AstraZeneca, the British maker of anti-cholesterol drug Crestor, recently pitted its popular medication in a test trial with its competitor, Pfizer’s Lipitor, and industry analysts and media observers say the results have been disastrous for AstraZeneca. The company’s shares dropped after results of clinical study it funded in an attempt to place it above its rival in the highly competitive arena of cholesterol drug sales. As reported by the Wall Street Journal:

“Analysts said the absence of Crestor showing superiority in the Saturn study will hurt the drug’s prospects and are, therefore, likely to trigger broker downgrades for the British company. ‘It’s bad news for Crestor and effectively tells physicians they should broadly consider Lipitor, which will soon be cheaper, on similar merit to Crestor,’ said Navid Malik, pharma analyst at Matrix. ‘We expect to see downgrades to Crestor sales in the market and are reviewing our sales estimates in light of this update.’” The newspaper reported that “billions of dollars in sales of AstraZeneca’s Crestor could be at risk from Lipitor’s transition to a cheap generic drug.”

Financial analysts and legal experts say AstraZeneca also could face huge costs if it has to pay out damages in hundreds of Crestor lawsuits that have been filed by patients who allege they have suffered life-threatening side effects from their use of the medication. The major complaints stem from patients suffering heart problems, diabetes and a serious breakdown of muscle tissue known as Crestor rhabdomyolysis. Many more victims are seeking information about Crestor kidney problems.

Reuters News Agency is reporting an important development in the massive DePuy Orthopaedics Inc. recall of two of its metal artificial hip implant systems in which DePuy’s parent company, Johnson & Johnson is apparently trying to limit its financial exposure. Facing more than 2,000 DePuy lawsuits and billions of dollars in damages from DePuy lawsuits in state and federal courts Johnson & Johnson has hired another company to handle patient claims for medical costs that they have incurred because of the recall. Over 93,000 devices were recalled after the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing systems had failure rates of as high as 13 percent reported and the systems drew heavy criticism from medical researchers and consumer advocates. The DePuy lawsuits were filed by victims who suffered from painful inflammations and infections caused by metal particles flaking from the systems with many of them having to undergo second operations. Many victims are looking into the DePuy Hip Recall

As Reuters reported about the hiring of Broadspire Services Inc.: “The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court.” Legal experts say that the development emphasizes the importance of obtaining an experienced DePuy lawyer who will be able to protect the rights of the recall victims and ensure that they are not denied whatever damages they may be entitled to. Reuters also reported that lawyers representing patients say the amount of information being collected by Broadspire is excessive.

There has been a recent development in the handling of the Darvon and Darvocet lawsuits filed in federal courts by patients who have suffered heart problems as a result of their use of the pain-killing medications. Because there have been suits filed across the country and because they contain the same central allegations that the drugs can cause cardiac problems and even death the federal court system has decided to consolidate them before a U.S. District Court Judge in the Eastern District of Kentucky.

Legal experts say this is the procedure that is typically followed in major drug defect cases in which a large number of victims file litigation that contains similar allegations against a single drug manufacturer, in this case Xanodyne Pharmaceuticals. There likely will be several months of meetings and hearings between the lawyers and the judge over how the cases should proceed before he decides whether to classify the litigation as a class-action proceeding. Class-action cases have a history of generating large settlements and jury verdicts on behalf of plaintiffs.

The legal experts say that they expect a substantial increase in the filing of Darvon and Darvocet lawsuit in the future now that the Food and Drug Administration has banned the drugs and Xanodyne is in the middle of a massive recall. The FDA included the following reference in its recall notice: “The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.”

It’s difficult to pinpoint the exact number of Yaz and Yasmin lawsuits that have been filed over allegations that the birth control pills cause side effects that can lead to life-threatening blood-clotting problems but there are certainly well over 6,000 and the number seems to be growing rather rapidly in recent months.

Several thousand of those have been consolidated into what is called multi-district litigation before a federal judge in Illinois who is expected to rule soon on whether he will grant class-action status to the litigation. This is a common legal practice in situations in which there are large numbers of lawsuits that have similar claims and the same defendant, in this case the pharmaceutical giant Bayer. While this litigation is ongoing there are also hundreds of other state and federal suits across the company which are more difficult to track because they are in such diverse locations. More information on Yasmin Lawsuits

However, those suits also carry the same allegations against Bayer: that there was inadequate research into the possible dangers of Yaz and Yasmin, particularly into the effects of the ingredient drospirenone, which the Yaz and Yasmin lawyers for the victims say has caused their clients to have suffered from blood clots, deep vein thrombosis, stokes and heart attacks and have linked some deaths to these side effects. Bayer has denied all of the allegations but the Food and Drug Administration recently announced it has receive new information about these side effects and will conduct a review of findings in recent medical research studies and release the results of the investigation to the public.

The FDA has just issued a warning to the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. The announcement comes as an increasing number of Diflucan lawsuits are being filed by women who are seeking damages against the manufacturer of the drug on the grounds that there is a link between their use of the medication and the birth defects suffered by their infants.

The FDA said this risk does not appear to be associated with women who take a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). However, the agency said, based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C. This may prompt women to seek out a Diflucan lawsuit.

The FDA said Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Diflucan is also used to treat meningitis caused by a certain type of fungus. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

Changes appear to be in the wind at the Food and Drug Administration in the wake of the massive recall of the DePuy hip implant systems and problems that have surfaced with other medical devices that had been approved by the government regulatory agency. FDA Commissioner Margaret Hamburg announced that she will make improving the FDA’s device unit a priority and said that The Institute of Medicine has been called in to review the unit’s processes and make recommendations for improvement. One of the unit’s procedures — called the accelerated 510(k) process — has come under specific criticism by agency skeptics who say that it does not adequately test new, proposed medical devices and allows them to be rushed into the marketplace without sufficient safeguards for patient safety.

