Pharmacy Law

Pharmaceutical Law

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Pharmaceutical litigation is no different from other product liability cases in terms of complexity. They also require expertise and experience, and also require a detailed understanding of the particular product that is the subject of the litigation. Panter, Panter & Sampedro has pursued claims on behalf of individuals injured from such pharmaceutical products as Baycol and phenylpropanolamine, or PPA.

Levaquin

Recently, Public Citizen, a national non-profit public interest organization, and the Illinois Attorney General, petitioned the U.S. Food and Drug Administration to add a "Black Box" warning to the drug Levaquin's packaging. They also urged the FDA to require that pharmacists give patients FDA- approved medication guides that also carry the warning of tendon rupture associated with the drug. Levaquin (Generic: Levofloxacin) has been linked to tendon damage and ruptures in the Achilles tendon, bicep, shoulder(rotator cuff), the hand, and the thumb.

Tendon ruptures associated with these drugs continue to occur at a disturbing rate. They could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, swelling and bruising, and difficulty walking, and switched to other antibiotics. The FDA's adverse event database shows 262 reported cases of tendon ruptures, and sixty-one percent of the ruptures were associated with Levaquin.

Trasylol

In November 2007, following a request from the U.S. Food and Drug Administration, Bayer Pharmaceutical suspended the sale of Trasylol. Trasylol (asprotonin injection) is a clotting drug administered to patients during cardiac bypass and other complex heart surgeries to prevent bleeding and reduce blood loss. Results from a Canadian study suggested an increased risk of death for Trasylol users compared to similar drugs. Trasylol has also been linked to heart attacks, strokes, and kidney problems.

A Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac Surgery

Vioxx

On September 30, 2004, the giant drug manufacturer Merck has announced that Vioxx, the widely prescribed and hugely popular arthritis drug, is dangerous and increases the risk of serious medical complications including heart attacks, strokes, and kidney failure. As a result, all Vioxx currently on pharmaceutical shelves was withdrawn.

Vioxx News- www.fda.gov/bbs/topics/news/2004/NEW01122.html

Vioxx Letter

Baycol

Bayer Pharmaceutical voluntarily withdrew Baycol (cerivastatin), a cholesterol-lowering product, from the U.S. market because of reports of sometimes-fatal rhabdomyolysis. Rhabdomyolysis is a very rare condition where serious muscle damage causes the release of muscle cell contents into the bloodstream. In rare instances, rhabdomyolysis may result in kidney and other organ damage, which may be fatal.

Baycol Information- www.fda.gov/cder/drug/infopage/baycol/default.htm

Baycol Questions and Answers- www.fda.gov/cder/drug/infopage/baycol/baycol-qa.htm

Phenylpropanolamine (PPA)

According to the FDA, it has issued a public health advisory and is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. PPA is an ingredient used in many over-the-counter and prescription cough and cold medications as a decongestant, and in over-the-counter weight loss products. Taking PPA increases the risk of hemorrhagic stroke, or bleeding into the brain. Women and men alike are at risk. While the risk of hemorrhagic stroke is very low, the FDA recommends that consumers not take any products containing PPA. If you think you or a family member have been injured as a result of PPA, contact Panter, Panter & Sampedro.

PPA Information Page- www.fda.gov/cder/drug/infopage/ppa/default.htm
PPA Questions and Answers- www.fda.gov/cder/drug/infopage/ppa/qa.htm

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