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Medtronic Neuromodulation Implantable Infusion Pumps Recalled.

January 21, 2008 | FDA

Filed Under: Medtronic Recall Lawsuit, Medtronic Infusion Pumps

On January 21, 2008 the Food and Drug Administration announces the recall of Medtronic Neuromodulation SynchroMed, EL, SynchroMed II and IsoMed Implantable Infusion Pumps. The Devices included in this Class 1 recall are as follows:

SynchroMed EL Implantable Infusion Pump, Models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, 8627L-18 SynchroMed II Implantable Infusion Pump, Models 8637-20, 8637-40, IsoMed Implantable Infusion Pump, Models 8472-20, 8472-35, 8472-60.

for more information please visit the Medtronic section of the site.

Actavis Recalls Certain Fentanyl Patches

February 18, 2008 | 2008

Filed Under: Actavis Fentanyl Patch Recall

Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl patches sold by Actavis in Europe are not affected by this recall.

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Johnson & Johnson Duragesic Pain Patch Flaw Recall.

February 13, 2008 |

Filed Under: Pain Patch Recall

A recall has been issued by Johnson & Johnson and Novartis AG's Sandoz on 25-microgram-per-hour patches with expiration dates on or before December 2009. The Duragesic Pain Patch has been recalled because defects in the manufacture of the patch could lead to accidental overdoses. Johnson & Johnson is recalling about 32 million of the fentanyl-containing Duragesic Pain Patches, and the company estimates that about two out of every million patches could be defective.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Today’s Duragesic Patch recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. It was found that a manufacturing problem led to some of the patches having a cut in the internal reservoir lining. This cut may cause a leaking problem of the patch. The danger is if anyone touches a defective pain patch they may be delivered a dose of the prescription painkiller fentanyl which may lead to breathing problems or even an accidental overdose which can be fatal. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

The Duragesic Pain Patch has been a problematic device ever since it first came on the market. In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

It was found that a manufacturing problem led to some of the patches having a cut in the internal reservoir lining. This cut may cause a leaking problem of the patch. The danger is if anyone touches a defective pain patch they may be delivered a dose of the prescription painkiller fentanyl which may lead to breathing problems or even an accidental overdose.

FDA Warns Public of Syrigne Contamination.

Food & Drug Administration announces a nation wide recall for contaminated syringes.

January 25, 2008 | FDA News

Filed Under: Bacteria Syringe Contamination, Sierra Pre-Filled, Heparin Lock, Normal Saline Syringe Contamination.

The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.

More Information Here.

FDA reviewing Vytorin cholesterol drug

Recent study showed it wasn't any better than a generic medication

January 25, 2008 | MSNBC

Filed Under: Vytorin, Vytorin Lawsuit, Vytorin clogged arteries

U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc’s and Schering-Plough Corp’s popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.

The Food and Drug Administration said it had not yet received a final report on the study, called Enhance. The agency’s review of Vytorin will take about six months after final results are received, the FDA said.

In the meantime, patients with questions about the Enhance study should talk with their doctors, the FDA advised.

“At this time, it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone,” an FDA statement said.

Simvastatin is the generic name for Zocor. Vytorin combines Zocor with a newer cholesterol-fighting pill called Zetia.

The FDA review puts an even bigger spotlight on a debate over Vytorin’s value in the wake of the Enhance results early last week and concern over a long delay in releasing the data.

Decline in Vytorin prescriptions
Major medical groups, prominent cardiologists and U.S. lawmakers have weighed in, while prescriptions for the drug have slipped.

“The FDA is attempting to buy time so noise can be filtered out and cooler heads can look at the Vytorin data, but it is unlikely even the FDA will be able to draw clear conclusions,” said Viren Mehta, principal at Mehta Partners, which provides investment advice to the global pharmaceutical and biotechnology industries.

“For a clear picture, we will need to wait for outcomes data (data on heart attack and stroke risk) from larger Vytorin trials” due by 2010 or 2011, Mehta said.

Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion.

The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels. Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but it did a better job of reducing “bad” LDL cholesterol.

Beyond Vytorin, the FDA said it also would review “whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.” High LDL is commonly believed to be a major risk factor for heart disease.

FDA officials cautioned the public not to overreact to the Enhance study by turning away from cholesterol-lowering drugs.

Drugs that cut LDL are among the largest selling drugs in the world, and also include Pfizer Inc’s Lipitor and AstraZeneca Plc’s Crestor. Shares of Pfizer and AstraZeneca were also lower after the FDA announcement.

Lipitor, Zocor and other drugs in the same statin class have consistently shown the ability to reduce heart attacks and strokes by up to 30 percent.

Drugmakers criticized for delay
The drugmakers have been criticized by doctors, industry analysts and lawmakers for delaying presentation of results from the trial, which was concluded in 2006, until last week.

“The delay has made everyone uncomfortable,” Mehta said. ”We don’t know why they didn’t come out earlier and just say ... the trial was not showing any possible benefit” in cutting plaque.

Deborah Cohn, a professor of marketing at Touro College Graduate School of Business in New York, said the delay in releasing the results had caused an understandable backlash.

“Consumers feel like there may be something else they’re not telling us,” Cohn said. “Nobody likes feeling like they’re being lied to and that’s how everybody’s reacting.”

Merck spokesman Christopher Garland said the company ”welcomes today’s statement from the FDA as it appropriately communicates information about the Enhance trial as well as information about Vytorin and Zetia.”

A Schering-Plough spokesman could not immediately be reached after the FDA announcement

Pfizer Strengthens Suicide Warning On Chantix Label

January 19 , 2008 | Pharmalot.com

Filed Under: Chantix Health Risks, Chantix Injury Lawsuit

The drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.

You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “a preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion and behavior within days to weeks of taking Chantix.”

And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.

A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.

The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.

FDA Reveals Reports: Chantix

FDA says Chantix reports reveal suicidal thoughts and aggressive and erratic behavior.

by: fda.gov

November 20 , 2007

Filed Under: Chantix Health Risks, Chantix Injury Lawsuit

FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

Chantix: More Information Here. | Free Consultation Form

Trasylol Pulled From Worldwide Market
More About Trasylol

FDA says clotting drug poses increased death risk, while company says drug still has benefits.

by: Steven Reinberg | usnews.com

November 5 , 2007

Filed Under: Trasylol Recall Lawsuit

MONDAY, Nov. 5 (HealthDay News) -- Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said at an early morning news conference Monday.

However, he added, "the suspension will include a slow phase-out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs." And he added that Bayer could continue to supply the drug if physicians can identify specific patients who would benefit from it.

"Studies have found that Trasylol can increase the risk of kidney damage compared with other drugs," Dr. Gerald Dal Pan, the FDA's director of the Office of Surveillance and Epidemiology, said during the news conference.

In 2006, he added, the FDA limited the use of Trasylol and strengthened its warnings. Subsequently, he said, studies found that Trasylol increased the risk of in-hospital death among patients undergoing cardiac bypass surgery. In addition, Dal Pan said, two studies this year found that the drug increased the long-term mortality of patients who had undergone bypass surgery.

The suspension follows news last month that a major Canadian trial of the drug was terminated because of an increase in deaths for cardiac surgery patients using it.

The trial was designed to show that Trasylol was better than other drugs in controlling bleeding, Dal Pan said. "That study was halted, because Trasylol appeared to increase the risk for death compared with two other drugs," he said.

Based on these findings, the FDA requested last week that Bayer suspend Trasylol pending further review, Dal Pan added.

In a company statement on its Web site Monday, Bayer stressed that the suspension was temporary. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the statement said.

Heart experts said, however, that the drug's suspension came as no surprise.

"This is not really new news. It has been surfacing in the past year and a half," said Dr. W. Douglas Weaver, president-elect of the American College of Cardiology and co-director of the Heart & Vascular Institute at Henry Ford Hospital in Detroit. "Many surgeons have stopped using the drug. This won't have a huge impact, but surgeons want to know [the danger]."

