Another Blockbuster Drug Updates Label: NMPA Mandates Safety Revisions for Methylprednisolone Sodium Succinate Containing Bovine Lactose

Recently, another best-selling drug has revised its package insert.

On June 12, the National Medical Products Administration (hereinafter referred to as the NMPA) issued an announcement stating its decision to revise the [Contraindications] and [Precautions] sections of the package insert for Methylprednisolone Sodium Succinate for Injection containing bovine-derived lactose.

Image Source: National Medical Products Administration

[Contraindications] As required by the announcement, the following content has been added to the [Contraindications] section: This product is contraindicated in patients with a confirmed allergy to cow's milk.

Additionally, the following information needs to be added in the precautions:

This product contains bovine-derived lactose as an excipient and therefore may contain trace amounts of bovine milk proteins (milk allergens). Severe hypersensitivity reactions, including bronchospasm and anaphylaxis, have been reported in patients with milk protein allergy when this product was used to treat acute allergic conditions. This product is contraindicated in patients with a confirmed cow’s milk allergy (see [Contraindications]). It should be used with caution in patients with suspected cow’s milk allergy, particularly in children.

For patients using this product to treat acute allergic diseases, if symptoms worsen or new allergic symptoms appear, an allergic reaction caused by cow's milk protein should be considered (see [Contraindications]). This product should be discontinued, and the patient's condition should be treated accordingly.

(Note: Any other content in the package insert that is inconsistent with the aforementioned revision requirements shall be revised accordingly.)

The National Medical Products Administration requires that manufacturers of methylprednisolone sodium succinate for injection containing bovine-derived lactose conduct in-depth research into the mechanisms underlying newly identified adverse reactions, implement effective measures to carry out publicity and training on product use and safety issues, promptly notify drug distributors and healthcare institutions of any changes related to medication safety through appropriate channels, and provide guidance to physicians and pharmacists on the rational use of the drug.

Pfizer's Market Share Exceeds 70%

Methylprednisolone Sodium Succinate for Injection, developed by Pfizer Inc., is a glucocorticoid medication with anti-inflammatory, immunosuppressive, and anti-shock therapeutic effects. It is used as an adjunctive therapy in severe diseases and for hormone replacement therapy in cases of relative or absolute adrenal corticosteroid insufficiency.

According to Pfizer’s 2018 annual report, Medrol (methylprednisolone) generated sales of $427 million in 2018, accounting for approximately 0.8% of total revenue; sales in 2017 were $483 million, representing a 12% year-over-year decline.

Health界 found by querying the National Medical Products Administration database that there are currently 8 companies approved in China for Methylprednisolone Sodium Succinate for Injection, with 21 approval numbers. Among them, 2 are imported (Pfizer, Nankang Chemical), and 6 are domestically produced (Chongqing Huabang, Jinyao Pharmaceutical, Liaoning Haisike, Sinopharm Rongsheng, Fuan Pharmaceutical, Changzhou Siyao).

Publicly available data show that in 2016, the market size of methylprednisolone sodium succinate for injection in China was approximately RMB 1.2 billion, with Pfizer, the originator, holding a 76% market share. Although Jinyao Pharmaceutical’s market share has been continuously increasing, it accounted for only 6% in 2016.

Data Source: Public Information, Compiled by Health界

The enterprise ranking second in market share is Sinopharm Rongsheng, which held a 15% market share in 2016. Its flagship product, Methylprednisolone Sodium Succinate for Injection, ranks first in sales among domestic manufacturers.

Fuan Pharmaceutical also obtained the drug registration approval for Methylprednisolone Sodium Succinate for Injection in 2018, officially announcing its entry into the market for Methylprednisolone Sodium Succinate for Injection.

The revision of the drug labeling will, to varying degrees, impact the sales of the aforementioned companies.

Drug Revision Updates for the First Half of the Year

According to the database of the National Medical Products Administration (NMPA), in addition to the aforementioned revision announcements, a total of 12 package insert revision announcements were published by the NMPA in the first half of 2019 as of June 17, with more than 80% pertaining to prescription drugs.

In the announcements on revised drug labeling issued in the first half of the year, most drugs required revisions to sections such as contraindications, adverse reactions, and precautions, thereby further ensuring the safety and appropriate use of these drugs in clinical practice.

Health界 has compiled a summary of these revisions to ensure full awareness of all changes and prevent serious adverse drug events.

Attached Figure: Announcements on Package Insert Revisions Published by the National Medical Products Administration in the First Half of 2019

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