Emerging New Drug Dockets

By Bob Schwartz

Dilantin is an antiepileptic drug that can be useful in the treatment of epilepsy.  It can also cause very painful and disfiguring severe skin blistering known as Stevens-Johnson Syndrome and toxic epidermal necrolysis.

On 11/24/2008, the FDA announced it is investigating new preliminary data regarding a potential increased risk of serious skin reactions, including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians and Thais. Because fosphenytoin is a prodrug and is converted to phenytoin after administration, any concern regarding this association is also applicable to fosphenytoin. Phenytoin and fosphenytoin are used to control tonic-clonic (grand mal) and complex-partial seizures in epilepsy.

More recent reports, however, indicate that certain other populations may be at increased risk for developing these conditions as well.  For instance, these reactions are estimated to occur in 1 to 6 per 10,000 new users of CBZ in countries with mainly Caucasian populations. The risk in some Asian countries is estimated to be about 10 times higher.

If you were prescribed and took DILANTIN prior to April 2009 and were diagnosed with Stevens Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) while taking DILANTIN, or received medical attention for either Stevens Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), call us to discuss your legal rights.

YAZ/YASMIN is a birth control medication that can increase risk of strokes, heart attacks and blood clots.

Bayer, the manufacturer of the birth control pills Yaz and Yasmin, is alleged to have concealed health risks, such as an increased risk of strokes, heart attacks and blood clots, associated with these dangerous drugs and, further, Bayer has been accused of lying about the drugs’ effectiveness.

Yaz and Yasmin are “fourth generation” birth control pills, which contain a new ingredient, drospirenone, and combine estrogen and progestin to prevent pregnancy.

Drospirenone, a diuretic, causes an increase in potassium that can lead to “hyperkalemia” or unsafe levels of potassium that disrupt heart rhythms and slow the flow of blood, leading to clotting.  Yaz/Yasmin were Bayer’s top-selling pharmaceuticals last year, with global sales of $1.8 billion.

In addition to the lawsuits, the drugs remain under scrutiny by the Food and Drug Administration for quality control issues at a company plant that makes drospirenone.

Bayer has been warned repeatedly about its advertising for Yaz and Yasmin, from ads that overstated the drugs’ safety to others that inaccurately touted their effectiveness in treating acne and premenstrual syndrome.

Reglan is a short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

The FDA has required Reglan’s manufacturer to include a Black Box Warning on its label.  A Black Box Warning is the strongest possible warning for prescription drugs.  Pharmaceutical companies avoid Black Box Warnings because prescribing doctors avoid prescribing drugs with Black Box Warnings.

The Black Box Warning warns that Reglan can cause tardive dyskinesia, a serious and often irreversible and disfiguring movement disorder that is characterized by involuntary movements of the face, tongue or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and total cumulative dose. Less commonly, the syndrome can develop after relatively brief treatment periods at low doses; in these cases, symptoms appear more likely to be reversible.  There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, within several weeks or months after metoclopramide is withdrawn.

Leave a Reply