In the case of the DePuy hip implant systems, which was one of the most high-profile medical device recalls in recent years, DePuy Orthopaedics was forced to recall its popular DePuy ASR Xl Acetabular and ASR Resurfacing Systems after failure rates as high as 13 percent were reported. The systems had long been the target of consumer advocates, DePuy lawsuits by victims of these defects and had been the subject of government restrictions in other countries. One of the questions raised by FDA critics and in the lawsuits filed by DePuy Hip Recall lawyers on behalf of the victims was why it took so long for the FDA to act after these concerns became known.

The DePuy victims also are claiming in their allegations that Johnson & Johnson, DePuy’s parent company, knew about these defects and was negligent in not recalling the systems or making known these defects earlier.

Nov. 19, 2010 was an important date in the long battle that consumer groups and patients have waged over the safety of Darvon, Darvocet and other painkillers that contain the opiate propoxyphene. On that date the Food and Drug Administration announced that Xanodyne Pharmaceuticals Inc. which manufacturers Darvon and Darvocet, had accepted the FDA’s request that the drugs be pulled from the U.S. market over concerns for consumer safety.

“The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities,” the FDA said in its announcement. “As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.” Information on a Darvocet lawsuit can be found online.

But, as outlined in numerous Darvon and Darvocet lawsuits and in public statements by the respected consumer watchdog Public Citizen, the FDA’s time lapse in taking action that European countries had done months and years before may have resulted in numerous victims losing their lives to these side effects. Propoxyphene “has been linked to many thousands of U.S. deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart,” Public Citizen said in responding to the FDA action

Add diabetes to the list of possible dangerous side effects that can develop among patients who use Crestor and other statin drugs that are designed to reduce cholesterol. The drugs have long been controversial because of links to life-threatening conditions that can lead to kidney failure and muscle deterioration causing rhabdomyolysis. The consumer advocacy group Public Citizen, which is a non-profit, non-partisan organization, has long advocated that Crestor be banned because of its health hazards and has asked the Food and Drug Administration to order the recall of the medication.

Public Citizen has produced figures from medical research studies that show the risk of developing kidney problems is about 75 times higher with Crestor than with all of the other medications in its drug classification combined. The organization also has compiled statistics that show that there have been just over six reports of acute kidney failure damage out of every one million Crestor patients for whom the medication is provided. Crestor lawyers who have filed lawsuits on behalf of these victims in their court documents present a picture of a devastating condition in which masses of muscle die and release huge amounts of proteins into the bloodstream which eventually block the kidneys and in some cases cause death. Many are seeking information about a possible Crestor heart attack as well.

Now, the Journal of the American Medical Association is reporting that Crestor and the other statin drugs can increase the risk of diabetes. Although the statins are one of the choices of health care professionals in treating victims of diabetes they have been found, when administered in large doses to people with diabetes for heart problems actually can increase the risk of new-onset diabetes.

In a continuing Internet discussion on a wide variety of health topics the staff of the Mayo Clinic discussed the question of whether anti-depressant medications are safe to take during a pregnancy.

To boil down the discussion, the answer was that women suffering from depression should continue taking medication but be aware that some anti-depressants put them more at risk of giving birth to an infant suffering from a birth defect than other types of anti-depressant medications.

The staff wrote: “Overall the risk of birth defects and other problems for babies of mothers who take anti-depressants during pregnancy is low. Still, few medications have been proved safe without question during pregnancy and some types of anti-depressants have been associated with health problems in babies.”

The Mayo Clinic staff then listed Zoloft as having side effects that could cause birth defects such as a life-threatening condition called Persistent Pulmonary Hypertension of the Newborn, septal heart defects and omphalocele, in which the infant’s intestine or other internal organs stick out of the belly button.

These same allegations have been common in Zoloft lawsuits filed by women and families that have had children suffering from these Zoloft birth defects. While there have been calls for the Food and Drug Administration to ban the sale of Zoloft the agency has declined to do so thus far but has directed Zoloft’s manufacturer to include more expansive warning labeling.

For those who have been involved or affected by the increasing number of Fosamax lawsuits filed over dangerous side effects such as bone fractures and life-threatening jaw conditions there were some interesting figures recently reported in a Hawaiian newspaper. In detailing a Fosamax lawsuit filed against drug manufacturer Merck by a Hawaiian woman who suffered a broken thigh while standing in a gym with some friends, the Honolulu Star-Advertiser did some research about these cases. Here’s what they reported:

“As of March 31, about 1,450 Fosamax cases had been filed in the U.S. against the pharmaceutical giant for osteonecrosis – a severe bone disease of the jaw – femur fractures and other bone injuries associated with long-term use of the drug, according to company filings with the U.S. Securities and Exchange Commission. Worldwide sales of Fosamax, a top-selling drug for Merck, were $208 million in the first quarter, a 10 percent decline from a year earlier, SEC filings show.”

The newspaper also reported that the U.S. Food and Drug Administration “issued a safety warning last year about atypical thigh-bone fractures possibly being associated with the long-term use of Fosamax and required a warning label to be added to the product.” Fosamax and other drugs classified as bisphosphonates are prescribed for the treatment of osteoporosis, primarily for postmenopausal women and elderly men. If you’ve suffered a Fosamax femur fracture you may want to seek out an attorney.