Regulators Probe Pain Patches

The Food and Drug Administration has issued a public health advisory on patches designed to relieve pain and is investigating about 120 deaths that may be related to their use.

A division of drug and consumer products giant Johnson & Johnson (JNJ Quote) sells pain-relief patches under the brand name Duragesic. The Duragesic patch contains the opioid painkiller fentanyl, which is also available in a generic formulation made by Mylan Laboratories (MYL Quote).

Mylan issued a brief statement on Monday, saying it "has been working with and continues to work with the FDA in connection with this matter." Mylan received FDA approval in late January to begin marketing the generic fentanyl transdermal patch in four different dosage strengths.

J&J shares fell 7 cents to $64.96, and Mylan was lower by 95 cents, or 5%, to $18.45.

However, both companies were in the news for matters other than the fentanyl patches. Guidant (GDT Quote), which J&J is in the process of acquiring, is telling doctors that problems could arise in some of its older pacemakers and said the FDA might classify the action as a recall. Also, J&J is scheduled to report quarterly earnings Tuesday.

As for Mylan, Carl Icahn, the company's biggest shareholder, appears to have traded out of the company. Mylan priced a Dutch auction tender offer over the weekend at $19.50 a share and expects to buy back roughly 19% of its shares.

Last month, the FDA ordered that Duragesic labels include a black box warning, calling doctors' attention to the risks of using the patch and the signs of fentanyl overdose. The new labeling includes information on respiratory and central nervous system problems and drug interactions that could occur when using fentanyl. The FDA also warns that using a damaged patch could lead to a fatal dose of the drug.

The FDA has also told Purdue Pharma, maker of the painkiller OxyContin, to stop selling its extended-release Palladone capsules because of potentially fatal reactions when the drug is mixed with alcohol. The extended-release mechanism in the painkiller can be damaged by alcohol, leading to a concentrated dose reaching the bloodstream.