FDA stresses birth defect risks with Roche drug (CellCept)

San Luis Obispo Tribune ^ | May. 16, 2008 | MATTHEW PERRONE

[neverdem]

AP Business Writer

Health regulators warned again Friday that Roche and Novartis drugs prescribed to organ transplant patients can cause miscarriages and birth defects when used by pregnant women.

The Food and Drug Administration last October said it received reports of miscarriages and infants born with ear and mouth birth defects after their mothers took Roche's CellCept. At the time, FDA added its most serious warning to CellCept and a similar Novartis AG drug, Myfortic.

FDA spokesman Christopher Kelly said the agency has not received any new reports of pregnancy-related problems, but was concerned some doctors may not have seen the initial warning.

CellCept and Myfortic are used to suppress the body's immune system to avoid organ rejection in transplant patients.

In a notice posted online Friday, FDA said that before prescribing the drugs doctors should confirm their transplant patients are not pregnant, and are using effective contraception.

FDA said most of the reported problems came from mothers who were taking CellCept before their pregnancies were detected. Some of the patients were taking the drug for conditions it was not approved to treat - including rheumatoid arthritis and lupus.

A spokesman for Roche said it has not received any new reports of miscarriages or birth defects since updating the drug's labeling. The company previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007.

The agency said it will continue working with Roche and Novartis to reduce use of the drugs by pregnant women.

Friday's FDA warning was the second in less than two months for Roche's CellCept, which was the Swiss drugmaker's sixth best-selling drug last year with revenue of nearly $2 billion.

Last month FDA said it was investigating 16 patients who developed a rare neurological disease while taking the drug.

The disease, known as progressive multifocal leukoencephalopathy, attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss. Patients who survive are often permanently disabled, according to the FDA.

Shares of Novartis AG rose 8 cents Friday to $51.27.

[ExTexasRedhead]

Read the fine print about the side effects of the majority of drugs physicians are handing out like candy today. There are numerous blogs discussing these side effects. Most doctors are oblivious to your side effects and blow you off when you complain. IMO, you’re lucky if they even know who you are and why you’re in their office.

[Born Conservative]

That may be true with some drugs, but I would argue that a doctor rx’ing CellCept for it’s labeled use DOES know what the side effects are.

From the prescribing guidelines issued by the company:

Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

and

Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant woman. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.

So, this isn’t a med that’s handed out by a general practitioner. It’s a highly specialized drug (for prevention of organ rejection after transplant). I’m sure that prior to initiating this med, the doc will order a pregnancy test before giving to a woman of childbearing age.