Health & Safety Issues in Orlando | Orlando Legal Examiner

Ortho Evra Patch Maker Says Blood Clot Risk Doubles with Birth Control Patch

Women who use the Ortho Evra birth-control patch face twice the risk of developing blood clots as those who take the Pill, the patch’s manufacturer said late Thursday, citing recent company-funded research.The finding comes from one of two studies comparing the patch and Pill, said Ortho Women’s Hea

By The Legal Examiner

/ 17 Feb 2006

FDA Places New Restrictions on Guidant

New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures. In the l

By The Legal Examiner

/ 16 Feb 2006

FDA: Certain Parkinson's Drugs Lead to Greater Risk of Gambling

The FDA is reporting that certain drugs used to treat tremors associated with Parkinson’s disease actually increase the risk of pathological gambling. The latest results are consistent with earlier observations and add to evidence that Parkinson’s drugs may lead to impulsive behavior as they make up

By The Legal Examiner

/ 15 Feb 2006

"Black Box" Drug Warnings Often Ignored by Healthcare Providers

In a Wall St. Journal article published today, many patients are told to use drugs with black box warning in spite of these drugs being unsuitable for them. A new study of medicines prescribed in the U.S. has found that many patients are told to use drugs with “black box” warnings even though those

By The Legal Examiner

/ 14 Feb 2006

FDA Official Says Vioxx Maker Merck Had Plenty of Time to Warn Patients of Danger

Merck could have immediately warned Vioxx patients that the drug might cause an increased risk of heart attacks rather than waiting two years before issuing a warning, according to a former FDA official. Richard Kapit said there was plenty of time to alert the public before Richard “Dickie” Irvin be

By The Legal Examiner

/ 12 Feb 2006

Health Experts: FDA Oversight Needs to be More Open and Transparent

The chairman of an outside committee of medical experts that advises the Food and Drug Administration on drug-safety issues said Friday the agency’s own drug-safety oversight board needed to be more open and transparent. The chairman of the committee recommended that the FDA add new members to its o

By The Legal Examiner

/ 11 Feb 2006

FDA Panel Recommends Black Box Warning for Certain ADHD Drugs

In a surprise move, a Food and Drug Administration advisory committee voted to recommend that stimulant drugs widely prescribed for attention-deficit hyperactivity disorder carry strong “black box” warnings about potential cardiovascular risks.The warning proposed by a member of the committee would

By The Legal Examiner

/ 10 Feb 2006

Guidant CEO to Receive $1.5Million Bonus. . . For What?

Guidant’s chief executive will receive a $1.5 million bonus after the acquisition by Boston Scientific is complete, according to documents filed with the U.S. Securities and Exchange Commission. Since June, Guidant has recalled or issued safety advisories on about 88,000 defibrillators and more than

By The Legal Examiner

/ 10 Feb 2006

Boston Scientific's Mea Culpa

Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. “It’s clear we have not done enough to resolve the issues raised by the F.D.A., “a spokesman, Paul Donovan, said in a statement yesterday, “and we recognize

By The Legal Examiner

/ 5 Feb 2006

Propofol Infusion Syndrome and Heart Failure

Propofol , distributed by Astra Zenica, is used for general anesthesia during surgery, sedation, and reduction of intracranial pressure in head injury patients. Propofol administration has been associated with the development of propofol-infusion syndrome in pediatric and adult patients. The syndrom

By The Legal Examiner

/ 5 Feb 2006

Big Pharmaceutical Companies

When the FDA approved new rules making pharmaceutical companies provide clearer labeling and detailed warnings about their drug products, they also slipped in a second rule change that is both ridiculous in its scope and profoundly anti-consumer. This new rule change argues that because the FDA appr

By The Legal Examiner

/ 2 Feb 2006

FDA Sends Warning to Boston Scientific

Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker’s quality control. FDA officials who announced the warning involving Boston Scientific said it was only the thir

By The Legal Examiner

/ 30 Jan 2006