friday, May 10th, 2013

CBS News reports on a U.S. Food and Drug Administration warning that medications containing valproate sodium may cause lower IQs in children born to women who take them.

An agency news release quotes Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, as saying: “Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use.”

According to the CBS News story, products under the warning include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor) and their generics. Valproate medications are approved to prevent migraine headaches, treat epilepsy and treat manic episodes associated with bipolar disorder, the story says. (more…)

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