Litigation Again Reveals What Big Pharma Wants Kept Secret

Recent federal court filings in the Ortho Evra products liability litigation disclosed that Johnson & Johnson hid data from the FDA about their birth control patches’ side effects and failed to address flaws in the manufacturing process which could increase the risk of serious and potentially fatal problems.

The factual allegations were publicly released as part of the plaintiffs opposition to a motion by Johnson & Johnson to dismiss the claims of women injured by their birth control patch. The allegations include that Johnson & Johnson applied an apparently random correction factor of 60% to tests that measured the level … Read the rest

Direct to Consumer Advertising of Cypher Stent Draws Heavy Criticism and Points to Need for Legislation

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke.

The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, … Read the rest

Possible Medical Malpractice LASIK Cases? FDA Advisers Recommend Clearer Warnings of Risks and Contraindications For Would-Be Patients

The U.S. Food and Drug Administration’s Ophthalmic Devices Panel convened last Friday to discuss post-LASIK surgery (laser-assisted in situ keratomileusis) quality-of-life issues. Of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA.

Approximately one in four people who seeks Lasik is not a good candidate. Perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. One young man committed suicide because of severe eye pain and fuzzy vision. Some patients have had to … Read the rest

Taking Mirapex or Requip for Restless Leg Syndrome? Beware of “Disease Mongering”

“Disease mongering” is a term coined by some drug-marketing critics to describe what they view as an effort by pharmaceutical companies to enlarge the market for a drug by convincing people that they are suffering from something that can be medically treated and encouraging them to ask their doctor to prescribe the drug in order to enlarge the market for drug treatment and promote a particular product.

An example of such a tactic is advertising for Restless Leg Syndrome (RLS), a neurological disorder characterized by unpleasant feelings in the legs with an associated uncontrollable urge to move when resting because … Read the rest

Suspension of Heparin Sales More than a Matter of Products Liability; Described as “a National Security Issue.”

Since Baxter International announced recently that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications including allergic reactions, many of them serious and potentially life-threatening, significant concerns have arisen as to the effectiveness of the U.S. Food and Drug Administration’s oversight of imported drugs. Baxter bought the active ingredient for heparin, which is derived from an enzyme in pig intestines, from Scientific Protein Laboratories, which produces heparin’s active ingredient in its factory in Changzhou, China.

Scientific Protein moved production to China three years ago because the country is the world’s largest … Read the rest

FDA Issues Public Health Advisory on Chantix, Which May Become the Subject of Product Liability Suits

The U.S. Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Chantix has been suggested as being a possibly significant contributing factor to the bizarre and tragic death of musician Carter Albrecht on September 5, 2007.

The FDA action adds credibility to the belief that Chantix … Read the rest

Off-Label Marketing of Fentora Leads to $425 Million Penalty

On September 27, 2007, the Food and Drug Administration issued a warning about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action came less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths. Cephalon has just recently agreed to settle the U.S. Justice Department investigation of its allegedly illegal off-label marketing of Fentora (fentanyl buccal) and Actiq outside the indications on their labels. Cephalon denied it marketed the drugs improperly and claims the problems are a result of improper prescribing.

In settling, they have … Read the rest

Heart Surgery Drug Trasylol Withdrawn from Market

The German pharmaceutical company, Bayer AG, announced that it will withdraw Trasylol, its controversial drug used for heart surgery, from the market. The withdrawal was due in part to a study performed in Canada which suggested that Trasylol increased rates of death.

The New England Journal of Medicine published the results of a study it conducted finding that Trasylol increased the risks of stroke, heart attack, kidney failure, and death. The research concluded that stopping the use of Trasylol would result in the prevention of 10,000 to 11,000 cases of kidney failure per year along with the savings of over … Read the rest

Childrens’ Toy Aqua Dots Recalled for Containing a Chemical That When Eaten Converts Into “Date Rape Drug”

Aqua Dots, a/k/a Aqua Beads, a Chinese-made toy, was recalled Wednesday, November 7, 2007, by the Consumer Product Safety Commission after two children in the United States and three in Australia were hospitalized after swallowing the beads.

Aqua Dots are packets of brightly colored beads that children arrange into mosaic designs. When sprinkled with water, the beads then stick together in as little as 10 minutes to form durable artworks. The toy was pulled from shelves after scientists found they contain a chemical that converts into a dangerous, potentially fatal drug when eaten. The chemical coating on the beads, when … Read the rest

FDA Warns Off-Label Prescription of Painkiller Fentora Can Cause Death and Life-Threatening Side Effects

The Food and Drug Administration issued a warning today about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action comes less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths.

The FDA has received reports of death and life-threatening side effects in patients who have taken Fentora. The reported deaths were the result of improper selection of patients, dosing, or improper product substitution, according to the FDA. One of the deaths was a suicide.

Last October, the FDA approved Fentora for use in cancer patients … Read the rest