The FDA plans to do a detailed review of the preliminary results from the Canadian trial before deciding whether to allow Trasylol, which it first approved in 1993, back on the U.S. market.

In the Canadian trial, called BART, an elevated 30-day and overall death risk caused the study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

A month before, on Sept. 12, an FDA advisory panel had recommended that Trasylol remain on the market, despite mounting evidence that it might have serious side effects.

In addition, in February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.

"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."

His team's study tracked the long-term survival of almost 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide and found that the five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid.

After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor Trasylol patients for kidney, heart and brain damage -- an action taken after Bayer itself disclosed study data showing that the drug increased the risk of death, kidney damage, congestive heart failure and stroke.

Merck profits signal a rebound

The drugmaker said sales were key to overcoming Vioxx losses.

by: Karl Stark (Inquirer Staff Writer)

October 23 , 2007

Filed Under: Vioxx Lawsuit

Merck & Co. Inc. is coming back.
Two years ago, the company was reeling from its failed pain reliever, Vioxx, and from the impending loss of one of its most profitable drugs. Analysts were openly skeptical about the company's prospects.

But yesterday, Merck reported a 62 percent rise in net income for the third quarter, fueled by a doubling of vaccine sales.

Merck, whose vaccine operations are based in West Point, Montgomery County, made more money in part because it cut marketing and administrative costs 18 percent and increased revenue 12 percent.

Driving sales were Merck's heavily marketed drugs, including its top seller, the asthma and allergy medication Singulair, and more recent additions, including the human papillomavirus vaccine Gardasil.

So far, the market has responded, driving up Merck's share price 20 percent over the last year.

Merck's return to glory is far from assured. Like its competitors, the third-largest U.S. drugmaker faces patent expirations on key products in the next few years. And the company's quarterly results improved in part because executives chose to reserve less money for Vioxx lawsuits than in the quarter a year earlier.

Merck must still contend with 26,600 lawsuits involving Vioxx, which the company pulled from the market three years ago for safety reasons.

Vioxx "is still the biggest risk," said Michael Levesque, a credit analyst and senior vice president with Moody's Investors Service.

Still, Levesque added, "they have executed on their pipelines in the last several years in a way that sets them apart from many of their peers."

The company cited the third quarter, which ended Sept. 30, as part of a trend. "The momentum that Merck began to build last year continues, as proven by the strong performance in this last quarter," chief executive officer Richard T. Clark said in a conference call with Wall Street analysts.

Sales for the quarter were $6.1 billion, up from $5.4 billion in 2006. Net income increased to $1.5 billion from $941 million. And earnings per diluted share rose to 70 cents from 43 cents.

Merck's biggest seller, Singulair, which goes off patent in 2012, saw its sales rise 17 percent to $1 billion in the quarter.

The antihypertension drugs, Cozaar and Hyzaar, reached $814 million, or about even with last year. Those patents expire in April 2010.

Another big seller, Fosamax for bone loss, chalked up $725 million in sales, representing a 6 percent drop. It goes off patent in February.

Total vaccine sales were a bright spot, rising from $555 million a year earlier to $1.2 billion. Leading the firm's vaccine sector was Gardasil, the new vaccine against the human papillomavirus, which can cause cervical cancer and genital warts. The drug accounted for $418 million for the quarter and is expected to have one of the largest markets in history for a vaccine.

Rotateq, the vaccine against rotavirus that launched in February 2006, had sales of $171 million in the third quarter. BothChildren's Hospital of Philadelphia and the nearby Wistar Institute helped develop the vaccine and receive royalties.

Eight Merck drugs have been approved by the FDA in the last two years, including six novel compounds, such as Januvia, Gardasil and the new HIV drug Isentress.

Isentress, which won approval this month, is a first-in-class treatment for HIV patients whose infections have become resistant to other drugs.

