Category Archives: Drugs & Pharma

FDA Clears Generic Yaz For Market

December 26th, 2011

The Food and Drug Administration has approved a generic version of the birth control pill Yaz, despite thousands of lawsuits linking the pill with blood clots, pulmonary embolism, strokes and heart attacks in women.

The generic version, called Ventura, is marketed and sold by Watson Pharmaceuticals. Watson is claiming that Ventura can not only prevent pregnancy, but also treat moderate acne in women at least 14 years of age.

Bayer, the manufacturer of Yaz, was sent three different letters by the FDA in 2003, 2008, and 2009, warning the company about misleading consumers about the drug’s effective use for acne prevention and downplaying the serious side-effects that are possible when using it.

Drospirenone is the active drug in both the commercial and generic version of the pill, and is the chemical associated with the serious side-effects.

There are other birth control options that are just as effective as drospirenone-containing pills. Why has the FDA, instead of removing the dangerous drug from the market, instead allowed the entry of yet another dangerous pill?

The Edgar Law Firm asked a similar question last week. We wonder why as well.

Sarelson Law Firm – Miami litigation attorneys

 

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GlaxoSmithKline Settlement Over Defective Drugs

December 16th, 2011

SB Pharmco Puerto Rico Inc., a subsidiary of drug manufacturing giant GlaxoSmithKline, has pled guilty to charges of manufacturing defective drugs. Reaching a settlement with the Justice Department, the company agreed to pay criminal fines of $150 million and civil settlements in state claims of approximately $600 million.

The methods used in the manufacture of some of the drugs at the pharmaceutical plant were found to be unsafe, meaning they did not conform to good manufacturing standards. This led to products being produced that were either impure or defective in some way. The drugs, considered “adulterated”, were released into interstate commerce in violation of the Food, Drug, and Cosmetic Act (FDCA).

Some of the defective drugs included a time-release version of the anti-depressant Paxil, Kytril, an anti-nausea medication, Bactrobank, a topical anti-infection ointment, and Avandamet, a Type II diabetes drug.

The defect in the Paxil CR pills produced pills that frequently split, leading some pills to release all of the drug at once in each dose instead of being released over time, and some pills to have no effect at all.

The law firm of McGowan, Hood & Felder LLC discussed the settlement recently, pointing out the recent crackdown of the federal government on health care fraud.

We hope the government’s efforts result in better consumer protection for everyone.

Sarelson Law Firm – Miami litigation attorneys

 

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Class Action Suit Filed for Stimulants In Supplements

November 21st, 2011

Attorneys have filed a class action suit against a successful Florida-based supplement manufacturer, claiming their bodybuilding supplements “contain a dangerous amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects.”

BPI Sports manufactures and sells multiple dietary supplements, including 1.M.R powder and tablets, RoxyLean ECA and Rx6. Marketed as bodybuilding and weight loss supplements, the products contain DMAA, a known stimulant that has been banned by multiple organizations and several countries. Both the World Anti-Doping Agency and Major League Baseball prohibit the use of DMAA, and Canada and New Zealand have prohibited the sale of the substance.

According to the class action lawsuit, BPI failed to inform customers that its products contain a dangerous stimulant. Don Caitlin, an anti-doping scientist, told the Washington Post that DMAA is chemically similar to amphetamine and ephedrine, and can raise one’s heart rate and blood pressure to fatal levels.

The plaintiffs in the class action are seeking restitution and class damages for consumer law violations, unfair competition, false and misleading advertising, breach of express warranty and breach of implied warranty.

Have you used a dietary supplement that contains DMAA and are considering legal action? If you have questions about your legal options, please contact our Miami class action attorneys for a free consultation.

Sarelson Law Firm – Miami class action attorneys

 

Posted in Class Action Litigation, Class Actions, Consumer Protection, Diet & Fitness Fads, Drugs & Pharma, False and Deceptive Advertising, Supplements & Herbals | Tagged , , , | Leave a comment