The medication could gain more than half the sales in its projected $1 billion class by 2016, said analyst Sylvia Eash of Decision Resources, a privately held firm in Waltham, Mass., that analyzes drugs for pharmaceutical and biotech firms.

On the Vioxx front, Merck put aside an additional $70 million for its legal defense, a big drop from the $598 million it reserved in last year's third quarter. The difference helped cut marketing and administrative expenses in this year's third quarter, the company said.

Merck spent $160 million on the suits in the third quarter alone. It has not put aside any money to pay verdicts, a company spokeswoman confirmed.

The company's scorecard, as of yesterday, showed 11 victories and five losses.

The five losses carry judgments totaling $102.5 million, though the company is appealing each case and has yet to pay any money.

Marc Grossman, a Long Island lawyer who is representing about 350 Vioxx plaintiffs, said Merck was "playing this denial game" and "creating the perception that their Vioxx strategy is working . . . when in fact the litigation is just beginning."

Daniel Hoffman, a pharmaceutical analyst based in Glenmore, Chester County, praised management for starting to turn around the company, but said the Vioxx cases remained a concern. "They're not out of the woods by any stretch of the imagination," he said.

Merck's stock rose $1.53, or 2.9 percent, to close at $54.64.

Related Pages: VIOXX

Patients Warned as Maker Halts Sale of Heart Implant Part

by: The New York Times | Barnaby J. Feder

October 15 , 2007

Filed Under: Medtronic, Defibrillator Recall

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.

The faulty component is an electrical “lead,” or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data. .. (read more)

Renewed call to ban Avandia

by: News Day | Delthia Ricks (delthia.ricks@newsday.com)

September 17, 2007

A consumer watchdog group stands by its belief that Avandia, the embattled type 2 diabetes drug, should be removed from the market, a demand the group's leadership says was fortified last week by additional research.

Avandia, made by GlaxoSmithKline, is designed to lower glucose in the blood, but it has been under a spotlight - and on the hot seat - for months, along with rival drug Actos, manufactured by Takeda Pharmaceutical Co. ( .. read more ..)

Copyright © 2007, Newsday Inc.

Family plans to sue Adventureland after tot's injury

Days after a 6-year-old boy's hand was mangled at Adventureland in Farmingdale, his family is planning to sue the park, their attorney said Wednesday.

Charlie DeMarco of Bellmore lost his balance on the Super Raider, a walk-through attraction, at about 2:30 p.m. Saturday, said attorney David Woycik of Mineola. He fell on a portion of the it where kids cross an elevated walkway of moving metal plates and ended up with his hand stuck between one of the horizontal plates and a vertical wall on the side of the ride, Woycik said. ... (read more) ...

Boston Scientific Settles Guidant Cases

Boston Scientific Corp. said Friday it has agreed to pay $195 million to settle around 4,000 claims involving heart defibrillators and pacemakers made by Guidant Corp., which it acquired last year. ... (read more)...

OxyContin is addictive

ADHD Drug to Get Stronger Warning

Dexedrine, like other similar drugs, linked to heart risks

By Amanda Gardner, HealthDay Reporter [ Source: MSNBC News]

TUESDAY, Aug. 22 (HealthDay News) -- U.S. officials have asked a pharmaceutical company to add a label warning of a risk for heart problems for patients taking the prescription drug Dexedrine, a stimulant used to treat attention-deficit hyperactivity disorder (ADHD).... (read more) ..

FIRST FOSAMAX CASE BROUGHT IN NEW JERSEY SANDERS VIENER GROSSMAN, LLP (Mineola, New York) files first suit against Merck & Co., Inc.'s (NYSE: MRK) in Superior Court of the State of New Jersey, Atlantic County, on behalf of a retired 77-year old Married Man from Smithtown, New York, who was recently diagnosed with Osteonecrosis of the jaw (ONJ). Mr. Rhys Wass began taking Fosamax in 1996 and took 70 mg once a week for almost 10 years until .... (read more) ...